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CN-121971392-A - Preparation and application of traditional Chinese medicine granules for preventing children influenza virus infection

CN121971392ACN 121971392 ACN121971392 ACN 121971392ACN-121971392-A

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and discloses a preparation method and application of traditional Chinese medicine granules for preventing children influenza virus infection, wherein the method comprises the steps of adding mixed crude medicine powder into citric acid-sodium citrate buffer solution for dynamic extraction to obtain filtrate; adding polyvinylpyrrolidone K30 into the filtrate, concentrating under reduced pressure, introducing high-purity nitrogen, vacuum breaking, cooling, pumping industrial ethanol to induce heterogeneous precipitation of polysaccharide, performing stepwise vacuum to evaporate ethanol and stable ethanol mixture to obtain suspension extract, mixing the suspension extract with adjuvants, and granulating by fluidized bed top spray granulation to obtain the final product. According to the invention, through extraction by weak acid buffer solution and mild alcohol precipitation and azeotropic desolventizing under the protection of nitrogen, the hydrolysis and oxidative degradation of thermosensitive components are inhibited, the transfer rate of active ingredients is improved, and the prepared granules are porous and loose, quickly rehydrate, and meet the medication requirements of children.

Inventors

  • JIN YOUPENG
  • GAO YANTING

Assignees

  • 山东第一医科大学附属省立医院(山东省立医院)

Dates

Publication Date
20260505
Application Date
20260326

Claims (10)

  1. 1. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection is characterized by comprising the following steps: Adding the mixed crude powder into citric acid-sodium citrate buffer solution, stirring under heating for dynamic extraction, and filtering to obtain filtrate; placing the filtrate into a concentration kettle, adding polyvinylpyrrolidone K30, stirring until the polyvinylpyrrolidone K30 is completely dissolved into a homogeneous aqueous solution, and then carrying out pure water phase reduced pressure concentration under a vacuum condition to obtain concentrated water; After the pure water phase is decompressed and concentrated, high-purity nitrogen is introduced to break vacuum to normal pressure, after the temperature of the concentrated water liquid is reduced, industrial ethanol is pumped, and stirring is maintained to cause heterogeneous precipitation of polysaccharide; stopping introducing the high-purity nitrogen after the polysaccharide is caused to be heterogeneous to separate out, decompressing in steps, heating to ensure that ethanol and water are stably mixed and evaporated, and concentrating until no obvious ethanol is distilled off to obtain a suspension extract; Mixing the suspension extract with auxiliary materials, performing fluidized bed top spraying granulation, and performing fluidized drying and granule finishing to obtain the traditional Chinese medicine granule for preventing children influenza virus infection.
  2. 2. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the preparation method of the mixed crude medicine powder comprises the following steps: Mixing flos Lonicerae decoction pieces and fructus forsythiae decoction pieces at a weight ratio of (40-60), adding into a mechanical pulverizer, coarse pulverizing, and collecting powder passing through 10-20 mesh screen.
  3. 3. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the initial pH value of the citric acid-sodium citrate buffer solution is 4.5-5.0, and the specific preparation steps are as follows: Dissolving the citric acid monohydrate and the sodium citrate dihydrate in industrial purified water, and fixing the volume, wherein the mass concentration of the citric acid monohydrate is 7.35-11.56g/L, the mass concentration of the sodium citrate dihydrate is 13.23-19.12g/L, and detecting and fine-adjusting the initial pH value of the citric acid-sodium citrate buffer solution by using an online pH meter.
  4. 4. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the specific technological parameters of stirring dynamic extraction are as follows: Taking 100 parts by weight of the mixed crude drug powder, pumping 800-1000 parts by weight of the citric acid-sodium citrate buffer solution, starting a jacket and heating to 73-77 ℃, carrying out stirring and dynamic extraction for 1.5-2.0h, and then carrying out rough filtration through a 100-mesh duplex filter.
  5. 5. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the specific implementation method of pure water phase decompression concentration is as follows: Uniformly scattering 3.0-5.0kg of polyvinylpyrrolidone K30 at 50-60 ℃ and stirring at a rotating speed of 60-100rpm for 15-20min; Concentrating the pure water phase under reduced pressure at a vacuum degree of-0.08 to-0.09 MPa and a boiling temperature of the homogeneous aqueous solution of 55 ℃ or less, stopping heating when the relative density of the concentrated water solution reaches 1.08-1.12, wherein the relative density of the concentrated water solution is measured under the temperature condition of 60 ℃.
  6. 6. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the specific implementation mode for triggering heterogeneous precipitation of polysaccharide is as follows: introducing the high-purity nitrogen to break vacuum to normal pressure of 0.1MPa, and naturally reducing the temperature of the concentrated water to 45-50 ℃; And (3) under the conditions of normal pressure and the temperature of the concentrated water solution being maintained at 45-50 ℃, pumping industrial ethanol with the mass fraction of ethanol being more than or equal to 95% into the concentrated water solution at a constant speed through a submerged pipe according to the pumping rate of 10-15L/min, wherein the pumping volume is 30-50% of the current volume of the concentrated water solution, and stirring at 40-60rpm is kept to cause heterogeneous precipitation of polysaccharide.
  7. 7. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the specific implementation manner of the stable mixed evaporation is as follows: Stopping introducing the high-purity nitrogen, reducing the pressure in a step until reaching minus 0.08 to minus 0.09MPa again, starting a jacket to heat for 45-50 ℃ to ensure that ethanol and water are subjected to the stable mixing evaporation at 35-40 ℃, and the obtained suspension extract has a relative density of 1.30-1.35, wherein the relative density of the suspension extract is measured at the temperature of 60 ℃.
  8. 8. The method for preparing the traditional Chinese medicine granules for preventing children influenza virus infection according to claim 1, wherein the auxiliary material is maltodextrin or a mixture of maltodextrin and microcrystalline cellulose.
  9. 9. The preparation method of the traditional Chinese medicine granule for preventing children influenza virus infection according to claim 1, wherein the specific process parameters of fluidized bed top spraying granulation, fluidized drying and granule finishing are as follows: The air inlet is set at 65-75 ℃ and the bed temperature is set at 40-45 ℃, the suspension extract is uniformly sprayed at the pressure of 0.15-0.20MPa through a 1.2-1.5mm double-fluid atomizing nozzle, and the suspension extract is fluidized and dried until the water content is less than or equal to 3.0%, and is granulated through a 14-mesh swing granulator.
  10. 10. Use of the prepared traditional Chinese medicine granule for preventing children influenza virus infection according to any one of claims 1-9 in preparing medicine for preventing children influenza virus infection.

Description

Preparation and application of traditional Chinese medicine granules for preventing children influenza virus infection Technical Field The invention relates to the technical field of traditional Chinese medicine preparations, in particular to preparation and application of traditional Chinese medicine granules for preventing children from influenza virus infection. Background Influenza virus infection is common in children, and traditional Chinese medicines have the advantage of multi-target synergy in the aspects of prevention and antivirus. Medicinal materials such as honeysuckle, weeping forsythiae capsule and the like are rich in active ingredients such as chlorogenic acid, forsythin and the like, and are often used for developing anti-influenza medicaments. Because the granule has the characteristics of accurate dosage, convenient administration and the like, the granule is a common traditional Chinese medicine preparation for children at present. However, conventional traditional Chinese medicine granule preparation generally adopts pure water high temperature extraction technology. Under the condition, polyphenol and ester active ingredients in the medicinal materials are easy to generate phenolic hydroxyl dissociation and ester bond hydrolysis in the heated and unspecified pH value environment, so that isomerization and degradation are generated, and the initial dissolution rate and chemical stability of the antiviral active ingredients are reduced. In the subsequent concentration and heterocyclic ring removal, the traditional water extraction and alcohol precipitation process usually carries out high-temperature and reduced-pressure concentration in air, so that the oxidation reaction of a liquid phase system is easily initiated, and the failure of active ingredients is aggravated. Meanwhile, when ethanol is added for precipitation and impurity removal, the conventional operation often causes the concentration of the ethanol in a local system to rise suddenly. The violent polarity change of the solvent can cause macromolecular impurities such as polysaccharide, protein and the like to instantaneously flocculate and agglomerate to form compact sediment, thereby wrapping and entraining micromolecular active substances such as free flavone, polyphenol and the like in the system and causing the loss of medicinal components. In addition, in the dealcoholization concentration stage after the alcohol precipitation, the conventional high-temperature dealcoholization method requires a relatively high heating temperature, and is easy to cause secondary thermal damage to residual thermosensitive components. After the thick paste prepared by the traditional process is subjected to subsequent granulating and drying, the internal structure of the granule is often compact, so that the rehydration dissolution speed of the preparation is slow. For children with higher brewing requirements, incomplete dissolution of the particles not only affects the dissolution and absorption rates of the drugs, but also reduces the drug taking compliance of children. Disclosure of Invention Aiming at the defects of the prior art, the invention provides the preparation and the application of the traditional Chinese medicine granule for preventing the infection of the children influenza virus, and solves the problems that the heat-sensitive active ingredients are easy to hydrolyze and oxidatively degrade in the traditional water extraction and alcohol precipitation process, active small molecules are wrapped and lost due to rapid flocculation of macromolecular impurities, and secondary heat damage and poor rehydration solubility of final formed particles are caused by high-temperature dealcoholization. In order to achieve the above purpose, the invention is realized by the following technical scheme: in a first aspect, the invention provides a preparation method of traditional Chinese medicine granules for preventing children influenza virus infection, which comprises the following steps: Adding the mixed crude powder into citric acid-sodium citrate buffer solution, stirring under heating for dynamic extraction, and filtering to obtain filtrate; placing the filtrate into a concentration kettle, adding polyvinylpyrrolidone K30, stirring until the polyvinylpyrrolidone K30 is completely dissolved into a homogeneous aqueous solution, and then carrying out pure water phase reduced pressure concentration under a vacuum condition to obtain concentrated water; after the pure water phase is decompressed and concentrated, high-purity nitrogen is introduced to break vacuum to normal pressure, after the temperature of the material is reduced, industrial ethanol is pumped in, and stirring is maintained to cause heterogeneous precipitation of polysaccharide; stopping introducing the high-purity nitrogen after the polysaccharide is caused to be heterogeneous to separate out, decompressing in steps, heating to ensure that ethanol and water are stab