CN113663028A

CN113663028A - Traditional Chinese medicine gel for treating tuberculous ulcer and preparation method thereof

Info

Publication number: CN113663028A
Application number: CN202010412512.4A
Authority: CN
Inventors: 黄子慧; 柯学; 钱佳燕; 刘万里; 施金土; 李欣; 王旭; 朱群; 朱敏; 颜延凤; 陈磊垚; 赵璟
Original assignee: NANJING INTEGRATED TRADITIONAL CHINESE AND WESTERN MEDICINE HOSPITAL
Current assignee: NANJING INTEGRATED TRADITIONAL CHINESE AND WESTERN MEDICINE HOSPITAL
Priority date: 2020-05-15
Filing date: 2020-05-15
Publication date: 2021-11-19

Abstract

The invention discloses a traditional Chinese medicine gel for treating tuberculous ulcer and a preparation method thereof. The traditional Chinese medicine preparation provided by the invention adopts the compatibility of the five-phoenix-fern, the bletilla striata and the radix ranunculi ternati, and has the effects of expelling toxin, removing putrefaction, and transforming muscles and promoting tissue regeneration. The gel prepared by the invention has excellent spreadability, good coupling with wound surface, full contact of the medicine and difficult loss from the wound surface, so that the dosage and the administration frequency can be stabilized. Clinical tests prove that the novel traditional Chinese medicine gel for treating tuberculous ulcer has the effects of detoxifying, removing putrefaction, astringing and promoting granulation. The invention provides a traditional Chinese medicine gel preparation for treating tuberculous ulcer, which has simple preparation process, does not need a large amount of equipment, is suitable for industrial production, is beneficial to popularization and application, and can be used as an option for improving the dosage form of the traditional Chinese medicine preparation.

Description

Traditional Chinese medicine gel for treating tuberculous ulcer and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine gel for treating tuberculous ulcer and a preparation method thereof.

Background

Tuberculous ulcer, also called ulcerative tuberculosis of skin, refers to the wound surface formed by the necrosis of soft tissues, subcutaneous tissues and skin around the focus of infection caused by the invasion of local tissues of organisms by Mycobacterium Tuberculosis (MTB) through various propagation paths and the final liquefaction and ulceration, belongs to extrapulmonary tuberculosis, and is the most common clinical specific infectious ulcer. Tuberculous ulcer can be classified into exogenous, endogenous and blood-derived disseminated type according to its infection source and transmission route. Clinically, it is marked by profuse and dribbling pus on the wound surface, pale granulation, lingering and difficult to heal, or recurrent attacks after pseudohealing, and is considered as clinically intractable aeipathia. With the progress of the mutation of Mycobacterium tuberculosis and the generation of drug-resistant strains, the incidence of tuberculosis has been increasing in recent years. The latest research shows that the number of patients with diabetes and AIDS combined tuberculosis is gradually increased, and the drug resistance rate is obviously higher than that of the tuberculosis group only. It is inferred that the incidence of tuberculous ulcer and the treatment difficulty are increased.

The existing treatment method aiming at the disease is mainly based on systemic antitubercular chemotherapy and assisted by local treatment. Local treatment mostly adopts the technology or drug therapy for promoting wound repair. Common means of technical treatment include surgical treatment, negative pressure wound treatment, microwave treatment and the like. Surgical operations are risky, for example, failure of the operation can bring greater attacks to diseases, and the operation is expensive and has limited groups; negative pressure wound therapy is only applicable to low to moderate exudation wounds and cannot be applied to large, deep wounds or sinus tracts; the microwave treatment is not suitable for wound surfaces with large pus volume, and has long treatment time for one time and inconvenient use. The topical medicine comprises western anti-tuberculosis medicines such as streptomycin, rifampicin, isoniazid, etc., and some Chinese medicinal preparations and pellet medicines in hospital. The traditional Chinese medicine, especially the pellet preparation, has obvious effect superior to the western medicine for resisting tuberculosis, but the safety of the traditional Chinese medicine is clinically questioned.

A large amount of clinical and laboratory researches are carried out in the early stage of a subject group, the pathogenesis characteristics of the tuberculous ulcer, namely toxic decay stagnation and deficiency of qi and blood are combined, the proved recipe of the famous and old traditional Chinese medicine is selected, and the obtained compound external traditional Chinese medicine (the five-phoenix-leaf, the bletilla striata and the radix ranunculi ternate) is prepared into a hospital preparation, so that the clinical effect is exact, and the hospital preparation is safe and reliable. But the prior preparation process is quite simple, the preparation process is extremely crude, the drug effect is unstable, the administration is inconvenient, the dosage is not easy to control, and the long-term storage is not facilitated. In order to develop clinical demonstration research for popularization and application, the improvement of the dosage form is urgent.

The gel is a thick liquid or semi-solid preparation prepared from the medicine and auxiliary materials capable of forming gel and in the form of solution, suspension or emulsion, and is suitable for administration on skin, mucous membrane and cavity. The gel has the advantages of easy coating, easy cleaning, no contamination to clothes, high absorption rate, high bioavailability, etc., and has certain controlled release effect on the medicine. In addition, the gel is simple to prepare, and usually, the polymer material is swelled in the solvent and then added with the drug solution and other additives to fully swell and absorb the drug. The gel preparation starts earlier and develops faster in foreign countries, but all belong to chemical drug gel preparations. Chinese traditional medicine gel is in development stage.

The traditional Chinese medicine is a treasure in China, and the traditional Chinese medicine dosage form is difficult to meet the requirements of high efficiency, quick acting, small administration dosage, low toxic and side effects and sustained and controlled release administration, so that the development of a new traditional Chinese medicine dosage form for treating tuberculous ulcer is significant in the face of high-prevalence environment.

Disclosure of Invention

The invention aims to provide a novel traditional Chinese medicine gel for treating tuberculous ulcer.

The second purpose of the invention is to provide a preparation method of the novel traditional Chinese medicine gel for treating tuberculous ulcer.

The third purpose of the invention is to provide the application of the prepared traditional Chinese medicine gel as a medicine for treating tuberculous ulcer.

In order to achieve the purpose, the technical scheme provided by the invention is as follows:

a traditional Chinese medicine gel for treating tuberculous ulcer comprises the following raw material components in parts by mass: 160-240 parts of five-leaf phoenix-tail fern, 15-35 parts of bletilla striata and 20-60 parts of radix ranunculi ternati; the gel matrix comprises the following components in parts by mass: 15-30 parts of a gel framework material, 75-150 parts of a humectant, 844-1688 parts of purified water, 1-2 parts of a preservative, 5-10 parts of 95% ethanol and 30-60 parts of a neutralizer.

Wherein the gel matrix material is carbomer, the humectant is glycerin, the preservative is ethylparaben, and the neutralizer is triethanolamine.

Carbomer type is carbomer 980.

The preparation method of the traditional Chinese medicine gel for treating tuberculous ulcer comprises the following steps:

1) weighing the raw materials according to the mass parts, soaking the raw materials in pure water for 1h, and then adding water for decocting for 1h to obtain a first extraction solution; soaking the residue in purified water, and decocting for 40min to obtain a second extractive solution; concentrating the first and second extractive solutions, precipitating for 24 hr, collecting supernatant, and concentrating under heating to obtain compound radix Aconiti Kusnezoffii solution;

2) distilling the compound herba Pteridis Multifidae extractive solution under reduced pressure to obtain compound herba Pteridis Multifidae concentrated solution;

3) weighing a gel framework material, adding a humectant to moisten the gel framework material, gradually adding a proper amount of water, and continuously grinding to uniformly disperse the gel framework material;

4) adding the compound herba pteridis multifidae concentrated solution into the mixed solution obtained in the step 3) under stirring;

5) dissolving a preservative in 95% ethanol, and adding the preservative into the mixed solution obtained in the step 4) under stirring;

6) and (4) dropwise adding a neutralizer into the mixed solution obtained in the step 5), and continuously stirring to obtain the Wufengcao gel.

In the step 1), 8 times of pure water is adopted when the raw material medicines are soaked in the pure water; the decoction is carried out by 5 times of pure water.

In the step 2), the reduced pressure distillation condition is 60 ℃ and-0.1 MPa.

The invention also protects the application of the prepared traditional Chinese medicine gel as a medicine for treating tuberculous ulcer.

Compared with the prior art, the invention has the beneficial effects that:

the traditional Chinese medicine gel for treating tuberculous ulcer is prepared from five-phoenix-tree fern, bletilla striata and radix ranunculi ternati. The pharmaceutical preparation selects the five-phoenix-leaved sweetflag herb aiming at the pathogenesis of tuberculous ulcer, has bitter and slightly cold properties, enters large intestine, small intestine and spleen channels, has the effects of removing putrefaction and detoxifying, and can inhibit the growth of tubercle bacillus at relative concentration as shown by pharmacological experiments; the bletilla striata is sweet and bitter in property and slightly cold in property, enters lung, liver and stomach channels, has the effects of promoting tissue regeneration, healing sore and stopping bleeding, and is found to have an inhibiting effect on human mycobacterium tuberculosis, increase the number of macrophages in wounds and play a role in protecting tissue healing through modern pharmacological research; the radix ranunculi ternati is sweet and pungent in nature and slightly warm, enters liver and lung meridians, can detoxify and reduce swelling, and decoction, crude drug powder and alcohol extract of the radix ranunculi ternati have different degrees of inhibition effects on virulent human tubercle bacillus (H37RV) in a test tube in modern pharmacological research. The medicines are used together to achieve the purposes of expelling toxin, removing putrefaction, and transforming muscle to generate new tissue, so as to treat chronic intractable tuberculous wound caused by pathogenic toxin retention and qi and blood deficiency.

The compatibility of the medicines of the traditional Chinese medicine preparation has the effects of expelling toxin, removing putrefaction, transforming muscles and promoting tissue regeneration, and the clinical verification proves that the novel traditional Chinese medicine gel for treating tuberculous ulcer has the obvious functions of detoxifying, removing putrefaction, astringing and promoting tissue regeneration.

The traditional Chinese medicine gel provided by the invention is an external medicine, directly acts on a local wound or sinus, has excellent spreadability, good coupling property with the wound, is fully contacted with the medicine, is not easy to run off from the wound, keeps the medicine concentration in a local tissue at an effective concentration, and can stabilize the administration dosage and the administration frequency.

In addition, the invention is the first traditional Chinese medicine gel preparation for treating tuberculous ulcer, has simple preparation process, does not need a large amount of equipment, is suitable for industrial production, is beneficial to popularization and application, and can be used as an option for improving the dosage form of the traditional Chinese medicine preparation.

Drawings

FIG. 1: the invention relates to a process flow chart for preparing a novel traditional Chinese medicine gel for treating tuberculous ulcer.

FIG. 2: the traditional Chinese medicine gel provided by the invention is used for treating a syndrome integral change chart of a tuberculous ulcer patient.

FIG. 3: the total effective rate change chart of the traditional Chinese medicine gel during the treatment period of the observation test example.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples. The following examples are intended to illustrate the invention only and are not intended to limit the scope of the invention.

Example 1

A preparation method of a novel traditional Chinese medicine gel for treating tuberculous ulcer comprises the following steps:

a. the following raw material medicines are taken according to the weight ratio: 160-240 g of five-phoenix-tree fern, 15-35 g of bletilla striata and 20-60 g of radix ranunculi ternati for later use.

b. Soaking the above materials in 8 times of pure water for 1h, and decocting with 5 times of water for 1h to obtain first extractive solution. Soaking the residues in 5 times of pure water, and decocting for 40min to obtain a second extractive solution. Concentrating the first and second extractive solutions to obtain a certain amount, precipitating for 24h, collecting supernatant, and heating and concentrating to 200mL to obtain FUFANGWUFENGCAO liquid.

c. And distilling the compound five-phoenix-tree fern extract under reduced pressure (60 ℃ and-0.1 MPa) to obtain 30-60 g of a concentrated solution for later use.

d. Taking 15-30 g of carbomer, adding 75-150 g of glycerol to moisten the carbomer, then gradually adding a proper amount of water, and continuously grinding to uniformly disperse the carbomer.

e. Adding 30-60 g of compound five-phoenix-fern concentrated solution under stirring.

f. Dissolving 1-2 g of ethylparaben in 5-10 g of 95% ethanol, and adding while stirring.

g. And (3) dropwise adding 30-60 g of triethanolamine and continuously stirring to obtain the Wufengcao gel.

Example 2

Selection of gel matrix material:

the following gels were prepared, respectively, based on 100g of the gel produced. The gels were examined for appearance, viscosity, spreadability, and primary stability. The results are shown in Table 1.

(1) Preparing carbomer gel:

9801.0 g of carbomer and 5.0g of glycerol are weighed, 70ml of water is added, 3.5g of compound five-phoenix-tree-grass concentrated solution is added after swelling, 1.5g of triethanolamine is added for neutralization to adjust viscosity, water is added to 100g, and stirring is carried out uniformly.

(2) Preparing hydroxypropyl methylcellulose, sodium carboxymethylcellulose and methylcellulose gel:

weighing 1.5g of hydroxypropyl cellulose, 1.5g of sodium carboxymethylcellulose and 6.0g of methyl cellulose, adding 5.0g of glycerol and 10g of water respectively, adding 3.5g of compound five-phoenix-grass concentrated solution after the matrix is swelled, adding water to 100g, and stirring uniformly.

Preliminary stability testing: taking the Wufengcao gel prepared by the matrixes, and respectively carrying out a centrifugal test, a heat resistance test and a cold resistance test.

(1) And (3) centrifugal test: 10g of the above five-phoenix-grass gel is taken, placed in a centrifuge tube, centrifuged at 3000rpm for 30min and then taken out.

(2) Heat resistance test: 10g of the five-phoenix-grass gel is taken, placed in a centrifuge tube, placed in a water bath at 55 ℃ for 6h and then taken out.

(3) Cold resistance test: 10g of the five-phoenix-grass gel is taken, placed in a centrifuge tube, placed at-15 ℃ for 24h and then taken out.

TABLE 1 gel matrix Material selection test

The result shows that the gel prepared by the carbomer in the gel matrix material has better appearance, spreadability and stability than other gel matrix materials, so the carbomer is preferably used as the gel matrix material.

Example 3

Selecting carbomer types:

the following different types of carbomer gels were prepared, respectively, based on 100g of gel produced. The gels were examined for appearance, viscosity, spreadability, and primary stability. The results are shown in Table 2.

Preparing carbomer gel: 9341.0 g of carbomer, 9401.0 g of carbomer and 9801.0 g of carbomer are weighed, 5.0g of glycerin is respectively added, 70ml of water is added, 3.5g of compound five-phoenix-tree-like grass concentrated solution is added after swelling, 1.5g of triethanolamine is added for neutralization to adjust the viscosity, water is added to 100g, and the mixture is stirred uniformly.

(1) And (3) centrifugal test: 10g of the above five-phoenix-grass gel is taken out respectively, placed in a centrifuge tube, centrifuged at 3000rpm for 30min and then taken out.

TABLE 2 carbomer type selection test

Carbomer is commonly used as an external gel matrix material in types of 934, 940 and 980, but experiments show that carbomer 980 can prepare gel with better appearance, spreadability and stability than carbomers 934 and 940, and therefore carbomer 980 is preferably used as a gel matrix material.

Example 4

And (3) screening the amount of carbomer 980:

the conventional amount of carbomer 980 is 0.5% -2.5%, stability and viscosity are taken as indexes, and carbomer 980 gel with three concentrations is examined.

Sample preparation: weighing 0.5g, 1.5g and 2.5g, respectively adding 5.0g of glycerol and 70ml of water, adding 3.5g of compound five-phoenix-grass concentrated solution after swelling, adding triethanolamine according to the dosage of 1g of carbomer 980 and 1.5g of triethanolamine, adding water to 100g, and uniformly stirring.

Preliminary stability testing: taking the Wufengcao gel prepared by the matrixes, and respectively carrying out a centrifugal test, a heat resistance test and a cold resistance test. The results are shown in Table 3.

TABLE 3 carbomer 980 dosage screening test

	1	2	3
				Carbomer 980 amount (%)	0.5	1.5	2.5
Centrifuging at 3000rpm for 30min	With a layer separation	Stabilization	Stabilization
				Standing at 55 deg.C for 6h	Not layering	Not layering	Not layering
Standing at-15 deg.C for 24 hr, and thawing at normal temperature	Not layering	Not layering	Not layering

The results show that 0.5% carbomer 980 contained the drug in a gel with a lower viscosity and delamination occurred after centrifugation. Although the 2.5% carbomer 980-containing gel is relatively stable, the gel has relatively high consistency, more foams are generated in the preparation process, and the gel is difficult to remove, so that the difficulty of the preparation process is increased. The 1.5% carbomer 980-containing gel has moderate viscosity, good stability, less generated bubbles, more attractive appearance and easy removal of the bubbles. Thus, the amount of carbomer 980 was selected to be 1.5% of the total formulation, i.e., 15g carbomer 980 was used to make 1000g of gel.

Example 5

Screening the using amount of glycerol:

the gel can be dehydrated and hardened in the storage process, so that a dry gel is formed and is not easy to spread, and a humectant is required to be added to maintain the stability of the dosage form and prevent the skin from being dried and cracked. The commonly used humectant in the external gel is glycerin, so the glycerin is selected as the humectant in the compound five-feng grass gel.

Sample preparation: weighing three parts of 1.5g carbomer, respectively adding 5.0g glycerol, 7.5g glycerol and 10.0g glycerol, adding 70ml water, swelling, adding 3.5g compound herba Penaeonidis concentrated solution, adding 3.0g triethanolamine, adding water to 100g, and stirring.

The samples are flatly laid in a flat weighing bottle, the weight of 3 samples is the same, and the samples are examined and placed at 25 ℃ for 24 hours under the condition of the same relative humidity, and then the samples are weighed to calculate the percentage of water loss. The results are shown in Table 4.

TABLE 4 Glycerol dosage Screen

The results show that 5.0% glycerol has slightly poor moisturizing effect, while 7.5% and 10.0% glycerol have similar moisturizing effect in the product gel, and from the viewpoint of saving cost, the amount of glycerol is selected to be 7.5%, namely 75g of glycerol is used for preparing 1000g of gel.

Example 6

Determining the type and the amount of the preservative:

the carbomer matrix is not itself nutritive and does not support the growth of bacteria and molds, but does not prevent bacteria and molds from utilizing the nutritional components present in the gel system. Different preservatives are selected according to the situation, such as ethylparaben, 0.01 percent of thimerosal, benzoic acid and sodium salt thereof, benzalkonium chloride and the like. The preservative can also be combined by mixing a plurality of preservatives to reduce the dosage and achieve the synergistic bacteriostatic effect.

Because of the high toxicity of thimerosal, benzoic acid and its sodium salt, benzalkonium chloride, reduce the viscosity of carbomer gel and even cause precipitation. The ethylparaben is a common preservative in the external gel, the optimal pH value for the ethylparaben to act is 4-7, and the ethylparaben is selected as the preservative in the compound five-phoenix-grass gel considering that the product is an external skin gel and the pH value is about 7. Referring to other literature studies, the amount was determined to be 0.1% by weight of the formulation, i.e., 1.0g of ethylparaben was used to make 1000g of gel.

Example 7

Determining the type of the neutralizer:

in order to form stable gel by the carbomer, the pH of the carbomer needs to be adjusted to 6-11, and the viscosity is reduced when the pH is less than 3 or more than 12. The mechanism is as follows: carboxyl in carbomer is ionized under the action of neutralizing agent, and curled molecules are unfolded due to the mutual repulsion of negative charges, so that the original volume is increased to about 1000 times, and the thickening effect is achieved. Neutralizing with alkaline substances such as sodium hydroxide, potassium bicarbonate, borax and triethanolamine in water and other polar solvents to form salt of carbomer; in less polar or non-polar solvents, neutralization with non-polar laurylamine and stearylamine, etc. is required.

The variety is aqueous gel, and sodium hydroxide and triethanolamine are most commonly used as neutralizing agents of the aqueous gel. Early experiments show that when sodium hydroxide is used as a neutralizing agent, the viscosity of the generated gel is extremely low, when the amount of the sodium hydroxide is increased, the viscosity is not increased, and when triethanolamine is used as the neutralizing agent, the gel with moderate viscosity can be formed, so that triethanolamine is selected as the neutralizing agent in the compound five-feng grass gel.

Example 8

Screening the dosage of triethanolamine:

sample preparation: weighing 1.5g of carbomer, adding 7.5g of glycerol, adding 70ml of water, adding 3.5g of compound five-phoenix-leaved sweetgum concentrated solution after swelling, finally respectively adding 2.5%, 3.0% and 3.5% of triethanolamine, adding water to 100g, and uniformly stirring to obtain the compound five-phoenix-leaved sweetgum gel with different triethanolamine dosages. Taking about 1.0g of compound wufengcao gel by using a 10mL beaker respectively, adding a small amount of distilled water, stirring, transferring to a 10mL volumetric flask, adding a proper amount of distilled water, performing ultrasonic treatment for 20min, cooling, performing constant volume, centrifuging, filtering, taking filtrate, measuring the pH value of a sample according to a pH value measuring method of 0631 in the four-part rules of the 2015 edition of Chinese pharmacopoeia, and obtaining a result shown in Table 5.

TABLE 5 triethanolamine dosage Screen

Amount of triethanolamine used	2.5％	3.0％	3.5％
				pH value	6.02	7.14	8.80

According to the test result, the pH value of the compound five-feng grass gel increases along with the increase of the dosage of the triethanolamine. Because the preparation is a skin external preparation, the pH value is about 7, and therefore, the triethanolamine dosage is 3.0 percent, namely the triethanolamine dosage for preparing 1000g of gel is 30 g.

Example 9

109 patients with tuberculous ulcer are treated by external application of the invention:

(1) collecting samples:

according to the relevant diagnosis standards of modern tuberculosis science and Chinese and western medicine pyocutaneous disease diagnosis and treatment science, 109 patients which are diagnosed as tuberculous ulcer in 2019-2020 in a Nanjing Chinese medicine and pharmacy affiliated Nanjing City Chinese and western medicine combined hospital are collected, wherein 41 patients are 41 patients, 68 patients are female patients, the patients are 18-70 years old, and the average age is 34.3 +/-2.63 years old; the disease course is 1.3-29 months, and the average is 6.76 +/-5.41 months; the wound area is 4-16cm²Average of 7.62 +/-3.26 cm²(ii) a The sinus depth is 2-4cm, and the average depth is 2.74 +/-0.63 cm.

(2) The local treatment method comprises the following steps:

removing adhesive plaster and dressing by conventional method, and cleaning pus and dirt around wound surface with dry cotton ball; disinfecting the skin around the wound by using an iodophor cotton ball, and performing circular centripetal wiping from the periphery of the wound surface to the edge of the wound surface; removing the drainage matter in the focus; gently wiping purulent secretion on the wound surface by a saline cotton ball; the wound surface and the sinus are probed by matching with a vascular forceps and a curette; gently removing necrotic granulation tissue with forceps, aseptic scissors, vascular forceps, and curet; according to the area of the wound surface and the depth, the width and the width of the sinus, externally applied medicines are put in; covering with sterile gauze, and fixing with medical adhesive plaster; the dressing change is performed every other day for 1 time.

(3) And (3) observation of curative effect:

the observation time is 28 days, and clinical effect observation is carried out before treatment, on the 7 th day, 14 th day, 21 st day and 28 th day in the treatment period.

The method comprises the following specific steps:

1) wound healing rate: the area of the wound surface is calculated by inputting the data into a microcomputer through a scanner and adopting a method of calculating pixels by using software Osiris version 4.19. The wound area measured for the first time is taken as the initial area of ulcer, and the area measured when the material is taken at each time point is taken as the wound area at the time point. The wound healing rate is (original wound area-time point wound area)/original wound area × 100%.

2) The wound surface decay speed is as follows: the time required from the application of the medicine to the wound surface until the slough on the wound surface is completely removed; the wound decay rate (the area of the wound surface and the slough area of the wound surface for the first 1 times) and the interval time of two observations.

3) Wound healing speed: wound healing rate (first wound area 1-this wound area)/interval time of two observations.

4) Traditional Chinese medicine syndrome integration: refer to the "diagnosis and treatment guidelines for common diseases in surgery of traditional Chinese medicine". The main symptom signs of ulcer area and sinus depth are divided into 4 grades, wherein the ulcer area is 0cm²Is counted by 0min and is less than 4cm²1 minute, 4-9 cm²2 minutes in meter, 9-16 cm²3 minutes and more than 16cm²4 points are counted), and the weight is 2; depth of sinus (0cm for 0min, less than 2cm for 1 min, 2-3 cm for 2 min, 3-4 cm for 3 min, more than 4cm for 3 min)4 points), the weight is 2; the amount of meat and pus (0 point, 1 point for lightness, 2 points for moderate, 3 points for severe and 4 points for severe) is 1.

5) The total effective rate judgment standard is as follows: referring to the Chinese medicine industry standard of the people's republic of China, the standard of curative effect for diagnosing the traditional Chinese medicine syndrome (ZY/T001.2-94) in 1995 and the diagnosis and treatment scheme of tuberculous ulcer of key special cooperation of the State administration of traditional Chinese medicine:

and (3) curing: the wound surface or the sinus is healed, and the general symptoms disappear.

Improvement: the wound surface is reduced or the purulent water in the sinus is reduced, and the general symptoms are improved.

The disease is not cured: the wound surface and the sinus tract are not healed or enlarged, and the general symptoms are not improved.

The total effective rate is as follows: total effective rate (number of cured cases + number of good cases)/total number of cases × 100%.

(4) As a result:

1) observing the change of wound healing rate, wound decay rate and healing rate on 7 th, 14 th, 21 th and 28 th days in the treatment period of the test example

The results show that the healing rates, the wound decay rates and the healing rates of the wound surfaces at 7 th, 14 th, 21 th and 28 th days in the treatment period respectively have statistical differences (P is less than 0.01). The differences were statistically significant (P < 0.01) at days 14, 21, and 28 of treatment compared to day 7 of treatment. See table 6 for details.

TABLE 6 wound healing rates on days 7, 14, 21, and 28 of the treatment period: (

% decay and rate of healing: (

cm²/

Day) comparison

Note: p was < 0.01 on days 14, 21, and 28 of treatment compared to day 7 of treatment.

2) Observing the integral change of syndrome during the treatment period of the experimental example

The results show that the syndrome score of 21 st and 28 th days in the treatment period is lower than that before treatment, and the statistical significance is achieved (P is less than 0.01). See fig. 2.

Note: on days 21 and 28 of treatment, P was < 0.01, compared to pre-treatment.

3) The total effective rate during the treatment period of the test cases was observed. See FIG. 3

Therefore, the medicine has good effect on treating the tuberculous ulcer. The traditional Chinese medicine preparation is a local external medicine and directly acts on a focus, the medicine is in overall contact with granulation on a wound surface, the medicine concentration of local tissues is effectively maintained, the administration dosage and the administration frequency are stable, the effects of expelling toxin, removing putrefaction, transforming muscle and promoting tissue regeneration are fully exerted, and the healing of tuberculous ulcer is effectively promoted. The traditional Chinese medicine gel preparation for treating tuberculous ulcer is simple in preparation process, short in preparation time, suitable for industrial production, beneficial to popularization and application and capable of being used as a choice for improving the dosage form of the traditional Chinese medicine preparation.

The above description is only a preferred embodiment of the present invention, and should not be taken as limiting the invention in any way, and any person skilled in the art can make any simple modification, equivalent replacement, and improvement on the above embodiment without departing from the technical spirit of the present invention, and still fall within the protection scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine gel for treating tuberculous ulcer is characterized in that: comprises the following raw material components in parts by mass: 160-240 parts of five-leaf phoenix-tail fern, 15-35 parts of bletilla striata and 20-60 parts of radix ranunculi ternati; the gel matrix comprises the following components in parts by mass: 15-30 parts of a gel framework material, 75-150 parts of a humectant, 844-1688 parts of purified water, 1-2 parts of a preservative, 5-10 parts of 95% ethanol and 30-60 parts of a neutralizer.

2. The traditional Chinese medicine gel for treating tuberculous ulcer according to claim 1, which is characterized in that: wherein the gel matrix material is carbomer, the humectant is glycerin, the preservative is ethylparaben, and the neutralizer is triethanolamine.

3. The traditional Chinese medicine gel for treating tuberculous ulcer according to claim 1, which is characterized in that: carbomer type is carbomer 980.

4. The preparation method of the traditional Chinese medicine gel for treating tuberculous ulcer according to claim 1, which is characterized by comprising the following steps: the method comprises the following steps:

1) weighing the raw materials according to the mass parts, soaking the raw materials in pure water for 1h, and then adding water for decocting for 1h to obtain a first extracting solution; soaking the residue in purified water, and decocting for 40min to obtain a second extractive solution; concentrating the first and second extractive solutions, precipitating for 24 hr, collecting supernatant, and concentrating under heating to obtain compound Ficus simplicissima lour solution;

5. The preparation method of the traditional Chinese medicine gel for treating tuberculous ulcer according to claim 4, which is characterized by comprising the following steps: in the step 1), 8 times of pure water is adopted when the raw material medicines are soaked in the pure water; the decoction is carried out by 5 times of pure water.

6. The preparation method of the traditional Chinese medicine gel for treating tuberculous ulcer according to claim 4, which is characterized by comprising the following steps: in the step 2), the reduced pressure distillation condition is 60 ℃ and-0.1 MPa.

7. The use of the traditional Chinese medicine gel of claim 1 as a medicament for the treatment of tuberculous ulcers.