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Quality control method of volatile ingredients fingerprint of bone knitting medicine of traumatology

A quality control method and technology of volatile components, applied in the field of quality control of gas chromatographic fingerprints of bone medicine preparations in traumatology, can solve problems such as difficult to characterize the physical and chemical characteristics of volatile components, achieve reagent saving, high precision, and reproducibility good sex effect

Inactive Publication Date: 2009-03-11
大连美罗中药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, no fingerprint quality control method has been established for the volatile components of this product, and it is difficult to characterize the physicochemical characteristics of the volatile components in this pharmaceutical composition

Method used

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  • Quality control method of volatile ingredients fingerprint of bone knitting medicine of traumatology
  • Quality control method of volatile ingredients fingerprint of bone knitting medicine of traumatology
  • Quality control method of volatile ingredients fingerprint of bone knitting medicine of traumatology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] 1. Instruments and reagents

[0054] 1.1 Instrument

[0055] Shimadzu 14C gas chromatograph, Zhejiang Zhida N3000 chromatographic workstation, KUDOS ultrasonic cleaner (Shanghai Kedao Ultrasonic Instrument Co., Ltd.).

[0056] 1.2 Reagents and reagents

[0057] Methyl salicylate is sourced from China National Institute for the Control of Pharmaceutical and Biological Products, and Shangke Jiegu Tablets and Shangke Jiegu Capsules are provided by Dalian Merro Traditional Chinese Medicine Factory Co., Ltd. Ethyl acetate and ethanol were of analytical grade

[0058] 2. Determination of standard fingerprints of Shangke Jiegu Tablets and Shangke Jiegu Capsules

[0059] 2.1 Gas chromatography conditions

[0060] DB-5 capillary chromatographic column (30m×0.25mm, 0.25μm); inlet temperature 270°C, detector temperature 290°C; carrier gas is nitrogen, split ratio 20:1, pre-column pressure 120KPa; injection volume 0.5μl . Programmed temperature rise: keep at 60°C for 5 minute...

Embodiment 2

[0077] 1. Determination of standard fingerprints of Shangke Jiegu Tablets and Shangke Jiegu Capsules

[0078] 1.1 Preparation of internal standard solution

[0079] Take an appropriate amount of methyl salicylate, accurately weighed, and use ethyl acetate to make a solution containing 1 mg per 1 ml of the solution as the internal standard solution.

[0080] 1.2 Preparation of the test solution

[0081] Take 2.0g of Shangke Jiegu Tablets or Shangke Jiegu Capsules for comparison, add 6.0ml of ethyl acetate internal standard solution of methyl salicylate, ultrasonically extract for 30min, let cool to room temperature, and shake well to obtain the test solution.

[0082] 1.3 Other conditions are the same as in Example 1

[0083] 2. Determination of fingerprints of Shangke Jiegu Tablets and Shangke Jiegu Capsule samples Select 20 batches of samples of Shangke Jiegu Tablets with different batch numbers and 3 batches of samples of Shangke Jiegu Capsules with different batch numbers...

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Abstract

The invention discloses a gas chromatography finger printing quality control method for volatile ingredient in bone-knitting pharmaceutical preparation added with internal standard in the department of traumatology, which comprises the following steps: (1) preparing internal standard liquor: methyl salicylate is accurately weighed, and absolute ethyl alcohol or ethyl adetate is used for dissolving the methyl salicylate; (2) preparing test sample liquor: internal standard solution is added into the bone-knitting pharmaceutical preparation in the department of traumatology and after the ultra audible sound extraction, the test sample solution can be obtained; (3) analyzing and detecting the programmed temperature gas chromatography of sample solution of the bone-knitting pharmaceutical preparation in the department of traumatology; (4) building up the standard finger printing and analyzing the finger printing of the volatile ingredient of the bone-knitting pharmaceutical preparation in the department of traumatology. The invention has the advantages that the method is simple and stable, the precision is high, the reproduction quality is good, the method is reliable, scientific and effective evaluation can be done to the bone-knitting pharmaceutical preparation in the department of traumatology, and the method can be used for the quality control in practical production, which has beneficial effect on the whole control of producing quality of bone-knitting pharmaceutical preparation in the department of traumatology.

Description

technical field [0001] The invention relates to a quality control method of gas chromatographic fingerprints of Chinese patent medicines. Specifically, the invention relates to a quality control method of gas chromatographic fingerprints of traumatology and osteosynthetic medicine preparations added with an internal standard. Background technique [0002] There are many varieties of Chinese herbal medicines, their sources are complicated, and the phenomenon of variety confusion such as the same name and different substances, and the same substance with different names is extremely common. The quality of Chinese medicinal materials is also affected by many factors such as origin, harvest, processing, processing and storage. The chemical substances contained in Chinese medicinal materials are very complex. A Chinese medicinal material contains at least several to dozens of compounds, and the chemical components contained in the compound preparation composed of Chinese medicina...

Claims

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Application Information

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IPC IPC(8): A61K36/56A61P19/08G01N30/86G01N30/02A61K31/045A61K33/26A61K33/28A61K35/32A61K35/56A61K35/64
Inventor 张成海周文波陈心石桂芳
Owner 大连美罗中药厂有限公司
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