Fingerprint checking method of gadol injection

A fingerprint and inspection method technology, which is applied in the field of quality inspection of traditional Chinese medicine preparations, can solve problems such as drug risks, achieve good reproducibility, and improve inspection efficiency

Inactive Publication Date: 2009-02-11
TONGHUA YUSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The quality and curative effect of general traditional Chinese medicine injection are mainly determined by the content of the measurable components in the liquid and the compliance with the national injection standards. However, there are cases where different medicinal materials contain the same active ingredient, so it is very likely to use different medicinal materials to replace another It may introduce new impurities and undeterminable factors, which will bring great risks to the clinical practice of drugs.

Method used

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  • Fingerprint checking method of gadol injection
  • Fingerprint checking method of gadol injection
  • Fingerprint checking method of gadol injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: the standard fingerprint collection of rhodiola injection

[0024] The establishment of the standard fingerprint of Rhodiola injection includes the following steps:

[0025] a, preparation of test solution

[0026] Precisely measure 2ml of Rhodiola injection, put it in a 10ml measuring bottle, add water for injection to dilute to the mark, shake well, shake and extract 3 times with n-butanol saturated with water, 5ml each time, combine the n-butanol solution, and evaporate to dryness , the residue is dissolved in water for injection, transferred to a 5ml measuring bottle, diluted to the mark with water for injection, filtered through a microporous membrane (0.45 μm), and the filtrate is obtained.

[0027] b. Preparation of standard solution

[0028] Accurately weigh an appropriate amount of salidroside reference substance, add water for injection to dissolve, and make a solution containing 0.05mg salidroside per 1ml

[0029] c. Chromatographic condition...

Embodiment 2

[0045] Embodiment 2: Application of Rhodiola Rosea Injection Fingerprint Spectrum

[0046] 3 batches of samples for mass production are inspected. The sample fingerprint was established according to the method for establishing the standard fingerprint, and the figure 2 , 3 , 4 fingerprints. Evaluation and determination method compare the fingerprints of three batches of Rhodiola injection with the fingerprints of standard Rhodiola injection. The fingerprints of the test samples are similar to the standard fingerprints. The relative retention times and peaks of 18 common peaks of the three batches of samples The ratio of the non-common peak area to the total peak area was calculated, and all of them met the requirements of the standard fingerprint of Rhodiola injection. The standard fingerprint of Rhodiola injection can be used to check the mass-produced Rhodiola injection and has specificity.

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Abstract

The invention relates to a quality inspection method for traditional Chinese medicine preparations, in particular to a fingerprint inspection method of integripetal rhodiola herb injection. The method comprises the steps of: (1) establishing the standard fingerprint of the integripetal rhodiola herb injection; (2) establishing the fingerprints of integripetal rhodiola herb injection samples; and (3) making a comparison between the fingerprints of the integripetal rhodiola herb injection samples and the standard fingerprint of the integripetal rhodiola herb injection and selecting a sample that meets the requirements of the standard fingerprint of the integripetal rhodiola herb injection. The method can qualitatively determine the major ingredients of the integripetal rhodiola herb injection and establish the proportion relationship between active ingredients and inactive ingredients in the injection so as to ensure the drug quality and the therapeutic effect of the integripetal rhodiola herb injection, effectively and reliably represent the product quality of the integripetal rhodiola herb injection and provide a new comparing standard for completely and correctly evaluating the quality of the integripetal rhodiola herb injection.

Description

technical field [0001] The invention relates to a quality inspection method for traditional Chinese medicine preparations, in particular to a fingerprint inspection method for Rhodiola injection. Background technique [0002] In the existing technology, Rhodiola injection is a patented product exclusively produced by Tonghua Yusheng Pharmaceutical Co., Ltd., approved by the State Drug Administration Z20060361. Ingredients: Rhodiola rosea. Function: Strengthening Qi, promoting blood circulation and removing blood stasis, dredging channels and relieving pain. Indications: For coronary heart disease with angina pectoris syndrome of heart-blood stasis type chest pain. Symptoms include chest stabbing pain or cramping pain, which comes on and off, and the pain has a fixed location, which is worse at night, or palpitations, restlessness, shortness of breath, fatigue, dark purple tongue, or ecchymosis; deep and astringent pulse, etc. The quality and curative effect of general tra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/41A61P9/10G01N33/86A61K125/00
Inventor 曹明光
Owner TONGHUA YUSHENG PHARMA
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