TWI785178B - Use of Pien Tze Huang and its preparations in the treatment of herpes zoster - Google Patents

Abstract

The invention belongs to the field of traditional Chinese medicine, and in particular relates to the new application of Pien Tze Huang and its preparation in treating herpes zoster. Clinical studies have found that Pien Tze Huang combined with antiviral drugs valacyclovir, acyclovir and mecobalamin has a definite curative effect on acute herpes zoster of liver meridian stagnation-heat type, which can not only improve the clinical symptoms of patients, but also rapidly promote The scab of herpes can prevent the generation of new herpes, relieve pain, and can shorten the treatment time. In addition, it can also reduce the incidence of postherpetic neuralgia and the incidence of adverse reactions after treatment. It has obvious advantages in clinical application.

Description

Use of Pien Tze Huang and its preparations in the treatment of herpes zoster

The invention belongs to the field of traditional Chinese medicine, and in particular relates to the new application of Pien Tze Huang and its preparation in treating herpes zoster.

Herpes zoster is an acute infectious skin disease caused by varicella -zoster virus, characterized by clusters of herpes and neuralgia along the distribution of unilateral peripheral nerves. Patients with acute herpes zoster suffer from severe and unbearable neuralgia, which seriously affects the daily work and life of patients.

At present, western medicine treats herpes zoster based on the principle of anti-virus and relieving neuralgia. Because western medicine can only alleviate the symptoms of patients to a certain extent, and because western medicine has defects such as obvious adverse reactions and prone to drug resistance, As a result, there are certain limitations in its clinical application. Traditional Chinese medicine believes that the onset of herpes zoster is related to liver meridian stagnation and heat, qi stagnation and blood stasis, and internal dampness and heat, resulting in blockage of meridians, lack of righteousness, and infiltration of toxins into the skin. Treatment should focus on clearing heat and dampness, detoxifying and regulating qi. At present, although there are related reports on the use of Shuanghuanglian and Longdan Xiegan Decoction combined with western medicine to treat herpes zoster, there is still a lack of drugs with definite curative effect and rapid onset of effect.

Pien Tze Huang is a national first-class protected variety of traditional Chinese medicine. It is refined from natural musk, natural bezoar, snake gall, Sanqi and other precious traditional Chinese medicines. It has the effects of clearing away heat and detoxifying, cooling blood and removing blood stasis, reducing swelling and relieving pain. Malignant tumors, carbuncles, furuncles, unknown swollen toxins, bruises, and various inflammations.

At present, there is no relevant report that Pien Tze Huang and its preparations are used for the preparation of treatment of herpes zoster.

For this reason, the present invention proposes the new application of Pien Tze Huang and its preparation in the preparation of medicine for treating herpes zoster.

In order to solve the above problems, the present invention is achieved through the following technologies: In the first aspect, the present invention provides the use of Pien Tze Huang and its preparation in the preparation of medicine for treating herpes zoster.

Preferably, the use includes the use in the preparation of a medicament for treating herpes zoster with stagnant heat in the liver meridian.

Preferably, the use includes the use in the preparation of a medicament for treating herpes zoster in the acute phase.

Further preferably, in the above use, the treatment of herpes zoster refers to shortening the anti-herpes time.

Further preferably, in the above use, the treatment of herpes zoster refers to shortening the scab formation time.

Further preferably, in the above use, the treatment of herpes zoster refers to reducing the incidence of postherpetic neuralgia.

Further preferably, for the above purposes, Pien Tze Huang is added with conventional excipients and prepared into clinically acceptable preparations according to conventional techniques.

The pharmaceutically acceptable auxiliary materials are: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases and the like. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropylmethylcellulose, etc.; binders include starch slurry, polyvinylpyrrolidone, hydroxypropylmethylcellulose, etc.; sweeteners include: Sodium saccharin, aspartame, sucrose, cyclamate, glycyrrhetinic acid, etc.; flavoring agents include: sweeteners and various essences; preservatives include: parabens, benzoic acid, sodium benzoate, sorbic acid and their salts , benzalkonium bromide, chlorhexidine acetate, eucalyptus oil, etc.; substrates include: PEG6000, PEG4000, insect wax, etc.

Further preferably, for the above use, the preparation is selected from lozenges, tablets, capsules, granules, powders, pills, tinctures, liquors, decoctions or mixtures.

Further preferably, for the above-mentioned purposes, each administration of the Pien Tze Huang preparation contains 0.3-0.9 g of Pien Tze Huang.

In the second aspect, the present invention also provides a pharmaceutical composition for treating herpes zoster, comprising the following active ingredients: (i) Pien Tze Huang, (ii) antiviral drugs.

Preferably, in the above-mentioned pharmaceutical composition for treating herpes zoster, the antiviral drug is at least one selected from valacyclovir, acyclovir and methylcobalamin.

Compared with the prior art, the above-mentioned technology of the present invention has the following advantages: Clinical studies have found that Pien Tze Huang combined with antiviral drugs valacyclovir, acyclovir and methylcobalamin have definite curative effects on herpes zoster in the acute stage of liver meridian stagnant heat type, It can not only promote the improvement of patients' clinical symptoms, but also quickly promote the scab of herpes, prevent the generation of new herpes, relieve pain, and shorten the treatment time. In addition, it can also reduce the incidence of postherpetic neuralgia and adverse reactions after treatment Incidence rate, clinical application has obvious advantages.

In the following examples and experimental examples of the present invention, Pien Tze Huang is produced by Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd.

Example 1

Pien Tze Huang is made into clinically acceptable lozenges by adding conventional auxiliary materials according to conventional techniques.

Example 2

Pien Tze Huang is made into clinically acceptable tablets by adding conventional auxiliary materials according to conventional techniques.

Example 3

Pien Tze Huang is made into clinically acceptable capsules by adding conventional auxiliary materials according to conventional techniques.

Example 4

Pien Tze Huang is made into clinically acceptable granules by adding conventional auxiliary materials according to conventional techniques.

Experimental example 1 Study on the therapeutic effect of Pien Tze Huang on herpes zoster of liver meridian stagnation and heat

1. Purpose of the experiment

To study the therapeutic effect of Pien Tze Huang on herpes zoster of stagnant heat in the liver meridian.

2. Experimental method 2.1 General information

From January to December 2016, 144 patients with acute herpes zoster were treated, including 69 males and 75 females, aged 34-69 years, with an average age of 50.2 years. All patients met the diagnostic criteria of western medicine for herpes zoster and the diagnostic criteria of traditional Chinese medicine for stagnant heat syndrome in the liver meridian. All patients were randomly divided into two groups, namely the treatment group and the control group. Among them, there were 72 cases in the treatment group, 33 males and 39 females; 72 cases in the control group, 35 males and 37 females. There was no significant difference in basic information such as age, gender, disease duration, and VAS pain score between the two groups (P>0.05).

2.2 Inclusion criteria

5分；(5)按燒傷面積“手掌法”計算，皮損面積不超過2%體表面積；(6)皮損部位均為軀幹部(包括四肢)；(7)帶狀皰疹皮損發病時間在72小時以內；(8)入組前1周內未服用或外用過相關治療藥物；(9)認知功能完整，簽署知情同意書。 (1) aged 18-75 years old; (2) meeting the diagnostic criteria of western medicine; (3) meeting the symptoms of liver meridian depression and heat syndrome; (4) pain intensity of herpes zoster

5 points; (5) Calculated according to the "palm method" of the burned area, the skin lesion area does not exceed 2% of the body surface area; (6) The skin lesions are all on the trunk (including the limbs); (7) The onset of herpes zoster skin lesions The time is within 72 hours; (8) No relevant therapeutic drugs have been taken or used externally within 1 week before enrollment; (9) The cognitive function is complete, and the informed consent is signed.

2.3 Exclusion criteria

(1) Exclude herpes zoster in special parts, such as head and face, front and back, and perianal herpes; (2) Skin lesions with pustules, erosions, ulcers, necrosis, etc., combined with severe infection; (3) Those who have used drugs that have a therapeutic effect on herpes zoster, or used glucocorticoids and immunosuppressants within one week before enrollment; (4) those with allergic constitution, or those who are allergic to the known ingredients of this drug; (5) those with Cancer, AIDS and other serious diseases, low liver and kidney function (such as ALT, AST exceeding 1.5 times the upper limit of normal value, Cr exceeding the upper limit of normal value), or patients with other immunocompromised diseases; (6) Pregnant, preparing for pregnancy or breastfeeding Women; (7) Subjects who are participating in or have participated in other drug clinical trials within 3 months before enrollment; (8) Those who are considered by the investigators to be inappropriate to participate in this clinical trial.

2.4 Treatment methods

Basic treatment: valacyclovir tablets (GlaxoSmithKline (China) Investment Co., Ltd., 0.3g each time, twice a day, orally) + acyclovir cream (GlaxoSmithKline (China) Investment Co., Ltd. , after cleaning and disinfecting the affected part of the skin, apply it on the affected part, 4 times/day) + methylcobalamin tablets (Hangzhou Kangenbei Pharmaceutical Co., Ltd., 0.5mg each time, 3 times/day).

Treatment group: oral administration of Pien Tze Huang capsules (0.3g/grain) prepared in Example 3 (produced by Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd., each 2 capsules, 3 times/day)+basic treatment; matched group: oral administration of Pien Tze Huang capsule simulator (0.3g/capsule) (namely: placebo) (2 capsules each time, 3 times/day) + basic treatment; other treatments: ibuprofen sustained-release capsules (0.3g/capsule), take as needed, 1 capsule each time grain. The course of treatment for the above two groups is 7 days. After the course of treatment is over, observe the results and evaluate the curative effect. The time of drug use can be extended as appropriate according to the recovery of the patient.

2.5 Observation indicators

(1) During the treatment period, observe the patient’s blistering, scabbing, pain relief, and recovery time; blistering: no new blisters appear, and the original blisters begin to dry up; scabs: blisters dry up and scabs; analgesia: pain disappears; (2) clinical treatment Total effective rate; (3) Safety indicators: including important signs, blood routine, urine routine + urine sediment microscopy, stool routine + OB, liver function, kidney function, adverse events, etc.; (4) follow-up for 1 month to observe patients Whether there is any residual neuralgia.

2.6 Efficacy Judgment Criteria

Cured: the symptoms and signs completely disappeared, the rash basically disappeared, and the pain disappeared; markedly effective: the symptoms and signs were significantly improved, the skin lesions disappeared >70.0%, and the pain was significantly relieved; effective: the symptoms and signs were improved, and the skin lesions disappeared >50.0%, The pain was relieved; invalid: the symptoms and signs did not improve significantly, the skin lesions disappeared <50.0%, and the pain was obvious.

The total effective rate of clinical treatment = (cured + markedly effective + effective) / total number of cases × 100%.

2.7 Statistical Analysis

At the end of the experiment, all observation indicators were evaluated and analyzed at the same time, and P<0.05 was regarded as the standard of statistical significance.

3. Experimental results 3.1 Comparison of symptom improvement time and incidence of postherpetic neuralgia between the two groups

The experimental results of the symptom improvement time and the incidence of postherpetic neuralgia in the two groups of patients are shown in Table 1.

It can be seen from Table 1 that, compared with the control group, the treatment group had significantly shortened blistering time and scabbing time, and significantly decreased the incidence of postherpetic neuralgia, with statistically significant differences (P<0.05, P<0.01); The analgesic time was similar, which indicated that Pien Tze Huang also had a good analgesic effect.

3.2 Comparison of curative effect between two groups of patients

The experimental results of the curative effect of the two groups of patients are shown in Table 2.

As can be seen from Table 2, after 7 days of treatment, the total effective rate of the treatment group was 90.3%, and that of the control group was 79.2%. number and number of effective cases.

3.3 Adverse reactions

General adverse reactions include headache, nausea, skin burning, stomach discomfort, loss of appetite, leukopenia, insomnia, proteinuria, etc. Adverse reactions were found in 9 patients in the control group, and adverse reactions were found in 2 patients in the treatment group, indicating that the incidence of adverse reactions in the treatment group was significantly lower than that in the control group.

4. Experimental conclusion

Clinical studies have found that Pien Tze Huang combined with antiviral drugs valacyclovir, acyclovir and mecobalamin has a definite curative effect on acute herpes zoster of liver meridian stagnation-heat type, which can not only improve the clinical symptoms of patients, but also rapidly promote The scab of herpes can prevent the generation of new herpes, relieve pain, and can shorten the treatment time. In addition, it can also reduce the incidence of postherpetic neuralgia and the incidence of adverse reactions after treatment. It has obvious advantages in clinical application.

Apparently, the above-mentioned embodiments are only examples for clear description, rather than limiting the implementation. For those skilled in the art, other changes or modifications in different forms can be made on the basis of the above description. It is not necessary and impossible to exhaustively list all the implementation manners here. However, the obvious changes or changes derived therefrom are still within the scope of protection of the present invention.

Claims (10)

A kind of purposes of pharmaceutical composition, it is used for preparing treatment herpes zoster, and this pharmaceutical composition comprises following active ingredient: (i) Pien Tze Huang; (ii) antiviral drug, this antiviral drug is valacyclovir; ( iii) Methylcobalamin. The use as described in claim 1, wherein the use includes the use of a medicine in the treatment of herpes zoster with stagnant heat in the liver meridian. The use as described in Claim 1, wherein the use includes the use of a drug in the treatment of acute herpes zoster. The use as described in any one of claims 1 to 3, wherein the treatment of herpes zoster refers to shortening the anti-herpes time. The use as described in any one of claims 1 to 3, wherein the treatment of herpes zoster refers to shortening the scab time. The use as described in any one of claims 1 to 3, wherein the treatment of herpes zoster refers to reducing the incidence of postherpetic neuralgia. The use as described in any one of claim items 1 to 3, wherein the Pien Tze Huang is prepared into a clinically acceptable preparation by adding conventional excipients according to conventional techniques. Use as described in item 7 of the scope of the patent application, wherein the preparation is selected from lozenges, tablets, capsules, granules, powders, pills, tinctures, liquors, decoctions or mixtures. The use as described in any one of claim items 1 to 3, wherein each dosage preparation of the pharmaceutical composition contains 0.3-0.9 g of Pien Tze Huang. A pharmaceutical composition for treating recurrence of herpes zoster, comprising the following active ingredients: (i) Pien Tze Huang; (ii) antiviral drug, the antiviral drug being valacyclovir; (iii) methylcobalamin.