Traditional Chinese medicine composition, knee-strengthening ointment and preparation method of knee-strengthening ointment

Abstract

The invention provides a traditional Chinese medicine composition, a knee strengthening ointment and a preparation method thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 8-12 parts of golden cypress, 7-15 parts of scutellaria baicalensis, 6-10 parts of coptis chinensis, 8-13 parts of rheum officinale, 5-15 parts of herba lycopi, 18-23 parts of lycopodium clavatum and 15-25 parts of obscured homalomena rhizome. The formula of the traditional Chinese medicine composition is based on the theory of traditional Chinese medicine, aims at the core pathogenesis of damp-heat blockage type knee joint edema, achieves the comprehensive treatment effects of clearing damp-heat, activating collaterals and relieving swelling and pain through the synergistic effect of multiple medicinal materials, and effectively solves the problem that three major pathological links of inflammation, vascular permeability and matrix degradation are difficult to regulate and control at the same time through an existing treatment means.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition, a knee health ointment and a preparation method thereof. BACKGROUND

[0002] Knee joint edema is the core pathological manifestation of acute exacerbation of knee osteoarthritis, and its essence is closely related to the release of inflammatory factors caused by synovitis, the increase of microvascular permeability and the degradation of cartilage matrix. Patients with damp-heat stagnation type have typical symptoms such as redness, swelling, heat and pain, joint effusion, and limited flexion and extension, which are highly consistent with the pathological chain of "inflammation amplification-vascular leakage-matrix degradation" mediated by molecules such as TNF-α, VEGFA and MMPs in modern medicine.

[0003] The existing clinical treatment methods have significant defects: although non-steroidal anti-inflammatory drugs (such as celecoxib) commonly used in Western medicine have a quick effect, they have limited improvement on joint effusion (14-day effusion only improved from 6.01 mm to 5.00 mm), and the incidence of gastrointestinal adverse reactions is as high as 50%; joint cavity injection of hormones, hyaluronic acid and the like has problems such as cartilage damage, infection risk, high cost and large individual differences; the recurrence rate of joint puncture and drainage is high. Although traditional Chinese medicine external treatment has the advantage of overall regulation, most of the existing ointments focus on analgesia, lack multi-target regulation of the triple microenvironment of "inflammation-vascular-matrix", and the mechanism is not clear, so it is difficult to form a standardized treatment plan.

[0004] Therefore, it is a key requirement to develop a safe and effective Chinese ointment that can be used for a long time and can synergistically regulate the TNF-VEGFA-MMP axis to solve the treatment dilemma of knee joint edema of damp-heat stagnation type. SUMMARY

[0005] In view of the above-mentioned defects of the prior art, the purpose of the present application is to provide a traditional Chinese medicine composition, a knee health ointment and a preparation method thereof, which can solve the problems that the existing traditional Chinese medicine knee health ointments focus on analgesia, lack multi-target regulation of the triple microenvironment of "inflammation-vascular-matrix", and the mechanism is not clear, and it is difficult to form a standardized treatment plan.

[0006] To achieve the above-mentioned purpose and other related purposes, the present application provides a traditional Chinese medicine composition, which comprises the following components in parts by weight: 8-12 parts of Huangbai, 7-15 parts of Huangqin, 6-10 parts of Huanglian, 8-13 parts of Dahuang, 5-15 parts of Zelan leaves, 18-23 parts of Shenzhigan and 15-25 parts of Qianianjian.

[0007] The traditional Chinese medicine composition of the application comprises: Huangbai, Huangqin, Huanglian and Dahuang as monarch and minister drugs, and Zelan leaves, Shenzhengcao and Qianianjian as auxiliary drugs; the application takes Huangbai, Huangqin, Huanglian and Dahuang as monarch and minister drugs, focuses on clearing damp-heat, detoxifying and resisting inflammation, and inhibiting synovial membrane inflammation and joint cavity inflammatory exudation; Zelan leaves are added to activate blood and remove stasis, drain water and reduce swelling, and promote the absorption of effusion and soft tissue edema; Shenzhengcao and Qianianjian are added to dispel wind and dampness, relax muscles and tendons, strengthen bones and relieve pain, and form the overall treatment strategy of "clearing damp-heat, activating blood and reducing swelling and pain", so that the core pathological problems of damp-heat and arthralgia type knee edema are solved in a targeted manner.

[0008] Preferably, the traditional Chinese medicine composition comprises the following components by weight: Huangbai 9-10 parts, Huangqin 10-12 parts, Huanglian 9-10 parts, Dahuang 8-10 parts, Zelan leaves 9-10 parts, Shenzhengcao 19-21 parts and Qianianjian 18-20 parts.

[0009] Preferably, the traditional Chinese medicine composition comprises the following components by weight: Huangbai 10 parts, Huangqin 10 parts, Huanglian 10 parts, Dahuang 10 parts, Zelan leaves 10 parts, Shenzhengcao 20 parts and Qianianjian 20 parts.

[0010] The application further provides a knee health cream, which comprises a matrix and the above traditional Chinese medicine composition.

[0011] The knee health cream of the application has multiple target point synergistic effects and remarkable curative effects: the effective components in the knee health cream can jointly act on key target points such as TNF, VEGFA, MMP1, MMP2, MMP3 and MMP9, improve three pathological links of inflammatory factor storm, blood vessel leakage and matrix destruction through the regulation of the "TNF-VEGFA-MMP axis", and the knee health cream has high safety and good tolerance: the knee health cream is an external preparation, and the drug directly acts on the local lesion, avoiding the stimulation of oral drugs on the gastrointestinal tract, and the incidence of adverse reactions in the pre-experiment is only 20%, and the adverse reactions are mainly slight skin itching and redness, and there is no systemic adverse reactions such as gastrointestinal discomfort, and the safety is significantly better than that of oral non-steroidal anti-inflammatory drugs, and the knee health cream is suitable for long-term use.

[0012] Preferably, the mass percentage content of the traditional Chinese medicine components is 15-25% based on the total weight of the knee health cream.

[0013] The application further provides a preparation method of the knee health cream, which comprises the following steps:

[0014] (1) The components of the traditional Chinese medicine composition are respectively crushed, sieved and uniformly mixed to obtain traditional Chinese medicine fine powder;

[0015] (2) The matrix is heated to completely melt to obtain a liquid matrix;

[0016] (3) The traditional Chinese medicine fine powder is mixed with a liquid matrix uniformly, and then is divided into sterile containers, cooled to room temperature, and sealed for storage, to obtain the knee health cream.

[0017] The knee health cream of the present application is simple to prepare, low in cost, and easy for patients to comply with, and is convenient for promotion and application in primary hospitals, rehabilitation specialists, and traditional Chinese medicine medical systems.

[0018] Preferably, in step (1), the sieving uses an 80-100 mesh sieve.

[0019] Preferably, in step (2), the heating uses a 60-80℃ water bath.

[0020] Preferably, in step (3), the mixing process is constant temperature stirring at 40-50℃ for 30-40min.

[0021] As described above, the traditional Chinese medicine composition, the knee health cream, and the preparation method thereof of the present application have the following beneficial effects:

[0022] (1) The traditional Chinese medicine composition formula of the present application is based on traditional Chinese medicine theory, and aims at the core pathogenesis of damp-heat blockage type knee joint edema. Through the synergistic effect of multiple medicinal materials, the comprehensive treatment effect of "clearing damp-heat, promoting blood circulation to remove blood stasis, and relieving swelling and pain" is achieved, effectively solving the problem that existing treatment methods are difficult to simultaneously regulate inflammation, vascular permeability, and matrix degradation.

[0023] (2) The knee health cream regulates the "TNF-VEGFA-MMP axis", significantly promotes joint effusion absorption, relieves redness, swelling, heat, and pain, improves joint function, has definite clinical efficacy, and is safe and has few adverse reactions in external use, suitable for long-term use, and has good patient compliance.

[0024] (3) The preparation process of the present application is simple, low in cost, and convenient to use, and is convenient for industrialized production and clinical popularization and application, can provide a new safe and effective treatment option for damp-heat blockage type knee joint edema patients, and has important scientific value, social benefits, and economic benefits. DETAILED DESCRIPTION

[0025] The embodiments of the present application are described below through specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the disclosure. The present application can also be implemented or applied in different specific embodiments, and various modifications or changes can be made to the details in the specification without departing from the spirit of the present application.

[0026] It should be understood that the process equipment or device not specifically mentioned in the following examples all uses conventional equipment or device in the art.

[0027] Furthermore, it should be understood that the combination of one or more method steps mentioned in the present application does not exclude that other method steps can be present before and after the mentioned combination of steps or that other method steps can be inserted between the explicitly mentioned steps, unless otherwise indicated. It should also be understood that the combination of one or more devices / apparatuses mentioned in the present application does not exclude that other devices / apparatuses can be present before and after the mentioned combination of devices / apparatuses or that other devices / apparatuses can be inserted between the explicitly mentioned two devices / apparatuses, unless otherwise indicated. Moreover, the numbering of the method steps is only a convenient tool to identify individual method steps and does not serve as a means to limit the order of the method steps or to define the scope of the application, which is defined by the appended claims. A change or adaptation of the relative relationship of the individual method steps, without substantial change of the technical content, is also deemed to be within the scope of the application.

[0028] Example 1

[0029] The present example provides a preparation method of a knee health ointment, comprising the following steps:

[0030] (1) The seven Chinese medicinal ingredients are ground respectively, and the raw material dosages are as follows: 10 g of Huangbai, 10 g of Huangqin, 10 g of Huanglian, 10 g of Dahuang, 10 g of Zelan leaves, 20 g of Shenjincao, and 20 g of Qianianjian. The mixture is passed through a 100-mesh sieve to obtain 80 g of Chinese medicinal fine powder;

[0031] (2) 100 g of vaseline is taken and melted in a 70°C water bath, and stirred uniformly to obtain melted vaseline;

[0032] (3) 20 g of the Chinese medicinal fine powder is added into the melted vaseline, and stirred at 45°C for 35 minutes. The mixture is uniformly mixed and then packed into sterile ointment boxes, cooled to room temperature, and sealed to obtain the knee health ointment.

[0033] The mass percentage of the Chinese medicinal ingredients in the knee health ointment is 16% based on the total weight of the knee health ointment.

[0034] Clinical application effect verification

[0035] Test design: 30 patients meeting the diagnostic criteria of damp-heat arthralgia type of knee joint edema were selected and randomly divided into a knee health ointment group (10 cases), a Celecoxib group (10 cases), and a placebo group (10 cases).

[0036] Knee health ointment group:

[0037] Clean and dry the skin of the medial, lateral and main tender points of the knee joint, take the appropriate amount of Jianxi Plaster, spread it in the middle of the medical cotton pad with a spatula, leaving 5 mm empty around the edges, with a thickness of about 2-3 mm, and apply it to the medial and lateral sides of the knee joint around the patella, and then apply an elastic bandage with a little more elasticity to the knee joint. Each time, apply 1 piece (about 8 cm x 10 cm), once every 2 days, 3 times a week, for 2 weeks. The same patient should be applied at the same time every day. During the intervention, observe the skin closely, and if there is obvious itching, redness or blistering, stop using the drug and record it.

[0038] Placebo group:

[0039] Use a placebo plaster (vaseline plus caramel powder) that is similar in appearance, size, color and application method to Jianxi Plaster, but does not contain the main drug ingredients. The application site, time and course of treatment are exactly the same as the Jianxi Plaster group: once every 2 days, 3 times a week, for 2 weeks, ensuring that the only difference between the two groups is in the drug ingredients of the plaster, so as to control the placebo effect and the physical effect of the plaster itself.

[0040] Celecoxib group:

[0041] Oral celecoxib (Guojiazhunzi H20010207, Yangtze River Pharmaceutical Group Co., Ltd.) 1, once a day in the morning and evening, after meals, for 1 week.

[0042] Observation index: Before treatment and on the 7th and 14th day of treatment, measure the depth of effusion in the knee joint (ultrasound), VAS pain score, knee circumference and Damp-Heat Bi-Obstruction Syndrome score, and record adverse reactions.

[0043] The results of the trial are shown in Tables 1 and 2:

[0044] Table 1. Comparison of VAS scores and effusion depth before and after treatment in the three groups .

[0045] Table 2. Adverse reaction statistics of patients in the three groups .

[0046] In Tables 1 and 2, F value is the statistical test value in analysis of variance, used to compare whether the difference between the means of the groups is significant, and its value is the ratio of the between-group mean square to the within-group mean square. P value is the probability corresponding to the statistical test value, indicating the probability of observing the current result when the null hypothesis is true.

[0047] From Tables 1 and 2, we can see that:

[0048] Fluid depth improvement: The fluid depth of the Jianxi Plaster group was reduced to 4.85±0.52mm on the 7th day and 4.05±0.50mm on the 14th day, which was significantly better than the Celecoxib group (5.00±0.55mm on the 14th day) and the placebo group (6.50±0.55mm on the 14th day);

[0049] Pain relief: The VAS score of the Jianxi Plaster group was reduced to 3.45±0.46 on the 14th day, which was not significantly different from the Celecoxib group (2.90±0.50) and significantly better than the placebo group (7.00±0.48);

[0050] Safety: Only 2 cases of mild skin itching occurred in the Jianxi Plaster group, with an adverse reaction rate of 20%; 5 cases of gastrointestinal discomfort occurred in the Celecoxib group, with an adverse reaction rate of 50%; and no adverse reactions occurred in the placebo group.

[0051] Example 2

[0052] The present embodiment provides a preparation method of Jianxi Plaster, which comprises the following steps:

[0053] (1) Seven kinds of traditional Chinese medicines are crushed respectively, and the raw material dosages are as follows: 8g of Huangbai, 15g of Huangqi, 6g of Huanglian, 13g of Dahuang, 15g of Zelan leaves, 23g of Shenjincao, and 25g of Qianianjian; the traditional Chinese medicine fine powder 80g is obtained by mixing after being sieved through an 80-mesh sieve;

[0054] (2) 100g of vaseline is melted in a 80℃ water bath, and is uniformly stirred to obtain melted vaseline;

[0055] (3) 25g of the traditional Chinese medicine fine powder is added into the melted vaseline, and is uniformly mixed after being stirred at 40℃ for 40 minutes; the Jianxi Plaster is obtained by being packaged into sterile ointment boxes, being cooled to room temperature, and being sealed.

[0056] The mass percentage content of the traditional Chinese medicine components is 20% based on the total weight of the Jianxi Plaster.

[0057] Example 3

[0058] The present embodiment provides a preparation method of Jianxi Plaster, which comprises the following steps:

[0059] (1) Seven kinds of traditional Chinese medicines are crushed respectively, and the raw material dosages are as follows: 12g of Huangbai, 7g of Huangqi, 8g of Huanglian, 8g of Dahuang, 5g of Zelan leaves, 18g of Shenjincao, and 15g of Qianianjian; the traditional Chinese medicine fine powder 80g is obtained by mixing after being sieved through a 100-mesh sieve;

[0060] (2) 100g of vaseline is melted in a 60℃ water bath, and is uniformly stirred to obtain melted vaseline;

[0061] (3) Take 30g of fine powder of traditional Chinese medicine, add into melted vaseline, stir at 50°C for 30 minutes, mix evenly, divide into sterile ointment boxes, cool to room temperature, seal to obtain the Jianxi Ointment.

[0062] The mass percentage of the traditional Chinese medicine component is 23% based on the total weight of the Jianxi Ointment.

[0063] The above examples are intended to illustrate the disclosed embodiments of the present application and should not be construed as limiting the present application. Furthermore, various modifications to the implementations described in this disclosure will be apparent to those with skill in the art, and the general principles defined herein can be applied to other implementations without departing from the scope and spirit of the application. While the application has been particularly shown and described with reference to particular preferred embodiments, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the application. Indeed, various modifications of the above-described modes for carrying out the application can be employed by persons skilled in the art.

Claims

1. A traditional Chinese medicine composition, characterized in that, It comprises the following components in parts by weight: 8-12 parts of Huangbai, 7-15 parts of Huangqin, 6-10 parts of Huanglian, 8-13 parts of Dahuang, 5-15 parts of Zelan leaves, 18-23 parts of Shenjincao and 15-25 parts of Qian Nianjian.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: It comprises the following components in parts by weight: 9-10 parts of Huangbai, 10-12 parts of Huangqin, 9-10 parts of Huanglian, 8-10 parts of Dahuang, 9-10 parts of Zelan leaves, 19-21 parts of Shenjincao and 18-20 parts of Qian Nianjian.

3. The traditional Chinese medicine composition according to claim 1, characterized in that: It comprises the following components in parts by weight: 10 parts of Huangbai, 10 parts of Huangqin, 10 parts of Huanglian, 10 parts of Dahuang, 10 parts of Zelan leaves, 20 parts of Shenjincao and 20 parts of Qian Nianjian.

4. A knee health cream, characterized by: It comprises a base and the traditional Chinese medicine composition according to any one of claims 1-3.

5. The knee cream as claimed in claim 4, wherein: The mass percentage of the traditional Chinese medicine components is 15-25% based on the total weight of the knee-care ointment.

6. The knee cream of claim 5, wherein: The base is vaseline.

7. A process for the preparation of the knee cream as claimed in any one of claims 4 to 6, characterized in that: It comprises the following steps: (1) grinding, sieving and mixing the raw materials of the traditional Chinese medicine composition to obtain a fine powder of the traditional Chinese medicine composition; (2) heating the base to complete melting to obtain a liquid base; (3) mixing the fine powder of the traditional Chinese medicine composition with the liquid base, dispensing into sterile containers, cooling to room temperature and sealing for storage to obtain the knee-care ointment.

8. The method of claim 7, wherein: In step (1), the sieving is performed using a 80-100 mesh sieve.

9. The method of claim 7, wherein: In step (2), the heating is performed using a 60-80℃ water bath.

10. The method of claim 7, wherein: In step (3), the mixing is performed by constant temperature stirring at 40-50℃ for 30-40 minutes.