Traditional Chinese medicine liniment for tonifying qi and activating blood and preparation method of traditional Chinese medicine liniment

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine liniment for tonifying qi and activating blood and a preparation method thereof.The traditional Chinese medicine liniment is prepared from, by weight, 23-25 parts of traditional Chinese medicine active ingredients, 40-50 parts of ethyl alcohol, 40-50 parts of distilled water, 5-8 parts of butanediol, 0.5-1.2 parts of methyl salicylate, 0.3-0.8 part of vanillyl butyl ether and 0.4-1 part of auxiliaries. The traditional Chinese medicine liniment for tonifying qi and activating blood, prepared by the invention, has relatively high permeability and a good treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and in particular to a traditional Chinese medicine liniment for invigorating qi and activating blood circulation and a preparation method thereof. Background Art

[0002] Traditional Chinese medicine preparations are made from Chinese medicinal materials (plants, animals, minerals, etc.) through specific processing techniques based on TCM theory. These include oral preparations (such as pills, powders, and decoctions) and topical preparations (such as liniments, plasters, and patches). Their core characteristics are holistic conditioning and syndrome differentiation, emphasizing the synergistic effects of multiple ingredients rather than targeted treatments based on a single ingredient. For conditions such as chronic pain, traumatic injuries, and postoperative recovery, tonifying Qi and activating blood circulation are core principles of TCM treatment, and external treatments with traditional Chinese medicine are often used. Therefore, researchers in this field have studied topical preparations with different formulations.

[0003] Patent CN104147533B discloses a blood-activating, blood-stasis-removing, and pain-relieving cream and its preparation method. The cream contains the following ingredients: safflower seed oil, evening primrose oil, horse oil, sea buckthorn fruit oil, zedoaria oil, peppermint oil, borneol, menthol, azone, ethanol, multifunctional emulsifier G57, universal self-emulsifying composite emulsifier AC-402, Panax notoginseng extract, safflower extract, quinquefolia extract, Cibotium barometz extract, Acer truncatum extract, Zanthoxylum bungeana extract, 5% sodium carboxymethylcellulose, ethylparaben, 1,2-propylene glycol, water, and flavor. Compared to existing technologies, the blood-activating, blood-stasis-removing, and pain-relieving cream provided by this invention can activate blood circulation, resolve blood stasis, reduce swelling and relieve pain, clear away heat, cool blood, and promote tissue regeneration, accelerating the healing of rheumatic bone pain, bruises, lumps, minor burns, and frostbite, while also providing basic skincare benefits.

[0004] Patent CN110227102B provides a blood-activating and detumescent ointment and its preparation method. The ointment comprises a blood-activating and detumescent composition, a hydrophilic gel matrix, and additives. The composition comprises 12.92-21.60% by weight of the ointment. The hydrophilic gel matrix comprises the following raw materials in percentage by weight: 3.22-6.82% of a hydrophilic polymer skeleton material; 23.16-32.53% of a moisturizer; 0.86-5.7% of a permeation enhancer; 0.08-0.21% of a cross-linking agent; 0.17-0.42% of a cross-linking regulator; and 62.08-66.54% of purified water. The additives include at least one of a preservative, a filler, and a cooling agent. The ointment can be used to treat fractures, sprains, muscle swelling and pain, or chest and flank pain and leg and intestinal pain caused by stagnant heat.

[0005] The above patents are all ointment preparations with relatively poor transdermal performance and slow effect. Therefore, the development of a Chinese herbal ointment that has good therapeutic effect and fast effect and can replenish qi and activate blood circulation has become one of the current research and development focuses. Summary of the Invention

[0006] In view of the problems existing in the prior art, the purpose of the present invention is to obtain a traditional Chinese medicine liniment for invigorating qi and activating blood circulation with high skin permeability, good therapeutic effect and simple preparation process.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] On the one hand, the present invention provides a traditional Chinese medicine liniment for invigorating qi and activating blood circulation, which comprises the following raw materials, measured in parts by weight: 23-25 ​​parts of traditional Chinese medicine active ingredients, 40-50 parts of ethanol, 40-50 parts of distilled water, 5-8 parts of butylene glycol, 0.5-1.2 parts of methyl salicylate, 0.3-0.8 parts of vanillyl butyl ether, and 0.4-1 parts of an auxiliary agent.

[0009] In some embodiments, the active ingredients of traditional Chinese medicine are obtained by mixing a composite extract of Rhizoma Scutellariae, Rhizoma Glycyrrhizae Inflata and Rhizoma Sophorae Flavescentis with a composite extract of Eucommia ulmoides leaves and Cistanche deserticola, and the mass ratio of the two is (2.8-3.2):1.

[0010] In some embodiments, the method for preparing the composite extract of the root of Scutellaria baicalensis, the root of Glycyrrhiza inflata, and the root of Sophora flavescens comprises the following steps:

[0011] The root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens are mixed to obtain a mixture, the mixture is ground into a slurry by adding deionized water in an amount of 8-10 times the mass of the mixture, the mixture is frozen at -22 to -18°C for 22-25 hours and then thawed, deionized water at 45-55°C is added, and intermittent ultrasonic treatment is performed. The supernatants are then centrifuged and combined, concentrated and freeze-dried to obtain a composite extract of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens.

[0012] In some embodiments, the mass ratio of the Huangling root, the Glycyrrhiza inflata root, and the Sophora flavescens root is (1.3-1.6): (0.9-1.1): 1; the conditions for intermittent ultrasonic treatment are: ultrasonic frequency 35-40KHz, ultrasonic 25-30min / standing 9-10min, and cycle 2-4 times.

[0013] The present invention first destroys the plant cell wall structure through the expansion of ice crystals to promote the release of active ingredients in plant cells, then thaws and uses warm water for extraction to avoid the destruction of heat-sensitive components in the active ingredients, then performs intermittent ultrasonic treatment, uses the ultrasonic cavitation effect to further break up cell debris, shortens the extraction time, and increases the dissolution rate of water-soluble components. In addition, freeze-drying of the composite extract can fully retain volatile components and easily oxidized substances, avoiding heat loss caused by traditional evaporation concentration; in addition, the three traditional Chinese medicines of Huangling root, Zhangguo Licorice root, and Kushen root are extracted through composite extraction rather than single extraction and then mixing. During the extraction process, the three traditional Chinese medicines may interact with each other, thereby enhancing solubility and stability, and being closer to the traditional Chinese medicine "co-decoction" compatibility concept.

[0014] In some embodiments, the method for preparing the composite extract of Eucommia ulmoides leaves and Cistanche deserticola comprises the following steps:

[0015] Mix eucommia leaves and cistanche deserticola, add 6-8 times volume of 55-65wt% ethanol solution, extract at 45-55℃ for 1.5-2.5h, filter and extract repeatedly, combine the filtrate, reduce pressure to recover ethanol, and freeze-dry to obtain a composite extract of eucommia leaves and cistanche deserticola.

[0016] In some embodiments, the mass ratio of the Eucommia ulmoides leaves to the Cistanche deserticola is 1:(0.9-1.1).

[0017] In some embodiments, the preparation method of the auxiliary agent comprises the following steps:

[0018] (1) Add menthol and 9-decenoic acid to tetrahydrofuran, heat to 65-75° C., then add sulfuric acid, react for 5-6 hours, column chromatography, and dry to obtain a compound;

[0019] (2) adding the compound obtained in step (1), N-vinylcaprolactam and an initiator into a solvent and reacting them at 40-50° C. for 1-2 hours, washing and drying to obtain an auxiliary agent.

[0020] In some embodiments, the mass ratio of the compound obtained in step (1) to N-vinylcaprolactam is 1:(0.2-0.6).

[0021] Using only methyl salicylate and vanillyl butyl ether as penetration enhancers has limited penetration effect on polar components such as flavonoids. In addition, in order to take into account the dissolution of lipophilic and hydrophilic components in the active ingredients, a large amount of ethanol is usually required. However, a large amount of ethanol can easily cause skin sensitivity and dryness. The present invention prepares an auxiliary agent that can not only cooperate with the solvent to dissolve various components and improve the utilization rate of the active ingredients of traditional Chinese medicine, but also promote the skin's absorption of the active ingredients, enhance the drug utilization, and improve the therapeutic effect. The possible reason is that the ester group and alkane chain segment present in the auxiliary agent increase the solubility of the lipophilic component and at the same time increase the compatibility with skin cells, so that the free alkane long chain interacts with the hydrophobic region of the lipid between the stratum corneum cells, inserts into the lipid bilayer, destroys its tightly arranged crystalline structure to form "temporary pores", reduces the diffusion resistance of the active ingredient, and promotes skin absorption; in addition, the nitrogen atoms and ketone groups on the auxiliary agent can combine with the water in the stratum corneum, enhance local hydration, loosen the stratum corneum, expand the penetration channel of the hydrophilic component, synergistically increase the drug utilization, and improve the therapeutic effect.

[0022] A second aspect of the present invention provides a method for preparing a traditional Chinese medicine liniment for invigorating qi and activating blood circulation, comprising the following steps:

[0023] S1. Add the active ingredient of the traditional Chinese medicine to a portion of distilled water to obtain a concentrated solution, then mix it with ethanol and methyl salicylate, and stir at 38-42°C and 390-410 rpm for 30-40 minutes to obtain solution A;

[0024] S2. Add the remaining distilled water, vanillyl butyl ether and auxiliary agent to the solution A obtained in step S1, and continue stirring at 38-42° C. for 1-2 hours to obtain solution B;

[0025] S3. Adjust the pH of solution B obtained in step S2 to 5.5-6.0, and filter to obtain a Chinese medicine liniment.

[0026] In some embodiments, the Chinese herbal ointment needs to be refrigerated and stabilized at 3-5°C for 23-25 ​​hours.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] (1) The present invention is to obtain a Chinese medicine ointment by extracting active ingredients from various Chinese medicines with good compatibility, and then compounding them with other auxiliary agents. The Chinese medicine ointment has the advantages of rapid absorption and good therapeutic effect.

[0029] (2) In the present invention, the three Chinese medicinal herbs, namely, Rhizoma Scutellariae, Rhizoma Glycyrrhizae Inflata, and Rhizoma Sophorae Flavescentis, are first subjected to ice crystal expansion to destroy the plant cell wall structure, thereby promoting the release of active ingredients in the plant cells. The herbs are then thawed and extracted with warm water to avoid the destruction of heat-sensitive ingredients in the active ingredients. Intermittent ultrasonic treatment is then performed to further break up cell debris using the ultrasonic cavitation effect, thereby shortening the extraction time and increasing the dissolution rate of water-soluble ingredients. In addition, the composite extraction is more conducive to drug interaction, enhancing solubility and stability, and is closer to the traditional Chinese medicine "co-decoction" compatibility concept.

[0030] (3) The present invention prepares an auxiliary agent that can not only cooperate with the solvent to dissolve various ingredients and improve the utilization rate of the active ingredients of traditional Chinese medicine, but also promote the skin's absorption of the active ingredients and enhance the drug utilization. It solves the problem that only methyl salicylate and vanillyl butyl ether are used as penetration enhancers, which have limited penetration effects on polar ingredients such as flavonoid glycosides and poor therapeutic effects. At the same time, it avoids the problem that a large amount of ethanol can easily cause skin sensitivity and dryness. DETAILED DESCRIPTION

[0031] The present invention will be described below in conjunction with specific embodiments. It should be noted that the following examples are illustrative of the present invention and are intended only to illustrate the present invention and are not intended to limit the present invention. Other combinations and various modifications within the scope of the present invention may be made without departing from the spirit or scope of the present invention.

[0032] In the following examples and comparative examples, the compounds and related reagents used can be purchased from the market.

[0033] Preparation Example 1

[0034] The preparation method of the composite extract 1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza inflata and the root of Sophora flavescens comprises the following steps:

[0035] The root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis, and the root of Sophora flavescens were mixed in a mass ratio of 1.5:1:1 to obtain a mixture, and deionized water 9 times the mass of the mixture was added to grind into a slurry. The mixture was frozen at -20°C for 24 hours and then thawed. Deionized water at 50°C was added and intermittent ultrasonic treatment was performed at an ultrasonic frequency of 38KHz, ultrasonication for 28 minutes / standing for 10 minutes, and the cycle was repeated 3 times. The supernatants were then centrifuged and combined, concentrated, and freeze-dried to obtain a composite extract-1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis, and the root of Sophora flavescens.

[0036] Preparation Example 2

[0037] The preparation method of composite extract 2 of Rhizoma Scutellariae, Rhizoma Glycyrrhizae Inflata and Rhizoma Sophorae Flavescentis is the same as that of Preparation Example 1, except that the mass ratio of Rhizoma Scutellariae, Rhizoma Glycyrrhizae Inflata and Rhizoma Sophorae Flavescentis is 1.8:1:1.

[0038] Preparation Example 3

[0039] The preparation method of the composite extract-3 of the root of Scutellaria baicalensis, the root of Glycyrrhiza inflata and the root of Sophora flavescens is the same as that of Preparation Example 1, except that the ultrasonic frequency is 45KHz.

[0040] Preparation Example 4

[0041] The preparation method of the composite extract 1 of Eucommia ulmoides leaves and Cistanche deserticola comprises the following steps:

[0042] Eucommia leaves and Cistanche deserticola were mixed in a mass ratio of 1:1, 7 times the volume of 60wt% ethanol solution was added, and the mixture was extracted at 50°C for 2h. After filtration, the extraction was repeated once, the filtrate was combined and decompressed to recover ethanol, and the mixture was freeze-dried at -20°C to obtain a composite extract of Eucommia leaves and Cistanche deserticola-1.

[0043] Preparation Example 5

[0044] The preparation method of the composite extract of Eucommia ulmoides leaves and Cistanche deserticola-2 is the same as that of Preparation Example 4, except that the Eucommia ulmoides leaves and Cistanche deserticola are mixed in a mass ratio of 1:1.5.

[0045] Preparation Example 6

[0046] The preparation method of auxiliary agent-1 comprises the following steps:

[0047] (1) 15.6 g of DL-menthol and 18.7 g of 9-decenoic acid were added to 500 ml of tetrahydrofuran, the temperature was raised to 70° C., 0.5 g of 85 wt % sulfuric acid was added, the reaction was continued for 5.5 h, column chromatography was performed, and the compound was dried;

[0048] (2) 10 g of the compound obtained in step (1), 4 g of N-vinylcaprolactam, and 0.1 g of azobisisobutylimidazoline hydrochloride were added to 100 ml of 70 wt% ethanol aqueous solution and reacted at 45° C. for 1.5 h. The mixture was washed and dried to obtain auxiliary agent-1.

[0049] Preparation Example 7

[0050] The preparation method of auxiliary agent-2 is the same as that of Preparation Example 6, except that the amount of N-vinylcaprolactam added is 7 g.

[0051] Preparation Example 8

[0052] The preparation method of auxiliary agent-3 is the same as that of Preparation Example 6, except that an equal amount of 9-decenoic acid is replaced by 2-dodecenoic acid.

[0053] Example 1

[0054] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation, comprising the following raw materials: 24 parts of traditional Chinese medicine active ingredients, 45 parts of anhydrous ethanol, 45 parts of distilled water, 6 parts of butylene glycol, 1 part of methyl salicylate, 0.5 parts of vanillyl butyl ether, and 0.7 parts of auxiliary agent-1;

[0055] The active ingredients of the traditional Chinese medicine are obtained by combining a composite extract-1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens with a composite extract-1 of the leaf of Eucommia ulmoides and the herb of Cistanche deserticola, with the mass ratio of the two being 3:1.

[0056] The preparation method of the traditional Chinese medicine liniment for invigorating qi and activating blood circulation in this embodiment comprises the following steps:

[0057] S1. Add the active ingredient of the traditional Chinese medicine to one-fourth of distilled water to obtain a concentrate, then mix with anhydrous ethanol and methyl salicylate, and stir at 40°C and 400 rpm for 35 minutes to obtain solution A;

[0058] S2. Add the remaining distilled water, vanillyl butyl ether and additive-1 to solution A obtained in step S1, and continue stirring at 40° C. for 1.5 h to obtain solution B;

[0059] S3. Adjust the pH of solution B obtained in step S2 to 5.8 with acetic acid, filter, and obtain a Chinese medicine ointment. Storing the Chinese medicine ointment at 4° C. for 24 hours for stabilization.

[0060] Example 2

[0061] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation, comprising the following raw materials: 23 parts of traditional Chinese medicine active ingredients, 40 parts of anhydrous ethanol, 40 parts of distilled water, 5 parts of butylene glycol, 0.5 parts of methyl salicylate, 0.3 parts of vanillyl butyl ether, and 0.4 parts of auxiliary agent-1;

[0062] The active ingredients of the traditional Chinese medicine are obtained by mixing a composite extract-1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens with a composite extract-1 of the leaf of Eucommia ulmoides and Cistanche deserticola, with the mass ratio of the two being 2.8:1.

[0063] The preparation method of the traditional Chinese medicine liniment for invigorating qi and activating blood circulation in this embodiment comprises the following steps:

[0064] S1. Add the active ingredient of the traditional Chinese medicine to one-fourth of distilled water to obtain a concentrate, which is then mixed with anhydrous ethanol and methyl salicylate, and stirred at 38°C and 390 rpm for 40 min to obtain solution A.

[0065] S2. Add the remaining distilled water, vanillyl butyl ether and additive-1 to solution A obtained in step S1, and continue stirring at 38° C. for 2 h to obtain solution B;

[0066] S3. Adjust the pH of solution B obtained in step S2 to 5.5 with acetic acid, filter, and obtain a Chinese medicine ointment. Store the Chinese medicine ointment at 3° C. for 23 h for stabilization.

[0067] Example 3

[0068] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation, comprising the following raw materials: 25 parts of traditional Chinese medicine active ingredients, 50 parts of anhydrous ethanol, 50 parts of distilled water, 8 parts of butylene glycol, 1.2 parts of methyl salicylate, 0.8 parts of vanillyl butyl ether, and 1 part of auxiliary agent-1;

[0069] The active ingredients of the traditional Chinese medicine are obtained by combining a composite extract-1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens with a composite extract-1 of the leaf of Eucommia ulmoides and the herb of Cistanche deserticola, with the mass ratio of the two being 3.2:1.

[0070] The preparation method of the traditional Chinese medicine liniment for invigorating qi and activating blood circulation in this embodiment comprises the following steps:

[0071] S1. Add the active ingredient of the traditional Chinese medicine to one-fourth of distilled water by weight to obtain a concentrate, which is then mixed with anhydrous ethanol and methyl salicylate, and stirred at 42°C and 410 rpm for 30 min to obtain solution A.

[0072] S2. Add the remaining distilled water, vanillyl butyl ether and additive-1 to solution A obtained in step S1, and continue stirring at 42° C. for 1 h to obtain solution B;

[0073] S3. Adjust the pH of solution B obtained in step S2 to 6.0 with acetic acid, filter, and obtain a Chinese medicine ointment. Storing the Chinese medicine ointment at 5° C. for stabilization for 25 hours.

[0074] Example 4

[0075] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that the composite extract-1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens is replaced by the composite extract-2 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens in equal amounts.

[0076] Example 5

[0077] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that an equal amount of a composite extract 1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis, and the root of Sophora flavescens is replaced with an equal amount of a composite extract 3 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis, and the root of Sophora flavescens.

[0078] Example 6

[0079] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that an equal amount of a composite extract 1 of eucommia leaves and cistanche deserticola is replaced by a composite extract 2 of eucommia leaves and cistanche deserticola.

[0080] Example 7

[0081] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that an equal amount of auxiliary agent-1 is replaced by auxiliary agent-2.

[0082] Example 8

[0083] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation and a preparation method thereof. The specific implementation method is the same as that of Example 1, except that an equal amount of auxiliary agent-1 is replaced by auxiliary agent-3.

[0084] Comparative Example 1

[0085] A traditional Chinese medicine liniment for invigorating qi and activating blood circulation, comprising the following raw materials: 24 parts of traditional Chinese medicine active ingredients, 45 parts of anhydrous ethanol, 45 parts of distilled water, 6 parts of butylene glycol, 1 part of methyl salicylate, and 0.5 part of vanillyl butyl ether;

[0086] The active ingredients of the traditional Chinese medicine are obtained by combining a composite extract-1 of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens with a composite extract-1 of the leaf of Eucommia ulmoides and the herb of Cistanche deserticola, with the mass ratio of the two being 3:1.

[0087] The preparation method of the traditional Chinese medicine liniment for invigorating qi and activating blood circulation in this embodiment comprises the following steps:

[0088] S1. Add the active ingredient of the traditional Chinese medicine to one-fourth of distilled water to obtain a concentrate, then mix with anhydrous ethanol and methyl salicylate, and stir at 40°C and 400 rpm for 35 minutes to obtain solution A;

[0089] S2. Add the remaining distilled water and vanillyl butyl ether to the solution A obtained in step S1, and continue stirring at 40° C. for 1.5 h to obtain solution B;

[0090] S3. Adjust the pH of solution B obtained in step S2 to 5.8 with acetic acid, and filter to obtain a Chinese medicine liniment.

[0091] Performance Testing

[0092] 1. In vitro percutaneous absorption test

[0093] Preparation of ex vivo skin: Take healthy mice weighing 20±5g and kill them by cervical dislocation. Separate the skin under the xiphoid process, remove the hair with sodium sulfide, separate the abdominal skin, remove the subcutaneous tissue and fat, wash with physiological saline, cut into small pieces of appropriate size, and store in a refrigerator at -15℃ for later use. Thaw at room temperature before use, wash with physiological saline, and spread flat on the receiving pool. (2) Use a Franz diffusion device to fix the prepared ex vivo skin between the drug administration pool and the receiving pool. The effective penetration area of ​​the diffusion pool is 2.80cm 2 , the stratum corneum faces the supply chamber, and the dermis side contacts the receiving liquid to eliminate bubbles. The receiving liquid is physiological saline. Weigh 1g of the Chinese medicine ointment prepared in Examples 1-3, 7, 8, and Comparative Example 1 and apply it on the skin so that it is in close contact with the skin. Put a small glass bead in the receiving pool to help stir the receiving liquid in the pool. The supply chamber is closed with plastic wrap. A water bath is used to maintain a constant temperature outside the receiving pool, and the water bath temperature is 37°C. After 6 hours, all the receiving liquid is taken out as the sample liquid, and the concentration of flavonoids in the receiving liquid is determined by ultraviolet spectrophotometer and the total amount is calculated as the total absorption. The total amount of flavonoids in 1g of Chinese medicine ointment is taken as the total amount of administration. Transdermal absorption rate = total absorption / total amount of administration × 100%. The test results are shown in Table 1:

[0094] Table 1

[0095] Group Transdermal absorption rate (%) Example 1 80.2 Example 2 79.6 Example 3 80.0 Example 7 72.3 Example 8 63.6 Comparative Example 1 50.4

[0096] From the experimental data in Table 1, it can be seen that the traditional Chinese medicine ointment obtained in Examples 1-3 has a good transdermal effect; compared with the data of Example 1 and Example 7, it can be seen that the change in the ratio of the compound to N-vinylcaprolactam may cause the skin stratum corneum to be destroyed, resulting in the retention of the active ingredients of the traditional Chinese medicine in the skin, the reduction of the permeation amount, and the reduction of the transdermal absorption rate; compared with the data of Example 1 and Example 8, it can be seen that due to the excessive length of the hydrophobic chain segment of 2-dodecenoic acid, it is difficult to insert into the lipid layer, resulting in a decrease in the transdermal absorption rate; compared with the data of Example 1 and Comparative Example 1, it can be seen that without the use of an adjuvant, the transdermal absorbability of the traditional Chinese medicine ointment is poor.

[0097] 2. Clinical trials

[0098] The Chinese medicine ointments prepared in Examples 1-6 were subjected to clinical trials:

[0099] Sixty patients with bruises and pain in the affected areas, as well as similar symptoms, were selected and agreed to undergo clinical research treatment with the Chinese herbal ointments prepared in the above examples. Each group consisted of 10 volunteers. Professional nursing staff administered the ointment to the volunteers based on the size of the affected area, applying the ointment three times a day. After two days, the treatment effect was recorded and the affected areas of the patients were observed: complete disappearance of bruises and pain was considered cured; no pain but bruises did not completely disappear was considered markedly effective; reduced pain but bruises did not completely disappear was considered effective; and none of the above symptoms was considered ineffective.

[0100] The test results are shown in Table 2:

[0101] Table 2

[0102] Group get well Significant effect efficient invalid Example 1 9 1 0 0 Example 2 8 1 1 0 Example 3 8 1 1 0 Example 4 5 3 2 0 Example 5 6 3 1 0 Example 6 6 2 2 0

[0103] As can be seen from the data in Table 2, the Chinese herbal liniments for invigorating qi and activating blood circulation in Examples 1-3 of the present invention have good therapeutic effects. A comparison of Examples 4 and 6 with Example 1 shows that changing the ratio of Scutellaria root, Glycyrrhiza uralensis root, and Sophora flavescens root, as well as the ratio of Eucommia leaf and Cistanche deserticola will affect the compatibility of the drugs, resulting in a worsening of the therapeutic effect. A comparison of Example 5 with Example 1 shows that changing the frequency of ultrasound may cause some limited components to be destroyed, resulting in a poor therapeutic effect.

[0104] The above embodiments are only for illustrating the technical concept and features of the present invention. Its purpose is to enable people familiar with this technology to understand the content of the present invention and implement it. It cannot be used to limit the scope of protection of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicinal liniment for invigorating qi and activating blood circulation, characterized in that: The preparation comprises the following raw materials in parts by weight: 23-25 ​​parts of traditional Chinese medicine active ingredients, 40-50 parts of ethanol, 40-50 parts of distilled water, 5-8 parts of butylene glycol, 0.5-1.2 parts of methyl salicylate, 0.3-0.8 parts of vanillyl butyl ether, and 0.4-1 parts of auxiliary agents.

2. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 1, characterized in that: The active ingredients of traditional Chinese medicine are prepared by mixing the composite extracts of rhizoma scutellariae, rhizoma glycyrrhizae and rhizoma sophorae flavescentis with the composite extracts of eucommia barbata leaves and cistanche deserticola, with the mass ratio of the two being (2.8-3.2):

1.

3. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 2, characterized in that: The preparation method of the composite extract of the root of Scutellaria baicalensis, the root of Glycyrrhiza inflata and the root of Sophora flavescens comprises the following steps: The root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens are mixed to obtain a mixture, the mixture is ground into a slurry by adding deionized water in an amount of 8-10 times the mass of the mixture, the mixture is frozen at -22 to -18°C for 22-25 hours and then thawed, deionized water at 45-55°C is added, and intermittent ultrasonic treatment is performed. The supernatants are then centrifuged and combined, concentrated and freeze-dried to obtain a composite extract of the root of Scutellaria baicalensis, the root of Glycyrrhiza uralensis and the root of Sophora flavescens.

4. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 3, characterized in that: The mass ratio of the Rhizoma Scutellariae, the Rhizoma Glycyrrhizae Inflata and the Rhizoma Sophorae Flavescentis is (1.3-1.6): (0.9-1.1): 1; the conditions for the intermittent ultrasonic treatment are: ultrasonic frequency 35-40KHz, ultrasonication 25-30min / standing 9-10min, and 2-4 cycles.

5. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 2, characterized in that: The preparation method of the composite extract of Eucommia ulmoides leaves and Cistanche deserticola comprises the following steps: Mix eucommia leaves and cistanche deserticola, add 6-8 times volume of 55-65wt% ethanol solution, extract at 45-55℃ for 1.5-2.5h, filter and extract repeatedly, combine the filtrate, reduce pressure to recover ethanol, and freeze-dry to obtain a composite extract of eucommia leaves and cistanche deserticola.

6. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 5, characterized in that: The mass ratio of the Eucommia ulmoides leaves to the Cistanche deserticola is 1:(0.9-1.1).

7. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 1, characterized in that: The preparation method of the auxiliary agent comprises the following steps: (1) Add menthol and 9-decenoic acid to tetrahydrofuran, heat to 65-75° C., then add sulfuric acid, react for 5-6 hours, column chromatography, and dry to obtain a compound; (2) adding the compound obtained in step (1), N-vinylcaprolactam and an initiator into a solvent and reacting them at 40-50° C. for 1-2 hours, washing and drying to obtain an auxiliary agent.

8. The Chinese medicinal liniment for invigorating qi and activating blood circulation according to claim 7, characterized in that: The mass ratio of the compound obtained in step (1) to N-vinylcaprolactam is 1:(0.2-0.6).

9. A method for preparing the traditional Chinese medicine liniment for invigorating qi and activating blood circulation according to any one of claims 1 to 8, characterized in that: The following steps are involved: S1. Add the active ingredient of the traditional Chinese medicine to a portion of distilled water to obtain a concentrated solution, then mix it with ethanol and methyl salicylate, and stir at 38-42°C and 390-410 rpm for 30-40 minutes to obtain solution A; S2. Add the remaining distilled water, vanillyl butyl ether and auxiliary agent to the solution A obtained in step S1, and continue stirring at 38-42° C. for 1-2 hours to obtain solution B; S3. Adjust the pH of solution B obtained in step S2 to 5.5-6.0, and filter to obtain a Chinese medicine liniment.

10. The method for preparing the traditional Chinese medicine liniment for invigorating qi and activating blood circulation according to claim 9, characterized in that: The Chinese medicine ointment needs to be refrigerated and stabilized at 3-5°C for 23-25 ​​hours.