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CN-121971521-A - Composition for treating constipation and preparation method and application thereof

CN121971521ACN 121971521 ACN121971521 ACN 121971521ACN-121971521-A

Abstract

The invention discloses a composition for treating constipation, a preparation method and application thereof, and relates to the technical field of medicines. The invention comprises the following raw materials of peach kernel, notopterygium root, rhubarb, angelica, hemp seed, cassia seed, bunge cherry seed and immature bitter orange, and auxiliary materials of beta-cyclodextrin, talcum powder, magnesium stearate, corn starch, microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose and silicon dioxide. The composition has the efficacy of treating constipation equivalent to that of the traditional positive medicine, has multidirectional action mechanisms including moistening intestines, increasing intestinal contents, directly stimulating intestinal walls and regulating gastrointestinal hormone, and reflects the treatment advantages of the traditional Chinese medicine compound multiple mechanisms. The invention adopts hydroxypropyl methyl cellulose film coating and optimized auxiliary material system, effectively blocks moisture, prevents moisture absorption and caking, keeps the indexes such as appearance, moisture content and the like stable under the condition of accelerated test, and is suitable for long-term storage.

Inventors

  • TANG WENXING
  • SHEN YUNTONG
  • LI ZEWEI

Assignees

  • 广州琥瑞医药科技发展有限公司

Dates

Publication Date
20260505
Application Date
20260306

Claims (9)

  1. 1. A composition for treating constipation is characterized by comprising the following raw materials of peach kernel, notopterygium root, rhubarb, angelica, fructus cannabis, semen cassiae, bunge cherry seed, immature bitter orange and auxiliary materials of beta-cyclodextrin, talcum powder, magnesium stearate, corn starch, microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose and silicon dioxide.
  2. 2. The composition for treating constipation according to claim 1, wherein the raw materials comprise, by weight, 10% -20% of peach kernel, 5% -15% of notopterygium root, 10% -20% of rheum officinale, 5% -15% of Chinese angelica, 10% -20% of fructus cannabis, 5% -15% of semen cassiae, 5% -15% of bunge cherry seed, 5% -15% of immature bitter orange, and the auxiliary materials comprise, by weight, 1% -5% of beta-cyclodextrin, 1% -3% of talcum powder, 0.5% -2% of magnesium stearate, 5% -10% of corn starch, 5% -15% of microcrystalline cellulose, 2% -5% of croscarmellose sodium and 0.5% -2% of silicon dioxide.
  3. 3. A composition for treating constipation according to claim 1, wherein the composition is in the form of a capsule, tablet or granule.
  4. 4. A method of preparing a composition for treating constipation as claimed in claim 1, comprising the steps of: Step 1, weighing according to the prescription amount of each material, and carrying out pretreatment on medicinal materials, respectively cleaning peach kernels, fructus cannabis and notopterygium roots, respectively crushing the cleaned peach kernels and fructus cannabis by using a crusher with a screen mesh of 8mm, crushing the notopterygium roots by using a crusher with a screen mesh of 6mm, and crushing the notopterygium roots by using a crusher with a screen mesh of 10 meshes; Step 2, taking 1/2 rheum officinale, cleaning, crushing by using a crusher with a1 cm-aperture screen after cleaning, and crushing by using a crusher with a 10-mesh screen to obtain rheum officinale coarse powder, collecting the rest 1/2 rheum officinale, cleaning, washing by water after cleaning, drying at 55-65 ℃ until the water content is less than or equal to 4.0%, crushing the dried rheum officinale by using a crusher with a1 cm-aperture screen, and crushing by using a crusher with a 80-mesh screen to obtain Huang Xifen; Step 3, cleaning angelica, washing the cleaned angelica, drying the cleaned angelica until the moisture is less than or equal to 7.0% at the temperature of 55-65 ℃, crushing the dried angelica by using a crusher provided with a screen with a 1cm aperture, crushing the angelica by using a crusher provided with a screen with an 80 mesh, and mixing the angelica for 30 minutes according to the rotation speed of 6 rpm after the crushing is finished; Cleaning semen cassiae, bunge cherry seeds and immature bitter oranges respectively, washing the semen cassiae, bunge cherry seeds and immature bitter oranges after cleaning, drying the semen cassiae, bunge cherry seeds and immature bitter oranges at the temperature of 55-65 ℃ until the moisture is less than or equal to 5.0%, crushing the dried semen cassiae, bunge cherry seeds and immature bitter oranges by using a crusher provided with a screen with the aperture of 1cm, and crushing the dried semen cassiae, bunge cherry seeds and immature bitter oranges by using a crusher provided with a screen with the aperture of 80 meshes to obtain fine powder of semen cassiae, bunge cherry seeds and immature bitter oranges; step 5, putting the coarse powder of the rheum officinale crushed in the step 2 into a percolating tank, adding 2 times of 60% ethanol for wetting and soaking, adding 10 times of 60% ethanol for percolating after soaking for 24 hours, collecting percolate, and controlling the percolating speed to be 3-5 ml/kg.min; step 6, putting the crushed peach kernel, fructus cannabis and notopterygium root coarse powder in the step 1 into a percolating tank, adding 2 times of 70% ethanol for wetting and soaking, adding 6 times of 70% ethanol for percolating after soaking for 24 hours, and collecting percolate, wherein the percolating speed is controlled to be 3-5 ml/kg.min; Step 7, collecting the percolate in the steps 5 and 6, starting a single-effect concentrator, concentrating to thick paste with the relative density of 1.05-1.15, filtering with a 150-mesh screen, and pumping into a spray drying storage tank for later use; step 8, adding beta-cyclodextrin into a spray drying storage tank, heating and stirring uniformly, keeping the temperature at 50-70 ℃, controlling the rotating speed of a material pump at 6-13 r/min, controlling the pressure in a tower to be negative pressure, setting the rotating speed of a mixer at 6 r/min, and mixing the dry extract for 30 min, wherein the moisture of the dry extract is not more than 7.0%; Step 9, putting the extract, pretreated Chinese angelica, semen cassiae, semen pruni, immature bitter orange fine powder, and prescription amounts of corn starch, microcrystalline cellulose and croscarmellose sodium into a wet mixing granulator, setting the speed of the stirrer to 120rpm, stirring and mixing for 15 minutes, slowly adding a small amount of adhesive ethanol from a pulp adding hole after the stirring and mixing time is up, setting the speed of a chopper to 1200rpm after the adding is finished, chopping for 70-120 s, preparing a soft material, and preparing granules from the soft material by a swinging granulation machine with a 20-mesh screen; Step 10, putting the prepared particles into a fluidized bed for drying, and detecting that the moisture of the dried particles is less than or equal to 7.0%; step 11, preparing dry whole particles by a swing granulation machine provided with a 30-mesh screen; Step 12, pouring the crushed half rhubarb fine powder, half talcum powder, half magnesium stearate and half silicon dioxide into a mixing pot, mixing for 15 minutes at the mixing speed of 50Hz, pouring the rest half rhubarb fine powder, half talcum powder, half magnesium stearate and half silicon dioxide into the mixing pot, and continuing mixing for 15 minutes; step 13, putting a half-dry whole granule into a mixing pot, mixing for 15 minutes at a mixing speed of 50Hz, putting the rest half-dry whole granule into the mixing pot, and mixing for 30 minutes at a mixing speed of 50Hz to obtain total mixed granules; Step 14, installing corresponding moulds by a capsule filling machine, taking total mixed particles, filling the capsules according to the target filling amount of 0.3g, coating the filled capsules by a film coating machine, wherein the coating material is hydroxypropyl methyl cellulose, the coating weight is increased by 2% -5%, and the coating temperature is 40-50 ℃ so as to mask the taste and control the release; And 15, taking the packing material and packaging the filled capsules with aluminum plastic.
  5. 5. The method for preparing a composition for treating constipation according to claim 4, wherein in the step 7, parameters of the single-effect concentrator are controlled such that steam pressure is 0-0.10 MPa, temperature is 60-85 ℃, and vacuum degree is-0.03-0.09 MPa.
  6. 6. The method of claim 4, wherein in step 8, the inlet air temperature of spray drying is controlled to be 195+ -10deg.C, and the outlet air temperature is controlled to be 95+ -10deg.C.
  7. 7. The method of claim 4, wherein in step 10, the temperature of the fluidized bed drying inlet air is 85 ℃, and the fluidized bed drying inlet air is heated to 63-67 ℃.
  8. 8. The method of claim 4, wherein the film coating in step 14 has a concentration of 5% -10%, a spraying speed of 5% -10 mL/min and a drying time of 10% -20 min.
  9. 9. Use of a composition for treating constipation according to any one of claims 1-3 in the preparation of a medicament for treating functional constipation, senile constipation or pharmaceutical constipation.

Description

Composition for treating constipation and preparation method and application thereof Technical Field The invention belongs to the technical field of medicines, and in particular relates to a composition for treating constipation, a preparation method and application thereof. Background Constipation is a common digestive system disease, and is clinically manifested by difficulty in defecation, reduced number of times of defecation or dry stool. Current drugs for treating constipation mainly include stimulant laxatives such as bisacodyl, osmotic laxatives such as lactulose, bulk laxatives, and the like. However, the existing medicines have the problems of strong dependence, easy electrolyte disorder, easy recurrence after stopping medicine and the like, and part of the medicines have slow effect and low bioavailability, so that the clinical requirements are difficult to meet. The traditional Chinese medicine has the advantages of multiple components, small side effect and the like in the aspect of treating constipation, but the traditional Chinese medicine preparation has the problems of lag in preparation process, low dissolution rate of active ingredients, poor stability and the like, and limits the clinical application and the industrialized development of the traditional Chinese medicine preparation. Therefore, the traditional Chinese medicine composition which has the advantages of quick response, good stability and definite curative effect, is suitable for constipation of different types and has important clinical significance and market value is developed. We have therefore proposed a composition for treating constipation, and a method of preparing and using the same, so as to solve the problems set out above. The above information disclosed in this background section is only for enhancement of understanding of the background section of the invention and therefore it may not form the prior art that is already known to those of ordinary skill in the art. Disclosure of Invention The invention aims to provide a composition for treating constipation, and a preparation method and application thereof, so as to solve the problems in the prior art. The invention provides a composition for treating constipation, which comprises the following raw materials of peach kernel, notopterygium root, rhubarb, chinese angelica, hemp seed, cassia seed, bunge cherry seed, immature bitter orange, and auxiliary materials of beta-cyclodextrin, talcum powder, magnesium stearate, corn starch, microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose and silicon dioxide. Preferably, the weight percentage of the raw materials is 10% -20% of peach kernel, 5% -15% of notopterygium root, 10% -20% of rheum officinale, 5% -15% of Chinese angelica, 10% -20% of fructus cannabis, 5% -15% of semen cassiae, 5% -15% of semen pruni, 5% -15% of fructus aurantii immaturus, and the weight percentage of the auxiliary materials is 1% -5% of beta-cyclodextrin, 1% -3% of talcum powder, 0.5% -2% of magnesium stearate, 5% -10% of corn starch, 5% -15% of microcrystalline cellulose, 2% -5% of crosslinked sodium carboxymethyl cellulose and 0.5% -2% of silicon dioxide. Preferably, the composition is in the form of a capsule, tablet or granule. The invention also provides a preparation method of the composition for treating constipation, which comprises the following steps: Step 1, weighing according to the prescription amount of each material, and carrying out pretreatment on medicinal materials, respectively cleaning peach kernels, fructus cannabis and notopterygium roots, respectively crushing the cleaned peach kernels and fructus cannabis by using a crusher with a screen mesh of 8mm, crushing the notopterygium roots by using a crusher with a screen mesh of 6mm, and crushing the notopterygium roots by using a crusher with a screen mesh of 10 meshes; Step 2, taking 1/2 rheum officinale, cleaning, crushing by using a crusher with a1 cm-aperture screen after cleaning, and crushing by using a crusher with a 10-mesh screen to obtain rheum officinale coarse powder, collecting the rest 1/2 rheum officinale, cleaning, washing by water after cleaning, drying at 55-65 ℃ until the water content is less than or equal to 4.0%, crushing the dried rheum officinale by using a crusher with a1 cm-aperture screen, and crushing by using a crusher with a 80-mesh screen to obtain Huang Xifen; Step 3, cleaning angelica, washing the cleaned angelica, drying the cleaned angelica until the moisture is less than or equal to 7.0% at the temperature of 55-65 ℃, crushing the dried angelica by using a crusher provided with a screen with a 1cm aperture, crushing the angelica by using a crusher provided with a screen with an 80 mesh, and mixing the angelica for 30 minutes according to the rotation speed of 6 rpm after the crushing is finished; Cleaning semen cassiae, bunge cherry seeds and immature bitter oranges respectively, washing the semen cassiae, bunge cherry seeds