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Bone-strengthening drug quality detection method

A quality inspection method and drug technology, applied in measuring devices, color/spectral characteristic measurement, instruments, etc., can solve problems such as large errors, large limitations, and poor operability

Active Publication Date: 2015-11-04
XIAN DAQING PHARMA FACTORY JINHUA ENTERPRISE GROUP CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The National Drug Standard YBZ01592003-2009Z of the State Food and Drug Administration promulgated the quality control standard for Jintiange Capsules. The content of total amino acids in the original quality control method was determined by traditional hydrolysis and manual derivation using high performance liquid chromatography. The original quality The control method only measures the amount of total phosphorus, which has relatively large limitations
At the same time, the original method has poor operability, large error, low efficiency, 2 days of operation time, and poor specificity

Method used

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  • Bone-strengthening drug quality detection method
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  • Bone-strengthening drug quality detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Get 324g of artificial tiger bone powder and 76g of auxiliary materials to make 1000 capsules of bone strengthening medicine Jintiange Capsules. Every grain weighs 0.4g, and the quality control method of this medicine comprises the following steps:

[0056] (1) Determination of the total amino acid content containing hydroxyproline in the bone strengthening drug Jintiange capsules with a fully automatic amino acid analyzer;

[0057] a Preparation of reference substance solution: accurately weigh L-hydroxyproline, proline, aspartic acid, glutamic acid, serine, glycine, histidine, arginine, threonine, alanine, Add appropriate amount of tyrosine, valine, methionine, isoleucine, leucine, phenylalanine, and lysine reference substance, add 0.02mol / L hydrochloric acid solution to prepare a corresponding concentration of reference substance solution; The reference substance solution preparation relation is as follows:

[0058] amino acid

three letter code

Sam...

Embodiment 2

[0068] Get 324g of artificial tiger bone powder and 76g of auxiliary materials to make 1000 Jintiange capsules. Every grain weighs 0.4g, and the quality control method of this medicine comprises the following steps:

[0069] (1) Determination of the total amino acid content comprising hydroxyproline in Jintiange capsules by high performance liquid chromatography;

[0070] a Chromatographic conditions: use octadecylsilane bonded silica gel as filler (Shim-pack VP-ODS4.6mm×250mm); use 0.1mol / L sodium acetate buffer solution (use glacial acetic acid to adjust the pH value to 6.3±0.05) It is mobile phase A, and methanol-acetonitrile-water (20:60:20) is mobile phase B; carry out gradient elution according to the following table:

[0071]

[0072]

[0073] The detection wavelength is 254 nm, the column temperature is 35° C., and the injection volume is 2 μl.

[0074] b Preparation of reference substance solution: Accurately weigh the following amino acid reference substances...

Embodiment 3

[0086] Get 324g of artificial tiger bone powder and 76g of auxiliary materials to make 1000 Jintiange capsules. Every grain weighs 0.4g, and the quality control method of this medicine comprises the following steps:

[0087] (3) Using traditional hydrolysis and post-column automatic on-line derivatization, a fully automatic amino acid analyzer was used to determine the total amino acid content containing hydroxyproline in Jintiange capsules;

[0088] a Preparation of reference substance solution: accurately weigh L-hydroxyproline, proline, aspartic acid, glutamic acid, serine, glycine, histidine, arginine, threonine, alanine, An appropriate amount of tyrosine, valine, methionine, isoleucine, leucine, phenylalanine, lysine reference substance, add 0.02mol / L hydrochloric acid solution to configure a corresponding concentration of reference substance solution, The reference substance solution preparation relationship is the same as in Example 1.

[0089] b Preparation of the test...

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Abstract

The invention discloses a bone-strengthening drug quality detection method, and belongs to the drug quality detection technical field. The adopted technical scheme comprises that the bone-strengthening drug is made into capsules by an artificial tiger bone powder and auxiliary materials, and the quality detection method includes the following determining steps: 1) after the bone-strengthening drug is hydrolyzed, determining the content of total amino acids in the samples, wherein each capsule contains not less than 65 mg of the total amino acids; and 2) determining the content of total calcium in the bone-strengthening drug by adopting atomic absorption spectrophotometry, wherein each capsule contains not less than 55 mg of calcium. The determination method for determining the content of the total amino acids in the preparation by adopting microwave hydrolysis and automatic online derivation, using a full-automatic amino acid analyzer or adopting traditional hydrolysis and PITC derivation method and using high performance liquid chromatography is established, the determination method for determining the content of calcium in the samples by adopting the atomic absorption spectrophotometry is increased, the accuracy and advancement of the quality detection method is ensured, and the product quality of Jintiange capsules can be effectively controlled.

Description

technical field [0001] The invention belongs to the technical field of drug quality detection, and in particular relates to a quality detection method of bone-enhancing drugs. Background technique [0002] Jintiange Capsule is a kind of bone-building drug, which is a preparation made of artificial tiger bone powder and appropriate amount of auxiliary materials. Artificial tiger bone powder has a bone-building effect. improve. [0003] Tiger bone is a precious Chinese herbal medicine and its medicinal value has been fully proved after thousands of years of clinical practice. Tiger bone has significant anti-inflammatory, chasing wind, analgesic, bone strengthening and other effects, mainly used for Treatment of osteoporosis, rheumatism and bone injuries. In 1993, in order to comply with international conventions, after my country banned the trade and medicinal use of tiger bone, many famous Chinese patent medicines containing tiger bone disappeared quietly. In order to prev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N21/31
Inventor 陶玉
Owner XIAN DAQING PHARMA FACTORY JINHUA ENTERPRISE GROUP CORP
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