CN100400033C - Preparation method of Xiangsha nourishing stomach chewable tablet - Google Patents

Abstract

The present invention relates to a Xiangsha stomach nourishing chewable tablet and a preparation method thereof. According to the legal medicine standard, raw materials are selected, and volatile oil and extract are extracted, wherein the volatile oil is prepared into an inclusion compound by adopting beta-cyclodextrin or hydroxypropyl beta-cyclodextrin; the extract is prepared into dry extract powder by concentration and drying; a right amount of microcrystalline cellulose, aspartame, mannitol, xylitol and magnesium stearate are used as a chewable tablet excipient; the prepared granules are dried at low temperature and are prepared into the Xiangsha stomach nourishing chewable tablet by press. Thereby, the Xiangsha stomach nourishing chewable tablet can perform the function of treating patients with stomach discomfort caused by anorexia, vomit of acid water, dyspepsia, distending pain in the stomach, etc. The preparation method has the advantages that the method ensures that effective components of the Xiangsha stomach nourishing preparation satisfy medicinal requirements and enables the Xiangsha stomach nourishing preparation to rapidly dissolve in the stomach and the effective components to dissolve in time by mastication in the oral cavity; the preparation method greatly reduces stimulation to the stomach caused by the long-term difficult disintegration and dispersion of medicines.

Description

Preparation method of Xiangsha nourishing stomach chewable tablet

technical field

The invention relates to a preparation method of Xiangsha nourishing stomach chewable tablet.

Background technique

Xiangsha Nourishing Stomach Preparation is a medicine that warms the stomach and relieves stomach discomfort such as indigestion, vomiting of acid water, indigestion, and epigastric pain. Twenty volumes (the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China 1998) just recorded Xiangsha Yangwei Oral Liquid and Xiangsha Yangwei Soft Capsules. According to a large number of literatures, various volatile oils contained in the Xiangsha Yangwei preparation play a very important pharmacological role in its therapeutic effect. Insufficient content of volatile oil will reduce the efficacy of the medicine. In the preparation process of the improved Xiangsha Yangwei Granules, Xiangsha Yangwei Capsules, Xiangsha Yangwei Tablets, Xiangsha Yangwei Oral Liquid and other series of Xiangsha Yangwei preparations, a large amount of volatile oil will be volatilized due to the high temperature And the loss; the part where these drugs produce drug effect is in the patient's stomach. Factors such as delay and slow release of active ingredients of the drug not only affect the curative effect of the drug, but also stimulate the patient's stomach, which limits its application. Patent application No. 01100749 is to use nanotechnology for the raw materials of Xiangsha Nourishing Stomach Preparation, but the nano-grinding technology is difficult and requires high equipment. At the same time, due to the rupture of the cell wall during the milling process, a large amount of volatile oil can be lost. And cause drug effect to reduce; Patent Application No. 03118954 is Xiangsha nourishing stomach biphasic hard capsule, before preparing hard capsule, volatile oil will be made into soft capsule or capsule earlier, preparation requirement is high, and process is complicated, hard capsule after molding It is more difficult to disintegrate in the stomach, and the active ingredients are more difficult to dissolve, and produce different degrees of irritation to the stomach.

Contents of the invention

In view of the above-mentioned situation, the present invention provides a method to make the active ingredients of the medicine meet the needs of medical treatment without changing the prescription composition of the Xiangsha nourishing stomach preparation, and to make the medicine disintegrate and disperse rapidly in the stomach after being chewed by the mouth, and the active ingredients can be recovered in time. Dissolution, a new type of Xiangsha nourishing stomach chewable tablet that reduces irritation to the stomach. On this basis, the present invention will also provide a method for preparing Xiangsha nourishing stomach chewable tablet and the application of its additives in the preparation.

The present invention is achieved through the following technical solutions:

For Xiangsha Yangwei Chewable Tablets, the prescription raw materials and dosage ratio include any one of the following two statutory standards:

Prescription ①: 154 parts of woody incense, 154 parts of amomum, 221 parts of Atractylodes macrocephala, 221 parts of tangerine peel, 221 parts of poria cocos, 221 parts of pinellia, 154 parts of vinegar cyperus, 154 parts of citrus aurantium, 154 parts of shelled white cardamom, 154 parts of ginger magnolia, 154 parts of patchouli, 66 parts of licorice, 66 parts of ginger, 110 parts of jujube;

Prescription ②: 100 parts of Cyperus cyperi, 100 parts of amomum, 100 parts of patchouli, 100 parts of Poria cocos, 100 parts of magnolia bark made from ginger, 100 parts of pinellia, 100 parts of Atractylodes macrocephala, 100 parts of citrus aurantium, 50 parts of licorice, Shell white cardamom 50 parts, tangerine peel 50 parts, woody fragrance 50 parts, jujube 40 parts, ginger 10 parts;

The preparation method is:

(1) According to prescription ① or prescription ② to extract volatile oil and extract respectively, according to prescription ① to extract volatile oil from woody incense, amomum, patchouli, shelled white cardamom, and tangerine peel, and collect the distilled aqueous solution in another device; Radix Cyperi, Ginger Magnolia officinalis, Citrus Aurantium, Poria Cocos, Pinellia Rhizoma Atractylodes Rhizome, Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizome, Jujube, Ginger, and Licorice are heated and refluxed twice with 80% ethanol for 1-2 hours each time, filtered, and the filtrates are combined to recover ethanol; The above two aqueous solutions are combined to obtain the extract of Xiangsha Nourishing Stomach; according to the prescription ② soak the vinegar-made Cyperi cyperi, ginger-made Magnolia officinalis, Atractylodes macrocephala, Citrus aurantium, and tangerine peel with 60% ethanol, collect the percolation liquid, and set aside; patchouli, Extract volatile oil from amomum, woody, shelled white cardamom, and ginger; after extracting volatile oil, decoct medicinal dregs with poria cocos, pinellia chinensis, jujube, and licorice twice, for 2 hours each time, filter, and add the above-mentioned filter after cooling the filtrate In the solution, let it stand for 20-24h, filter, recover ethanol, and obtain the extract of fragrant sand nourishing the stomach;

(2) The volatile oil is prepared into an inclusion compound using β-cyclodextrin or hydroxypropyl β-cyclodextrin, and each milliliter of volatile oil is equivalent to 6-12 grams of β-cyclodextrin; each milliliter of volatile oil is equivalent to hydroxypropyl β-cyclodextrin Cyclodextrin 3-10 grams;

(3) The extract is concentrated into a thick paste, and dried below 80°C into a dry extract powder;

(4) Select 80-120% microcrystalline cellulose, 1-2% aspartame, 50-100% mannitol, 5-30 % xylitol and 0.5-1% magnesium stearate are mixed as excipients; the content is 80-95% ethanol soft material as wetting agent;

(5) Granulate with a 16-mesh sieve, and vacuum dry at a low temperature below 60°C;

(6) Sieve the 16-mesh granules, press into tablets, and pack according to the general tablet packaging method. After passing the inspection, the product—Xiangsha Yangwei Chewable Tablets is obtained.

The present invention selects the optimized inclusion process route, carries out the inclusion inclusion of the extracted volatile oil, and adopts different additives such as excipients respectively, and is a new type of fragrant sand nourishing stomach preparation made according to the traditional compression method tabletting process, not only It ensures that the active ingredients of the drug meet the needs of medical treatment, and enables the drug to quickly disintegrate and disperse in the stomach after oral chewing, and the active ingredients dissolve in time, greatly reducing the irritation to the stomach caused by the long-term difficulty of disintegrating and dispersing the drug . It can solve the stomach discomfort caused by the patient's lack of appetite, vomiting of acid water, indigestion, and epigastric pain.

The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

Description of drawings

Fig. 1 is a schematic diagram of the preparation process of the technical solution (1) of the present invention.

Fig. 2 is a schematic diagram of the preparation process of the technical solution (2) of the present invention.

Detailed ways

With reference to accompanying drawing, the preparation technological process of technical scheme of the present invention is:

Technical solution (1):

Xiangsha Yangwei Chewable Tablets, the prescription raw materials and dosage ratio are 154 parts of Muxiang, 154 parts of Amomum, 221 parts of Atractylodes macrocephala, 221 parts of dried tangerine peel, 221 parts of Poria cocos, 221 parts of made pinellia, 154 parts of vinegar made Cyperus citrus 154 parts, 154 parts of shelled white cardamom, 154 parts of ginger magnolia, 154 parts of patchouli, 66 parts of licorice, 66 parts of ginger, 110 parts of jujube.

Extract volatile oil from raw material I—including woody incense, amomum, patchouli, shelled white cardamom, and tangerine peel, and use one of β-cyclodextrin and hydroxypropyl β-cyclodextrin per milliliter of volatile oil. Each milliliter of volatile oil is equivalent to 6-12 grams of β-cyclodextrin; each milliliter of volatile oil is equivalent to 3-10 grams of hydroxypropyl β-cyclodextrin, and the volume ratio of the extracted volatile oil is 50%. Add the ethanol solution to the saturated solution of β-cyclodextrin or hydroxypropyl β-cyclodextrin, incubate at a constant speed of 100-120 rpm at 15-25°C for 1-2 hours, collect the clathrate, and place Refrigerate for 20-24 hours, filter with suction, wash the clathrate with a small amount of water, dry it in vacuum at 40°C for 4-6 hours, and collect the clathrate; the distilled aqueous solution is collected in another device; raw materials II--including cyperus cyperus and magnolia bark made from ginger , Citrus aurantium, Poria cocos, pinellia chinensis, Atractylodes macrocephala, jujube, ginger, and licorice are heated and refluxed twice with 80% ethanol, each time for 1-2h, filtered, combined filtrates, and ethanol is recovered; the above two aqueous solutions are combined, Concentrate into a thick paste, dry below 80°C into a dry extract, and pulverize.

The product prepared by the above method—Xiangsha Yangwei chewable tablet volatile oil inclusion compound and crushed dry extract powder and 80-120% microcrystalline cellulose equivalent to the total amount of volatile oil inclusion compound and dry extract, 1 -2% aspartame, 50-100% mannitol, 5-30% xylitol, 0.5-1% magnesium stearate are mixed as excipients, and the content is 80-95% ethanol Soft material is used as wetting agent, granulated with 16 mesh sieve, vacuum dried at low temperature below 60°C, granulated with 16 mesh sieve, pressed into tablets, packed according to the general tablet packaging method, and the product is obtained after passing the inspection—Xiangsha Nourishing Stomach Chewing piece.

Technical solution (2):

Xiangsha nourishing stomach chewable tablets, the prescription raw materials and dosage ratio are 100 parts of Cyperus cyperi, 100 parts of Amomum, 100 parts of Patchouli, 100 parts of Poria cocos, 100 parts of Magnolia officinalis made from ginger, 100 parts of pinellia, 100 parts of Atractylodes macrocephala, 100 parts of citrus aurantium, 50 parts of licorice, 50 parts of shelled white cardamom, 50 parts of tangerine peel, 50 parts of woody fragrance, 40 parts of jujube, and 10 parts of ginger.

Raw materials I—including Cyperus cyperi, Ginger Magnolia officinalis, Atractylodes Rhizoma Atractylodes, Fructus Aurantii, Tangerine Peel, soaked with 60% ethanol, and the percolation liquid was collected for later use; Raw Material II—including patchouli, amomum, woody, desiccated The volatile oil is extracted from white cardamom and ginger, and the extracted volatile oil is prepared as an inclusion complex by using one of β-cyclodextrin and hydroxypropyl β-cyclodextrin per ml of volatile oil, and each ml of volatile oil is equivalent to β-cyclodextrin 6-12 grams; each milliliter of volatile oil is equivalent to 3-10 grams of hydroxypropyl β-cyclodextrin. In the dextrin saturated solution, under the condition of 15-25°C and 100-120 rev/min, the clathrate was clathrated at a constant speed for 1-2h, and the clathrate was collected, kept in the refrigerator for 20-24h, filtered with suction, and the clathrate was washed with a small amount of water. Vacuum dry at 40°C for 4-6 hours to collect clathrates; raw material III—including medicinal residues after extracting volatile oil, poria cocos, pinellia chinensis, jujube, and licorice, add water and decoct twice, each time for 2 hours, filter and cool the filtrate Add it to the above filtrate, let it stand for 20-24h, filter, recover ethanol, concentrate into a thick paste, dry below 80°C into a dry extract, and pulverize.

The product prepared by the above method—Xiangsha Yangwei chewable tablet volatile oil inclusion compound and crushed dry extract powder and 80-120% microcrystalline cellulose equivalent to the total amount of volatile oil inclusion compound and dry extract, 1 -2% aspartame, 50-100% mannitol, 5-30% xylitol, 0.5-1% magnesium stearate are mixed as excipients, and the content is 80-95% ethanol Soft material is used as wetting agent, granulated with 16 mesh sieve, vacuum dried at low temperature below 60°C, granulated with 16 mesh sieve, pressed into tablets, packed according to the general tablet packaging method, and the product is obtained after passing the inspection—Xiangsha Nourishing Stomach Chewing piece.

Example 1

According to the Ministry of Health of the People's Republic of China "Drug Standard Traditional Chinese Medicine Prescriptions" Volume 20, page 253 (Pharmacopoeia Committee of the Ministry of Health of the People's Republic of China, the raw material composition and dosage ratio of Xiangsha Yangwei Soft Capsules), take woody 154g , Amomum 154g, Atractylodes macrocephala 221g, Chenpi 221g, Poria cocos 221g, Pinellia 221g, Cyperus cyperi 154g, Citrus aurantium 154g, White cardamom 154g, Ginger Magnolia officinalis 154g, Patchouli 154g, Licorice 66g, Ginger 66g, Jujube 110g.

Preparation method:

(1) Preparation of Xiangsha Nourishing Stomach Volatile Oil Inclusion Compound

Extract volatile oil from woody, amomum, patchouli, shelled white cardamom, and tangerine peel by steam distillation to obtain 15.5ml of volatile oil. The extracted volatile oil is made into a 50% ethanol solution with a volume ratio of 100 gram of saturated solution, at 25°C with a rotation speed of 110 rpm for 1.5h, and refrigerated for 20h. After suction filtration, the clathrate was washed with a small amount of water, dried under vacuum at 40°C for 6 hours, and 41 g of clathrate was collected. The distilled aqueous solution was collected in another device and set aside.

(2) Preparation of Xiangsha nourishing stomach dry extract powder

Use 80% ethanol to heat and reflux extract twice, each time for 2 hours, filter, recover ethanol, and use the above-mentioned The distilled aqueous solutions were combined, concentrated into a thick paste, dried at 70° C. into a dry extract, and crushed to obtain 75 g of dry extract powder.

(3) Preparation of Xiangsha Yangwei Chewable Tablets

Chewable tablets are prepared according to the following formulation prescription:

Xiangsha Nourishing Stomach Volatile Oil Inclusion Complex 41g Xiangsha Yangwei Dry Extract Powder 75g

Microcrystalline Cellulose 130g Aspartame 2g

Mannitol 110g Xylitol 40g

Magnesium stearate 1g 90% ethanol about 100ml

Made into 1000 pieces

Put the above-mentioned Xiangsha nourishing stomach volatile oil clathrate, Xiangsha nourishing stomach dry extract powder, microcrystalline cellulose, aspartame, mannitol, xylitol, and magnesium stearate in a mixing tank Mix, use 90% ethanol to make a soft material, granulate with a 16-mesh sieve, dry at a low temperature in a vacuum oven at 60°C, granulate with a 16-mesh sieve, and compress into tablets, each tablet weighing 0.4g. Packed according to the general tablet packaging method, after passing the inspection, it will be Xiangsha Yangwei Chewable Tablets.

(4) Quality inspection

Properties: It is dark brown flakes, fragrant, sweet and slightly bitter.

上，以环己烷-丙酮(10∶3)为展开剂，展开，取出，晾干，喷以5％香草醛硫酸溶液，热风吹至斑点显色清晰。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的斑点。Identification: ①Take 5 tablets of this product, grind them up, add 40ml of ether, shake, separate the ether solution, filter, put the filtrate into two test tubes, evaporate one tube to dry, add a few drops of 5% vanillin sulfuric acid solution to the residue , which becomes red and gradually turns purple; one tube is evaporated to 2ml, dotted on filter paper, dried in the air, sprayed with 0.05% ethanol solution of bromophenol blue, and yellow spots will appear on the blue background. ②Take 5 tablets of this product, crush them, add 40ml of diethyl ether, shake and extract three times, separate the diethyl ether solution, filter, evaporate to dryness, add 1ml of ethyl acetate to dissolve, and use it as the test solution. In addition, take ginger magnolol and ginger magnolol reference substance, add ethyl acetate to make a mixed solution containing 2mg per 1ml, as the reference substance solution. According to thin-layer chromatography (Appendix VII A of Chinese Pharmacopoeia 2000 Edition), draw 4 μl of each of the above two solutions and spot on the same silica gel respectively.

On top, use cyclohexane-acetone (10:3) as the developer, develop, take out, dry in the air, spray with 5% vanillin sulfuric acid solution, and blow hot air until the spots are clearly colored. In the chromatogram of the test product, there are spots of the same color at the position corresponding to the chromatogram of the reference product.

Inspection: As it is a chewable tablet, the disintegration time limit is not inspected. The relevant items under the tablet meet the requirements (two appendices I K of Chinese Pharmacopoeia version in 2000).

Example 2

According to the prescription and method of Example 1, collect 15ml of volatile oil of Xiangsha Yangwei, add it to a saturated solution containing 150 grams of β-cyclodextrin for inclusion at 20°C, obtain 41.5g of volatile oil inclusion compound after inclusion, and obtain Xiangsha Yangwei dry extract powder 85g, the microcrystalline cellulose is adjusted to 140g, other formulation prescriptions are unchanged, prepare Xiangsha Yangwei chewable tablets according to Example 1, each theoretical sheet weighs 0.4g; according to the quality inspection method of Example 1 Carry out quality inspection, all in compliance with regulations.

Example 3

According to the prescription and method of Example 1, collect 16ml of volatile oil from Xiangsha nourishing stomach, add it to a saturated solution containing 150 grams of hydroxypropyl β-cyclodextrin for inclusion at 25°C, and obtain 42g of volatile oil inclusion compound after inclusion. Xiangsha nourishing stomach dry extract powder 83g, microcrystalline cellulose is adjusted to 140g, other preparation prescriptions are unchanged, prepare Xiangsha nourishing stomach chewable tablets according to Example 1, each theoretical piece weighs 0.4g; according to Example 1 quality The inspection method is to carry out quality inspection, and all items are in compliance with the regulations.

Example 4

According to the Ministry of Health of the People's Republic of China "Drug Standard Chinese Medicine Prescriptions" Volume 20, page 252 (Pharmacopoeia Committee of the Ministry of Health of the People's Republic of China, 1998) the raw materials composition and dosage ratio of Xiangsha Yangwei Oral Liquid, take vinegar to make incense Fu 150g, Amomum 150g, Patchouli 150g, Poria 150g, Ginger Magnolia 150g, Pinellia 150g, Atractylodes macrocephala 150g, Citrus aurantium 150g, Licorice 75g, White Cardamom 75g, Tangerine Peel 75g, Woody Fragrance 75g, Jujube 60g , ginger 15g.

(1) Preparation of Xiangsha Nourishing Stomach Volatile Oil Inclusion Compound

Extract volatile oil from woody, amomum, patchouli, shelled white cardamom, and ginger with steam distillation to obtain 9ml of volatile oil. The extracted volatile oil is made into a 50% ethanol solution with a volume ratio, and added to 90 grams of β-cyclodextrin in a saturated solution of 20°C for 2 hours at 100 rpm, and refrigerated for 24 hours. After suction filtration, the clathrate was washed with a small amount of water, dried under vacuum at 40°C for 6 hours, and 35 g of clathrate was collected.

(2) Preparation of Xiangsha nourishing stomach dry extract powder

Take Cyperus cyperi made from vinegar, Magnolia officinalis made from ginger, Atractylodes macrocephala, Citrus aurantium and Tangerine peel, use 60% ethanol as solvent, soak for 24 hours, slowly percolate, collect about 10 times the amount of medicinal materials percolate, and store the percolate for later use. After extracting the volatile oil, decoct the dregs with Poria cocos, pinellia, jujube, and licorice twice, each time for 2 hours, filter, add the filtrate to the above filtrate after cooling, let stand for 24 hours, filter, and recover ethanol from the filtrate , concentrated into a thick paste, dried at 75°C to form a dry extract, and pulverized to obtain 133g of a dry extract powder.

(3) Preparation of Xiangsha Yangwei Chewable Tablets

Chewable tablets are prepared according to the following formulation prescription:

Xiangsha Nourishing Stomach Volatile Oil Inclusion Complex 35g

Xiangsha nourishing stomach dry extract powder 133g

Microcrystalline Cellulose 100g

Aspartame 2g

Mannitol 90g

Xylitol 40g

Magnesium stearate 1g

90% Ethanol About 100ml

Made into 1000 pieces

According to the tablet preparation method of Example 1, Xiangsha Yangwei chewable tablets were prepared, each tablet weighing 0.4 g.

(4) Quality inspection

Properties: the same as Example 1.

Identification: the same as Example 1.

Inspection: As it is a chewable tablet, the disintegration time limit is not inspected. The relevant items under the tablet meet the requirements (two appendices I K of Chinese Pharmacopoeia version in 2000).

Example 5

According to the prescription and method of Example 4, collect 7ml of Xiangsha nourishing stomach volatile oil, add it to a saturated solution containing 55 grams of hydroxypropyl β-cyclodextrin for inclusion at 25°C, and obtain 27g of volatile oil inclusion compound after inclusion, and obtain Xiangsha nourishing stomach dry extract powder 115g, microcrystalline cellulose is adjusted to 120g, mannitol is adjusted to 100g, other preparation prescriptions are unchanged according to Example 4, and Xiangsha nourishing stomach chewable tablets are prepared according to Example 1, each theoretically The weight of the tablet is 0.4g; after quality inspection, all items meet the requirements.

Example 6

According to the prescription and method of Example 4, collect 8ml of Xiangsha nourishing stomach volatile oil, add it to a saturated solution containing 40 grams of hydroxypropyl β-cyclodextrin for inclusion at 20°C, and obtain 22g of volatile oil inclusion compound after inclusion, and obtain Xiangsha nourishing stomach dry extract powder 120g, microcrystalline cellulose is adjusted to 120g, mannitol is adjusted to 100g, other preparation prescriptions are unchanged according to Example 4, and Xiangsha nourishing stomach chewable tablets are prepared according to Example 1, each theoretically The weight of the tablet is 0.4g; after quality inspection, all items meet the requirements.

Example 7

Preliminary Stability Investigation of Xiangsha Yangwei Chewable Tablet Product of the Present Invention

(1) Test sample

According to the same method as in Example 1, Example 3, Example 4, and Example 5, there were 3 batches of Xiangsha Yangwei Chewable Tablets, totaling 12 batches.

(2) Test conditions

Accelerated test (temperature 40°C, humidity 75%) storage time is 1, 2, 3, 6 months;

The room temperature reserved samples (temperature 25°C, humidity 40-50%) are stored for 1, 2, 3, 6 months.

(3) Inspection items and methods

Properties: visual inspection.

Identification: the same method used in Example 1.

Check: relevant provisions and methods thereof under the tablet item are with reference to the contents of two appendix I K of "Chinese Pharmacopoeia" version in 2000.

Microorganism: measure according to microbial limit test method (Appendix XIII C of Chinese Pharmacopoeia edition in 2000).

(4) Investigation results

Twelve batches of samples were subjected to the accelerated test for 6 months and the samples were kept at room temperature for 6 months, and their properties, identification, inspection, microorganisms and other tablet requirements did not change significantly, which met the quality standards. According to the stability investigation of 1 month, the validity period of this product can reach more than 2 years.

Claims (1)

1. a preparation method of Xiangsha nourishing stomach chewable tablet, it comprises the following steps: (1) According to the prescription raw materials, 154 parts of woody incense, 154 parts of amomum, 154 parts of patchouli, 154 parts of shelled white cardamom, 221 parts of tangerine peel are extracted to extract volatile oil, and the distilled aqueous solution is collected in another device; 154 parts of vinegar-made Cyperus 154 parts of Magnolia officinalis made from ginger, 154 parts of Citrus aurantium, 221 parts of Poria cocos, 221 parts of pinellia, 221 parts of Atractylodes macrocephala, 110 parts of jujube, 66 parts of ginger, 66 parts of licorice. After 1-2 hours, filter and combine the filtrates to recover ethanol; combine the above two aqueous solutions to obtain the extract of Xiangsha Nourishing Stomach; (2) The volatile oil is made into a 50% ethanol solution with a volume ratio, and added to a saturated solution of β-cyclodextrin or hydroxypropyl β-cyclodextrin, and every milliliter of volatile oil is equivalent to 6-12 grams of β-cyclodextrin ;Each milliliter of volatile oil is equivalent to 3-10 grams of hydroxypropyl β-cyclodextrin, inclusion at 15-25°C and 100-120 rpm for 1-2 hours, collect the inclusion liquid, and refrigerate for 20-24 hours. Suction filtration, wash the clathrate with a small amount of water, dry in vacuum at 40°C for 4-6 hours, and collect the clathrate; (3) The extract is concentrated into a thick paste, dried below 80°C, and crushed into a dry extract powder; (4) The volatile oil inclusion compound and the pulverized dry extract powder and 80-120% microcrystalline cellulose and 1-2% aspartame equivalent to the total amount of the volatile oil inclusion compound and dry extract Acid methyl ester, 50-100% mannitol, 5-30% xylitol, 0.5-1% magnesium stearate are mixed, and the soft material is made of 80-95% ethanol; (5) Granulate with a 16-mesh sieve, and vacuum dry at a low temperature below 60°C; (6) Sieve through a 16-mesh sieve, press into tablets, pack according to the general tablet packaging method, and obtain the product after passing the inspection.

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