Fingered citron powder transdermal patch for treating primary dysmenorrhea and preparation method of fingered citron powder transdermal patch

Abstract

The invention provides a fingered citron powder transdermal patch for treating primary dysmenorrhea and a preparation method of the fingered citron powder transdermal patch. The patch sequentially comprises a self-heating layer, a backing layer, a medicine carrying layer and an anti-sticking layer from top to bottom. The medicine carrying layer is prepared from thick paste extracted from radix angelicae sinensis and rhizoma chuanxiong, PEG 6000, PEG 4000, PEG 400 and water-soluble azone. The traditional Chinese medicine patch is applied to the Shenque acupoint through acupoint application, so that the medicine property is directly absorbed in a transdermal manner, and the patch is mounted to be prepared into a heating material to promote medicine absorption.

Description

Technical Field

[0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to a foshu powder transdermal patch and a preparation method thereof. Background Art

[0002] Dysmenorrhea is a common and frequently occurring disease in gynecology. Its symptoms are usually periodic pain or heaviness in the lower abdomen, accompanied by backache, vomiting, etc. It is divided into primary dysmenorrhea (PD) and secondary dysmenorrhea (SDM), of which primary dysmenorrhea is the most common. In addition to seriously affecting the physical and mental health of patients, PD also indirectly affects the socioeconomic and educational development. Therefore, how to effectively prevent and treat PD is a problem that clinicians need to solve. According to the data table released by the Domestic Epidemiology Association, the incidence of dysmenorrhea is between 30% and 80%, of which more than half are primary dysmenorrhea patients. Primary dysmenorrhea (PD) is common in adolescent women, which affects women's quality of life and work efficiency to varying degrees, and may even lead to depression or primary infertility in women. Therefore, research on the treatment of primary dysmenorrhea is of great significance.

[0003] The traditional Chinese medicine Foshou powder originated from the "Puji Benshi Fang". After more than 20 years of clinical application, it is composed of two herbs, Angelica and Chuanxiong, which have the effects of promoting blood circulation and qi, unblocking meridians and relieving pain. It has significant effects in treating gynecological diseases such as dysmenorrhea and irregular menstruation. Using ancient prescriptions as carriers to explore the material basis of the efficacy of traditional Chinese medicine and develop new drugs based on this has become a hot topic in today's medical research. The earliest record of Chinese medicine umbilical application therapy was in the "Wuerbing Fang". According to traditional medical theory, the human navel is also called "Shenque Point", which is one of the important acupuncture points on the Ren Meridian. Modern medicine also believes that the thinnest cortical layer of the human body is located in the navel, and its barrier function is weak, so umbilical administration is one of the suitable ways for transdermal absorption system. Traditional umbilical application therapy mostly breaks the Chinese medicinal materials into powder or mashes them into mud, mixes them with excipients such as honey to make them viscous, and applies them to the navel. The powder composed of two herbs, Angelica and Chuanxiong, has significant efficacy, but patients have poor compliance, are not conducive to carrying, and lack a complete quality standard inspection system.

[0004] This study is guided by the theory of traditional Chinese medicine, uses modern pharmaceutical technology to transform its preparations, and rationally optimizes the extraction and preparation processes, establishes a complete quality standard system, and conducts pharmacodynamic experiments to verify the efficacy. The purpose is to obtain a safe, efficient, stable, and controllable umbilical therapy preparation, provide a reference for further use of traditional Chinese medicine compound to treat primary dysmenorrhea, and provide a safe and effective new drug for the clinical treatment of primary dysmenorrhea. Summary of the invention

[0005] The invention provides a buddha's hand powder transdermal patch and a preparation method thereof, adopts a new dosage form, makes full use of the effective ingredients of buddha's hand powder, and improves bioavailability. The preferred formula and preparation process, the preparation of buddha's hand powder transdermal patch is simple to operate, and saves manpower. The product adopts a hot melt method to prepare a drug core suppository, the suppository is solid at room temperature, the melting temperature and consistency are adjustable, softens or melts at the umbilicus acupoint with the increase of temperature, is conducive to the release of the drug, because its size and weight can be adjusted according to the drug, the dosage is accurate, and various transdermal absorption promoters can be selected to be fused with a matrix to improve the transdermal effect, and the matrix and the drug can be fused to form a shape suitable for the size of the umbilicus. Therefore, in this experiment, the drug core of the buddha's hand patch is made into a suppository.

[0006] The specific technical scheme of the present invention is: In the first aspect, the present invention provides a transdermal patch of Foshousan for treating primary dysmenorrhea, which comprises a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer from bottom to top. In parts by weight, the raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 3 parts of drug-carrying matrix and a transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of Chuanxiong; the drug-carrying matrix includes 1.88 parts of PEG6000, 1.32 parts of PEG4000 and 0.8 parts of PEG400; the transdermal absorption enhancer is water-soluble azone.

[0007] The patch of the present invention can effectively treat primary dysmenorrhea, has the advantages of large drug loading capacity, good release effect, good air permeability, low irritation, non-allergenic, repeated sticking, mild viscosity, easy to carry, etc., has high usability, and has considerable social and economic value.

[0008] The prescription of this preparation is composed of angelica and chuanxiong, and the whole prescription has the effects of nourishing blood, activating blood circulation, unblocking meridians and relieving pain. Modern pharmacological studies have shown that the main drugs contained in this prescription have a good therapeutic effect on primary dysmenorrhea. Angelica, also known as Qin Gui, is the dried root of the Umbelliferae plant. The main production areas are Minxian and Dangchang in Gansu Province, my country. It is sweet, pungent and warm in nature, and enters the heart, liver and spleen meridians. It mainly has the effects of nourishing blood, activating blood circulation, regulating menstruation and relieving pain, moisturizing and lubricating intestines, and promoting muscle growth and strengthening bones; chuanxiong is a plant of the genus Ligusticum in the umbelliferae family. The rhizome of chuanxiong is warm in nature, pungent and slightly bitter in taste, and has the effects of promoting qi and activating blood circulation, dispelling wind and relieving pain. It mainly treats irregular menstruation caused by blood stasis and qi stagnation, dysmenorrhea, amenorrhea, flank pain and abdominal pain.

[0009] Preferably, the method for preparing the drug-loaded matrix comprises the following steps: (1) Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60°C water bath to melt; (2) Add PEG400 and water-soluble azone in sequence, stir evenly and then slowly add the thick paste while stirring; (3) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool it to obtain a drug-loaded matrix.

[0010] Preferably, in step (3), the demoulding time of the Chinese medicine core suppository is 30 minutes and the molding temperature is 60°C.

[0011] Preferably, the ratio of the self-heating materials is reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 6:8:8:2:4.

[0012] Preferably, the self-heating mounting material is prepared by weighing activated carbon, sodium chloride and vermiculite respectively in proportion and mixing them evenly in a mortar, then using a pipette to draw a certain amount of distilled water into the mortar, finally adding reduced iron powder and grinding evenly, and packaging it in microporous breathable film composite non-woven fabric bags to obtain samples.

[0013] Preferably, the weight proportions of the components of the drug-loaded matrix are: PEG4000 1.88 parts by weight PEG6000 1.32 parts by weight PEG400 0.8 parts by weight.

[0014] Preferably, the weight parts of the components of the thick paste are: 18 parts by weight of Chinese Angelica 12 parts by weight of Ligusticum chuanxiong.

[0015] Preferably, the transdermal absorption enhancer in the drug-carrying layer is water-soluble azone.

[0016] In a second aspect, the present invention also provides a method for preparing a Foshousan transdermal patch for treating primary dysmenorrhea, comprising the following steps: S1, reflux the Chinese medicinal ingredients in the drug-carrying layer twice in an ethanol aqueous solution with a mass concentration of 85%, concentrate to a certain specific gravity, and prepare a thick paste; S2. Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60℃ water bath to melt. Add PEG400 and water-soluble azone in sequence. Stir well and slowly add the thick paste while stirring. After mixing well, quickly pour into the suppository mold coated with glycerin. After waiting for 30 minutes, scrape off the overflowed part, open the mold to obtain the suppository, put the suppository in the blank non-woven fabric of umbilical therapy patch, and cover it with a cover liner.

[0017] Further preferably, during the preparation of the thick paste, 6 times the amount of 85% ethanol is used for extraction twice, 1.5 h / times, and the two reflux filtrates are combined.

[0018] Further preferably, during the preparation of the thick paste, 360 ml of the extract is concentrated to 6 ml by vacuum concentration, and the relative density is 1.20 g / mL.

[0019] Further preferably, during the preparation of the thick paste, the reduced pressure concentration temperature is 60°C.

[0020] Beneficial effects of the present invention: 1) This study selected transdermal drug delivery preparations, which are convenient to carry and improve the comprehensive efficacy of drugs. In order to further increase the local drug concentration, the backing is prepared into a heating material to promote drug absorption, avoid gastrointestinal irritation, reduce the number of medications, and have a sustained release effect.

[0021] 2) This study administered the drug through the navel Shenque point. The navel is the innate origin of the human body and the origin of all nerves. It is a part that has extremely important physiological and pathological connections with the twelve meridians, internal organs, limbs, skin, fur, bones and flesh of the human body. The navel has a very rich distribution of blood vessels and a high sensitivity of the skin, which is conducive to the drug exerting its effect through the meridians.

[0022] 3) The causes of primary dysmenorrhea are mostly related to eating cold food and catching cold. Combining traditional patches with heating materials can maximize the efficacy of the medicine and relieve the patient's symptoms. DETAILED DESCRIPTION

[0023] In order to make the purpose and technical scheme of the present invention clearer, the present invention is further described below in conjunction with embodiment, but the protection scope of the present invention is not limited to these embodiments, and the embodiment is only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention. The present invention is further described below in conjunction with embodiment, but the present invention is not limited by the embodiment.

[0024] Example 1 A foshu powder transdermal patch for treating primary dysmenorrhea comprises a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer from top to bottom.

[0025] The ratio of the self-heating materials is reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 6:8:8:2:4. The raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 3 parts of drug-carrying matrix and transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of Chuanxiong; the drug-carrying matrix includes 1.88 parts of PEG6000, 1.32 parts of PEG4000 and 0.8 parts of PEG400; the transdermal absorption enhancer is water-soluble azone.

[0026] The preparation method of the drug-loaded matrix comprises the following steps: (1) Weigh 1.88 g of PEG6000 and 1.32 g of PEG4000 and heat them in an evaporating dish at 60°C in a water bath to melt; (2) Add 0.8 g of PEG400 and 0.2 g of water-soluble azone in sequence, stir evenly, then slowly add 6 g of thick paste while stirring; (3) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool to obtain a drug-loaded matrix.

[0027] The preparation method of the above-mentioned Foshousan transdermal patch for treating primary dysmenorrhea comprises the following steps: S1. Take 18g of Chinese angelica and 12g of Chuanxiong and add 6 times the amount of 85% ethanol aqueous solution to the drug-carrying layer, reflux twice for 1.5h / times, and concentrate to a certain specific gravity to obtain a thick paste; S2. Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60℃ water bath to melt. Add PEG400 and water-soluble azone in sequence. Stir well and slowly add the thick paste while stirring. After mixing well, quickly pour into the suppository mold coated with glycerin. After waiting for 30 minutes, scrape off the overflowed part, open the mold to obtain the suppository, put the suppository in the blank non-woven fabric of umbilical therapy patch, and cover it with a cover liner.

[0028] Example 2 A foshu powder transdermal patch for treating primary dysmenorrhea comprises, from bottom to top, a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer.

[0029] The ratio of the self-heating materials is reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 4:8:4:2:1. The raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 3 parts of drug-carrying matrix and transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of Chuanxiong; the drug-carrying matrix includes 1.88 parts of PEG6000, 1.32 parts of PEG4000 and 0.8 parts of PEG400; the transdermal absorption enhancer is water-soluble azone.

[0030] The preparation method of the drug-loaded matrix comprises the following steps: (1) Weigh 1.88 g of PEG6000 and 1.32 g of PEG4000 and heat them in an evaporating dish at 60°C in a water bath to melt; (2) Add 0.8 g of PEG400 and 0.2 g of water-soluble azone in sequence, stir evenly, then slowly add 6 g of thick paste while stirring; (3) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool to obtain a drug-loaded matrix.

[0031] The preparation method of the above-mentioned Foshousan transdermal patch for treating primary dysmenorrhea comprises the following steps: S1. Take 18g of Chinese angelica and 12g of Chuanxiong and add 6 times the amount of 85% ethanol aqueous solution to the drug-carrying layer, reflux twice for 1.5h / times, and concentrate to a certain specific gravity to obtain a thick paste; S2. Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60℃ water bath to melt. Add PEG400 and water-soluble azone in sequence. Stir well and slowly add the thick paste while stirring. After mixing well, quickly pour into a suppository mold coated with glycerin. After waiting for 20 minutes, scrape off the overflowed part, open the mold to obtain the suppository, put the suppository in the blank non-woven fabric of the umbilical therapy patch, and cover it with a cover liner.

[0032] Example 3 A foshu powder transdermal patch for treating primary dysmenorrhea comprises, from bottom to top, a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer.

[0033] The ratio of the self-heating materials is reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 6:8:4:2:1. The raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 3 parts of drug-carrying matrix and transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of Chuanxiong; the drug-carrying matrix includes 1.88 parts of PEG6000, 1.32 parts of PEG4000 and 0.8 parts of PEG400; the transdermal absorption enhancer is water-soluble azone.

[0034] The preparation method of the drug-loaded matrix comprises the following steps: (1) Weigh 1.88 g of PEG6000 and 1.32 g of PEG4000 and heat them in an evaporating dish at 60°C in a water bath to melt; (2) Add 0.8 g of PEG400 and 0.2 g of water-soluble azone in sequence, stir evenly, then slowly add 6 g of thick paste while stirring; (3) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool to obtain a drug-loaded matrix.

[0035] The preparation method of the above-mentioned Foshousan transdermal patch for treating primary dysmenorrhea comprises the following steps: S1. Take 18g of Chinese angelica and 12g of Chuanxiong and add 6 times the amount of 85% ethanol aqueous solution to the drug-carrying layer, reflux twice for 1.5h / times, and concentrate to a certain specific gravity to obtain a thick paste; S2. Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60℃ water bath to melt. Add PEG400 and water-soluble azone in sequence. Stir well and slowly add the thick paste while stirring. After mixing well, quickly pour into a suppository mold coated with glycerin. After waiting for 40 minutes, scrape off the overflowed part, open the mold to obtain the suppository, put the suppository in the blank non-woven fabric of the umbilical therapy patch, and cover it with a cover liner.

[0036] Comparative Example 1 The difference from Example 1 is that no self-heating material is added.

[0037] A foshu powder transdermal patch for treating primary dysmenorrhea comprises a backing layer, a drug-carrying layer and an anti-adhesive layer from bottom to top.

[0038] The raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 3 parts of drug-carrying matrix and a transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of chuanxiong; the drug-carrying matrix includes 1.88 parts of PEG6000, 1.32 parts of PEG4000 and 0.8 parts of PEG4000; the transdermal absorption enhancer is water-soluble azone.

[0039] The preparation method of the drug-loaded matrix comprises the following steps: (1) Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60℃ water bath to melt; (2) Add PEG400 and water-soluble azone in sequence, stir evenly, then slowly add the thick paste while stirring; (3) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool to obtain a drug-loaded matrix.

[0040] The preparation method of the above-mentioned Foshousan transdermal patch for treating primary dysmenorrhea comprises the following steps: S1. Take 18g of Chinese angelica and 12g of Chuanxiong and add 6 times the amount of 85% ethanol aqueous solution to the drug-carrying layer, reflux twice for 1.5h / times, and concentrate to a certain specific gravity to obtain a thick paste; S2. Weigh PEG6000 and PEG4000 according to the prescription and heat them in an evaporating dish at 60℃ water bath to melt. Add PEG400 and water-soluble azone in sequence. Stir well and slowly add the thick paste while stirring. After mixing well, quickly pour into the suppository mold coated with glycerin. After waiting for 30 minutes, scrape off the overflowed part, open the mold to obtain the suppository, put the suppository in the blank non-woven fabric of umbilical therapy patch, and cover it with a cover liner.

[0041] Comparative Example 2 The difference from Example 1 is that the drug-carrying matrix is ​​semi-synthetic fatty acid glyceride.

[0042] A foshu powder transdermal patch for treating primary dysmenorrhea comprises, from bottom to top, a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer.

[0043] The ratio of the self-heating materials is reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 6:8:8:2:4. The raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 4 parts of drug-carrying matrix and transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of Chuanxiong; the drug-carrying matrix includes 4 parts of semi-synthetic fatty acid glyceride; the transdermal absorption enhancer is water-soluble azone.

[0044] The preparation method of the drug-loaded matrix comprises the following steps: (1) Weigh 4.0 g of semi-synthetic fatty acid glyceride and heat it in an evaporating dish at 60°C in a water bath to melt; (2) Add 0.2 g of water-soluble azone, stir evenly, then slowly add the thick paste while stirring; (3) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool to obtain a drug-loaded matrix.

[0045] The preparation method of the above-mentioned Foshousan transdermal patch for treating primary dysmenorrhea comprises the following steps: S1. Take 18g of Chinese angelica and 12g of Chuanxiong and add 6 times the amount of 85% ethanol aqueous solution to the drug-carrying layer, reflux twice for 1.5h / times, and concentrate to a certain specific gravity to obtain a thick paste; S2.) Weigh 4.0 g of semi-synthetic fatty acid glyceride into an evaporating dish and heat in a 60°C water bath to melt, add 0.2 g of water-soluble azone, stir evenly and slowly add the thick paste while stirring, and after mixing evenly, quickly pour into a suppository mold coated with glycerin, wait for 30 minutes, scrape off the overflowed part, open the mold, and obtain the suppository, put the suppository in a blank umbilical therapy patch non-woven fabric, and cover it with a cover liner.

[0046] Comparative Example 3 The difference from Example 1 is that the drug-carrying matrix is ​​glycerol-gelatin-water (7:2:1).

[0047] A foshu powder transdermal patch for treating primary dysmenorrhea comprises, from bottom to top, a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer.

[0048] The ratio of the self-heating materials is reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 6:8:8:2:4. The raw materials of the drug-carrying layer include 6 parts of traditional Chinese medicine ingredients, 4 parts of drug-carrying matrix and transdermal absorption enhancer; the traditional Chinese medicine ingredients include 18 parts of angelica and 12 parts of Chuanxiong; the drug-carrying matrix includes 7 parts of glycerol, 2 parts of gelatin and 1 part of water; the transdermal absorption enhancer is water-soluble azone.

[0049] The preparation method of the drug-loaded matrix comprises the following steps: (1) Weigh 0.8 g of gelatin and transfer it to a weighed evaporating dish. Then add an appropriate amount of distilled water to soak it for 0.5 h to make it swell and soften. (2) Place it in a water bath. Add 2.8 g of glycerol and wait until the solution evaporates until the content reaches the required weight, thus obtaining 4 g of glycerol-gelatin matrix (glycerol: gelatin: water = 7:2:1); (3) Add 0.2 g of water-soluble azone, stir evenly, then slowly add 6 g of thick paste while stirring; (4) After mixing evenly, pour the mixture into a suppository mold coated with glycerin and cool to obtain a drug-loaded matrix.

[0050] The preparation method of the above-mentioned Foshousan transdermal patch for treating primary dysmenorrhea comprises the following steps: S1. Take 18g of Chinese angelica and 12g of Chuanxiong and add 6 times the amount of 85% ethanol aqueous solution to the drug-carrying layer, reflux twice for 1.5h / times, and concentrate to a certain specific gravity to obtain a thick paste; S2. Weigh 0.8 g of gelatin and transfer it to a weighed evaporating dish. Then add an appropriate amount of distilled water to it and soak it for 0.5 hours to make it swell and soften. Place it in a water bath. Add 2.8 g of glycerol to it and wait for the solution to evaporate until the content reaches the required weight, and then obtain 4 g of glycerol gelatin matrix (glycerol: gelatin: water = 7:2:1). Weigh 6 g of thick paste, add it to the prepared matrix, stir evenly, and quickly pour it into the plug mold that has been coated with lubricant. After waiting for 30 minutes, scrape off the overflow, open the mold, and obtain the plug sheet. Put the plug sheet in the umbilical therapy blank non-woven fabric and cover it with a cover liner.

[0051] Table 1 Calculation of cumulative penetration Q, Qt equation, and correlation coefficient R of Buddha's hand patch and Buddha's hand heat patch using ferulic acid as the determination index 2 .

[0052]

[0053] Table 2 Test items Matrix hardness Melting time limit (min) Maximum drug loading Appearance Example 1 PEG4000-PEG6000-PEG400(33:47:20) Moderate 30 60% Smooth surface, uniform color, dense cross section without bubbles Comparative Example 2 Semi-synthetic fatty acid glycerides Too soft 20 50% The surface is smooth, the color is uneven, and the cross section is dense and free of bubbles. Comparative Example 3 Glycerin: gelatin: water = 7:2:1 Moderate 23 40% The surface is smooth, the color is uniform, and the cross section is dense and has bubbles Table 3 Test items Demolding time (min) Appearance Formability Demolding Example 1 30 smooth good Easy demoulding, no sticking Example 2 20 Rough Poor Unable to completely demould Example 3 40 smooth good Easy demoulding, slight sticking It can be seen from the data recorded in Table 1 that the cumulative permeation amount of ferulic acid in Example 1 at each time point is higher than that in Comparative Example 1, proving that the self-heating material promotes the transdermal absorption of drugs. As shown in Table 2, glycerol gelatin has a certain elasticity, but the drug loading is limited and the hardness is insufficient, and bubbles are generated on the surface; semi-synthetic fatty acid glyceride is a fat-soluble matrix, which is unevenly mixed with the drug, and the drug loading is insufficient. The polyethylene glycol mixed matrix has a certain hardness, can be mixed evenly with the drug, and the melting time limit meets the requirements. And Table 3 shows that when the demolding time is 30min, the suppository has good formability, is easy to demold and has no sticking phenomenon, so the optimal demolding time is 30min.

[0054] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Foshousan transdermal patch for treating primary dysmenorrhea, characterized in that: The patch comprises a self-heating layer, a backing layer, a drug-carrying layer and an anti-adhesive layer from top to bottom; The drug-carrying layer comprises a thick paste, a drug-carrying matrix, and a transdermal absorption enhancer; the thick paste in the drug-carrying layer of the transdermal patch contains angelica and ligusticum chuanxiong; The transdermal patch drug-carrying layer contains the following components in parts by weight: PEG6000 1.88 parts by weight, PEG4000 1.32 parts by weight, PEG400 0.8 parts by weight, 0.2 weight parts of water-soluble azone, Thick paste 6 parts by weight; The thick paste contains the following components in parts by weight: 18 parts by weight of Chinese Angelica sinensis, 12 parts by weight of Ligusticum chuanxiong.

2. A method for preparing the Buddha's hand thermal patch as claimed in claim 1, characterized in that: Contains the following steps: a) Preparation of self-heating mounting material: activated carbon, sodium chloride and vermiculite are weighed respectively in a mortar in a ratio of reduced iron powder: activated carbon: sodium chloride: vermiculite: water = 6:8:8:2:4 and mixed evenly, then a fixed amount of distilled water is drawn into the mortar with a pipette, and finally reduced iron powder is added and ground evenly, and the mixture is divided into microporous breathable film composite non-woven fabric bags to obtain samples; b) Preparation of thick paste: according to the prescription, 18 parts by weight of Chinese Angelica sinensis and 12 parts by weight of Chuanxiong were weighed, and 6 times the amount of 85% ethanol was added for extraction twice, 1.5 h / times, filtered, the filtrates were combined, and concentrated under reduced pressure at 60°C to a density of 1.20 g / mL to obtain 6 parts by weight of thick paste; c) Preparation of drug-loaded core suppositories: Weigh 1.88g of PEG6000 and 1.32g of PEG4000 according to the prescription and heat them in a 60°C water bath in an evaporating dish to melt. Then add 0.8g of PEG400 and 0.2g of water-soluble azone in sequence. After stirring evenly, slowly add 6g of thick paste while stirring. After mixing evenly, quickly pour into a suppository mold coated with glycerin. After waiting for 30 minutes, scrape off the overflowed part, open the mold, and obtain the suppository; d) Preparation of the patch: Place the suppository in the blank non-woven fabric of the umbilical therapy patch and cover it with a cover liner.

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