Compound musk suppository for promoting blood circulation to remove blood stasis and preparation method thereof

Abstract

The invention discloses a compound musk suppository for promoting blood circulation to remove blood stasis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine suppository preparation. Comprising the following raw materials in parts by weight: 30-40 parts of mixed traditional Chinese medicine extract dry powder, 60-65 parts of glycerol, 15-20 parts of gelatin, 15-20 parts of water, 15-20 parts of polyethylene glycol and 1.6-2 parts of an emulsifier. According to the compound musk suppository, radix aucklandiae, musk, pericarpium citri reticulatae, semen coicis, radix scutellariae, caulis spatholobi, Japanese peristrophe herb and rhizoma bletillae are used as traditional Chinese medicine efficacy raw materials of mixed traditional Chinese medicine extract dry powder in the compound musk suppository, and then the compound musk suppository is prepared, so that the prepared compound musk suppository has a good promoting effect on the curative effect of haemorrhoids.

Description

Technical Field

[0001] The invention belongs to the technical field of preparation of traditional Chinese medicine suppositories, and particularly relates to a compound musk suppository for promoting blood circulation and removing blood stasis and a preparation method thereof. Background Art

[0002] Hemorrhoids are a common anorectal condition caused by congestion or stasis and swelling of the venous plexus in the anal canal or lower rectum. Hemorrhoids can be divided into external, internal, and mixed hemorrhoids. Causes include prolapsed anal cushions, varicose veins, poor bowel habits, chronic diseases, and a low-fiber diet. Hemorrhoids may be asymptomatic in their early stages, but symptoms vary depending on the type and severity of the condition, including bleeding, perianal itching, pain, and prolapse. Western medicine treats hemorrhoids primarily by reducing inflammation, relieving swelling and pain, and improving microcirculation. While effective, these treatments can only alleviate symptoms, often leading to recurrence. Therefore, surgery remains the primary treatment. Traditional Chinese Medicine (TCM) has a long history of treating hemorrhoids. TCM believes that the development of hemorrhoids is related to factors such as damp-heat, qi and blood stasis, and spleen and stomach deficiency. Therefore, TCM primarily treats hemorrhoids through methods such as clearing heat and dampness, promoting blood circulation and removing blood stasis, and regulating the spleen and stomach, encompassing both internal and external therapies. Internal treatments, such as taking traditional Chinese medicine internally, are a common approach. Choosing an appropriate herbal formula is based on individual patient differences and the patient's specific condition. External treatments include hemorrhoid creams, suppositories, and sitz baths.

[0003] Patent CN107028911A discloses a self-emulsifying soft capsule of a traditional Chinese medicine composition for treating hemorrhoids and its preparation method. This invention achieves excellent therapeutic effects by combining a hemorrhoids treatment extract with other excipients to form an orally administered soft capsule. While oral administration is convenient, it can be slow for the active ingredients to reach the affected area, leading to a slower onset of effect.

[0004] Patent CN115364158A discloses a preparation method and application of a Chinese medicine composition ointment, which is prepared by dispersing Musk Wind-Turning and Pain-Relieving Fluid Extract, Rutaecarpa Extract and Belladonna Fluid Extract in appropriate water, and then by freeze-drying, removing moisture from the extract, and making the material become fluffy and soluble. Menthol, borneol, camphor, vanillyl butyl ether, methyl salicylate, glycerol, light liquid paraffin are then mixed, and then the ointment freeze-dried powder is added, and the paste obtained has good effect for treating hemorrhoids. Ointment is directly applied to the lesion site, and is quick-acting, but due to defects such as frequent activities, moisture, etc., it can affect the medication effect, and it is necessary to apply repeatedly, and it is less effective for the treatment of internal hemorrhoids.

[0005] Musk has excellent blood-activating and blood-stasis-removing effects, but its use in the preparation of suppositories for hemorrhoids has rarely been reported. Suppositories, on the other hand, are administered directly to the lesion site via rectal administration, requiring fewer doses, offering significant therapeutic effects, and are suitable for a variety of hemorrhoidal conditions. Therefore, combining musk with other traditional Chinese medicines to create a traditional Chinese medicine suppository for the treatment of hemorrhoids would be of great significance for the treatment of hemorrhoids. Summary of the Invention

[0006] In response to the deficiencies of the prior art, the present invention uses costus root, musk, dried tangerine peel, coix seed, scutellaria baicalensis, millet vine, small nine-headed lion grass, and white ginseng as the Chinese medicinal raw materials for the mixed Chinese medicinal extract dry powder in the compound musk suppository, which is then prepared into a compound musk suppository. The prepared compound musk suppository has a good promoting effect on the therapeutic effect of hemorrhoids, thereby solving the technical problems raised in the background art. Specifically, the technical solution of the present invention includes the following contents:

[0007] One of the purposes of the present invention is to provide a compound musk suppository for promoting blood circulation and removing blood stasis, wherein the compound musk suppository comprises the following raw materials in parts by weight:

[0008] 30-40 parts by weight of mixed traditional Chinese medicine extract dry powder, 60-65 parts by weight of glycerin, 15-20 parts by weight of gelatin, 15-20 parts by weight of water, 15-20 parts by weight of polyethylene glycol and 1.6-2 parts by weight of emulsifier.

[0009] Furthermore, the preparation method of the mixed Chinese herbal medicine extract dry powder is as follows:

[0010] Mixing Chinese medicinal powder and water in a weight ratio of 1:10-12, stirring, and performing microwave extraction to obtain a water extract and a filter residue;

[0011] The filter residue and the ethanol solution are mixed and stirred in a weight ratio of 1:5 to 8 and subjected to reflux extraction to obtain an ethanol extract;

[0012] The water extract and the alcohol extract are combined and then vacuum dried to obtain a mixed Chinese medicine extract dry powder.

[0013] Furthermore, the mixed Chinese medicine powder comprises the following raw materials in parts by weight:

[0014] 20-25 parts by weight of costus root, 20-25 parts by weight of musk, 15-20 parts by weight of dried tangerine peel, 13-16 parts by weight of coix seed, 9-13 parts by weight of scutellaria baicalensis, 10-14 parts by weight of millettia reticulata, 18-22 parts by weight of herba schizonepetae and 12-15 parts by weight of bletilla striata.

[0015] Furthermore, the microwave extraction conditions include a microwave power of 500W to 600W and a microwave treatment time of 90s to 120s.

[0016] Furthermore, the mass percentage concentration of the ethanol solution is 60% to 70%.

[0017] Furthermore, the conditions of the reflux extraction include a reflux temperature of 80° C. to 90° C. and a reflux time of 7 h to 10 h.

[0018] Furthermore, the vacuum drying conditions include a vacuum degree of 0.05 MPa to 0.07 MPa, a drying temperature of 60° C., and a drying time of 110 min to 120 min.

[0019] Furthermore, the polyethylene glycol includes polyethylene glycol 800.

[0020] Furthermore, the emulsifier includes Tween 61.

[0021] A second object of the present invention is to provide a method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, the method comprising the following steps:

[0022] Glycerin, gelatin, water and polyethylene glycol are mixed and heated until melted and then kept warm, and then mixed Chinese herbal medicine extract powder and emulsifier are added and mixed and stirred, and finally poured into a mold and cooled until solidified to obtain a compound musk suppository.

[0023] Furthermore, the temperature of the mixed heating is 45°C to 50°C.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] The present invention uses costus root, musk, tangerine peel, coix seed, scutellaria baicalensis, millettia reticulata, small nine-headed lion grass and white ginseng as the Chinese medicinal raw materials of the mixed Chinese medicinal extract dry powder in the compound musk suppository. In this formula, costus root can promote qi and blood circulation, relieve pain, and is particularly suitable for hemorrhoids caused by qi stagnation. Musk has an excellent blood circulation and stasis-removing effect, which can enhance the overall blood circulation effect. The combination of the two can effectively relieve the discomfort caused by hemorrhoids; tangerine peel has the effect of strengthening the spleen and regulating qi, can help digestion, enhance the spleen's transportation and transformation function, and thus reduce the impact of moisture on the internal environment. Coix seed It has obvious diuretic effect. The combination of the two can achieve the effect of strengthening the spleen and removing dampness, helping to improve the overall symptoms of hemorrhoid patients; Scutellaria baicalensis clears heat and dries dampness, suitable for people with damp-heat constitution, can help reduce inflammation, and alleviate the heat symptoms of hemorrhoids; Nine-headed Lion Grass also has the effect of clearing heat and detoxifying, can synergistically clear damp heat in the body, and further improve local inflammation; Millettia reticulata has the function of nourishing blood and activating blood circulation, can promote blood circulation, relax muscles and tendons, and is suitable for the blood circulation and blood stasis needs of hemorrhoids; Bletilla striata can astringe and stop bleeding, reduce swelling and promote tissue regeneration, can effectively relieve symptoms caused by hemorrhoid bleeding, and promote wound healing. The leaching of effective ingredients of traditional Chinese medicine is improved through the synergistic cooperation of microwave water extraction and ethanol alcohol extraction, and then the compound musk suppository is prepared. After the suppository is delivered into the body cavity, it is absorbed by the mucous membrane, reducing the decomposition and destruction caused by passing through the liver, and can fully exert the therapeutic effect of the drug, while reducing the toxicity and side effects of the drug on the liver. The delivery method of the suppository can prevent the oral drug from being destroyed by gastric acid and digestive enzymes, thereby reducing the therapeutic effect, while also reducing side effects such as irritation to the gastric mucosa, so that the prepared compound musk suppository has a good promoting effect on the therapeutic effect of hemorrhoids. DETAILED DESCRIPTION

[0026] The following will clearly and completely describe the technical solutions of the present invention through the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of the present invention.

[0027] Unless otherwise specified, the raw materials and reagents used in the present invention are commercially available or can be prepared by known methods.

[0028] Preparation Example 1:

[0029] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0030] The root of Radix Aucklandiae, Musk, Pericarpium Citri Reticulatae, Semen Coicis, Radix Scutellariae, Caulis Spatholobi, Herba Corydalis Roots and Radix Bletillae are rinsed with water to remove surface impurities, and then dried to remove surface moisture. Then 20 parts by weight of Radix Aucklandiae, 20 parts by weight of Musk, 15 parts by weight of Pericarpium Citri Reticulatae, 13 parts by weight of Semen Coicis, 9 parts by weight of Radix Scutellariae, 10 parts by weight of Caulis Spatholobi, 18 parts by weight of Herba Corydalis Roots and 12 parts by weight of Radix Bletillae are weighed, and after being cut into small pieces with a Chinese medicine slicer, they are put into a Chinese medicine grinder together and pulverized, until the particles after pulverization can pass a 40-mesh sieve to obtain a mixed Chinese medicine powder, 10 times of deionized water are added to the mixed Chinese medicine powder, and then the mixture is dispersed for 10 minutes with an ultrasonic power of 100W by adding an ultrasonic cleaning machine. After dispersion treatment, it is placed in a microwave reactor, and the power of the microwave reactor is adjusted to 500W, and then timed for 90s. After microwave treatment, water extract and filter residue are obtained by centrifugation at a speed of 1000r / min. The filter residue is taken out, and in the filter residue, 5 times of ethanol solution (the mass percent concentration of ethanol solution is 60%) is added again to mix and with the rotating speed of 200r / min mixed and stirred, then warmed to 80 ℃, reflux extraction process 7h. After reflux finishes, again obtain alcohol extract with the rotating speed centrifugation of 1000r / min. The above-mentioned water extract and alcohol extract obtained are merged, then put into vacuum drier, regulating vacuum degree is 0.05MPa, and the temperature of vacuum drying is 60 ℃, and then timed drying process 120min obtains the mixed Chinese medicine extract dry powder.

[0031] Preparation Example 2:

[0032] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0033] The root of Radix Aucklandiae, Musk, Pericarpium Citri Reticulatae, Semen Coicis, Radix Scutellariae, Caulis Spatholobi, Herba Coicis spp. and Radix Bletillae are rinsed with water to remove surface impurities, then dried to remove surface moisture.Then 22 weight portions of Radix Aucklandiae, 21 weight portions of Musk, 16 weight portions of Pericarpium Citri Reticulatae, 14 weight portions of Herba Coicis, 10 weight portions of Radix Scutellariae, 12 weight portions of Caulis Spatholobi, 20 weight portions of Herba Coicis spp. and 13 weight portions of Radix Bletillae are weighed, after being cut into small pieces with Chinese medicine slicer, are put into Chinese medicine grinder together and are pulverized, until the granule after pulverizing can pass 40 mesh screens and obtain mixed Chinese medicine powder, 10 times of weight portions of deionized water are added to the mixed Chinese medicine powder to mix, then through being put into ultrasonic cleaning machine with the ultrasonic power dispersion process 10min of 100W.After dispersion process terminates, be put into microwave reactor, the power of regulating microwave reactor is 550W, then timed process 100s. After the microwave treatment is completed, the mixture is centrifuged at a speed of 1000 r / min to obtain an aqueous extract and a filter residue. The filter residue is taken out, and 6 times the weight of an ethanol solution (the mass percentage concentration of the ethanol solution is 60%) is added to the filter residue and mixed and stirred at a speed of 200 r / min, then the temperature is raised to 85°C and refluxed for extraction for 8 hours. After the reflux is completed, the mixture is centrifuged again at a speed of 1000 r / min to obtain an alcohol extract. The aqueous extract and the alcohol extract obtained above are combined and then placed in a vacuum dryer, the vacuum degree is adjusted to 0.06 MPa, the vacuum drying temperature is 60°C, and then the mixed Chinese medicine extract powder is obtained by timed drying for 120 minutes.

[0034] Preparation Example 3:

[0035] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0036] The root of Radix Aucklandiae, Musk, Pericarpium Citri Reticulatae, Semen Coicis, Radix Scutellariae, Caulis Spatholobi, Herba Schizonepetae and Radix Bletillae are rinsed with water to remove surface impurities, and then dried to remove surface moisture.Then 24 weight portions of Radix Aucklandiae, 23 weight portions of Musk, 18 weight portions of Pericarpium Citri Reticulatae, 15 weight portions of Semen Coicis, 12 weight portions of Radix Scutellariae, 13 weight portions of Caulis Spatholobi, 21 weight portions of Herba Schizonepetae and 14 weight portions of Radix Bletillae are weighed, after being cut into small pieces with Chinese medicine slicer, are put into Chinese medicine grinder together and are pulverized, until the granule after pulverizing can pass 40 mesh screens and obtain mixed Chinese medicine powder, 11 times of weight portions of deionized water are added to the mixed Chinese medicine powder to mix, then through being put into ultrasonic cleaning machine with the ultrasonic power dispersion process 10min of 100W.After dispersion process terminates, be put into microwave reactor, the power of regulating microwave reactor is 550W, then timed process 110s. After the microwave treatment is completed, the mixture is centrifuged at a speed of 1000 r / min to obtain an aqueous extract and a filter residue. The filter residue is taken out, and 7 times the weight portion of ethanol solution (the mass percentage concentration of the ethanol solution is 70%) is added to the filter residue and mixed and stirred at a speed of 200 r / min, then the temperature is raised to 85°C and refluxed for 9 hours. After the reflux is completed, the mixture is centrifuged again at a speed of 1000 r / min to obtain an alcohol extract. The aqueous extract and the alcohol extract obtained above are combined and then placed in a vacuum dryer, the vacuum degree is adjusted to 0.06 MPa, the vacuum drying temperature is 60°C, and then the mixed Chinese medicine extract powder is obtained by timed drying for 110 minutes.

[0037] Preparation Example 4:

[0038] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0039] The root of Radix Aucklandiae, Musk, Pericarpium Citri Reticulatae, Semen Coicis, Radix Scutellariae, Caulis Spatholobi, Herba Schizonepetae and Radix Bletillae are rinsed with water to remove surface impurities, then dried to remove surface moisture.Then 25 weight portions of Radix Aucklandiae, 25 weight portions of Musk, 20 weight portions of Pericarpium Citri Reticulatae, 16 weight portions of Semen Coicis, 13 weight portions of Radix Scutellariae, 14 weight portions of Caulis Spatholobi, 22 weight portions of Herba Schizonepetae and 15 weight portions of Radix Bletillae are weighed, after being cut into small pieces with Chinese medicine slicer, are put into Chinese medicine grinder together and are pulverized, until the granule after pulverizing can pass 40 mesh screens and obtain mixed Chinese medicine powder, 12 times of weight portions of deionized water are added to the mixed Chinese medicine powder to mix, then through being put into ultrasonic cleaning machine with the ultrasonic power dispersion process 10min of 100W.After dispersion process terminates, be put into microwave reactor, the power of regulating microwave reactor is 600W, then timed process 120s. After the microwave treatment is completed, the mixture is centrifuged at a speed of 1000 r / min to obtain an aqueous extract and a filter residue. The filter residue is taken out, and 8 times the weight portion of ethanol solution (the mass percentage concentration of the ethanol solution is 70%) is added to the filter residue and mixed and stirred at a speed of 200 r / min, then the temperature is raised to 90° C. and refluxed for extraction for 10 hours. After the reflux is completed, the mixture is centrifuged again at a speed of 1000 r / min to obtain an alcohol extract. The aqueous extract and the alcohol extract obtained above are combined and then placed in a vacuum dryer, the vacuum degree is adjusted to 0.07 MPa, the vacuum drying temperature is 60° C., and then timed drying is performed for 110 minutes to obtain a mixed Chinese medicine extract powder.

[0040] Preparation Example 5:

[0041] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0042] The amount of costus root from 25 parts by weight in Preparation Example 4 was increased to 30 parts by weight, and the other preparation conditions remained the same as those in Preparation Example 4.

[0043] Preparation Example 6:

[0044] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0045] The 20 parts by weight of dried tangerine peel and 16 parts by weight of coix seed in Preparation Example 4 were increased to 25 parts by weight and 20 parts by weight, respectively, and the other preparation conditions remained the same as those in Preparation Example 4.

[0046] Preparation Example 7:

[0047] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0048] The amount of 14 parts by weight of Millettia spatholobi in Preparation Example 4 was reduced to 10 parts by weight, and the other preparation conditions remained the same as those in Preparation Example 4.

[0049] Preparation Example 8:

[0050] The preparation method of the mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0051] The roots of costus root, musk, dried tangerine peel, coix seed, scutellaria baicalensis, millet spatholobus, small nine-headed lion grass and white ginseng were rinsed with water to remove surface impurities, and then dried to remove surface moisture. Then 25 parts by weight of costus root, 25 parts by weight of musk, 20 parts by weight of dried tangerine peel, 16 parts by weight of coix seed, 13 parts by weight of scutellaria baicalensis, 14 parts by weight of millet spatholobus, 22 parts by weight of small nine-headed lion grass and 15 parts by weight of white ginseng were weighed, cut into small pieces with a Chinese medicine slicer, and then put into a Chinese medicine grinder for crushing until the crushed particles can pass a 200-mesh sieve to obtain a mixed Chinese medicine powder. The remaining preparation process is consistent with Preparation Example 4.

[0052] Preparation Example 9:

[0053] The preparation method of the mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0054] The root of Radix Aucklandiae, Musk, Pericarpium Citri Reticulatae, Semen Coicis, Radix Scutellariae, Caulis Spatholobi, Herba Corydalis Roots and Radix Bletillae are rinsed with water to remove surface impurities, and then dried to remove surface moisture. Then 25 weight portions of Radix Aucklandiae, 25 weight portions of Musk, 20 weight portions of Pericarpium Citri Reticulatae, 16 weight portions of Semen Coicis, 13 weight portions of Radix Scutellariae, 14 weight portions of Caulis Spatholobi, 22 weight portions of Herba Corydalis Roots and 15 weight portions of Radix Bletillae are weighed, after being cut into small pieces with a Chinese medicine slicer, they are put into a Chinese medicine grinder together and pulverized, until the particles after pulverization can pass 40 mesh screens to obtain mixed Chinese medicine powder, 12 times of weight portions of deionized water are added to the mixed Chinese medicine powder to mix, then dispersed for 10min with an ultrasonic power of 100W through being put into an ultrasonic cleaning machine. After dispersion treatment terminates, heat and temperature are raised to boiling, and kept for 5h under boiling state. Subsequently, water extract and filter residue are obtained by centrifugation at a speed of 1000r / min. The water extract obtained above was placed in a vacuum dryer, the vacuum degree was adjusted to 0.07 MPa, the vacuum drying temperature was 60° C., and then the drying process was timed for 110 min to obtain a mixed Chinese medicine extract dry powder.

[0055] Preparation Example 10:

[0056] The preparation method of the mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0057] The root of Radix Aucklandiae, Musk, Pericarpium Citri Reticulatae, Semen Coicis, Radix Scutellariae, Caulis Spatholobi, Herba Corydalis 9001 and Radix Bletillae Rhizoma are rinsed with water to remove surface impurities, and then dried to remove surface moisture. Then 25 weight portions of Radix Aucklandiae, 25 weight portions of Musk, 20 weight portions of Pericarpium Citri Reticulatae, 16 weight portions of Semen Coicis, 13 weight portions of Radix Scutellariae, 14 weight portions of Caulis Spatholobi, 22 weight portions of Herba Corydalis 9001 and 15 weight portions of Radix Bletillae Rhizomae are weighed, after being cut into small pieces with a Chinese medicine slicer, they are put into a Chinese medicine grinder together and pulverized, until the particles after pulverization can pass 40 mesh screens and obtain mixed Chinese medicine powder, 8 times of weight portions of ethanol solution (the mass percent concentration of ethanol solution is 70%) are added to the mixed Chinese medicine powder and mixed and stirred at a speed of 200r / min, then warmed to 90 DEG C, reflux extraction process 10h. After reflux terminates, ethanol extract is obtained again by centrifugation at a speed of 1000r / min. The alcohol extract obtained above was placed in a vacuum dryer, the vacuum degree was adjusted to 0.07 MPa, the vacuum drying temperature was 60° C., and then the drying process was timed for 110 min to obtain a mixed Chinese medicine extract dry powder.

[0058] Preparation Example 11:

[0059] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0060] The microwave power in Preparation Example 4 was increased to 800 W, the microwave treatment time was extended to 200 s, and the other preparation conditions remained the same as in Preparation Example 4.

[0061] Preparation Example 12:

[0062] The preparation method of mixed Chinese herbal medicine extract dry powder specifically includes the following steps:

[0063] The ethanol solution in Preparation Example 4 was replaced with an ethanol solution with a mass percentage concentration of 80%, and the other preparation conditions were consistent with Preparation Example 4.

[0064] Example 1:

[0065] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0066] 60 parts by weight of glycerin, 15 parts by weight of gelatin, 15 parts by weight of deionized water, and 15 parts by weight of polyethylene glycol 800 were weighed and mixed, and then placed in a 45°C water bath and heated until completely melted and then kept warm. Subsequently, 30 parts by weight of the mixed Chinese herbal extract powder obtained in Preparation Example 1 and 1.6 parts by weight of Tween 61 were weighed and mixed, and finally poured into a suppository mold. After cooling until solidified, the mold was removed to obtain a compound musk suppository.

[0067] Example 2:

[0068] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0069] 62 parts by weight of glycerin, 16 parts by weight of gelatin, 17 parts by weight of deionized water, and 16 parts by weight of polyethylene glycol 800 were weighed and mixed, and then placed in a 45°C water bath and heated until completely melted and then kept warm. Subsequently, 34 parts by weight of the mixed Chinese herbal extract powder obtained in Preparation Example 2 and 1.8 parts by weight of Tween 61 were weighed and mixed, and finally poured into a suppository mold. After cooling until solidified, the mold was removed to obtain a compound musk suppository.

[0070] Example 3:

[0071] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0072] 64 parts by weight of glycerin, 18 parts by weight of gelatin, 19 parts by weight of deionized water, and 19 parts by weight of polyethylene glycol 800 were weighed and mixed, and then placed in a 50°C water bath and heated until completely melted and then kept warm. Subsequently, 36 parts by weight of the mixed Chinese herbal extract powder obtained in Preparation Example 3 and 1.9 parts by weight of Tween 61 were weighed and mixed, and finally poured into a suppository mold. After cooling until solidified, the mold was removed to obtain a compound musk suppository.

[0073] Example 4:

[0074] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0075] 65 parts by weight of glycerin, 20 parts by weight of gelatin, 20 parts by weight of deionized water, and 20 parts by weight of polyethylene glycol 800 were weighed and mixed, and then placed in a 50°C water bath and heated until completely melted and then kept warm. Subsequently, 40 parts by weight of the mixed Chinese herbal extract powder obtained in Preparation Example 4 and 2 parts by weight of Tween 61 were weighed and mixed, and finally poured into a suppository mold. After cooling until solidified, the mold was removed to obtain a compound musk suppository.

[0076] Comparative Example 1:

[0077] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0078] The mixed Chinese herbal medicine extract powder in Example 4 was replaced by the mixed Chinese herbal medicine extract powder obtained in Preparation Example 5, and the rest of the preparation process remained the same as in Example 4.

[0079] Comparative Example 2:

[0080] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0081] The mixed Chinese herbal medicine extract powder in Example 4 was replaced by the mixed Chinese herbal medicine extract powder obtained in Preparation Example 6, and the rest of the preparation process remained the same as in Example 4.

[0082] Comparative Example 3:

[0083] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0084] The mixed Chinese herbal medicine extract powder in Example 4 was replaced by the mixed Chinese herbal medicine extract powder obtained in Preparation Example 7, and the rest of the preparation process remained the same as in Example 4.

[0085] Comparative Example 4:

[0086] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0087] The mixed Chinese herbal medicine extract dry powder in Example 4 was replaced by the mixed Chinese herbal medicine extract dry powder obtained in Preparation Example 8, and the rest of the preparation process remained the same as in Example 4.

[0088] Comparative Example 5:

[0089] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0090] The mixed Chinese herbal medicine extract powder in Example 4 was replaced by the mixed Chinese herbal medicine extract powder obtained in Preparation Example 9, and the rest of the preparation process remained the same as in Example 4.

[0091] Comparative Example 6:

[0092] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0093] The mixed Chinese herbal medicine extract dry powder in Example 4 was replaced by the mixed Chinese herbal medicine extract dry powder obtained in Preparation Example 10, and the rest of the preparation process remained the same as in Example 4.

[0094] Comparative Example 7:

[0095] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0096] The mixed Chinese herbal medicine extract powder in Example 4 was replaced by the mixed Chinese herbal medicine extract powder obtained in Preparation Example 11, and the rest of the preparation process remained the same as in Example 4.

[0097] Comparative Example 8:

[0098] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0099] The mixed Chinese herbal medicine extract powder in Example 4 was replaced by the mixed Chinese herbal medicine extract powder obtained in Preparation Example 12, and the rest of the preparation process remained the same as in Example 4.

[0100] Comparative Example 9:

[0101] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0102] The polyethylene glycol 800 in Example 4 was replaced by polyethylene glycol 2000, and the rest of the preparation process remained the same as that of Example 4.

[0103] Comparative Example 10:

[0104] A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis, specifically comprising the following steps:

[0105] The amount of polyethylene glycol 800 in Example 4 was increased to 20 parts by weight, and the rest of the preparation process was the same as that of Example 4.

[0106] Efficacy verification:

[0107] Fifteen rabbits were acclimated for one week in an environment with a temperature of 25±1°C and a relative humidity of 50±2%. Subsequently, 0.1 ml of 75% by mass glacial acetic acid was injected into the same location of the perianal skin of 14 of the rabbits. Perianal swelling and exudate were observed, indicating successful anal ulcer modeling. The remaining rabbit served as a control group and was not treated with glacial acetic acid. The compound musk suppositories obtained in Examples 1-4 and Comparative Examples 1-10 were then administered to the 14 rabbits for 10 consecutive days. After the eleventh day, the perianal skin swelling and exudate of the rabbits were observed, and the area of the perianal ulcer was calculated. The results are shown in Table 1 below.

[0108] Table 1 Hemorrhoids efficacy

[0109] Drug Source Perianal swelling and exudate <![CDATA[Perianal ulcer area (mm 2 )]]> Example 1 No swelling, erythema, or exudate 22.48 Example 2 No swelling, erythema, or exudate 20.15 Example 3 No swelling, erythema, or exudate 19.07 Example 4 No swelling, erythema, or exudate 19.83 Comparative Example 1 Obvious edema, erythema, and exudate 50.32 Comparative Example 2 Obvious edema, erythema, and exudate 47.31 Comparative Example 3 Obvious edema, erythema, and exudate 48.72 Comparative Example 4 Edema, slight erythema and exudate 33.94 Comparative Example 5 Edema, slight erythema and exudate 35.04 Comparative Example 6 Edema, slight erythema and exudate 35.86 Comparative Example 7 Edema, slight erythema and exudate 33.65 Comparative Example 8 Edema, slight exudate 32.74 Comparative Example 9 Edema, slight exudate 32.09 Comparative Example 10 Edema, slight exudate 30.11 control group No swelling, erythema, or exudate 0

[0110] The following conclusions can be drawn from Table 1:

[0111] (1) It can be found from Examples 1 to 4 that the compound musk suppository prepared by the present invention has a good therapeutic effect in treating hemorrhoids.

[0112] (2) Comparative Example 1 shows that the prepared compound musk suppository has a poor therapeutic effect. This may be because in this system, although costus root can promote qi and blood circulation, further increasing the dosage of costus root may easily lead to adverse effects such as hyperactivity and qi stagnation in the formula, which inhibits the efficacy of other drugs and aggravates the symptoms of hemorrhoids.

[0113] (3) Comparative Example 2 shows that the prepared compound musk suppository has a poor therapeutic effect. This may be because in this system, dried tangerine peel has the effect of regulating qi and promoting digestion, and coix seed has the effect of promoting diuresis and removing dampness. However, if the amount is too large, it may cause gastrointestinal irritation, and it is easy to cause uncomfortable symptoms such as abdominal pain or diarrhea, which is not conducive to the spleen-strengthening and dampness-removing effects of the two, thereby affecting the therapeutic effect of the whole prescription on hemorrhoids.

[0114] (4) Comparative Example 3 shows that the prepared compound musk suppository has a poor therapeutic effect. This may be because in this system, Millettia reticulata has the function of nourishing blood and activating blood circulation, which can promote blood circulation and relax muscles and tendons. If the dosage in this prescription is reduced, the blood circulation effect may be weakened and the pain may be aggravated, thereby affecting blood circulation, aggravating the symptoms of hemorrhoids, and affecting the efficacy.

[0115] (5) Comparative Example 4 shows that the therapeutic effect of the prepared compound musk suppository is poor. This may be because in this system, the Chinese medicine particles are over-crushed and the particle size of the Chinese medicine particles is too small, which significantly increases the specific surface area of the powder, causing the active ingredients to be adsorbed on the surface of the powder, hindering their diffusion into the solvent, and easily forming a viscous system, which in turn reduces the extraction efficiency, resulting in insufficient release of the active ingredients and affecting the therapeutic effect.

[0116] (6) It can be seen from Comparative Examples 5 and 6 that the therapeutic effect of the prepared compound musk suppositories is poor. This may be because in this system, a single water extraction method or alcohol extraction method is used, and the Chinese medicinal ingredients in the formula cannot effectively extract the medicinal components, thereby weakening the therapeutic effect of hemorrhoids.

[0117] (7) It can be seen from Comparative Example 7 that the therapeutic effect of the prepared compound musk suppository is poor. This may be because in this system, the microwave power is too high and the time is too long, which may cause some of the medicinal ingredients to be decomposed and lose their activity, thereby weakening the therapeutic effect of hemorrhoids.

[0118] (8) It can be seen from Comparative Example 8 that the therapeutic effect of the prepared compound musk suppository is poor. This may be because in this system, an excessively high concentration of ethanol solution may reduce the solubility of certain water-soluble active ingredients, causing the active ingredients to be wrapped and precipitated by impurities, reducing the content of the active ingredients and thus weakening the therapeutic effect of hemorrhoids.

[0119] (9) Comparative Example 9 shows that the therapeutic effect of the prepared compound musk suppository is poor. This may be because in this system, polyethylene glycol 2000 may be too large in molecular weight, resulting in insolubility at body temperature, which may cause the drug release to be too slow, resulting in poor efficacy.

[0120] (10) Comparative Example 10 shows that the therapeutic effect of the prepared compound musk suppository is poor. This may be because in this system, excessive polyethylene glycol 800 may cause the melting point of the suppository to be too low, making it easy to soften and melt in the body temperature environment, accelerating the release of the drug. However, too fast drug release may make it impossible to maintain the efficacy of the drug, resulting in the body's inability to absorb and process it in time, thereby weakening the efficacy of hemorrhoids.

[0121] The embodiments described above provide a detailed description of the technical solutions and beneficial effects of the present invention. It should be understood that the above descriptions are merely specific embodiments of the present invention and are not intended to limit the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention, and such changes and modifications fall within the scope of the present invention as claimed.

Claims

1. A compound musk suppository for promoting blood circulation and removing blood stasis, characterized in that: The compound musk suppository comprises the following raw materials in parts by weight: 30-40 parts by weight of mixed traditional Chinese medicine extract dry powder, 60-65 parts by weight of glycerin, 15-20 parts by weight of gelatin, 15-20 parts by weight of water, 15-20 parts by weight of polyethylene glycol and 1.6-2 parts by weight of emulsifier.

2. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The preparation method of the mixed Chinese medicine extract dry powder is as follows: Mixing Chinese medicinal powder and water in a weight ratio of 1:10-12, stirring, and performing microwave extraction to obtain a water extract and a filter residue; The filter residue and the ethanol solution are mixed and stirred in a weight ratio of 1:5 to 8 and subjected to reflux extraction to obtain an ethanol extract; The water extract and the alcohol extract are combined and then vacuum dried to obtain a mixed Chinese medicine extract dry powder.

3. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 2, characterized in that: The mixed Chinese medicine powder comprises the following raw materials in parts by weight: 20-25 parts by weight of costus root, 20-25 parts by weight of musk, 15-20 parts by weight of dried tangerine peel, 13-16 parts by weight of coix seed, 9-13 parts by weight of scutellaria baicalensis, 10-14 parts by weight of millettia reticulata, 18-22 parts by weight of herba schizonepetae and 12-15 parts by weight of bletilla striata.

4. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 2, characterized in that: The microwave extraction conditions include a microwave power of 500W to 600W and a microwave treatment time of 90s to 120s.

5. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The mass percentage concentration of the ethanol solution is 60% to 70%.

6. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 2, characterized in that: The conditions of the reflux extraction include a reflux temperature of 80° C. to 90° C. and a reflux time of 7 h to 10 h.

7. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The polyethylene glycol includes polyethylene glycol 800.

8. The compound musk suppository for promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The emulsifier includes Tween-61.

9. A method for preparing a compound musk suppository for promoting blood circulation and removing blood stasis as claimed in any one of claims 1 to 8, characterized in that: The preparation method comprises the following steps: Glycerin, gelatin, water and polyethylene glycol are mixed and heated until melted and then kept warm, and then mixed Chinese herbal medicine extract powder and emulsifier are added and mixed and stirred, and finally poured into a mold and cooled until solidified to obtain a compound musk suppository.