Huaier Granules

-> Sophora granules efficacy characteristics

Q: What are the advances and current status of oncology treatments?

Answer: With the development of science, people's research on tumor disease has been deepening at all levels and achieved remarkable results. For example, the understanding of tumor cells has been spreading its mysterious veil layer by layer from molecular level and gene level to nucleic acid level. The rapid development of tumor imaging and the detection of molecular markers with high sensitivity, good specificity and high localization of organs have created a good premise for early detection and treatment of tumors. Improvement of surgical level and innovation of surgical methods have made some forbidden areas that were considered inaccessible in the past become easy to access, and even gradually move towards minimally invasive. The continuous introduction of various new anticancer drugs makes us see the good prospect of tumor treatment, but the current status is still not optimistic. It is reported that 2/3 of the newly diagnosed solid tumor patients in China have already had clinical metastasis, and after local treatment (surgery, radiotherapy) plus systemic chemotherapy, there are still 1/2 patients with subclinical latent metastasis. 90% of the patients die of recurrence and metastasis within five years. Metastasis, for this reason, in the 2006 Scientific Anti-Cancer Expert Forum held by the Chinese Academy of Sciences, oncologists from all over the country have pointed out that the prevention of metastasis and recurrence of tumors is actually as important as the treatment.

Q: Why do tumors have high recurrence (metastasis)?

A: Why do tumors have such a high rate of recurrence and metastasis that patients die in a relatively short period of time? This is related to the special pathobiology of tumor, because tumor is not a local disease but a systemic disease. According to the research, as long as a solid tumor occurs in a certain organ of the body, all the so-called normal organs and tissues of the whole body have shown the tendency of the tumor, and it is even said that micro-metastatic foci may have appeared at this time. Due to the strong concealment of the tumor, there are often no symptoms in the early stage, which is not easy to detect, and when the symptoms are felt, the tumor is already in the middle or late stage. Clinically, the tumor often only manifests as a local tumor in one organ, but the hidden metastasis in other organs may have existed for a long time, and the current conventional treatment is surgery + chemotherapy (or radiotherapy), which seems to be a local and systemic treatment, but the result is that the tumor recurs or metastasizes again after one year or one and a half years. This is related to the limited effect of chemotherapeutic agents and also to the complexity of the tumor. In actual treatment, it is also difficult to grasp the scale of treatment, so there are often both over-treatment and under-treatment.

Firstly, over-treatment: mainly over-chemotherapy and high-dose chemotherapy, while over-chemotherapy carries great harm, even fatal, which can make thymus and spleen show squamous-like lesions, atrophy, and destruction of the immune system, and the health of the body and the cure of the tumor must ultimately depend on the complete immune system; in addition, the re-cancer of chemotherapy drugs itself should not be ignored.

Secondly, the treatment is insufficient, which is manifested in:

1. The specificity of patients' genes (e.g. the short arm of the 8th pair of chromosomes in liver cancer patients is regarded as possible recurrence);

2, different tumor cell lines (e.g. high metastatic cell line lung cancer L9981);

3, the quality of surgery (due to the variability of doctors and patients leading to variability in the quality of surgery); and

4. The limited efficiency of chemotherapeutic drugs is manifested in the following ways: (1) a considerable number of cancer cells are not sensitive to chemotherapy; (2) even if chemotherapy is sensitive and effective to tumor cells, it cannot kill all of them, and makes some tumor cells enter into a dormant state, and chemotherapeutic drugs are ineffective at this time, and the tumors usually begin to proliferate again in more than 10 months, resulting in recurrence or metastasis;

5. High-speed proliferation of tiny blood vessels after surgery, which activates the high-speed growth of tumor cells at the same time;

6. Earlier and more frequent occurrence of micro metastasis;

7. Disturbance of immune system, lack of effective monitoring and elimination of tumor cells;

8, mental, metabolic and endocrine imbalance without enough attention.

In other words, the recurrence of tumor is multifactorial, and in the actual treatment, due to various reasons, it is often only to control each point, and of course, the result is imaginable, just as the enemy enters into a certain city, he can be from the air, the sea, or from the land, and the tools are diversified, and it is not enough to block only one or two pathways.

Q: How can I effectively prevent or block recurrence?

A: Firstly, to avoid over-treatment, i.e., high-dose chemotherapy or excessive chemotherapy, in order to ensure that the immune organs are not destroyed destructively, and secondly, to provide effective treatment for the possible insufficiency of treatment, so as to block the recurrence of the tumor.

So far chemotherapeutic drugs are still the first choice of adjuvant treatment for tumor patients after surgery (except some tumors are clearly insensitive to chemotherapy, such as primary liver cancer), which plays a certain positive role in further killing tumor cells, preventing tumor recurrence in a short period of time and prolonging patient's survival, but it has two major fatal weaknesses: 1. Toxicity. Destruction of normal cells, especially the immune organs, the higher the dose, the more destructive it is.2. Incomplete treatment. Since chemotherapeutic agents generally act only in the S phase of the cell cycle and are ineffective against tumor cells in other phases, even if the dose is high, the use of low and medium doses of chemotherapeutic agents may be a wise choice. Both kill the limited number of tumor cells after surgery and protect the immune organs at the same time.

The understanding that tumor neoplasia is a systemic and chronic disease must first be addressed for possible under-treatment. Although chemotherapeutic drugs have the role of systemic treatment, but it can not completely eliminate the tumor, chemotherapeutic drugs can only have a good killing effect on the high-speed growth of tumor cells, at the same time, make some tumor cells in a dormant state, and at this time the chemotherapeutic drugs are not effective on the tumor cells that have been in a state of dormancy, and wait for about a year, with the infiltration of tiny blood vessels, making the tumor cells are activated, which leads to the recurrence and metastasis. This leads to recurrence and metastasis. Therefore, there must be at least three efficacies of drugs to block tumor recurrence: 1. preventing the generation of neovascularization; 2. eliminating the tumor cells when they are just activated, and the apoptosis of tumor cells must be in the G1 stage; 3. reorganizing the perfect immune system to effectively identify, monitor and eliminate the tumor cells. At the same time, tumor is a chronic disease (genetic disease), and it has been proved that it is not possible to rely solely on a few courses of simple treatment, therefore, the treatment of tumor must be multifaceted, effective long-term treatment, and Sophora Ear Granules have: good neovascularization inhibition; direct apoptosis in the G1 phase and S phase; special immune regulation, reorganization of the body's immune system, so as to effectively identify and remove the tumor cells. It can effectively recognize and remove tumor cells.

Q: Why does Sophora Ear Granules block the pathway to tumor recurrence?

A: Sophora ear granules are a kind of new anticancer drugs, which have been proved to have the following anticancer mechanisms by many authoritative scientific research institutions:

1. Promote apoptosis of tumor cells: Sophora ear prevents A549 lung cancer cells from entering G2/M phase from S phase, which is manifested by the appearance of a sub-G1 peak in front of the G1 peak, inducing apoptosis of cells. However, no toxic side effects of chemotherapeutic drugs. In human rectal cancer HR8348 cells, it can both inhibit growth and induce apoptosis, and its mechanism of inducing cell death may be related to the elevation of Bak/Bcl-2, Bak/Bcl-XL ratio and the up-regulation of p53 gene expression. In the study on the inhibition of growth and metastasis of pancreatic cancer cells, it was observed that the apoptosis rate of the cells could reach 15-20%, which was better than that of 5-Fu, and it was believed that its apoptosis-promoting effect was related to the up-regulation of the expression of apoptosis gene Caspase-3.

2. Anti-tumor angiogenesis: Tumor angiogenesis is the result of the interaction between vascular endothelial cells, tumor cells and their microenvironment; it is an important factor in tumor growth, invasion and metastasis. When the concentration of Sophora ear cream is 0.1-10g/L, the proliferation of VEGF-induced endothelial cells is obviously inhibited, and there is a quantitative relationship between the two. Matrigel's experiments showed that Sophora ear cream at a concentration of 1.0g/L can inhibit the VEGF-induced HUVECs from differentiating into tubular structures, and the concentration of 10.0g/L completely blocked the ability of HUVECs to differentiate into tubular structures in vitro. The ability of HUVECs to differentiate into tube-like structures in vitro was completely blocked at a concentration of 10 0 g/L. It is believed that the inhibitory effect of Sophora auricula cream on the neovascularization of vascular endothelial cells in vitro may be related to the blockage of endothelial cells from the S-phase to the G2/M-phase. Sophora Ear Cream had a significant inhibitory effect on the growth of human high metastatic large cell lung cancer L9981 cells in vitro, and the inhibition rate increased with the increase of drug concentration. There was no significant difference in the inhibition rate between the Sophora Ear Cream group (1 g/L) and the cisplatin chemotherapy group (cisplatin 3 mg/L) and the combination group (Sophora Ear Cream 0.05 g/L + cisplatin 1.5 mg/L) ( P > 0.05). The mRNA expression levels of β-catenin, E-cadherin, TIMP-1, endostatin and MMP-2 were up-regulated, while the expression levels of VEGF and CD44V6 were down-regulated in L9981 cells after treatment with Sophora japonica ointment, among which TIMP-1 and endostatin were significantly up-regulated, and the expression level of CD44V6 was down-regulated. The expression levels of TIMP-1 and endostatin were obviously up-regulated, while that of CD44V6 was down-regulated. The growth inhibitory effect of Sophora auriculata cream on L9981 may be related to its regulation of mRNA expression of angiogenesis-related genes.

3. Sensitization and reversal of resistance to chemotherapeutic drugs: In addition to its own apoptosis-promoting effect, Sophora Ear Cream can also sensitize and reverse the resistance to chemotherapeutic drugs used in combination with it. It is found that Sophora Ear Cream can increase the apoptotic effect of cisplatin on A549DDP to improve the sensitivity of cisplatin to chemotherapy of this cell line. Fluorescence quantitative PCR demonstrated that a small dose of Sophora granules could down-regulate the expression of mdr-1, a drug-resistance gene in adriamycin-resistant breast cancer cell line MCF-7/ADM, suggesting that the inhibition of the function and expression of cell membrane P2 glycoprotein (P-gp) and the increase of the intracellular drug concentration are the main mechanisms of Sophora granules in the reversal of multidrug resistance. It was found that Sophora Ear Paste could significantly enhance the killing effect of tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) on hepatocellular carcinoma cell line HepG2 and hepatocellular carcinoma adriamycin-resistant cell line HepG2-ADM, but the killing effect on normal hepatocellular carcinoma cell line L02 was slight.

4. Regulation of body immunity: modern medicine believes that the body kills tumor cells under the synergy of cellular immunity and humoral immunity. The biological treatment of tumors aims at stimulating and mobilizing the immune system of the body, enhancing the anti-tumor ability of the microenvironment, so as to control and kill tumor cells. It is found that Sophora Ear Clear Cream can significantly increase the number of IL-2 receptor positive cells in the liver and improve the specific cellular immunity of the body. Sophora ear granules alone can increase the levels of IL-2, TNF-α and INF-γ in patients with chronic granulocytic leukemia (CML), and reduce the level of immunosuppressive factor SIL-2R, thus promoting the body's tumor immunity effect. However, unlike cytokine therapy, cytokines such as IFN (α,γ) and IL-2 induced by Sophora japonica are endogenous and have the characteristics of small dose, multiple stimulation and combined action. Therefore, Sophora japonica has its unique aspects compared with other polysaccharide drugs, and is a more ideal immunomodulator and tumor suppressor.

5. Safe and non-toxic: the acute toxicity test is equivalent to 126.6 times the human clinical dose, 95 times the rat are measured LD50, long-term toxicity test in rats according to the human clinical dose of 95 times the gavage for 3 months, the small dose group of domestic dogs for the clinical equivalent dose of human, the large dose group of 24.7 times for 6 months with the drug-induced pathology has not been found to change, the experimental results show that the acacia auricula particles are The experimental results show that Sophora ear granules are safe.

6. Granular preparation, easy to use.

Q: How do I properly use Sophora Ear Granules?

A: From the above part of the experiment, these characteristics and effects of locust ear granules can solve the problem of insufficient treatment in the process of tumor treatment due to various reasons and make up for it effectively. Method one is that it can be used in combination with chemotherapeutic drugs after tumor surgery. Chemotherapeutic drugs mainly work in S phase, while Sophora ear granules have good performance in both G1 phase and S phase. Sophora ear granules' G1 phase and chemotherapeutic drugs' S phase work at the same time with good synergy, which should be better than using chemotherapy alone. When chemotherapy is finished, long-term use of locust ear granules must still be maintained. Another method is to wait for the end of chemotherapy and then use locust ear granules for a long time to treat the tumor cells in dormant state. If long-term use is not possible due to various reasons, then it must be used continuously for 6 months every year to ensure the efficacy of treatment. Several clinical trials have confirmed the correctness of this method of use. Long-term standardized use of Sophora granules is the key, because the tumor is not a local disease, but a systemic disease, genetic disease, the World Health Organization recently pointed out more clearly that the tumor is a chronic disease, so only long-term standardized use of the tumor can change the cancer genes, in order to effectively block the recurrence of the disease.

Q: Are locust ear granules Chinese or Western medicines?

A: Sophora ear granules belong to a class of traditional Chinese medicine, extracted from a class of Chinese medicine raw material medicine Sophora ear fungus.

Q: What is locust ear mycelium?

A: Sophora Fungus is a bioconversion of mycelium isolated from Sophora Fungus grown on wild Chinese acacia, inoculated in the specified substrate, and fermented under strict quality control indexes.

Q: The common problem with traditional Chinese medicine is poor stability, which affects the efficacy, what is the stability of Sophora Fungus Granules?

A: Yes, a common problem in Chinese medicine is poor stability, and poor stability is caused by two factors: herbs and preparations. First of all, the medicinal materials: First, because the origin of the medicinal materials is not the same, the efficacy will have a big difference. Secondly, Chinese medicine is often composed of many medicines, so it is difficult to ensure the quality of each medicine and each batch of medicine is consistent. Secondly, the finished preparations are extracted due to various factors, such as extraction temperature, time, concentration of organic solvents, etc. Slightly different may lead to the instability of the product batch. Sophora ear granules is firstly a single prescription drug, the raw materials are fermented in the same substrate, environment and good GMP workshop, there is no problem of different origins and multiple flavors of traditional Chinese medicines, the preparation process, including extraction, granulation and so on, are run under computer control, and to ensure its quality. Therefore, the stability of locust ear granules is guaranteed.

Q: Chinese medicine always gives people the feeling of confusion, as if the active ingredient is what is generally can not say, I do not know how the locust ear particles?

A: Proved by a large number of studies: the composition of locust ear particles are mainly locust ear polysaccharide protein, some inorganic salts, mineral elements, a little bit of fiber. The real active ingredient is Sophora japonica polysaccharide protein, which is composed of 6 monosaccharides combined with 18 kinds of amino acids. We decompose Sophora Fungus polysaccharide protein into polysaccharides and proteins, and found that the proteins have very good direct apoptosis effect, while polysaccharides have better immunomodulatory effect, but it is easier to be decomposed into monosaccharides, which makes its effect weaker. Only when the polysaccharide protein is combined into one can it show a complete integrated effect, i.e. stronger direct apoptotic effect, neovascularization inhibition, and excellent immunomodulatory effect. So Sophora Ear Granules is a well-spoken traditional Chinese medicine.

Q: What are the main tumors that Sophora ear granules are localized to? Is it effective for tumors that it has not been localized to?

A: Approved by State Food and Drug Administration, Sophora Ear Granules can be used in the treatment of liver cancer, stomach cancer, intestinal cancer, breast cancer and lung cancer. From the information available so far, the efficacy of Sophora granules is wide, including direct apoptosis of tumor cells, neovascularization inhibition, regulation of immunity, etc. These features are not specific to tumors, so the treatment of other tumors can be explored. It has been reported to be effective in esophageal cancer, bladder cancer, malignant lymphoma, non-Hodgkin's lymphoma, chronic granulocytic leukemia, osteosarcoma and so on.

Q: Can Sophora Ear Granules be used alone?

A: Completely. For middle and advanced primary liver cancer patients without surgery and chemotherapy using Sophora granules alone, the effective rate of phase II clinic is 11.7% (CR+PR), the stabilization rate is 64.06%, and the one-year survival rate is 30%. If the patient can be surgically resected, the effect will be even better with the addition of Sophora granules.

Q: What should I pay attention to when using Sophora Ear Granules in combination with chemotherapy?

A: This is a complementary therapy, because more than 95% of chemotherapeutic drugs mainly act in the S phase, and Sophora ear granules mainly act in the G1 phase and S phase, the combination of G1 + S phase should be better than the combination of other proliferation cycle, so it is reasonable in terms of apoptosis cycle, but the high dose of chemotherapeutic drugs may make the patient's thymus and spleen atrophic, leading to the patient's immune function deficiency, which affects the patient's ultimate efficacy, therefore, we recommend medium-dose or low-dose chemotherapy. Therefore, it is suggested that the efficacy of medium-dose or small-dose chemotherapeutic drugs combined with Sophora Ear Granules will be better.

Q: Is Sophora granules combined with interventional, ablative, argon helium knife and other treatments?

A: Yes, and it is necessary to combine the treatments. Because these techniques are only for local treatment of tumor, and these local treatments are often incomplete. According to the current understanding of tumor disease, tumor is not a local disease, but a systemic disease, so the effect of purely local treatment is not ideal, and it must be combined with systemic treatment, and Sophora Ear Pellet is a good choice.

Q: The most terrible thing about tumor is recurrence, why can Sophora Ear Granules prevent tumor recurrence?

A: The World Health Organization suggests that tumor disease should be regarded as a chronic disease, which indicates that the treatment of tumor will be a long-term process. Originally, it is believed that after surgical resection of tumor and several courses of chemotherapy, the treatment is over, but the result is that a large number of patients have recurrence or metastasis after one year or one and a half years. During the period from the end of chemotherapy to the possibility of recurrence, we can see that the patients are afraid of recurrence in fear, and the doctors can do nothing about the recurrence, and they seem to be at their wits' end. The reason is that there is not enough theoretical basis to guide how to control relapse, and there is not an appropriate drug to block relapse. This medicine must have a more comprehensive integrated effect, such as direct apoptosis of tumor cells, effective inhibition of high-speed growth of neovascularization, comprehensive regulation of the immune system, no toxicity, good stability of efficacy, easy to take, affordable, etc., and Sophora Ear Granules is such an ideal medicine. Because of these comprehensive effects, as long as the long-term use of locust ear granules before the possible relapse is possible to block the relapse, and practice has proved to be so.

Q: What are the options available for Sophora Ear Granules to prevent recurrence?

A: There are two options to choose from, 1, chemotherapy and locust ear particles at the same time, the use of: ① chemotherapy + locust ear particles after the end of the use of locust ear particles, continue to continue the use of locust ear particles for 2-3 years, in order to further clear the tumor residues, all-round to improve the quality of the body. After chemotherapy + Sophora Ear Granules have been used for 6 months, the drug can be stopped, and then continue to be used for another 6 months before the high recurrence period of the tumor may appear to block the recurrence of the tumor.2. After the end of chemotherapy, continue to use Sophora Ear Granules continuously, or use it for 6 months every year in order to block the recurrence of the tumor. This is because Sophora Ear Granules are pure Chinese medicine preparations, which have the special taste of Chinese medicine in different degrees. During the chemotherapy period, some toxic side effects of chemotherapy drugs, such as nausea and vomiting, will be induced or aggravated if Sophora Ear Granules are taken at the same time. In addition, the intake of Sophora Auricula Granules is insufficient due to vomiting, thus affecting the efficacy of the treatment.

Q: What are the toxic side effects of locust ear granules?

A: So far, there are no significant side effects associated with Sophora Fritillariae Granules. However, a few patients may have thinning stools or diarrhea when taking Sophora Fungus Granules, which is related to one of the effects of Sophora Fungus Granules - breaking the blood. This diarrhea is related to one of the effects of Sophora Fungus Granules, which is to break the blood. This symptom will disappear after a few days of continuous intake. Another incidental finding of individual patients will appear a slight decline in the number of white blood cells, usually in about three days, this decline is not myelosuppressive type, may be the fight type, the reason is that in the induction of the production of gamma interferon will produce a large number of interleukin-2, and interleukin-2 production may make the number of white blood cells slightly decreased.

Q: In addition to some basic research information on pharmacology, efficacy, toxicology and clinical studies required for the approval of Sophora Ear Granules, what other studies have been done?

A: Other basic researches have been done, such as: the mechanism of apoptosis of Sophora Ear Cream, such as cycle-specific characterization, cycle time-phase analysis, pharmacological basis, etc.; neovascularization inhibition of many kinds of tumors, including the pharmacological basis, etc.; tumor-suppressing effect of high-metastatic hepatocellular carcinoma, high-metastatic lung carcinoma and its mechanism; tumor-suppressing effect of breast carcinoma; apoptosis and tumor-suppressing mechanism of rectal carcinoma, synergistic effect of combined chemotherapy and reversal of resistance to chemotherapy drugs, etc. The tumor-suppressing effect of Sophora granules and its mechanism. Sophora granules and related tumor-suppressing gene expression, combined with interleukin Ⅱ, necrosis factor and other synergistic issues research. Clinical research includes: prospective observation on the efficacy of using Sophora granules alone after surgical resection of primary liver cancer, observation on the efficacy of combined chemotherapy, observation on the efficacy of using Sophora granules alone after liver transplantation and its combination of chemotherapy, observation on the efficacy of combining Sophora granules with pure standard regimen after standard regimen of chemotherapy for breast cancer, and combination of chemotherapy for gastrointestinal cancer.

Q: Sophora granules were originally positioned only in primary liver cancer, but now it has been expanded to lung cancer, breast cancer, gastrointestinal cancer, etc. Why is there no effective rate for the corresponding indications after expansion?

A: Originally, the effective rate refers to the proportion of tumor volume reduction of more than 50% (i.e. CR+PR) without any other treatment by using a certain drug alone. Nowadays, the concept of treating tumors has undergone a fundamental change, and it is believed that the treatment of tumors is comprehensive and long term, and any single treatment method has its limitations, so it is necessary to consider whether there is a good treatment effect on tumors, whether the quality of life is improved, and whether the quality of life is improved, and why there is no effective rate for the corresponding indication after expansion. Therefore, in the whole treatment process, it is necessary to consider whether there is good therapeutic effect on the tumor, whether the quality of life is improved, and whether the survival period of the patient is prolonged in the end, which is the key of the problem, so we formulate the relevant programs and standards according to this requirement.

Q: Sophora ear granules have good immunomodulatory effect, will it cause rejection reaction when used after liver transplantation?

A: According to the current use of the situation, not found to prompt the liver body rejection reaction (of course, according to the routine use of immunosuppressive drugs), the reason is that the locust ear particles can induce the production of γ-interferon, γ-interferon is a very important effect is the role of immunomodulation, so that the body to maintain a relatively balanced immune state.

Q: What is the biggest advantage of Sophora Ear Granules?

A: Sophora ear particles have wide anticancer spectrum, high tumor inhibition rate, good stability of drug effect, both good direct apoptosis, the role of the G1 and S phase, especially the G1 phase, it can make the tumor cell reversal, but also has a good neovascularization inhibitory effect and a good immunomodulatory function, so far no obvious toxicity has been found, can be used individually or as a combination of medicines, not only to kill tumor cells and prevent the proliferation and metastasis of tumor cells, but also can be a relative balance of the body's immune status. It can directly kill tumor cells and prevent tumor cell proliferation and metastasis, and also significantly improve the quality of life and prolong the survival period of patients.

Q: There are a lot of Chinese and western anti-tumor drugs, are there any similar drugs of Sophora Ear Granules?

A: No comparability. From the information available, no matter from the theory of traditional Chinese medicine, the foundation of western medicine to the final clinical efficacy, Sophora Ear Granules have no similar drugs.

Safety Tests

(i) Acute toxicity test

The results of the acute test of Sophora ear clearing cream on mice were greater than 20,000 mg per kilogram by gavage. Intraperitoneal administration of polysaccharide was greater than 1500 mg per kilogram. Intravenous administration of polysaccharide is greater than 600 mg per kg. Acute test results in rats were: gavage (clear paste) was greater than 15,000 mg per kilogram. Intraperitoneal (polysaccharide) administration was greater than 1300 mg per kilogram. Intravenous (polysaccharide) administration was greater than 500 mg per kilogram. No deaths occurred in any of the experimental groups within 7 days of administration.LD50 was not measured. If continue to increase the dose of the drug, and the viscosity of the drug to increase, give the drug is very difficult, in the experimental process to give the maximum dose of the drug does not cause the death of the animal dose is called the maximum tolerated amount. Based on the above experimental results, it is concluded that Sophora Ear Cream has no significant effect on rats and mice. The maximum tolerated dose in mice is 20,000 mg by gavage. This dose is equivalent to 126.6 times of the usual human clinical dose. The maximum tolerated dose in rats was 15,000 mg by gavage. This dose is equivalent to 95 times the commonly used human dose. The experimental results indicate that Sophora Ear Cream is safe and non-toxic.

(II) Long-term toxicity test of Sophora Fungus Paste on rats and dogs.

1. Long-term toxicity test on rats:

As a result of the experiment, the solid animals of each administration group, with normal activity after taking the drug, the average growth of body weight was similar to that of the control group, and there was no significant difference in the statistical treatment. The measured biochemical, blood and other indicators were not significantly different after statistical treatment. Pathological specimens were mainly sent for histological and morphological observation of heart, liver, spleen, lungs and kidneys, etc. The results showed that the above organs were normal in the control group and the medicated group, which indicated that Sophora Ear Paste administered by gavage had no toxic effects on rats. After two weeks of observation after stopping the drug, the experimental animals in the latter group were executed, and the above biochemical, blood, pathological and other section examinations were still carried out. The results proved that the experimental groups and control groups after stopping the drug were still normal in all examinations and histomorphometric identification, and there were no adverse toxic side effects.

2. Long-term toxicity test of Sophora japonica Ear Cream on dogs by gavage:

During the period of administration, the general signs, behavior and appearance of the dogs were observed, there was no abnormality in feeding and feces, the change in body weight during the period of administration was similar to that of the control group, no obvious abnormality was seen in the measurement indexes, and there was no obvious change in the electrocardiogram measurement results. No lesions or abnormal changes were seen in the major organs with the naked eye, and there was no obvious abnormality in the histomorphological observation of pathological sections, comparing the drug administration group with the control group, and no pathological changes caused by the drug were found.

(iii) Stability:

Sophora granules are made of a single formula, fermented by Sophora japonica mycelium in a good GMP workshop, in order to ensure the quality of the medicinal material, there are strict quality control indexes for the fermentation substrate, temperature, humidity, fermentation termination time, operation process, etc., so no matter it is the original medicinal material or the preparation, there is a very good stability.

Approval date: May 10, 2007
Revision dates: June 13, 2013; August 15, 2022; June 26, 2023; July 19, 2024

Sophora Fungus Granules Instructions