Use of jingfang preparation in the preparation of a medicine for preventing or treating hepatitis a virus

Abstract

The application belongs to the technical field of medicine, and particularly relates to application of a jingfang preparation in prevention or treatment of type A viral hepatitis. Pharmacological experiments show that the jingfang preparation has a significant inhibitory effect on serum HAV-DNA level of infected ducks, can significantly inhibit the activity of type A hepatitis virus, and can be used for prevention and treatment of type A viral hepatitis, has a definite clinical curative effect, and is superior to jingfang baidu powder with modifications, and has a broad clinical application prospect.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology and relates to the application of Jingfang preparations in the preparation of drugs for the prevention or treatment of hepatitis A. Background Technology

[0002] Jingfang Baidu San is derived from Renshen Baidu San, known as the "Number One Formula for Treating Epidemics." It is made by removing ginseng, ginger, and mint from Renshen Baidu San and adding schizonepeta and saposhnikovia. Its indications have expanded from "typhoid fever and epidemic diseases" to "sores, seasonal infections, parotitis, and hemorrhoids." Jingfang Baidu San is suitable for the initial stage of exterior syndromes and is known as a "miracle remedy for colds in all four seasons." It is not only suitable for chills, fever, and limb pain caused by external wind-cold-dampness, but also an excellent remedy for the initial stage of epidemic diseases. It is also suitable for skin diseases such as sores, smallpox, and parotitis, where the toxins are on the skin surface.

[0003] Jingfang Granules are a traditional Chinese medicine preparation based on Jingfang Baidu Powder. In this formula, Schizonepeta and Saposhnikovia are the principal herbs, warm in nature and used to relieve exterior syndromes, dispel wind and cold. Notopterygium and Angelica pubescens dispel wind, eliminate dampness, and relieve pain, and also assist Schizonepeta and Saposhnikovia in relieving exterior syndromes; Ligusticum chuanxiong dispels wind from the blood and relieves pain, serving as the assistant herbs. Bupleurum, cool in nature and used to release exterior syndromes, disperses stagnant heat on the skin surface, and together with Peucedanum praeruptorum, Platycodon grandiflorus, and Citrus aurantium, it has both ascending and descending effects, working together to clear the lungs, resolve phlegm, open the chest, and promote qi circulation; Poria cocos, sweet and bland in nature, strengthens the spleen and eliminates dampness, these four herbs serving as adjuvant herbs. Licorice is the guiding herb, harmonizing the other herbs. The combined effects of these herbs are to induce sweating, relieve exterior syndromes, dispel wind, eliminate cold, and eliminate dampness. It has the functions of inducing sweating, relieving exterior syndromes, dispelling wind, eliminating dampness, and is clinically used to treat colds caused by wind and cold. Jingfang Baidu Powder is suitable for the initial stage of epidemic diseases, and is now often used clinically for the treatment of epidemic and infectious diseases. Examples include acute viral upper respiratory tract infections, dengue fever, H1N1 influenza, chickenpox, and mumps. Given the outstanding efficacy of Jingfang Baidu San in treating infectious diseases, Sichuan, Xinjiang, and Yunnan provinces have listed it as a recommended drug for the early treatment of COVID-19.

[0004] Hepatitis A, or hepatitis A for short, is an infectious disease caused by the hepatitis A virus (HAV). It primarily affects the liver and is mainly transmitted through the fecal-oral route. Clinically, it is characterized by fatigue, loss of appetite, hepatomegaly, and abnormal liver function; some cases also present with jaundice. Hepatitis A mainly affects children and adolescents. It is transmitted through infection and exhibits a clear seasonal pattern, often breaking out in periodic outbreaks, posing a significant threat to human health. In recent years, the incidence of hepatitis A has decreased due to vaccination and effective prevention and control measures; however, it still exists and is prevalent in some areas, and prevention and control efforts must not be relaxed.

[0005] Hepatitis A is often self-limiting, and there is currently no specific treatment. Treatment mainly focuses on isolation, liver protection, supportive care, and proper nutritional balance. Currently, interferon therapy is widely used in China to treat hepatitis A, but it has significant side effects, is expensive, and the long-term injections cause considerable suffering for patients. Therefore, developing a drug that can rapidly treat hepatitis A has become an important research topic in medicine. Summary of the Invention

[0006] This invention provides the use of a strychnine preparation in the preparation of drugs for the prevention or treatment of hepatitis A.

[0007] Preferably, the preparation of Schizonepeta and Saposhnikovia is composed of Schizonepeta, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, Poria cocos, Ligusticum chuanxiong, Platycodon grandiflorus, Bupleurum chinense, Peucedanum praeruptorum, Citrus aurantium, and Glycyrrhiza uralensis.

[0008] Preferably, the drug for treating or preventing diabetes may be Jingfang granules, Jingfang oral liquid, Jingfang compound, Jingfang pills, Jingfang dripping pills, Jingfang syrup, or Jingfang capsules.

[0009] Preferably, the thorn-preserving preparation further includes pharmaceutically acceptable excipients.

[0010] Preferably, the preparation of *Jingfang* is granules, oral liquid, compound preparation, pills, drop pills, syrup, or capsules.

[0011] Preferably, the thorn-preserving preparation of the present invention is prepared according to conventional methods in the art.

[0012] Preferably, the thorn-preventing preparation of the present invention is in granule form.

[0013] Compared with the prior art, the advantages of the present invention are:

[0014] 1. The Jingfang preparation of this invention is safe for clinical use, has a definite curative effect against hepatitis A virus in vivo, and has a significant inhibitory effect on HAV-DNA levels in infected duck serum. Compared with the modified Jingfang Baidu San group, the difference is significant, indicating that the anti-hepatitis A virus effect is better than that of the modified Jingfang Baidu San group, and it can be used to prevent and treat hepatitis A.

[0015] 2. The Jingfang preparation of this invention has a significant and definite curative effect in treating hepatitis A. Detailed Implementation

[0016] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Specific Implementation

[0018] Example 1: The therapeutic effect of Jingfang preparation on hepatitis A virus infection in ducks.

[0019] This invention uses an internationally recognized experimental model to conduct experiments in ducks infected with hepatitis A virus.

[0020] 1. Materials

[0021] Experimental drug: Jingfang granules (containing sugar), 15g per bag, Shandong New Era Pharmaceutical Co., Ltd.;

[0022] Modified Jingfang Baidu Powder: Granules were prepared according to the following formula using conventional methods in this field. Ingredients: Schizonepeta tenuifolia 30g, Saposhnikovia divaricata 30g, Notopterygium incisum 25g, Angelica pubescens 25g, Bupleurum chinense 25g, Peucedanum praeruptorum 25g, Ligusticum chuanxiong 20g, Citrus aurantium 25g, Poria cocos 45g, Platycodon grandiflorus 30g, Glycyrrhiza uralensis 15g, Forsythia suspensa 30g, Mentha haplocalyx 30g, Crataegus pinnatifida 60g, and Dioscorea opposita 60g.

[0023] 2. Experimental Methods

[0024] 2.1. HAV Infection: 48 ducklings were injected intravenously with HAV-DNA positive duck serum, 0.2 ml per duck. Blood was collected 7 days post-infection, and serum was separated. The serum was stored at -70℃ for later testing.

[0025] 2.2. Drug Treatment Trial: One-day-old Beijing ducks infected with HAV were randomly divided into three groups. The treatment group was administered Jingfang granules by gavage at three different doses: a low-dose group (1.4 g / kg), a medium-dose group (2.8 g / kg), and a high-dose group (5.6 g / kg). The model control group received physiological saline instead of the drug. The modified Jingfang Baidu San group was administered granules (5.6 g / kg) three times daily for 7 consecutive days. Blood was collected from the tibial vein of the duck leg before administration and on days 3 and 7 after administration. Serum was separated and stored at -70°C for later analysis.

[0026] 2.3. Detection Method: Take the above-mentioned duck serum samples and spot-dip the samples simultaneously on a membrane to determine the dynamic level of HAV-DNA in the duck serum. Following the instructions of the gap translation kit, label the HAV-DNA probe with 32p and perform spot hybridization on the duck serum. Measure the OD value (490 nm) of the spots on the autoradiographic membrane and calculate the serum HAV-DNA density. Use the OD value of the hybridization spots as the HAV-DNA level value of the sample.

[0027] 2.4. Efficacy Calculation: Serum HAV-DNA levels were calculated at different time points for each group. Paired t-tests were used to compare the HAV-DNA inhibition rate before and after drug administration in each group. The dynamic changes in HAV-DNA inhibition rate in duck serum were compared among the groups. Independent t-tests were used to compare the drug-treated group with the virus control group. HAV-DNA inhibition rate = (OD value before administration - OD value after administration) / OD value before administration × 100%. The results are shown in Table 1.

[0028] Table 1. Effects of Jingfang Granules on HAV-DNA Levels in HAV-Infected Duck Serum

[0029]

[0030] Compared with the model control group, * P < 0.05 ** P < 0.01; compared with the comparative example group, # P < 0.05 ## P < 0.01.

[0031] Table 1 shows that, compared with the model control group, all dosage groups of Jingfang granules had a highly significant inhibitory effect on HAV-DNA levels in the serum of infected ducks (P < 0.01). Compared with the modified Jingfang Baidu powder group, the inhibitory effects of all dosage groups of Jingfang granules on HAV-DNA levels in the serum of infected ducks were significantly or highly significantly different (P < 0.05, P < 0.01). This indicates that Jingfang granules have better anti-duck hepatitis A virus activity and a more significant inhibitory effect on HAV-DNA levels in the serum of infected ducks, showing better efficacy than the modified Jingfang Baidu powder group.

[0032] Typical Cases

[0033] 1. Li, male, 16 years old. The patient went to the hospital due to fever, loss of appetite, nausea and vomiting, with a fever of 38°C without obvious cause. He was diagnosed with hepatitis A by the doctor and was treated with Jingfang Granules of this invention. After taking it for 1 week, the symptoms were relieved and the fever subsided. After continuing to take it for 3 weeks, all symptoms disappeared and he was cured. A follow-up examination 3 months later showed no recurrence.

[0034] 2. Ms. Wang, female, 20 years old, had a decreased appetite, nausea and vomiting, fatigue, enlarged liver and abnormal liver function. She often had fever at the beginning of the illness. She went to the hospital for examination and was diagnosed with hepatitis A. After taking Jingfang Granules of this invention for treatment, her symptoms improved after 2 weeks. After continuing to take it for 3 weeks, the symptoms disappeared and she was cured.

Claims

1. The use of a thorn-preventing preparation, characterized in that, The application of the Jingfang preparation in the preparation of drugs for the prevention or treatment of hepatitis A; the Jingfang preparation is prepared from the following components: Qianghuo, Duhuo, Fuling, Fangfeng, Jingjie, Chuanxiong, Jiegeng, Chaihu, Qianhu, Zhike, Gancao, and other pharmaceutically acceptable excipients.

2. The use of the antiseptic preparation as described in claim 1, characterized in that, The prepared preparations include granules, oral liquids, mixtures, pills, syrups, and capsules.

3. The use of the thorn-preventing preparation as described in claim 1, characterized in that, The aforementioned schizonepeta preparation is in granule form.

4. The use of the thorn-preventing preparation as described in claim 1, characterized in that, The use of the aforementioned antiseptic preparation in drugs that inhibit the activity of hepatitis A virus.

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