KR20230046094A - A traditional Chinese medicine composition and a preparation method thereof - Google Patents

Abstract

The present invention relates to a composition for treating shingles and a manufacturing method thereof. The composition for treating shingles is manufactured by using Rhizoma corydalis, Ophiopogon japonicus, Angelica sinensis, rhubarb, and gentian as raw materials. The present invention aims at the etiology and pathogenesis of shingles, removes heat and toxicity, dries moisture, relieves pain, removes congestion and toxicity, removes necrosis, and grows muscles such that the synergistic effect of the active ingredients of various traditional Chinese medicines is utilized to treat shingles and there are no aftereffects such as wounds or neuralgia.

Description

A traditional Chinese medicine composition and a preparation method thereof}

The present invention relates to traditional Chinese medicine and a method for preparing the same, and particularly to a pharmaceutical composition for treating herpes zoster and a method for preparing the same.

Shingles is a viral skin disease caused by infection with the varicella-zoster virus, and is characterized by cluster herpes distributed along peripheral nerves and neuralgia, and is most prevalent in spring.

In modern medicine, the disease is considered to be that the herpes zoster virus invades the body through respiratory tract infection and lies dormant in nerve cells of spinal nerves or other nerves. The virus does not usually cause shingles, but easily causes shingles when the immune system of the elderly and weak is lowered, physical fatigue, cold, and the like.

The main oral western drugs used to treat shingles are antiviral drugs, analgesics, immunomodulators, and corticosteroids. Antiviral agents include acyclovir, valacyclovir, vidarabine, acyclovir and interferon. Anti-inflammatory analgesics include, for example, aspirin, anti-pain tablets, vitamin B1, vitamin B12 and the like. Topical drugs for local sores include: 2% gentian violet solution or Sanguisorba zinc oxide oil mixture for external use. If there is a secondary infection, neomycin ointment can be used externally.

The treatment methods and drugs mentioned above can reduce pain and eliminate clinical herpes symptoms. However, Western drug treatment methods have the disadvantages of long-term treatment process, liver and kidney damage, large side effects, high treatment cost, neuralgia sequelae and easy recurrence of patients after treatment.

A main object of the present invention is to provide a composition for treating shingles and a method for preparing the same in consideration of the above-mentioned problems. The composition targets the etiology and pathogenesis of herpes zoster and utilizes the synergistic effect of the active ingredients of various traditional Chinese medicines. It eliminates shingles by removing heat and toxicity, removing dampness and pain, removing blood stasis and detoxification, removing necrosis, and promoting muscle growth, without leaving scars, neuralgia and other sequelae. can treat

, Rhizoma Corydalis), 황금(

, Ophiopogon japonicus), 황백(

, Angelica sinensis), 대황(

, Rhubarb) 및 용담초(

, Gentian)를 주로 포함하는 대상포진 치료용 조성물로서, In order to achieve the above object of the present invention, one aspect of the present invention is yellow lotus (as a raw material)

, Rhizoma Corydalis), golden (

, Ophiopogon japonicus), yellowish white (

, Angelica sinensis), rhubarb (

, Rhubarb) and gentian (

, Gentian) as a composition for treating herpes zoster,

The weight ratio of the raw materials of the composition for treating herpes zoster is 3-20 parts by weight of gold, 2-15 parts by weight of gold, 3-15 parts by weight of yellow white, 2-20 parts by weight of rhubarb, and 3-15 parts by weight of gentian. composition is provided.

Another aspect of the present invention provides a method for preparing a composition for treating shingles comprising the following steps:

1) Preparing raw materials in the following parts by weight:

3-20 parts by weight of barberry, 2-15 parts by weight of gold, 3-15 parts by weight of yellow white, 2-20 parts by weight of rhubarb and 3-15 parts by weight of gentian;

2) uniformly mixing the raw materials, extracting the mixture by heating, and recovering the extract; and

3) Concentrating the recovered extract to prepare the active ingredient of the drug of the present invention.

In the present invention, the amount of the raw material is preferably as follows: 5-10 parts by weight of Barberry, 5-10 parts by weight of gold, 5-10 parts by weight of yellow white, 6-10 parts by weight of rhubarb and 5-10 parts by weight of gentian. .

In the present invention, in the above step 2), the raw materials are pulverized and then mixed, and the heat extraction includes the following steps:

A) The mixture is immersed in water with a weight ratio of added water to mixture of 3-6: 1, and after 20-90 minutes of immersion, the heating temperature is 100 ° C and the heat extraction time is 1-5 hours. First heat extraction performing;

B) filtering the primary extract and recovering the filtrate;

C) Water is added to the filtration residue at a weight ratio of added water to mixture of 1-5:1, heating temperature is 100 ° C, and heating extraction time is 1-3 hours to perform secondary heat extraction performing steps; and

D) After filtering, combining the two filtered filtrate.

Specifically, the raw material is pulverized into a coarse powder having a particle size of 10-50 mesh and then mixed; The soaking time in step A) is preferably 30-60 minutes, the weight ratio of added water to mixture is preferably 4-6:1, and the first heat extraction time is preferably 1-3 hours; The weight ratio of added water to mixture in step C) is 1-3:1.

In the present invention, when the extract is concentrated in step 3), the temperature is adjusted to be 80-100°C, preferably 100°C; The extract is concentrated to a concentrate with a specific gravity of 1.05-1.50, and the specific gravity is preferably 1.10-1.35.

The active ingredient of the drug of the present invention can be added together with various conventional auxiliary raw materials necessary for preparing different dosage forms, such as, for example, disintegrants, lubricants, binders, etc. A method for preparing Chinese medicine in any common oral dosage form, such as pill, powder, tablet, granule, capsule, oral liquid ) and the like.

When the composition for the treatment of herpes zoster prepared by the present invention is used, 5-7 grams (crude medicine) per time, 1-2 times a day, should be taken orally. Pregnant women are prohibited from taking it. During drug treatment, avoid spicy food, cold food, seafood, oily food, and smoking. After 5-10 days of use, pain is gone, banded blisters disappear, skin redness and swelling are restored. After treatment, there is no erythema or pigmentation, and no scars are left.

The following experimental examples are intended to explain in more detail the clinical therapeutic effect of the composition for treating herpes zoster of the present invention.

Experimental Example 1: Clinical observation of the effect of the composition for treating herpes zoster of the present invention on the treatment of herpes zoster

(1) General information:

In order to determine the therapeutic effect of the composition (powder) for the treatment of herpes zoster of the present invention, a total of 120 cases, including 60 male patients and 60 female patients aged 18 to 65 years, were observed. The cases were randomly divided into treatment and control groups. Of these, 70 cases were the treatment group and 50 cases were the control group. All of them were diagnosed with shingles, and there were no other complications or secondary diseases within 7 days of onset. There was no significant difference in age, gender, and disease course between the two groups.

(2) Diagnostic criteria for shingles:

1. The skin lesion is usually a water scar the size of a mung bean, clustered in clusters with a red hard scar wall at the bottom, often unilaterally distributed as a ribbon and are arranged. In severe cases, skin lesions may show hemorrhagic or gangrene damage. Skin lesions of the head and face tend to be more severe.

2. Prior to the onset of a rash, there is often a tingling or burning sensation on the skin, which may be accompanied by mild body discomfort and fever.

3. Perceived pain is evident and there is severe pain that is unbearable, or pain remains after the rash has subsided.

(3) Treatment method

Treatment group: Oral administration of the composition (powder) for the treatment of herpes zoster of the present invention twice a day, 5-7 grams (herbal medicine) per time, continuous drug treatment for 5-10 days, spicy food, cold food, Seafood, fatty foods and smoking were prohibited.

Control: Aciclovir tablets were orally administered 3 times/day, 0.2 g/time daily.

(4) Evaluation criteria for the treatment effect of shingles

1. Cure: The rash subsided, the clinical signs disappeared, and there were no pain sequelae.

2. Improvement: The rash subsided by about 30% or more, and the pain was significantly reduced.

3. Unhealed: Less than 30% of rashes subsided, still painful.

(5) Clinical trial results

The experimental results are shown in Tables 1 and 2 below.

healing (case) improvement (case) not healed (case) Cure rate (%) Treatment group (70 cases) 68 2 0 97.1% Control group (50 cases) 46 3 One 92%

Healing in 1-2 days (cases) Healing in 3-5 days (cases) Healing in 6-10 days (cases) Healing after 10 days (%) treatment group 7 12 45 4 control group 0 0 9 37

The above results show:

1. The therapeutic effect of the composition for treating herpes zoster of the present invention is noteworthy, and the clinical eruption of herpes zoster is clearly reduced. The cure rate reached 97.1%, the improvement rate reached 2.9%, and the total effective rate reached 100%.

2. The composition for the treatment of herpes zoster of the present invention has a rapid and rapid effect, and a short course of treatment. The cure rate of patients after 6-10 days of treatment reached 91.4%, of which the cure rate of 1-2 days reached 10%; The 3-5 day cure rate reached 17.1%; While the cure rate within 6-10 days reached 64.3%; The control group had a long treatment time, requiring at least 5 days of treatment.

3. The pharmaceutical composition of the present invention did not show any toxic side effects, allergic reactions and other adverse reactions, indicating that the composition for treating herpes zoster of the present invention has no side effects on the human body.

4. After using the present invention on the subjects, follow-up observations showed that the zoster did not recur for 6-12 months.

Experimental Example 2: Clinical pharmacology and toxicity test of the composition for treating herpes zoster of the present invention

(1) Acute toxicity test

The powder of the composition for treating herpes zoster of the present invention was administered to Kunming mice at 1000 g (herbal medicine)/kg.

There were no toxic reactions and no animals died within one week.

(2) long-term toxicity test

Tablets of the composition for treating herpes zoster of the present invention were used in a long-term toxicity test in rats, and a continuous high dose (100 times the adult dose) was administered by gavage. The administration period was long (90 days). General performance, weight, food intake, hematology and serum biochemical indicators, urine routine, bone marrow classification, organ weight weight) and organ coefficient were the detection indicators, and the toxicity status of the drug was comprehensively evaluated by supplementing with pathological examinations on various animal tissues and organs. As a result, all of the above indicators of the rat were found to be normal. Histopathological examination revealed no abnormalities in the rat's organs.

In summary, the composition for treating herpes zoster of the present invention has low toxicity and a wide safety range.

Example 1: Preparation of capsules of the medicament of the present invention

1) Raw materials were weighed in the following ratio (unit: g).

Yellow lotus 5, golden 15, yellow white 10, rhubarb 10, and gentian 5.

Of these, yellow lotus, golden, yellow white, rhubarb, and gentian were ground into coarse powders each having a particle size of 24-50 mesh, and mixed uniformly to prepare a coarse powder mixture for the next step. .

2) The uniformly mixed coarse powder mixture was put into a traditional Chinese medicine multifunctional extraction kettle, and tap water was added to soak for 30 minutes. At this time, the weight ratio of the added tap water to the coarse powder mixture was 6:1 .

3) Turn on the power of the multi-function extraction kettle for heating, heat to 100 ° C, maintain the temperature for 2 hours, and then filter to obtain a primary extract for use.

4) To the filter residue, tap water was added so that the weight ratio of the tap water to the coarse powder mixture was 3:1, followed by heating and extraction at a heating temperature of 100° C. and an extraction time of 1 hour, followed by filtration to obtain a secondary extract.

5) The two extracts were combined and concentrated to form an extract with a specific gravity of 1.30, and then dried at 45-50° C. to obtain a dry extract.

6) The dried extract was pulverized into a fine powder of 100-150 mesh, and then filled into a hard gelatin capsule to obtain a final product.

Example 2: Preparation of tablets of the medicament of the present invention

1) Raw materials were weighed in the following ratio (unit: g).

10 yellow lotus, 2 golden, 5 yellow white, 20 rhubarb, and 10 gentian.

Of these, yellow lotus, golden, yellow white, rhubarb, and gentian were ground into coarse powders each having a particle size of 24-50 mesh, and mixed uniformly to prepare a coarse powder mixture for the next step. .

2) The uniformly mixed coarse powder mixture was put into a traditional Chinese medicine multi-functional extraction kettle, tap water was added, and soaked for 60 minutes. At this time, the weight ratio of the added tap water to the coarse powder mixture was 4:1.

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, maintain the temperature for 1.5 hours, and then filter to obtain a primary extract for use.

4) To the filter residue, tap water was added so that the weight ratio of the tap water to the coarse powder mixture was 3:1, followed by heat extraction at a heating temperature of 100° C. and an extraction time of 1.5 hours, followed by filtration to obtain a secondary extract.

5) The two extracts were combined and concentrated to form an extract with a specific gravity of 1.35, and then dried at 45-50° C. to obtain a dry extract.

6) The dried extract was pulverized into a fine powder, and an auxiliary material was added to make particles, which were then dried and compressed into tablets.

Example 3: Preparation of a pellet of the medicament of the present invention

1) Raw materials were weighed in the following ratio (unit: g).

3 yellow lotus, 10 gold, 15 yellow white, 6 rhubarb, and 3 gentian plants.

Of these, yellow lotus, golden, yellow white, rhubarb, and gentian were ground into coarse powders each having a particle size of 24-50 mesh, and mixed uniformly to prepare a coarse powder mixture for the next step. .

2) The uniformly mixed coarse powder mixture was placed in a traditional Chinese medicine multifunctional extraction kettle, tap water was added, and soaked for 20 minutes. At this time, the weight ratio of the added tap water to the coarse powder mixture was 5:1.

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, maintain the temperature for 3 hours, and then filter to obtain a primary extract for use.

4) To the filter residue, tap water was added so that the weight ratio of the tap water to the coarse powder mixture was 1:1, followed by heat extraction at a heating temperature of 100° C. and an extraction time of 1 hour, followed by filtration to obtain a secondary extract.

5) The two extracts were combined and concentrated to form an extract with a specific gravity of 1.25, and then dried at 45-50 °C to obtain a dry extract.

6) The dried extract was pulverized into a fine powder, and purified honey was mixed as an auxiliary material. After stirring evenly, it was put into a pill making machine for pill manufacturing, and the manufactured pill was dried in a drying box to obtain a final product.

Example 4: Preparation of particles of the medicament of the present invention

1) Raw materials were weighed in the following ratio (unit: g).

20 yellow lotus, 5 gold, 3 yellow white, 2 rhubarb, and 15 gentian.

Of these, yellow lotus, golden, yellow white, rhubarb, and gentian were ground into coarse powders each having a particle size of 24-50 mesh, and mixed uniformly to prepare a coarse powder mixture for the next step. .

2) The uniformly mixed coarse powder mixture was placed in a traditional Chinese medicine multifunctional extraction kettle, tap water was added, and soaked for 90 minutes. At this time, the weight ratio of the added tap water to the coarse powder mixture was 3:1.

3) Turn on the power of the multi-function extraction kettle for heating, heat to 100 ° C, maintain the temperature for 1 hour, and then filter to obtain a primary extract for use.

4) To the filter residue, tap water was added so that the weight ratio of the tap water to the coarse powder mixture was 3:1, followed by heating and extraction at a heating temperature of 100° C. and an extraction time of 2 hours, followed by filtration to obtain a secondary extract.

5) The two extracts were combined and concentrated to form an extract with a specific gravity of 1.30, and then dried at 45-50° C. to obtain a dry extract.

6) The dried extract was pulverized into fine powder, ethanol was added as a binder, and starch was added as an auxiliary material to make granules.

Example 5: Preparation of oral liquid of the medicament of the present invention

1) Raw materials were weighed in the following ratio (unit: g).

Yellow rhubarb 7.5, golden 7.5, yellow white 7.5, rhubarb 8 and gentian 7.5.

Of these, yellow lotus, golden, yellow white, rhubarb, and gentian were ground into coarse powders each having a particle size of 24-50 mesh, and mixed uniformly to prepare a coarse powder mixture for the next step. .

2) The uniformly mixed coarse powder mixture was put into a traditional Chinese medicine multifunctional extraction kettle, tap water was added, and soaked for 45 minutes. At this time, the weight ratio of the added tap water to the coarse powder mixture was 6:1.

3) Turn on the power of the multi-function extraction kettle for heating, heat to 100 ° C, maintain the temperature for 2 hours, and then filter to obtain a primary extract for use.

4) To the filter residue, tap water was added so that the weight ratio of the tap water to the coarse powder mixture was 2:1, followed by heating and extraction at a heating temperature of 100° C. and an extraction time of 3 hours, followed by filtration to obtain a secondary extract.

5) The two extracts were combined and concentrated to form an extract with a specific gravity of 1.10.

6) The concentrate was packaged in a plastic composite film to prepare an oral liquid.

Claims (5)

The raw materials are yellow lotus, gold, yellow white, rhubarb and gentian, and the weight ratio of the raw materials is 3-20 parts by weight of yellow lotus, 2-15 parts by weight of gold, 3-15 parts by weight of yellow white, 2-20 parts by weight of rhubarb and gentian 3 A pharmaceutical composition for the treatment of herpes zoster, characterized in that -15 parts by weight. The composition of claim 1, wherein the weight ratio of the raw material is 5-10 parts by weight of Barberry, 5-10 parts by weight of gold, 5-10 parts by weight of yellow white, 6-10 parts by weight of rhubarb, and 5-10 parts by weight of gentian. A method for preparing a pharmaceutical composition for treating herpes zoster comprising the following steps:
1) Preparing raw materials in the following parts by weight:
3-20 parts by weight of barberry, 2-15 parts by weight of gold, 3-15 parts by weight of yellow white, 2-20 parts by weight of rhubarb and 3-15 parts by weight of gentian;
2) uniformly mixing the raw materials, adding and soaking in water, heat-extracting the mixture, and recovering the extract; and
3) concentrating the recovered extract to obtain a pharmaceutical composition. The method according to claim 3, wherein in step 2), the raw materials are pulverized and then mixed, and the heat extraction is performed according to the following steps:
A) The mixture is immersed in water with a weight ratio of added water to mixture of 3-6: 1, and after 20-90 minutes of immersion, the heating temperature is 100 ° C and the heat extraction time is 1-5 hours. First heat extraction performing;
B) filtering the primary extract and recovering the filtrate;
C) adding water to the filtration residue at a weight ratio of added water to the mixture of 1-5:1, performing secondary heating extraction at a heating temperature of 100 ° C and a heating extraction time of 1-3 hours; ; and
D) After filtering, combining the two filtered filtrate. The method according to claim 4, wherein the raw material is pulverized into a coarse powder having a particle size of 10-50 mesh and then mixed.