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CN-122005483-A - Compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases and preparation method thereof

CN122005483ACN 122005483 ACN122005483 ACN 122005483ACN-122005483-A

Abstract

The application relates to the technical field of traditional Chinese medicine preparations, in particular to a compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases and a preparation method thereof. The compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases comprises a tablet core and a film coating layer wrapping the tablet core, wherein the tablet core comprises phyllanthus emblica dry paste powder, compound dry powder, menthol, borneol, corn starch, sucrose powder and hypromellose, the compound dry powder is an aqueous extract of a mixture of radix scrophulariae, platycodon grandiflorum and liquorice, the weight ratio of the corn starch, the sucrose powder to the hypromellose is (0.5-15) 45-60) 0.5-8, the film coating layer comprises gelatin, and the weight ratio of the gelatin to the hypromellose is (0.5-8) 0.3-3. The compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases has good storage stability, and improves appearance and palatability.

Inventors

  • CHEN WENPING
  • CHEN XINYANG
  • LI KAILI
  • Lin Dingcha
  • HE ZIXIN
  • HUANG QIULING
  • NING NA
  • CHEN HAIPENG
  • LIU XIAOLI

Assignees

  • 广州白云山奇星药业有限公司

Dates

Publication Date
20260512
Application Date
20260318

Claims (10)

  1. 1. A compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases is characterized by comprising a tablet core and a film coating layer wrapping the tablet core; The tablet core comprises phyllanthus emblica dry paste powder, compound dry powder, menthol, borneol, corn starch, sucrose powder and hypromellose, wherein the compound dry powder is a water extract of a mixture of radix scrophulariae, platycodon grandiflorum and liquorice, and the weight ratio of the corn starch to the sucrose powder to the hypromellose is (0.5-15) (45-60) (0.5-8); the composition of the film coating layer comprises gelatin, wherein the weight ratio of the gelatin to the hypromellose is (0.5-8) to (0.3-3).
  2. 2. The compound phyllanthus emblica sore throat lozenge film coated tablet for treating throat diseases according to claim 1, wherein the compound phyllanthus emblica sore throat lozenge film coated tablet for treating throat diseases comprises 0.5% -2% of dry phyllanthus emblica paste powder, 3% -15% of compound dry powder, 0.1% -0.5% of menthol, 0.05% -0.5% of borneol, 0.5% -15% of corn starch, 45% -60% of sucrose powder, 0.5% -8% of hypromellose and 0.3% -3% of gelatin by weight.
  3. 3. The compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases according to claim 1 or 2, wherein the tablet core further comprises at least one of dextrin, talcum powder and magnesium stearate.
  4. 4. The compound phyllanthus emblica sore throat lozenge film coated tablet for treating throat diseases according to claim 3, wherein the compound phyllanthus emblica sore throat lozenge film coated tablet for treating throat diseases comprises, by weight of the compound phyllanthus emblica sore throat lozenge film coated tablet for treating throat diseases, 0.5% -2% of dry phyllanthus emblica paste powder, 3% -15% of compound dry powder, 0.1% -0.5% of menthol, 0.05% -0.5% of borneol, 0.5% -15% of corn starch, 45% -60% of sucrose powder, 0.5% -8% of hypromellose, 10% -30% of dextrin, 0.5% -5% of talcum powder and 0.5% -5% of magnesium stearate, and 0.3% -3% of gelatin.
  5. 5. The compound emblic tablet film coated tablet for treating throat diseases according to claim 1, wherein the preparation method of the dry emblic powder comprises the steps of cleaning fresh emblic, removing cores, squeezing juice, filtering to obtain filtrate, concentrating the filtrate, drying to obtain the dry emblic powder, and/or, The preparation method of the compound dry powder comprises the following steps of mixing radix scrophulariae, platycodon grandiflorum and liquorice according to the mass ratio of 3:3:1, decocting the mixture with water, concentrating, drying to obtain the compound dry powder, and/or, The weight ratio of the phyllanthus emblica dry paste powder to the compound dry powder to the menthol to the borneol is (0.5-2), 3-15, 0.1-0.5 and 0.05-0.5, and the sum accounts for 3.65-18% of the weight of the compound phyllanthus emblica sore throat relieving tablet film tablet for treating throat diseases.
  6. 6. The method for preparing the compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases as claimed in any one of claims 1 to 5, which is characterized by comprising the following steps: The tablet core is subjected to spray coating by using coating liquid, wherein the coating liquid comprises gelatin and a first alcohol solvent, the mass concentration of the gelatin is 1% -5%, and the first alcohol solvent comprises ethanol and water; the weight ratio of the coating liquid to the tablet core is (0.5-2) 100; optionally, the volume concentration of ethanol in the first alcohol solvent is 40% -80%.
  7. 7. The preparation method of claim 6, wherein the preparation method of the coating liquid comprises the following steps: adding the gelatin into the first alcohol solvent, mixing, standing for 2-24 h, and heating in water bath to dissolve to obtain a solution; filtering the solution with 80-100 mesh sieve to obtain the coating solution.
  8. 8. The method of manufacturing as claimed in claim 6 or 7, wherein the method of manufacturing the tablet core comprises the steps of: Mixing the phyllanthus emblica dry paste powder, the compound dry powder, the corn starch, the sucrose powder and the hypromellose, and adding a second alcohol solution to prepare a soft material, wherein the second alcohol solvent comprises ethanol and water; granulating, drying and screening the soft material to obtain granules; dissolving Borneolum Syntheticum and Mentholum in a third alcohol solution, spraying into the granule, mixing, adding magnesium stearate and pulvis Talci, and mixing to obtain mixed granule, wherein the third alcohol solvent comprises ethanol and water; Tabletting the mixed granules to obtain tablet cores; Optionally, the volume concentration of ethanol in the second solution is 60% -90%; Optionally, the volume concentration of ethanol in the third alcohol solution is 40% -95%.
  9. 9. The process of claim 8, wherein granulating comprises dispersing using a 10-14 mesh sieve, and/or, The drying temperature is 50-75 ℃, and/or, Screening includes screening using a 15-17 mesh screen.
  10. 10. The method of any one of claims 6-7, 9, wherein the step of spray coating the tablet core with a coating solution comprises: loading the tablet cores into a coating cylinder, and setting the rotating speed of the coating cylinder to be 3-8 revolutions per minute; atomizing the coating liquid and spraying the atomized coating liquid on the tablet core to form a coating and/or, In the step of spray coating the tablet core by using the coating liquid, the air outlet temperature is 45-65 ℃ and the air inlet temperature is less than or equal to 100 ℃.

Description

Compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases and preparation method thereof Technical Field The application relates to the technical field of traditional Chinese medicine preparations, in particular to a compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases and a preparation method thereof. Background The compound phyllanthus emblica throat-relieving lozenge (national standard B20020422) has the pharmacological effects of clearing heat and detoxicating, detumescence and relieving pain, and can be used for purposefully relieving throat symptoms such as dry throat itching and pain, burning discomfort, foreign body sensation, dry cough with little phlegm, and the like, and has clinical advantages in the field of auxiliary treatment of throat diseases. However, the compound phyllanthus emblica sore throat relieving lozenge has the phenomenon of active ingredient precipitation during storage, so that the dosage form of the compound phyllanthus emblica sore throat relieving lozenge needs to be improved, and the storage stability of the compound phyllanthus emblica sore throat relieving lozenge is improved. The film coating technology is a technology for forming a film on the surface of a medicine through a high polymer material to wrap the medicine, and compared with the traditional sugar coating technology, the film coating technology can reduce the weight gain of the coating, shorten the drying time, improve the moisture resistance and the dissolution rate, and is widely applied to the production of tablets and pills at present. At present, no film coated tablet of the compound phyllanthus emblica lozenges capable of relieving sore throat is reported. Meanwhile, the compound phyllanthus emblica sore throat relieving lozenge comprises borneol, menthol and the like, the blocking effect of the film coating technology on the volatile components is limited, and the volatile components can be separated out on the surface after being stored for a period of time, so that the quality of the medicine is affected. Disclosure of Invention Based on the above, one or more embodiments of the present application provide a compound phyllanthus emblica sore throat relieving tablet film coated tablet for treating throat diseases, which has good storage stability, can avoid precipitation of volatile active ingredients, and improves appearance and palatability, and a preparation method thereof. The application relates to a compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases, which comprises a tablet core and a film coating layer wrapping the tablet core; The tablet core comprises phyllanthus emblica dry paste powder, compound dry powder, menthol, borneol, corn starch, sucrose powder and hypromellose, wherein the compound dry powder is a water extract of a mixture of radix scrophulariae, platycodon grandiflorum and liquorice, and the weight ratio of the corn starch to the sucrose powder to the hypromellose is (0.5-15) (45-60) (0.5-8); the composition of the film coating layer comprises gelatin, wherein the weight ratio of the gelatin to the hypromellose is (0.5-8) to (0.3-3). Further, the compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases comprises 0.5% -2% of phyllanthus emblica dry paste powder, 3% -15% of compound dry powder, 0.1% -0.5% of menthol, 0.05% -0.5% of borneol, 0.5% -15% of corn starch, 45% -60% of sucrose powder, 0.5% -8% of hypromellose and 0.3% -3% of gelatin by weight. In some embodiments, the tablet core further comprises at least one of dextrin, talc, and magnesium stearate. Further, the compound phyllanthus emblica sore throat relieving lozenge film coated tablet for treating throat diseases comprises, by weight, 0.5% -2% of phyllanthus emblica dry paste powder, 3% -15% of compound dry powder, 0.1% -0.5% of menthol, 0.05% -0.5% of borneol, 0.5% -15% of corn starch, 45% -60% of sucrose powder, 0.5% -8% of hypromellose, 10% -30% of dextrin, 0.5% -5% of talcum powder, 0.5% -5% of magnesium stearate and 0.3% -3% of gelatin. In some embodiments, the method for preparing the dry extract powder of emblic leafflower fruit comprises the steps of cleaning fresh emblic leafflower fruit, removing cores, squeezing juice, filtering to obtain filtrate, concentrating the filtrate, drying to obtain the dry extract powder of emblic leafflower fruit, and/or, The preparation method of the compound dry powder comprises the following steps of mixing radix scrophulariae, platycodon grandiflorum and liquorice according to the mass ratio of 3:3:1, decocting the mixture with water, concentrating, drying to obtain the compound dry powder, and/or, The weight ratio of the phyllanthus emblica dry paste powder to the compound dry powder to the menthol to the borneol is (0.5-2), 3-15, 0.1-0.5 and 0.05-0.5, and the sum acc