A stasis-eliminating Chinese medicine composition and stasis-eliminating gel plaster

Abstract

The invention discloses a stasis-eliminating Chinese medicine composition and a stasis-eliminating gel plaster. The stasis-eliminating Chinese medicine composition includes the following components in parts by weight: 5-20 parts of rhubarb, 10-25 parts of bauhinia bark, 20-50 parts of dandelion, 5-20 parts of frankincense, 10-30 parts of angelica, 5-20 parts of myrrh, 10-30 parts of salvia miltiorrhiza, and 10-30 parts of zelan. The present invention simplifies traditional stasis-eliminating powder to obtain a simplified prescription that is equivalent to the full prescription of stasis-eliminating powder and has a small side effect, has the effects of promoting blood circulation and removing blood stasis, relieving pain and removing numbness, and can be used to treat lumbar disc herniation, cervical spondylosis, osteoarthritis, rheumatoid arthritis, pain caused by trauma, swelling and other diseases. The present invention makes the simplified prescription of stasis-eliminating powder into a stasis-eliminating gel plaster, and the gel plaster is a novel transdermal drug delivery preparation, and compared with the traditional stasis-eliminating plaster, its drug controlled sustained release effect is better, tolerance is better, affinity with drugs is stronger, non-irritating and sensitizing, and viscosity is more moderate and controllable.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine, and in particular to a stasis-eliminating Chinese medicinal composition and a stasis-eliminating gel plaster for osteoarthritis, cervical spondylosis, low back pain, pain and swelling caused by trauma. Background Art

[0002] Traditional Xiaoyu powder (such as Chinese invention patent ZL 201110273420.3) has many ingredients and a complex extraction process. Multiple complex drug ingredients directly contact the skin and may cause sensitization, causing itching. Secondly, traditional Xiaoyu powder needs to be prepared and used immediately, and the shelf life is limited. The traditional method is to grind the prescription required for Xiaoyu powder into powder and mix it with water and maltose for standby use. The storage condition is a 4°C refrigerator. When a patient needs it, take out the ointment and spread it on kraft paper with a thickness of about 2mm and an area of ​​about 10cm×15cm. Then cover it with thin cotton paper to make a traditional Xiaoyu patch. It is relatively troublesome to use and requires the cooperation of the patient. When the ointment gets on the skin, it needs to be wiped off with hot water, and the part needs to be braked to prevent the ointment from falling off, which is very labor-intensive. Summary of the invention

[0003] In order to solve the above technical problems, the present invention provides a stasis-eliminating Chinese medicine composition and a stasis-eliminating gel plaster.

[0004] In a first aspect, the present invention provides a blood stasis-eliminating Chinese medicinal composition, which is achieved by adopting the following technical scheme.

[0005] A stasis-eliminating Chinese medicinal composition comprises the following components in parts by weight: 5-20 parts of rhubarb, 10-25 parts of bauhinia bark, 20-50 parts of dandelion, 5-20 parts of frankincense, 10-30 parts of angelica, 5-20 parts of myrrh, 10-30 parts of salvia miltiorrhiza, and 10-30 parts of zedoaria.

[0006] Preferably, a stasis-eliminating Chinese medicinal composition comprises the following components in parts by weight: 12 parts of rhubarb, 17 parts of bauhinia bark, 30 parts of dandelion, 12 parts of frankincense, 16 parts of angelica, 12 parts of myrrh, 17 parts of salvia miltiorrhiza, and 16 parts of zedoaria.

[0007] The present invention is simplified to 8 medicinal materials based on the original prescription of Xiaoyusan with 16 herbs, wherein the main medicine is rhubarb for promoting blood circulation and removing blood stasis, clearing away heat and dispersing accumulation, and other herbs such as Bauhinia bark, frankincense, myrrh, angelica, and salvia miltiorrhiza are used together to enhance the effects of promoting blood circulation, reducing swelling and relieving pain, and dandelion and zelan are used together to enhance the effects of clearing away heat, detoxifying, promoting blood circulation and reducing swelling. The effects of the above 8 herbs are promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, and removing numbness. In clinical application, it is observed that the eight-flavor prescription of Xiaoyusan has obvious effects of removing blood stasis, relieving pain and reducing swelling for bruises, pain and swelling caused by soft tissue injuries; after applying it externally for one week for patients with knee synovitis, knee pain and swelling are relieved, and walking and activity functions are improved; and cervical and lumbar pain are significantly relieved.

[0008] In a second aspect, the present invention provides a stasis-eliminating gel plaster, which is achieved by adopting the following technical solution.

[0009] A stasis-eliminating gel plaster comprises a thick extract of the above-mentioned traditional Chinese medicine composition, an oil phase and a water phase.

[0010] Furthermore, the oil phase includes glycerol, aluminum glycolate, NP700 and carbomer 981.

[0011] Furthermore, the aqueous phase comprises water and tartaric acid.

[0012] More specifically, a stasis-eliminating gel plaster comprises 5-10% of traditional Chinese medicine thick extract, 28.5% of glycerol, 0.2% of aluminum glycolate, 10% of NP700, 11% of carbomer 98, 0.3% of tartaric acid and 50-55% of water.

[0013] This application has the following beneficial effects.

[0014] 1. The present invention simplifies the traditional Xiaoyu powder to obtain a simplified formula. Clinical studies have shown that the simplified formula has the same efficacy as the full Xiaoyu powder, has the effects of promoting blood circulation and removing blood stasis, relieving pain and removing numbness, and can be used to treat lumbar disc herniation, cervical spondylosis, osteoarthritis, rheumatoid arthritis, pain and swelling caused by trauma, etc.; because the simplified formula reduces the interference of complex ingredients, reduces sensitization, and has no obvious skin damage;

[0015] 2. The present invention prepares a new preparation, the Xiaoyu Powder Simplified Formula, into a Xiaoyu Gel Patch. The gel patch is a new transdermal drug delivery preparation. Compared with the traditional Xiaoyu patch, it has better drug controlled release effect, better tolerance, stronger affinity with drugs, no irritation and allergenicity, and more moderate and controllable viscosity. The gel patch fits tightly to the skin, does not affect limb movement, and will not fall off as easily as traditional patches;

[0016] 3. The gel patch of the present invention only needs to be stored at room temperature and away from light. Its storage time is longer than that of traditional patches. It is particularly suitable for patients who do not have the storage conditions for traditional patch preparations and want a convenient, simple to operate, light and clean product. It has clinical promotion and application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a physical picture of the stasis-eliminating gel plaster prepared by the present invention. DETAILED DESCRIPTION

[0018] The present patent application is further described below in conjunction with embodiments.

[0019] Example 1

[0020] A method for preparing a stasis-eliminating Chinese medicine composition comprises the following steps:

[0021] 1. Weigh 106.24g of rhubarb, 106.24g of frankincense, 106.24g of myrrh, 159.36g of angelica, 159.36g of celery, 265.6g of dandelion, 149.4g of salvia miltiorrhiza, and 149.4g of Bauhinia bark; a total of 100 patches, 1201.84g;

[0022] 2. Soak in 10 times the amount of water for 30 minutes;

[0023] 3. Use a casserole to boil over high heat, then simmer for 1 hour, take out the juice, add 8 times the amount of water and boil twice, each time for half an hour, and combine the three decoctions;

[0024] 4. Concentrate to 250ml*16 bags of Chinese medicine for later use.

[0025] Example 2

[0026] A preparation method of a stasis-eliminating gel plaster is as follows:

[0027] 1. Reagents and Materials

[0028] Glycerol Hunan Erkang Pharmaceutical Co., Ltd.

[0029] Tartaric acid Hunan Erkang Pharmaceutical Co., Ltd.

[0030] Glycohydroxyaluminum Japan Kyowa Chemical Co., Ltd.

[0031] Sodium polyacrylate (NP700) Japan Showa Denko Co., Ltd.

[0032] Tragacanth Gum Shanghai Quanwang Biotechnology Co., Ltd.

[0033] Carbomer 981 Lubrizol Management (Shanghai) Co., Ltd.

[0034] 2. Experimental instruments

[0035] SQP Analytical Balance Sartorius Scientific Instruments (Beijing) Co., Ltd.

[0036] MK-GBI Table MixerXiamen Jiansong Electric Co., Ltd.

[0037] TB-0612B Small Experimental Coating Machine Shanghai Kaikai Technology Trading Co., Ltd.

[0038] 3. Basic formula

[0039] The basic formula includes three parts: oil phase, water phase and thick extract made from the Chinese medicine composition of Example 1, as shown in Table 1. The gel ointment of this prescription uses two matrix formulas to conduct a comparative experiment on drug loading.

[0040] Table 1 Gel ointment matrix formula

[0041]

[0042] 4. Configuration steps

[0043] Prepare the oil phase and water phase separately, then mix the oil phase, water phase and medicine, stir until they are ready for coating, spread on a coating machine, and slice to obtain the product. Each slice is 10×13cm in size and 16-18g in weight. It has two layers: matrix and compress. The matrix is ​​about 0.08cm thick and the thickness is about 0.05cm.

[0044] 5. Drug loading comparison test

[0045] The comparative experimental results of different drug loading amounts are shown in Table 2.

[0046] Table 2 Comparative experimental results of different drug loading

[0047]

[0048]

[0049] 6. Experimental results

[0050] 6.1 Quality scoring table for gel patches with different matrices and the same drug loading

[0051]

[0052]

[0053]

[0054] 6.2 Gel patch molding quality score table with different drug loading

[0055]

[0056]

[0057]

[0058] According to the properties and viscosity of the gel patch after placement, a preparation molding formula 2 with a drug loading ratio of 5% was initially selected.

[0059] Comparative Example

[0060] The whole prescription of Xiaoyu San is made up of the following 16 Chinese medicinal materials: 12g of rhubarb, 30g of dandelion, 12g of Panax notoginseng, 12g of Pollen Typha, 12g of frankincense, 12g of myrrh, 38.5g of Aconiti Lateralis Preparata, 4g of Sappan Wood, 17g of Geranium, 16g of Achyranthes bidentata, 12g of Scolopendra subspinipes, 16g of Angelica sinensis, 17g of Salvia miltiorrhiza, 16g of Eupatorium fortunei, 12g of Semen Armeniacae Atractylodes, and 17g of Bauhinia bark.

[0061] Clinical Trials

[0062] 72 patients who met the diagnosis of knee OA were randomly divided into two groups. They were treated with external application of Xiaoyusan plaster and external application of Xiaoyusan Baweifang plaster, once a day for two weeks. The pain VAS score, WOMAC scale score, and TCM syndrome (TCM syndrome evaluation items are: ① waist and knee pain; ② walking weakness; ③ joint fear of cold; ④ increased pain in cold; ⑤ joint tingling; ⑥ fixed pain; ⑦ poor flexion and extension; ⑧ stiffness and deformation; ⑨ lower limb heaviness and pain; ⑩ aggravated on rainy days) were compared between the two groups before and after treatment. The t test was used to compare before and after treatment and between the two groups. P < 0.05 was considered statistically significant. The results are as follows.

[0063] Table 3 Comparison of pain VAS scores between the two groups before treatment and 2 weeks after treatment And the comparison between the two groups

[0064]

[0065] Table 3 shows the comparison of pain VAS scores between the two groups before treatment and 2 weeks after treatment. The t-test showed that the two groups were compared before and after treatment, P < 0.05, and the difference was statistically significant, indicating that both groups could relieve pain. The inter-group comparison was P > 0.05, indicating that there was no significant difference in pain VAS scores between the two groups.

[0066] Table 4 Comparison of WOMAC scores between the two groups before and 2 weeks after treatment And the comparison between the two groups

[0067]

[0068] Table 4 shows the comparison of WOMAC scores between the two groups before and after treatment. The t-test showed that the two groups were compared before and after treatment, P < 0.05, and the difference was statistically significant, indicating that both groups of treatment can improve the knee function of patients to a certain extent. The inter-group comparison, P > 0.05, indicated that there was no significant difference in WOMAC scores between the two groups.

[0069] Table 5 Comparison of TCM symptom scores between the two groups of patients before and after 2 weeks of treatment And the comparison between the two groups

[0070]

[0071] Table 5 shows the comparison of TCM symptom scores between the two groups before treatment and 2 weeks after treatment. The t-test showed that the two groups were compared before and after treatment, P < 0.05, and the difference was statistically significant, indicating that the TCM symptom indicators of the two groups of patients improved significantly while knee pain and function improved. The inter-group comparison showed that P > 0.05, indicating that there was no significant difference in TCM symptom scores between the two groups.

[0072] The results showed that both Xiaoyusan and Xiaoyusan eight-flavor formula could relieve pain, improve joint function and relieve symptoms to a certain extent in the treatment of KOA. The clinical efficacy of Xiaoyusan eight-flavor formula in the treatment of OA was equivalent to that of the original Xiaoyusan formula.

[0073] The embodiments of this specific implementation method are all preferred embodiments of the present invention, and are not intended to limit the protection scope of the present invention. Therefore, any equivalent changes made based on the structure, shape, and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A blood stasis removing Chinese medicine composition, characterized in that: The invention is prepared from the following components in parts by weight: 5-20 parts of rhubarb, 10-25 parts of bauhinia bark, 20-50 parts of dandelion, 5-20 parts of frankincense, 10-30 parts of angelica, 5-20 parts of myrrh, 10-30 parts of salvia miltiorrhiza and 10-30 parts of zedoaria.

2. A stasis-eliminating Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following components in parts by weight: 12 parts of rhubarb, 17 parts of bauhinia bark, 30 parts of dandelion, 12 parts of frankincense, 16 parts of angelica, 12 parts of myrrh, 17 parts of salvia miltiorrhiza and 16 parts of zedoaria.

3. A stasis-eliminating gel plaster, characterized in that: It is made from the thick extract of the traditional Chinese medicine composition according to claim 1 or 2, an oil phase and an aqueous phase.

4. The stasis-eliminating gel plaster according to claim 3, characterized in that: The oil phase comprises glycerol, aluminum glycolate, NP700 and carbomer 981.

5. The stasis-eliminating gel plaster according to claim 3, characterized in that: The aqueous phase is water and tartaric acid.

6. The stasis-eliminating gel plaster according to claim 3, characterized in that: Chinese medicine thick extract 5-10%, glycerol 28.5%, aluminum glycolate 0.2%, NP700 10%, carbomer 981 1%, tartaric acid 0.3%, water 50-55%.

Images