TW201929874A - Pien Tze Huang and new application of preparation thereof in preparing drug for treating herpes zoster - Google Patents

Abstract

The invention belongs to the field of traditional Chinese medicine, and particularly relates to Pien Tze Huang and new application of a preparation thereof in preparing a drug for treating herpes zoster. An in-vitro experiment shows that Pien Tze Huang can dose-dependently inhibit duplication of chicken varicella-herpes zoster viruses (VZV). A clinical study finds that the combination of Pien Tzehuang and anti-virus drugs of valaciclovir and acyclovir has an obvious curative effect on alert period zoster viruses due to liver yu heat from the line, improvement of clinical symptoms of a patientcan be promoted, incrustation of herpes can be quickly promoted, new herpes can be stopped from generating, pain can be relieved, and the treatment time can also be shortened; besides, the incidenceof postherpetic neuralgia and the occurrence rate of adverse reactions occurring after treatment can also be lowered, and the clinical application has obvious advantages.

Description

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

The invention belongs to the field of traditional Chinese medicine, and particularly relates to a new use of Pien Tze Huang and its preparation in the treatment of herpes zoster.

Herpes zoster is an acute infectious skin disease caused by varicella -zoster virus, characterized by clustered herpes and neuralgia distributed along the unilateral peripheral nerve. In patients with acute herpes zoster, the neuropathic pain is severe and unbearable, which seriously affects the daily work and life of the patient.

At present, Western medicine treats herpes zoster on the principle of anti-virus and relieving neuralgia. Because western medicine can only relieve the symptoms of patients to a certain extent, and because of the obvious adverse reactions of western medicine, it is prone to drug resistance and other defects. As a result, its clinical application has certain limitations. Chinese medicine believes that the incidence of herpes zoster is related to liver stagnation, qi stagnation and blood stasis, and dampness and heat, leading to meridian repression, lack of righteousness, and poisonous immersion in skin. The treatment should be based on heat and dampness, detoxification and qi. At present, although there have been reports on the use of Shuanghuanglian, Longdan Xiegan Decoction and western medicine for the treatment of herpes zoster, there is still no definitive curative effect and rapid onset of drugs.

Pien Tze Huang is a national first-class Chinese medicine protection variety. It is made from precious Chinese herbal medicines such as natural musk, natural bezoar, snake gall, and Sanqi. It has the effects of clearing away heat and detoxifying, cooling blood and removing blood stasis, reducing swelling and relieving pain. It is commonly used in the treatment of acute and chronic viral hepatitis. Malignant tumors, acne, unknown swollen poison, bruises and various inflammations.

At present, there is no report on the preparation of the treatment of herpes zoster by Pien Tze Huang and its preparations.

To this end, the present invention proposes a new use of Pien Tze Huang and its preparation in the preparation of a medicament for the treatment of herpes zoster.

In order to solve the above problems, the present invention is achieved by the following techniques: In a first aspect, the present invention provides the use of Pien Tze Huang and its preparation for the preparation of a medicament for treating herpes zoster.

Preferably, the use comprises the use in the manufacture of a medicament for the treatment of hydrolyzed herpes zoster.

Preferably, the use comprises the use in the manufacture of a medicament for the treatment of acute phase herpes zoster.

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

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

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

Further preferably, for the above use, Pien Tze Huang is added to a conventional excipient, and a clinically acceptable preparation is prepared according to a conventional technique.

The pharmaceutically acceptable excipients are: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices, and the like. Filling agents include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrating agents include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, cerium oxide, etc.; suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch syrup, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include: Saccharin sodium, aspartame, sucrose, cyclamate, glycyrrhetinic acid, etc.; flavoring agents include: sweeteners and various flavors; preservatives include: parabens, benzoic acid, sodium benzoate, sorbic acid and their salts , benzalkonium bromide, chlorhexidine acetate, eucalyptus oil, etc.; the matrix includes: PEG6000, PEG4000, insect wax and the like.

Further preferably, in the above use, the preparation is selected from the group consisting of a tablet, a tablet, a capsule, a granule, a powder, a pill, an elixir, a wine, a ointment or a mixture.

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

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

Preferably, the pharmaceutical composition for treating herpes zoster, wherein the antiviral drug is at least one selected from the group consisting of valacyclovir, acyclovir and mecobalamin.

The above technology of the present invention has the following advantages compared with the prior art: clinical studies have found that Pien Tze Huang combined with the antiviral drugs valacyclovir, acyclovir and mecobalamin are effective in treating acute herpes zoster in the liver. It not only promotes the improvement of clinical symptoms, but also promotes the scarring of herpes, prevents the production of herpes, relieves pain, and shortens the treatment time. It also reduces the incidence and adverse reactions of post-treatment neuralgia after treatment. Incidence, clinical application has obvious advantages.

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

Example 1

Pien Tze Huang is prepared according to conventional techniques by adding conventional excipients to make clinically acceptable lozenges.

Example 2

Pien Tze Huang is prepared according to conventional techniques by adding conventional excipients to make clinically acceptable tablets.

Example 3

Pien Tze Huang is prepared according to conventional techniques by adding conventional excipients to make clinically acceptable capsules.

Example 4

Pien Tze Huang is prepared according to conventional techniques by adding conventional excipients to make clinically acceptable granules.

Experimental Example 1 Therapeutic effect of Pien Tze Huang on hepatic stagnation type herpes zoster

 1. Experimental purpose  

To study the therapeutic effect of Pien Tze Huang on hepatic stagnation type herpes zoster.

 2, experimental methods    2.1 General Information  

From January to December 2016, 144 patients with acute herpes zoster were admitted, including 69 males and 75 females, aged 34-69 years, with an average of 50.2 years. All patients met the diagnostic criteria for herpes zoster Western medicine and the diagnostic criteria for liver stagnation syndrome. All patients were randomly divided into two groups, the treatment group and the control group. Among them, 72 patients in the treatment group, 33 males and 39 females; 72 patients in the control group, 35 males and 37 females. There were no significant differences in age, gender, duration of disease, and VAS pain score between the two groups (P>0.05).

 2.2 Inclusion criteria  

(1) Age 18-75 years old; (2) Meet the diagnostic criteria of Western medicine; (3) Conform to TCM syndrome patients with liver-stagnation syndrome; (4) Herpes zoster pain intensity 5 points; (5) according to the burn area "palm method", the lesion area does not exceed 2% of the body surface area; (6) the lesions are the trunk (including limbs); (7) the incidence of herpes zoster lesions The time is within 72 hours; (8) The relevant treatment drugs have not been taken or used for 1 week before the enrollment; (9) The cognitive function is complete and the informed consent is signed.

 2.3 Exclusion criteria  

(1) Exclusion of herpes zoster in special areas, such as head and face, anterior and posterior vaginal and perianal herpes; (2) pustules, erosions, ulcers, necrosis, etc. in the skin lesions, combined with severe infection; (3) Drugs that have been used to treat herpes zoster in the week before enrollment, or those who use glucocorticoids and immunosuppressive agents; (4) allergic persons, or those who are allergic to known ingredients of this drug; (5) suffer from Other serious diseases such as cancer, AIDS, liver and kidney dysfunction (such as ALT, AST exceeds the upper limit of 1.5 times the normal value, Cr exceeds the upper limit of normal), or other patients with low immune function; (6) pregnancy, pregnancy or lactation Women; (7) Subjects are participating, or have participated in other drug clinical trials within 3 months prior to enrollment; (8) The investigator considers it inappropriate to participate in this clinical trial.

 2.4 treatment methods  

Basic treatment: valacyclovir tablets (GlaxoSmithKline (China) Investment Co., Ltd., 0.3g each time, 2 times / day, oral) + acyclovir cream (GlaxoSmithKline (China) Investment Co., Ltd. Wipe the skin affected area, disinfect it, apply it to the affected area, 4 times / day) + mecobalamin tablets (Hangzhou Kangenbei Pharmaceutical Co., Ltd., 0.5mg each time, 3 times / day).

Treatment group: Oral preparation of the tablets (0.3g / granules) prepared in Example 3 (produced by Zhangzhou Pien Tiao Pharmaceutical Co., Ltd., 2 capsules per time, 3 times / day) + basic treatment; control group: oral tablets and capsules (0.3g / capsule) (ie: placebo) (2 capsules, 3 times / day) + basic treatment; other treatment: ibuprofen sustained-release capsules (0.3g / capsule), take as needed, each time 1 grain. The above two groups of treatments are 7 days. After the end of the treatment, the results are observed and the curative effect is evaluated. The medication use time can be extended according to the patient's recovery.

 2.5 Observation indicators  

(1) Observing the patient's blistering, crusting, analgesic and healing time during treatment; blistering: no new blisters appear, the original blisters begin to dry up; scarring: blister dryness and crusting; pain relief: 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, renal function, adverse events, etc.; (4) follow-up 1 month to observe patients There is no residual neuralgia.

 2.6 efficacy judgment criteria  

Healing: Symptoms and signs disappeared completely, rash disappeared and pain subsided; Significant effect: Symptoms and signs improved significantly, skin lesions disappeared >70.0%, pain was relieved effectively; Effectiveness: Symptoms and signs improved, skin lesions disappeared >50.0%, Pain was relieved; invalid: no obvious improvement in symptoms and signs, skin lesions disappeared <50.0%, pain was obvious.

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

 2.7 statistical analysis  

At the end of the experiment, each observation index was evaluated and analyzed at the same time, and P<0.05 was used as a statistically significant criterion.

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

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

As can be seen from Table 1, compared with the control group, the blistering time and scarring time of the treatment group were significantly shortened, and the incidence of sedative neuralgia was significantly decreased (P<0.05, P<0.01); The pain relief time is quite the same, which indicates that Pien Tze Huang also has a good analgesic effect.

 3.2 Comparison of efficacy between the two groups  

The experimental results of the efficacy 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 the total effective rate of the control group was 79.2%, and the number of cure cases and the number of marked cases in the treatment group were significantly higher than those in the control group. Number and number of effective cases.

 3.3 Adverse reactions  

Common adverse reactions include headache, nausea, skin burning, stomach discomfort, loss of appetite, decreased white blood cells, insomnia, and proteinuria. In the control group, 9 patients were found to have adverse reactions. In the treatment group, 2 patients were found to have adverse reactions, indicating that the incidence of adverse reactions in the treatment group was significantly lower than that in the control group.

 4, the conclusion of the experiment  

Clinical studies have found that Pien Tze Huang combined with the antiviral drugs valacyclovir, acyclovir and mecobalamin have a definite curative effect on acute zoster herpes in liver stagnation, which not only promotes the improvement of clinical symptoms, but also promotes it quickly. Herpes scars, prevent the production of new herpes, relieve pain, and can shorten the treatment time, in addition to reduce the incidence of post-treatment neuralgia and the incidence of adverse reactions after treatment, clinical application has obvious advantages.

It is apparent that the above-described embodiments are merely illustrative of the examples, and are not intended to limit the embodiments. Other variations or modifications of the various forms may be made by those skilled in the art in light of the above description. There is no need and no way to exhaust all of the implementations. Obvious changes or variations resulting therefrom are still within the scope of the invention.

Claims (11)

 Use of Pien Tze Huang and its preparations in the treatment of herpes zoster.    The use of claim 1, wherein the use comprises the use in the treatment of hydrolyzed herpes zoster.    The use of claim 1, wherein the use comprises the use in the treatment of acute stage herpes zoster.    The use according to any one of claims 1 to 3, wherein the treatment of herpes zoster refers to shortening the time of blistering.    The use of any one of claims 1 to 3, wherein the treating herpes zoster refers to shortening the scarring time.    The use of any one of claims 1 to 3, wherein the treating herpes zoster refers to reducing the incidence of post-herpetic neuralgia.    The use according to any one of claims 1 to 3, wherein the pupa is added to a conventional excipient, and a clinically acceptable preparation is prepared according to a conventional technique.    The use according to claim 7, wherein the preparation is selected from the group consisting of a tablet, a tablet, a capsule, a granule, a powder, a pill, an elixir, a wine, a ointment or a mixture.    The use according to any one of claims 1 to 3, wherein the tablet preparation has a dosage of 0.3-0.9 g of pupa.    A pharmaceutical composition for treating herpes zoster comprising the following active ingredients: (i) Pien Tze Huang; (ii) an antiviral drug.    A pharmaceutical composition for treating herpes zoster according to claim 10, wherein the antiviral drug is at least one selected from the group consisting of valacyclovir, acyclovir and mecobalamin.