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Colloid bismuth pectin compound and quality control method of pharmaceutical compositions thereof

A quality detection method, technology of colloidal pectin bismuth, applied in the direction of testing pharmaceutical preparations, material analysis through observation of the influence on chemical indicators, material inspection products, etc., can solve problems such as determination of acid radical pectin acid radical content

Inactive Publication Date: 2012-06-20
于学敏
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

In the existing colloidal bismuth pectin and its quality detection method, only the content determination of cationic bismuth in the pectin bismuth molecule is carried out under the [Assay] item of the original quality standard, and the content determination of the acid radical pectin acid group is not carried out (see " Chinese Pharmacopoeia, 2010 Edition, Part Two, P852-P853)

Method used

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  • Colloid bismuth pectin compound and quality control method of pharmaceutical compositions thereof
  • Colloid bismuth pectin compound and quality control method of pharmaceutical compositions thereof
  • Colloid bismuth pectin compound and quality control method of pharmaceutical compositions thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] [Identification] Inspection of gelling property: Grind colloidal bismuth pectin or the contents of colloidal bismuth pectin capsules finely, weigh 0.75g and place it in a 50ml colorimetric tube, add an appropriate amount of water to mix, add water to the constant volume scale, After shaking to make a glue, add 4 drops of hydrochloric acid (1→2), shake vigorously and let stand to form a gel that does not flow, dehydrate, break, or bubble.

Embodiment 2

[0098] [Inspection] Inspection of intrinsic viscosity: Grind colloidal bismuth pectin or the contents of colloidal bismuth pectin capsules through a 200-mesh sieve, accurately weigh 50 mg and place it in a 100ml volumetric flask, add water to the constant volume scale, and shake well , check according to the third method in " Chinese Pharmacopoeia " version two appendix VI G viscometry in 2010, and the result [η] is 149.

Embodiment 3

[0100] [Inspection] Item uniformity inspection: Weigh 10g of colloidal bismuth pectin, pass through a 200-mesh standard sieve, and take the same amount of sieve residue and under-sieve respectively according to "Chinese Pharmacopoeia" 2010 edition two P853 colloidal bismuth pectin [Content Determination] Determination of bismuth content under the method. Results: The bismuth content of the sieve residue was 15.71%, and the bismuth content of the undersieve was 15.53%, with a difference of 0.18%, which met the quality requirements.

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Abstract

The invention relates to a colloid bismuth pectin compound and a quality control method of pharmaceutical compositions of the colloid bismuth pectin compound, and specifically provides a colloid bismuth pectin compound, new quality control indexes of pharmaceutical compositions of the colloid bismuth pectin compound and a detection method of the colloid bismuth pectin compound and the pharmaceutical compositions of the colloid bismuth. In the prior art, the quality of products having poor efficacy can not be well controlled because the efficacy-related indexes are not controlled strictly in the existing quality control methods of colloid bismuth pectin and pharmaceuticals thereof. Based on the existing quality control methods of colloid bismuth pectin and pharmaceuticals thereof, the following detection items and indexes are added: intrinsic viscosity, gel property, uniformity and galacturonic acid content. The invention can effectively ensure clinical efficacy of products, make the product quality standards more scientific, reasonable and controllable, and has great significance in quality control of the colloid bismuth pectin and the pharmaceutical preparation of colloid bismuth pectin.

Description

technical field [0001] The invention relates to a quality detection method of colloidal pectin bismuth compound and its pharmaceutical composition, in particular, it provides a new quality control index and detection method of colloidal pectin bismuth compound and its pharmaceutical composition. Belongs to the field of medicine. Background technique [0002] The colloidal bismuth pectin capsules currently used clinically and the original quality standards of the raw material colloidal bismuth pectin were all developed by the National Institute of Drug Research of Datong City and Datong Weimin Pharmaceutical Co., Ltd. (formerly Datong Institute of Drug Research Pharmaceutical Factory) Researcher Xuemin presided over the drafting. The quality standard was initially the provisional standard of the Ministry of Health, and then it was converted into the official ministerial standard, and then included in the 2000, 2005, and 2010 editions of the "Chinese Pharmacopoeia". This sta...

Claims

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Application Information

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IPC IPC(8): G01N11/06G01N21/78G01N33/15
Inventor 于学敏冯辉于洋韩琴
Owner 于学敏
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