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CN-122005467-A - Polygonatum sibiricum prescription granule composition and preparation method thereof

CN122005467ACN 122005467 ACN122005467 ACN 122005467ACN-122005467-A

Abstract

The invention provides a rhizoma polygonati formula particle composition and a preparation method thereof, wherein the rhizoma polygonati formula particle comprises the following raw materials, by weight, 20 parts of rhizoma polygonati formula particles, 0.21-0.22 part of a composite anticaking agent, and 0.2 part of fumed silica and 0.01-0.02 part of sodium stearyl fumarate. According to the rhizoma polygonati formula particle, the specific composite anticaking agent composed of the fumed silica and the sodium stearyl fumarate is adopted, the fumed silica has a large specific surface area, an isolation layer can be formed on the surface of the particle by adsorption, and meanwhile, the porous structure of the fumed silica can absorb trace moisture, and the fumed silica and the sodium stearyl fumarate act cooperatively, so that the hygroscopicity of the rhizoma polygonati formula particle can be remarkably reduced, the particle agglomeration can be effectively prevented, the good fluidity of a product is ensured, and the packaging and the use are facilitated.

Inventors

  • YANG ZHIHUI
  • HE CHENGDONG
  • HUANG LIMING
  • ZHOU DAIJUN

Assignees

  • 长沙新林制药有限公司

Dates

Publication Date
20260512
Application Date
20260320

Claims (10)

  1. 1. The sealwort formula granule composition is characterized by comprising the following raw materials in parts by weight: 20 parts of rhizoma polygonati formula particles, 0.18-0.24 part of composite anticaking agent, wherein the composite anticaking agent comprises 0.16-0.22 part of fumed silica and 0.008-0.03 part of sodium stearyl fumarate.
  2. 2. The Polygonatum sibiricum formulation granule composition of claim 1 wherein the composite anticaking agent comprises fumed silica 0.2 parts and sodium stearyl fumarate 0.01 parts.
  3. 3. The Polygonatum sibiricum formulation granule composition of claim 1 wherein the composite anticaking agent comprises fumed silica 0.2 parts and sodium stearyl fumarate 0.02 parts.
  4. 4. The composition of claim 1, wherein the particles of the formulation have a particle size ranging from 80 to 120 mesh and the fumed silica has a specific surface area ranging from 150 to 250m2/g.
  5. 5. The sealwort formulation granule composition of any one of claims 1 to 4, wherein the fumed silica is hydrophilic fumed silica and/or hydrophobic fumed silica.
  6. 6. A process for preparing the granular formulation of rhizoma Polygonati according to any one of claims 1 to 5, comprising: s1, preparing a dry paste of rhizoma polygonati polysaccharide thick paste, crushing the dry paste, adding a proper amount of dextrin, and granulating to obtain rhizoma polygonati formula particles; S2, taking formula amount of rhizoma polygonati formula particles, adding formula amount of fumed silica and sodium stearyl fumarate, and uniformly mixing to obtain the rhizoma polygonati formula particle composition.
  7. 7. The method according to claim 6, wherein the dry extract of rhizoma Polygonati polysaccharide soft extract comprises: S11, taking rhizoma polygonati polysaccharide thick paste, wherein the relative density of the thick paste is 1.20-1.30, adding anti-sticking auxiliary materials accounting for 3-8% of the weight of the thick paste, and uniformly stirring; s12, uniformly coating the mixed materials on a conveyor belt of a belt dryer through a distributing device, wherein the thickness of the material is 3-8 mm; S13, drying is carried out in a sectional temperature control mode, wherein the temperature of a preheating section is 40-50 ℃ and accounts for 20-30% of the total drying length, the temperature of a main drying section is 60-70 ℃ and accounts for 50-60% of the total drying length, and the temperature of a cooling section is 30-40 ℃ and accounts for 10-20% of the total drying length; s14, drying until the moisture content is lower than 5%, and collecting the dry paste.
  8. 8. The method of claim 7, wherein the drying time is 40 to 90 minutes.
  9. 9. The method of claim 7, wherein the anti-sticking excipients are selected from one or more of pharmaceutically acceptable starches, microcrystalline cellulose, and dextrins.
  10. 10. The method of any one of claims 6-9, wherein 4 parts by weight of a pharmaceutical silica gel desiccant is placed in the inner package of the sealwort formula granule composition.

Description

Polygonatum sibiricum prescription granule composition and preparation method thereof Technical Field The invention belongs to the technical field of storage of traditional Chinese medicine formula granules, and particularly relates to a rhizoma polygonati formula granule composition and a preparation method thereof. Background Rhizoma Polygonati is dry rhizome of Polygonatum sibiricum Polygonatum sibiricum Red, polygonatum kingianum Polygonatum kingianum Coll et Hemsl or Polygonatum cyrtonema Polygonatum cyrtonema Hua, which is a traditional Chinese medicinal material commonly used in China, and has effects of invigorating qi, nourishing yin, invigorating spleen, moistening lung, invigorating kidney, and replenishing essence. Along with the rapid development of the traditional Chinese medicine formula particle industry, the rhizoma polygonati formula particle has the advantages of convenient administration, accurate dosage and the like, and is widely used in clinical application. However, rhizoma polygonati is rich in polysaccharide components, the extract (thick paste) thereof has extremely high viscosity, and when the formula particles are produced by adopting a belt type drying process, two technical bottlenecks commonly exist in two industries, namely, the high-viscosity thick paste is extremely easy to adhere to the surface of equipment in the drying process, so that the drying efficiency is low and the production continuity is poor, and the rhizoma polygonati formula particles still have relatively high hygroscopicity after being prepared into the formula particles by extraction, concentration and drying, are extremely easy to absorb moisture in the storage and use processes, so that the surfaces of the particles are wetted and adhered, agglomeration and hardening phenomena occur, and even smooth discharging or dissolving cannot be realized in severe cases, so that the physical stability, the flowability and the accuracy of clinical medication of the products are directly influenced. In order to solve the problem of moisture absorption and agglomeration of traditional Chinese medicine formula particles, a method of adding an anti-caking agent or a drying agent is commonly adopted in the prior art. Commonly used anticaking agents include microcrystalline cellulose, magnesium stearate, talc, silica, and the like, and drying agents include silica gel, molecular sieves, and the like. However, for the rhizoma polygonati which is a high-sugar high-viscosity material, the ideal anti-caking effect is difficult to achieve by a single anti-caking agent, and the dissolubility and taste of the particles are affected by the excessive addition amount. In addition, in the process of preparing dry paste powder by drying the rhizoma polygonati thick paste, the problems of wall sticking, paste banding and the like are very easy to occur, so that the yield is reduced, and the effective components are damaged by heating. Therefore, developing the sealwort formula granule composition with good fluidity, difficult moisture absorption and agglomeration and stable quality and the preparation method thereof has important practical significance. Disclosure of Invention The invention aims to solve the defects of the prior art and provide a sealwort formula granule composition with good fluidity, strong moisture absorption and caking resistance and stable quality and a preparation method thereof. In order to achieve the above purpose, the technical scheme of the invention is realized as follows: According to one aspect of the invention, the rhizoma polygonati formula particle composition is composed of, by weight, 20 parts of rhizoma polygonati formula particles and 0.18-0.24 part of a composite anticaking agent, wherein the composite anticaking agent comprises 0.16-0.22 part of fumed silica and 0.008-0.03 part of sodium stearyl fumarate. The specific composite anticaking agent composed of the fumed silica and the sodium stearyl fumarate is adopted, the fumed silica has a huge specific surface area, can be adsorbed on the surface of the particles to form an isolation layer, and meanwhile, the porous structure of the fumed silica can absorb trace moisture, and can be synergistic with the sodium stearyl fumarate, so that the hygroscopicity of the rhizoma polygonati formula particles can be remarkably reduced, the particles are effectively prevented from caking, good fluidity of the product is ensured, and the packaging and the use are facilitated. In one embodiment, the composite anticaking agent comprises fumed silica 0.2 parts, sodium stearyl fumarate 0.01 parts. In one embodiment, the composite anticaking agent comprises fumed silica 0.2 parts, sodium stearyl fumarate 0.02 parts. In one embodiment, the particle size of the Polygonatum sibiricum formulation particle ranges from 80 to 120 mesh, and the specific surface area of the fumed silica ranges from 150 to 250m2/g. By optimizing the particle size of the particles and the s