KR20230055253A - A traditional Chinese medicine composition and a preparation method thereof - Google Patents

Abstract

The present invention provides a composition for treating shingles and a preparation method thereof. The composition for treating shingles contains, as raw materials, Sterculia scaphigera, Scutellaria baicalensis Georgi, Phellodendron amurense, Rhubarb, and Gentian. The present invention uses the synergistic effect of various active ingredients of traditional Chinese medicine for the treatment of shingles and is capable of treating shingles without leaving scars, neuralgia, and other aftereffects by removing heat, performing detoxification, drying moisture, relieving pain, eliminating blood stasis, eliminating putrefaction, and promoting muscle growth while focusing on the etiological factors and the pathogenesis of shingles.

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 more particularly to a pharmaceutical composition for treating herpes zoster and a method for preparing the same.

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

Modern medicine sees the herpes zoster virus as a disease that invades the body through respiratory infection and hides in the nerve cells of the spinal nerves or other nerves. This virus usually does not cause disease, but it is easy to cause shingles in the case of physical fatigue, cold, etc. because the immune system of the elderly or the elderly is reduced.

The main oral Western medicines used to treat herpes zoster include antivirals, pain relievers, immunomodulators, and corticosteroids. Antiviral agents include acyclovir, valacyclovir, vidarabine, acyclovir, and interferon. Anti-inflammatory analgesics include aspirin, antiphen tablets, vitamin B1, vitamin B12, and the like. Topical medications for topical sores include: 2% gelatin violet solution or externally used acid sorba zinc oil compound. Neomycin ointment can be used externally if there is a secondary infection.

The treatment methods and medications mentioned above can relieve pain and eliminate clinical herpes symptoms. However, Western medicine treatment has the disadvantage of long treatment period, severe liver and kidney damage, high side effects, high treatment cost, frequent sequelae of neuralgia, and easy recurrence after complete recovery.

A primary 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 problems. This composition utilizes the synergistic effects of the active ingredients of various traditional Chinese medicines with a focus on the etiology and pathogenesis of shingles. The composition of the present invention can remove heat and toxins, remove moisture and pain, remove blood stasis, detoxify, remove, remove decay, and promote muscle growth, so as to treat shingles without leaving scars, neuralgia and other sequelae.

In order to achieve the object of the present invention, one aspect of the present invention provides a composition for treating shingles, which has the following raw materials as main components: Scutellaria scaphigera, 黃連, gold (Scutellaria baicalensis Georgi, 黃芩), yellow white ( Phellodendron amurense (黃柏), rhubarb (Rhubarb, 大黃), gentian (Gentian, 龍膽草).

The weight ratio of the raw materials is 3-20 for Sterculia scaphigera, 2-15 for Scutellaria baicalensis Georgi, 3-15 for Phellodendron amurense, and 3-15 for rhubarb. 2-20, Gentian, 3-15.

Another aspect of the present invention provides a method for preparing a composition for treating shingles comprising the following steps: 1) Prepare raw materials in the following weight ratio. Sterculia scaphigera 3-20, Scutellaria baicalensis Georgi 2-15, Phellodendron amurense 3-15, Rhubarb 2-20, Gentian Dragons and Dragons) 3-15; 2) uniformly mixing the raw materials, extracting by heating the mixture, and collecting the extract; 3) Concentrate the collected extract to prepare the active ingredient of the drug of the present invention.

Here, the amount of the raw material is preferably 5-10 parts by weight of Sterculia scaphigera, 5-10 parts by weight of gold (Scutellaria baicalensis Georgi, 黃芩), 5-10 parts by weight of Phellodendron amurense, rhubarb ( Rhubarb, 大黃) 6-10 parts by weight, gentian (Gentian, 龍膽草) 5-10 parts by weight.

Step 2) is a step of pulverizing and then mixing the raw materials, and the heating extraction includes the following steps: A) immersing the mixture in water, wherein the weight ratio of the added water to the mixture is 3-6:1 , and after 20-90 minutes of immersion, the first heat extraction is performed, wherein the heating temperature is 100 ° C. and the heat extraction time is 1-5 hours. B) filter the first extract and collect the filtrate; C) Water is added to the filter residue and secondary heating extraction is performed, wherein the weight ratio of the added water to the mixture is 1-5:1, the heating temperature is 100 ° C, and the heating extraction time is 1-3 hours; D) Filter and combine the two filtered filtrates.

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

Here, when concentrating the extract in step 3), the temperature is adjusted to 80 to 100 ° C, preferably 100 ° C; The extract is concentrated to a concentrated solution with a specific gravity of 1.05-1.50, preferably a specific gravity of 1.10-1.35.

The active ingredient of the medicine of the present invention can be added together with various conventional auxiliary substances necessary for preparing different dosage forms, such as disintegrants, lubricants, binders, etc., and can be formulated into any conventional oral dosage form by conventional Chinese traditional medicine preparation methods. , For example, it can be prepared into dosage forms such as pills, powders, tablets, granules, capsules, oral liquids, and the like.

When using the composition for the treatment of herpes zoster prepared by the present invention, 5 to 7 g (herbal medicine) is taken orally once or twice a day. Pregnant women are prohibited from taking it. Avoid spicy food, cold food, seafood food, oily food, and smoking while taking the medicine. After 5-10 days of use, pain disappears, band-shaped blisters disappear, and skin redness and swelling recover. After healing, there is no erythema or pigmentation, and no scars remain.

The clinical therapeutic effect of the composition for treating herpes zoster of the present invention will be further explained using the following test examples.

Test Example 1. Clinical observation of the effect of the composition for treating shingles of the present invention on the treatment of shingles

(1) General information:

In order to understand the therapeutic effect, a total of 120 cases, including 60 male patients and 60 female patients aged 18 to 65, were observed for the composition (powder) for the treatment of herpes zoster of the present invention. Cases were randomly divided into treatment and control groups. Of these, 70 cases were in the treatment group and 50 cases were in the control group. All of them were diagnosed with herpes zoster and developed within 7 days without any other complications or secondary diseases. There were no significant differences in age, sex and disease course between the two groups.

(2) Diagnostic criteria for herpes zoster:

1. The skin lesions are mostly watery scars the size of mung beans, clustered in clumps, with dense scar walls and a red base, often unilaterally distributed and arranged in ribbons. In severe cases, skin lesions may bleed or cause gangrene damage. Skin lesions of the head and face tend to be more severe.

2. There is often a tingling or burning sensation on the skin before the appearance of a rash, which may be accompanied by mild body discomfort and fever.

3. Conscious pain is evident, there is unbearably severe pain, or the pain remains even after the rash has subsided.

(3) Treatment method

Treatment group: Oral administration of the composition (powder) for treatment of herpes zoster of the present invention twice a day, 5-7 g each (herbal medicine), continuous administration for 5-10 days, spicy food, cold food, seafood food, greasy food during taking the medicine , prohibit smoking.

Control group: Acyclovir tablets were taken orally at 0.2 g/time, 3 times a day.

(4) Criteria for evaluating the treatment effect of herpes zoster:

1. Treatment: The rash subsides, the clinical symptoms disappear, and there are no pain sequelae.

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

3. Non-healing: Less than 30% of rashes have subsided and are still painful.

(5) Clinical trial results

The experimental results are shown in Tables 1 and 2.

Table 1. Herpes zoster treatment result table

Table 2: Herpes zoster treatment results table

The result shows:

1. The therapeutic effect of the composition for treating herpes zoster of the present invention is remarkable, and the clinical herpes zoster rash disappears; The cure rate was 97.1%, the improvement rate was 2.9%, and the total effective rate was 100%.

2. The composition for treating herpes zoster of the present invention has a fast effect and a short treatment period. After 6-10 days of treatment, the cure rate of patients reached 91.4%, of which: the cure rate of 1-2 days reached 10%; The cure rate of 3-5 days reached 17.1%; Within 6-10 days, the cure rate reached 64.3%; On the other hand, the control group had a long treatment period, requiring more than 5 days of treatment.

3. The pharmaceutical composition of the present invention is free from toxic side effects, allergic reactions and other side effects, indicating that the composition for treating herpes zoster of the present invention has no side effects on the human body.

4. After using the product of the present invention on subjects, it was followed up and observed that there was no recurrence of herpes zoster for 6-12 months.

Test Example 2. Clinical pharmacology and toxicity test of the composition for the treatment of herpes zoster of the present invention

(1) Acute toxicity test

The powder 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 1 week.

(2) long-term toxicity test

The herpes zoster composition tablet of the present invention was subjected to a long-term toxicity test on rats, and a high dose (100 times the adult dose) was continuously administered by gavage. The duration of administration is long (90 days). General performance, body weight, food intake, hematology and serum biochemical parameters, urine routine, bone marrow classification, organ weight, and organ counts are detection indicators, complemented by pathological examination of various animal tissues and organs to comprehensively evaluate the toxic status. do. Results showed that all indicators of house mice were normal. As a result of histopathological examination, there were no abnormalities in the organs of the rats.

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

Example 1. Preparation of pharmaceutical capsules of the present invention

1) Weigh raw materials according to the following ratio (Unit: g)

Sterculia scaphigera (黃連) 5, Golden (Scutellaria baicalensis Georgi, 黃芩) 15, Yellow baek (Phellodendron amurense, 黃柏) 10, Rhubarb (大黃) 10, Gentian (龍膽草) 5.

Of these, Sterculia scaphigera (黃連), Scutellaria baicalensis Georgi (黃芩), Phellodendron amurense (黃柏), Rhubarb (大黃), and Gentian (龍膽草) are each ground into coarse powder. Here, the size of the coarse powder is 24 to 50 mesh and is uniformly mixed to prepare a coarse powder mixture for later use.

2) Put the uniformly mixed coarse powder mixture into a traditional Chinese medicine multi-functional extraction kettle, add tap water and soak for 30 minutes, and set the weight ratio of the added tap water to the coarse powder mixture to be 6:1.

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, hold at this temperature, lift for 2 hours, and filter to obtain the first extract.

4) Add tap water to the filtration residue, the weight ratio of the added tap water and the coarse powder mixture is 3:1, proceed with thermal extraction, wherein the heating temperature is 100 ° C, the extraction time is 1 hour, and the second extraction liquid is obtained by filtration;

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

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

Example 2. Preparation of pharmaceutical tablets of the present invention

1) Weigh raw materials according to the following ratio (Unit: g)

Sterculia scaphigera (黃連) 10, Golden (Scutellaria baicalensis Georgi, 黃芩) 2, Yellow baek (Phellodendron amurense, 黃柏) 5, Rhubarb (大黃) 20, Gentian (龍膽草) 10.

Of these, Sterculia scaphigera (黃連), Scutellaria baicalensis Georgi (黃芩), Phellodendron amurense (黃柏), Rhubarb (大黃), and Gentian (龍膽草) are each ground into coarse powder. Here, the size of the coarse powder is 24 to 50 mesh and is uniformly mixed to prepare a coarse powder mixture for later use.

2) Put the uniformly mixed coarse powder mixture into a traditional Chinese medicine multifunctional extraction kettle and soak it in tap water for 60 minutes. At this time, the weight ratio of the added tap water and the coarse powder mixture was 4:1.

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, hold at this temperature, lift for 1.5 hours, and filter to obtain the first extract.

4) Add tap water to the filtration residue, the weight ratio of the added tap water and the coarse powder mixture is 3:1, proceed with thermal extraction, wherein the heating temperature is 100 ° C, the extraction time is 1.5 hours, and the second extraction liquid is obtained by filtration.

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

6) Grind the dried extract into fine powder, add sub-materials to make particles, and then dry to make tablets.

Example 3. Preparation of pellets of the medicament of the present invention

1) Weigh raw materials according to the following ratio (Unit: g)

Sterculia scaphigera 3, Scutellaria baicalensis Georgi 10, Phellodendron amurense 15, Rhubarb 6, Gentian 3.

Of these, Sterculia scaphigera (黃連), Scutellaria baicalensis Georgi (黃芩), Phellodendron amurense (黃柏), Rhubarb (大黃), and Gentian (龍膽草) are each ground into coarse powder. Here, the size of the coarse powder is 24 to 50 mesh and is uniformly mixed to prepare a coarse powder mixture for later use.

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

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, hold at this temperature, lift for 3 hours, and filter to obtain the first extract.

4) Add tap water to the filtration residue, the weight ratio of the added tap water and the coarse powder mixture is 1:1, proceed with thermal extraction, wherein the heating temperature is 100 ° C, the extraction time is 1 hour, and the second extraction liquid is obtained by filtration.

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

6) After pulverizing the dried extract into fine powder, mix it with purified honey as an auxiliary ingredient. After uniformly stirring, it is put into a pill maker for pills, and the prepared pills are dried in a drying box to make a finished product.

Example 4. Preparation of drug particles of the present invention

1) Weigh raw materials according to the following ratio (Unit: g)

Sterculia scaphigera 20, Scutellaria baicalensis Georgi 5, Phellodendron amurense 3, Rhubarb 2, Gentian 15.

Of these, Sterculia scaphigera (黃連), Scutellaria baicalensis Georgi (黃芩), Phellodendron amurense (黃柏), Rhubarb (大黃), and Gentian (龍膽草) are each ground into coarse powder. Here, the size of the coarse powder is 24 to 50 mesh and is uniformly mixed to prepare a coarse powder mixture for later use.

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

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, hold at this temperature, lift for 1 hour, and filter to obtain the first extract.

4) Add tap water to the filtration residue, the weight ratio of the added tap water and the coarse powder mixture is 3:1, conduct thermal extraction, wherein the heating temperature is 100 ° C, the extraction time is 2 hours, and the second extraction liquid is obtained by filtration.

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

6) Grind the dried extract into fine powder, add ethanol as a binder, and add starch as an auxiliary material to make granules.

Example 5. Preparation of an oral liquid of the medicament of the present invention

1) Weigh raw materials according to the following ratio (Unit: g)

Sterculia scaphigera 7.5, Scutellaria baicalensis Georgi 7.5, Phellodendron amurense 7.5, Rhubarb 8, Gentian 7.5.

Of these, Sterculia scaphigera (黃連), Scutellaria baicalensis Georgi (黃芩), Phellodendron amurense (黃柏), Rhubarb (大黃), and Gentian (龍膽草) are each ground into coarse powder. Here, the size of the coarse powder is 24 to 50 mesh and is uniformly mixed to prepare a coarse powder mixture for later use.

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

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, hold at this temperature, lift for 2 hours, and filter to obtain the first extract.

4) Add tap water to the filtration residue, the weight ratio of the added tap water and the coarse powder mixture is 2:1, conduct thermal extraction, wherein the heating temperature is 100 ° C, the extraction time is 3 hours, and the second extraction liquid is obtained by filtration.

5) Combine the two extracts and concentrate to obtain an extract with a specific gravity of 1.10.

6) The concentrated liquid is packaged in a plastic composite film to make an oral liquid formulation.

Claims (5)

Sterculia scaphigera, 3-20 parts by weight, Gold (Scutellaria baicalensis Georgi, 黃芩) 2-15 parts, Yellow 3-15 parts by weight, Rhubarb (Rhubarb, 大黃) 2-20 A composition for the treatment of herpes zoster containing 3-15 parts by weight of gentian, gentian herb. According to claim 1,
Sterculia scaphigera, 5-10 parts by weight, Gold (Scutellaria baicalensis Georgi, 黃芩) 5-10 parts, Yellow 5-10 parts by weight, Rhubarb (Rhubarb, 大黃) 6-10 A composition for treating herpes zoster containing 5 to 10 parts by weight of gentian, gentian herb. A method for preparing a pharmaceutical composition for treating herpes zoster, the method comprising:
1) As raw materials, 3-20 parts by weight of Sterculia scaphigera, 2-15 parts by weight of gold (Scutellaria baicalensis Georgi, 黃芩), 3-15 parts by weight of Phellodendron amurense, 3-15 parts by weight of rhubarb (Rhubarb, ) 2-20 parts by weight, preparing 3-15 parts by weight of Gentian;
2) uniformly mixing the raw materials, adding water to immersion, heating and extracting the mixture to collect extracts;
3) comprising the step of concentrating the collected extract,
method. According to claim 3,
In step 2), the raw materials are pulverized and then mixed, and the heating and extraction are:
A) The mixture is immersed in water, wherein the weight ratio of the added water and the mixture is 3-6:1, and the first heat extraction is performed after 20-90 minutes of immersion, wherein the heating temperature is 100 ° C and the heat extraction time is 1-5 hours, the first heating and extraction step;
B) filtering the first extract and collecting the filtrate;
C) Water is added to the filter residue, and secondary heating and extraction are performed, wherein the weight ratio of the added water and the mixture is 1-5:1, the heating temperature is 100 ° C, and the heating extraction is performed for an hour. a second heating and extraction step, which is 1-3 hours;
D) filtering and combining the two filtered filtrate;
including,
method. According to claim 4,
The raw material is ground into a coarse powder having a particle size of 10-50 mesh and then mixed.
method.