KR20230054100A - 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 preparation method thereof. The composition for treating shingles consists of the following raw materials: Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb, and Gentian. The present invention aims at the etiology and the occurrence of shingles and utilizes the synergistic effect of the active ingredients of various traditional Chinese medicine for the treatment of shingles by eliminating heat, toxins, moisture, pain, blood stagnation, and putrefaction, and promoting muscle growth. Additionally, there are no after effects such as scars, neuralgia, etc.

Description

A traditional Chinese medicine composition and a preparation method thereof}

The present invention relates to a traditional Chinese medicine and a method for preparing the same, particularly 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. Although this virus does not usually catch it, it is easy to cause shingles in the case of physical fatigue or cold because the immune system of the elderly is lowered.

The main oral Western medicines used to treat herpes zoster include antivirals, pain relievers, immunomodulators, and corticosteroids. Antiviral agents include acyclovir, valacyclovir, vidarabine, and interferon. Anti-inflammatory analgesics include aspirin, antifungals, vitamin B1 and vitamin B12. Topical medications for topical sores include: 2% gentian violet solution or Sanguisorba zinc oxide oil compound for external use. 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 symptoms of herpes. However, Western medicine treatment has the disadvantages of long treatment period, damage to the liver and kidneys, large side effects, and high treatment cost.

An object of the present invention is to provide a traditional Chinese medicine and a method for preparing the same, particularly a pharmaceutical composition for treating herpes zoster and a method for preparing the same.

In view of the above problems, an object of the present invention is to provide a composition for treating shingles and a method for preparing the same.

In order to achieve the object of the present invention, one aspect of the present invention provides a composition for treating herpes zoster comprising the following raw materials as main components: Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, rhubarb ( Rhubarb) and Gentian,

1) Prepare raw materials in the following weight ratio:

Codonopsis pilosula 3-20, Platycodon grandiflorus 2-15, Schizonepeta 3-15, Rhubarb 2-20 and Gentian 3-15;

2) The raw materials are uniformly mixed and the mixture is heated and extracted to obtain an extract;

3) Concentrate the obtained extract to prepare an effective pharmaceutical ingredient of the present invention.

The weight ratio of the raw materials is preferably Codonopsis pilosula 5-10, Platycodon grandiflorus 5-10, Schizonepeta 5-10, Rhubarb 6-10 and Gentian 5-10 am.

Step 2) is to grind and mix raw materials, and heat extraction includes the following steps.

A) The mixture is immersed in water, at this time, the weight ratio of the added water and the mixture is 3 to 6:1, and the first heat extraction is performed 20 to 90 minutes after immersion. At this time, the heating temperature is 100 ° C, and the heating extraction time is 1 hour to 5 hours;

B) filter the primary extract and obtain a filtrate;

C) Water is added to the filtration residue, and a second heat extraction is carried out. The weight ratio of the added water and 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;

In particular, raw materials are pulverized and mixed into a coarse powder having a particle size of 10 to 50 mesh; In step A), the immersion time is preferably 30 to 60 minutes, the weight ratio of the added water and the mixture is preferably 4 to 6: 1, and the first heating extraction time is preferably 1 to 3 hours, The weight ratio of the water added in step C) to the mixture is 1 to 3:1.

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

The pharmaceutically active ingredient of the present invention may be added with various conventional auxiliary substances necessary for preparing various formulations such as disintegrants, lubricants, binders, and the like. In addition, it can be made into any conventional oral dosage form such as pills, powders, tablets, granules, capsules, oral liquids and the like by the traditional Chinese medicine preparation method.

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

The composition for treating herpes zoster of the present invention targets the etiology and onset of herpes zoster, and utilizes the synergistic effect of active ingredients of various traditional Chinese medicines. In addition, it can treat shingles by removing heat, toxins, moisture, pain, blood stasis and decay, and promoting muscle growth, without leaving scars, neuralgia and other sequelae.

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

A total of 120 subjects, including 60 male patients and 60 female patients aged 18-65 years, were observed to confirm the therapeutic effect of the composition (powder) for treating herpes zoster of the present invention. Subjects were randomly divided into treatment and control groups. Among them, there were 70 cases in the treatment group and 50 cases 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. Most of the skin lesions are watery scars the size of mung bean, clustered in clumps, with dense scar walls and red bases, often unidirectionally 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 may be severe unbearable pain, or pain may remain 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, 5-7g once (herbal medicine), continuous taking for 5-10 days, prohibition of spicy and cold food, seafood and fatty food, Smoking cessation during medication.

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

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

1. Cured: 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. Untreated: Less than 30% of rashes have subsided and are still painful.

(5) Clinical trial results

Tables 1 and 2 are herpes zoster treatment results.

Target Cured (persons) improvement (person) Not treated (persons) Cure rate (%) Treatment group (70 people) 68 2 0 97.1% Control group (50 people) 46 3 One 92%

Target 1-2 days later
Cured (persons) after 3-5 days
Cured (persons) after 6-10 days
Cured (persons) Cured after more than 10 days (persons) treatment group 7 12 45 4 control group 0 0 9 37

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 patient's cure rate reached 91.4%, of which: 1-2 days' cure rate was 10%, 3-5 days' cure rate was 17.1%, and within 6-10 days, the cure rate reached 64.3%. On the other hand, the control group needed treatment for more than 5 days because the treatment period was long.

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 the subject, follow-up observation is performed to observe whether there is no recurrence of herpes zoster for 6-12 months.

Experimental 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 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 1 week.

(2) long-term toxicity test

A long-term toxicity test was performed on rats with the tablets of the herpes zoster composition of the present invention, and a continuous high dose (100 times the adult dose) was administered by gavage. The duration of treatment was long (90 days). General performance, body weight, food intake, blood and serum biochemical parameters, urine routine, bone marrow classification, organ weight, and organ count are detection indicators, and pathological examination of various animal tissues and organs to comprehensively evaluate the toxicity status of drugs. was supplemented with Results showed that all indicators of the rats were normal. As a result of histopathological examination, there was no abnormality in the organs of the rat.

In summary, the composition for treating 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)

Codonopsis pilosula 5, Platycodon grandiflorus 15, Schizonepeta 10, Rhubarb 10, Gentian 5

Of these, Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb, and Gentian are pulverized into coarse powder with a particle size of 24-50 mesh, and mixed uniformly to be used later. Prepared for use as a coarse powder mixture;

2) Put the uniformly mixed coarse powder mixture into an herbal multifunctional extraction kettle, add tap water, and soak for 30 minutes. The ratio of the weight of the added tap water to the weight of the coarse powder mixture is 6:1;

3) Turn on the power of the multi-functional extraction kettle for heating, heat to 100 ° C, and maintain this temperature for 2 hours by raising and filtering to obtain a primary extract;

4) Add tap water to the filtration residue, the ratio of the weight of the added tap water to the weight of the coarse powder mixture is 3:1, and heat the extract, wherein the heating temperature is 100°C and the extraction time is 1 hour; It was filtered to obtain a secondary extract;

5) The two extracts were 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) The dried extract was pulverized into a fine powder of 100-150 mesh and filled into hard gelatin capsules 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)

Codonopsis pilosula 10, Platycodon grandiflorus 2, Schizonepeta 5, Rhubarb 20, Gentian 10

Of these, Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb, and Gentian are pulverized into coarse powder with a particle size of 24-50 mesh, and mixed uniformly to be used later. Prepared for use as a coarse powder mixture;

2) Put the uniformly mixed coarse powder mixture into an herbal multifunctional extraction kettle, add tap water, and soak for 60 minutes. The ratio of the weight of the added tap water to the weight of the coarse powder mixture is 4:1;

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, and maintain this temperature for 1.5 hours by raising and filtering to obtain a primary extract;

4) Tap water was added to the filtration residue, the ratio of the weight of the added tap water to the weight of the coarse powder mixture was 3:1, and the extract was heated at a heating temperature of 100° C. and an extraction time of 1.5 hours. Filtration gave a secondary extract;

5) The two extracts were 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) The dried extract was finely pulverized and sub-materials were added to make particles, which were then dried and compressed into tablets.

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

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

Codonopsis pilosula 3, Platycodon grandiflorus 10, Schizonepeta 15, Rhubarb 6, Gentian 3

Of these, Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb, and Gentian are pulverized into coarse powder with a particle size of 24-50 mesh, and mixed uniformly to be used later. Prepared for use as a coarse powder mixture;

2) Put the uniformly mixed crude powder mixture into an herbal multifunctional extraction kettle, add tap water, and soak for 20 minutes. The ratio of the weight of the added tap water to the weight of the coarse powder mixture is 5:1;

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, and maintain this temperature for 3 hours by raising and filtering to obtain a primary extract;

4) Tap water was added to the filtration residue, the ratio of the weight of the added tap water to the weight of the coarse powder mixture was 1:1, and the extract was heated at a heating temperature of 100°C and an extraction time of 1 hour. Filtration gave a secondary extract;

5) The two extracts were 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, it was mixed with purified honey as a supplementary material. After stirring uniformly, it was put into a pill maker for pills, and the prepared pills were dried in a drying box to prepare a finished product.

Example 4. Preparation of drug particles of the present invention

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

Codonopsis pilosula 20, Platycodon grandiflorus 5, Schizonepeta 3, Rhubarb 2, Gentian 15

Of these, Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb, and Gentian are pulverized into coarse powder with a particle size of 24-50 mesh, and mixed uniformly to be used later. Prepared for use as a coarse powder mixture;

2) Put the uniformly mixed coarse powder mixture into an herbal multifunctional extraction kettle, add tap water, and soak for 90 minutes. The ratio of the weight of the added tap water to the weight of the coarse powder mixture is 3:1;

3) Turn on the power of the multifunctional extraction kettle for heating, heat to 100 ° C, and maintain this temperature for 1 hour by raising and filtering to obtain a primary extract;

4) Add tap water to the filtration residue, the ratio of the weight of the added tap water to the weight of the coarse powder mixture is 3:1, and the extract is heated, the heating temperature is 100°C and the extraction time is 2 hours; It was filtered to obtain a secondary extract;

5) The two extracts were 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) The dried extract was pulverized into a fine powder, ethanol was added as a binder, and starch as an auxiliary material was added 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)

Codonopsis pilosula 7.5, Platycodon grandiflorus 7.5, Schizonepeta 7.5, Rhubarb 8, Gentian 7.5

Of these, Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb, and Gentian are pulverized into coarse powder with a particle size of 24-50 mesh, and mixed uniformly to be used later. Prepared for use as a coarse powder mixture;

2) Put the uniformly mixed coarse powder mixture into an herbal multifunctional extraction kettle, add tap water, and soak for 45 minutes. The ratio of the weight of the added tap water to the weight of the coarse powder mixture is 6:1;

3) Turn on the power of the multi-functional extraction kettle for heating, heat to 100 ° C, and maintain this temperature for 2 hours by raising and filtering to obtain a primary extract;

4) Tap water was added to the filtration residue, the ratio of the weight of the added tap water to the weight of the coarse powder mixture was 2:1, and the extract was heated at a heating temperature of 100° C. and an extraction time of 3 hours. Filtration gave a secondary extract;

5) The two extracts were combined and concentrated to obtain 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 Codonopsis pilosula, Platycodon grandiflorus, Schizonepeta, Rhubarb and Gentian,
The weight ratio of the raw materials is Codonopsis pilosula 3-20, Platycodon grandiflorus 2-15, Schizonepeta 3-15, Rhubarb 2-20, Gentian 3-15, target A pharmaceutical composition for treating herpes.
The method according to claim 1, the weight ratio of the raw material is Codonopsis pilosula 5-10, Platycodon grandiflorus 5-10, Schizonepeta 5-10, Rhubarb 6-10 and Gentian 5-5 Which is selected from ~ 10, a pharmaceutical composition for the treatment of herpes zoster.
1) Preparing raw materials according to the following parts by weight:
Codonopsis pilosula 3-20, Platycodon grandiflorus 2-15, Schizonepeta 3-15, Rhubarb 2-20, Gentian 3-15;
2) uniformly mixing the raw materials, adding water to soak, and heat-extracting the mixture to obtain an extract; and
3) Concentrating the obtained extract to obtain a pharmaceutical composition; Method for producing a pharmaceutical composition for the treatment of herpes zoster, including.
The method according to claim 3, wherein in step 2), raw materials are ground and mixed, and heat extraction is performed according to the following steps:
A) The mixture is immersed in water, at this time, the weight ratio of the added water and the mixture is 3 to 6:1, and the first heat extraction is performed 20 to 90 minutes after immersion. At this time, the heating temperature is 100 ° C, and the heating extraction time is 1 hour to 5 hours;
B) filter the primary extract and obtain a filtrate;
C) Water is added to the filtration residue, and a second heat extraction is carried out. The weight ratio of the added water and 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 filtrate;
The method according to claim 4, wherein the raw material is pulverized and mixed into a coarse powder having a particle size of 10 to 50 mesh.