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A kind of pharmaceutical preparation for treating liver and gallbladder disease and preparation method thereof

A technology for pharmaceutical preparations and liver and gallbladder diseases, which is applied in the field of pharmaceutical preparations for the treatment of liver and gallbladder diseases and its preparation, and can solve problems affecting the quality and curative effect of ursodeoxycholic acid tablets, production processes, and differences in excipient ingredients

Active Publication Date: 2021-01-12
THE SECOND HOSPITAL OF HEBEI MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, in addition to importing ursodeoxycholic acid raw materials and preparations from abroad, there are more than 40 domestic companies producing ursodeoxycholic acid tablets, but there are obvious differences in the production process and excipient ingredients, which affect the production of ursodeoxycholic acid. Quality and efficacy of acid tablets

Method used

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  • A kind of pharmaceutical preparation for treating liver and gallbladder disease and preparation method thereof
  • A kind of pharmaceutical preparation for treating liver and gallbladder disease and preparation method thereof
  • A kind of pharmaceutical preparation for treating liver and gallbladder disease and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1: Ursodeoxycholic Acid Tablets

[0033] Prescription composition (1000 tablets):

[0034]

[0035] Preparation:

[0036] ① Micronization treatment of raw materials: Micronize the raw materials of ursodeoxycholic acid to obtain more than 90% of the micropowder with a particle size of no more than 40-50 microns, and set aside;

[0037] ② Pretreatment of excipients: hydroxypropyl cellulose, starch, and magnesium stearate are respectively passed through a 120-mesh sieve, and set aside; HS-15 is dissolved in 35% ethanol to prepare a binder solution, set aside;

[0038] ③ Mixing raw and auxiliary materials: mix ursodeoxycholic acid, starch, and hydroxypropyl cellulose evenly;

[0039] ④ Soft material granulation: add the powder in step ③ to the binder solution, stir to prepare soft material; take the prepared soft material and pass through a 14-mesh sieve to granulate.

[0040] ⑤ Drying and granulation: Take the prepared granules and dry them, then granulate th...

Embodiment 2

[0042] Example 2: Ursodeoxycholic Acid Tablets

[0043] Prescription composition (1000 tablets):

[0044]

[0045] Preparation:

[0046] ① Micronization treatment of raw material drug: micronized ursodeoxycholic acid raw material drug to obtain more than 90% of the micropowder with a particle size of no more than 40-50 microns, and set aside;

[0047] ②Excipient material pretreatment: hydroxypropyl cellulose, starch, and magnesium stearate are respectively passed through a 100-mesh sieve, and set aside; 40% ethanol is used to dissolve HS-15 to prepare a binder solution, set aside;

[0048] ③ Mixing raw and auxiliary materials: mix ursodeoxycholic acid, starch, and hydroxypropyl cellulose evenly;

[0049] ④ Soft material granulation: add the powder in step ③ to the binder solution, stir to prepare soft material; take the prepared soft material and pass through a 14-mesh sieve to granulate.

[0050] ⑤ Drying and granulation: Take the prepared granules and dry them, then gr...

Embodiment 3

[0052] Example 3: Ursodeoxycholic Acid Tablets

[0053] Prescription composition (1000 tablets):

[0054] components Weight (g) number of copies ursodeoxycholic acid 50 10 low substituted hydroxypropyl cellulose 12.5 2.5 starch 9 1.8 Magnesium stearate 2.5 0.5 HS-15 1 0.2 38% ethanol solution 53 —

[0055] Preparation:

[0056] ① Micronization treatment of raw material drug: micronized ursodeoxycholic acid raw material drug to obtain more than 90% of the micropowder with a particle size of no more than 40-50 microns, and set aside;

[0057]②Excipient material pretreatment: hydroxypropyl cellulose, starch, and magnesium stearate are respectively passed through a 100-mesh sieve, and set aside; dissolve HS-15 with 38% ethanol to prepare a binder solution, set aside;

[0058] ③ Mixing raw and auxiliary materials: mix ursodeoxycholic acid, starch, and hydroxypropyl cellulose evenly;

[0059] ④ Soft material granulation: ...

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Abstract

The invention provides a medicinal preparation for treating hepatobiliary diseases and a preparation method thereof. The medicinal preparation comprises ascariasis, hydroxypropyl cellulose, starch, magnesium stearate, HS-15 and an ethanol solution for preparing a soft material. The dissolution curves of an ascariasis tablet provided by the invention in four mediums are consistent with those of anoriginal product, thereby ensuring the same efficacy as the original product.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, more specifically, to a pharmaceutical preparation for treating hepatobiliary diseases and a preparation method thereof. Background technique [0002] The chemical composition of bear bile is relatively complex, including bile acids, cholesterol, bile pigments, amino acids, and trace elements. Bile acids include cholic acid (CA), chenodeoxycholic acid (CDCA), ursodeoxycholic acid (UDCA), deoxycholic acid (DCA), tauroursodeoxycholic acid (TUDCA), taurine Chenodeoxycholic acid (TCDCA) and so on. Ursodeoxycholic acid (UDCA for short) is the main component of bear bile, its chemical name is 3α, 7β-dihydroxy-5β-cholanic acid, which is the 7β-hydroxyl Epimers. [0003] [0004] Since the discovery that UDCA could effectively dissolve cholesterol gallstones in the 1980s, new studies have shown that UDCA has positive effects in the treatment of hepatobiliary diseases, especially in the tr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/36A61K47/14A61K31/575A61P1/16
CPCA61K9/2031A61K9/2054A61K9/2059A61K9/2095A61K31/575A61P1/16
Inventor 赵晓娟王永静赵永红律涛
Owner THE SECOND HOSPITAL OF HEBEI MEDICAL UNIV
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