Quality control method of compound injection liquid

A quality control method and injection technology, applied to medical preparations containing active ingredients, measuring devices, pharmaceutical formulas, etc., can solve problems such as the lack of quality control methods and the lack of technical solutions for quality control of Compound Danshen Injection, etc. To achieve safe and effective quality control, to ensure the effect of product quality

Inactive Publication Date: 2010-05-12
GUANGDONG PHARMA UNIV
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  • Abstract
  • Description
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Problems solved by technology

[0012] The invention with the application number of 200810048339.3 provides a preparation method of Xiangdan Injection, which describes that it can improve the purity of the liquid medicine and greatly reduce the adverse reaction rate when the medicine is used, but does not provide a quality control method
[0013] In summary, as a typical representative of existing traditional Chinese medicine injection preparations, Compound Danshen Injection currently lacks a reasonable technical solution for effective quality control

Method used

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  • Quality control method of compound injection liquid
  • Quality control method of compound injection liquid
  • Quality control method of compound injection liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Determination experiment of HPLC chromatographic elution conditions and GC chromatographic conditions

[0038] The present invention has done a lot of research experiments on HPLC chromatographic elution conditions and GC chromatographic conditions in a large number of long-term experimental studies, but cannot be repeated here. Several typical comparative experiments are selected below for description.

[0039] The HPLC chromatographic elution condition 1 is: the mobile phase composition includes that the mobile phase A is 1% acetic acid solution, and the mobile phase B is acetonitrile. For the gradient elution procedure, the specific conditions are 5% B for 0-10 min, 10% B for 120 min, 20% B50 for 35 min, 30% B for 50 min, and 40% B for 60 min; elution condition 2 is: mobile phase The composition included mobile phase A as 1% acetic acid solution and mobile phase B as acetonitrile. For the gradient elution procedure, the specific conditions are 12%B for 0-5...

Embodiment 2

[0041] The determination experiment of embodiment 2 quality control index component

[0042] Through the anti-myocardial ischemia and anti-hypoxia experiments on randomly selected compound injections containing salvia miltiorrhiza, pharmacological studies were carried out, and the fingerprint of the compound was studied. Salvianolic acid A, the peak area sum of protocatechuic aldehyde is more than 65%, see attached Image 6 and shown in Table 1. We carry out extraction with petroleum ether, chloroform, ethyl acetate, n-butanol successively to described injection, the consumption of extraction solvent is 500ml each time, extraction 3 times, obtains 5 different polar parts, respectively petroleum ether part ( A), the chloroform part (B), the ethyl acetate part (C), the n-butanol part (D) and the water part (E) are combined, and the fingerprints of each part and the combination of parts are obtained according to the HPLC chromatographic conditions. At the same time, pharmacolog...

Embodiment 3

[0078] Embodiment 3 Determination of trans-bitterol by gas chromatography

[0079] The present invention uses temperature-programmed gas chromatography to measure trans-bitterol. The certain gas chromatographic conditions used in the present invention include the following factors: the gas chromatograph is a Shimadzu GC-2010 gas chromatograph; a gas chromatographic column: an RTX-1701 gas chromatographic column; The split ratio is 5:1, and the mobile phase is high-purity N 2 , constant flow mode, n-tetradecanol as internal standard, FID as detector, injection volume 2μL, detector temperature 250℃, flow rate 2.72mL·min -1 . The temperature program of the gas chromatographic column in the certain chromatographic conditions is: 2°C·min -1 The temperature was increased to 124 °C at a rate of 10 min; at 10 °C·min -1 The temperature was raised to 138°C at a rate of 5min; -1 The rate was raised to 220°C and held for 5min.

[0080] Qualitative and quantitative control is carried...

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Abstract

The invention discloses a quality control method of a compound injection liquid. The method comprises content measurement of salvianic acid A sodium, salvianolic acid B, salvianolic acid A, protocatechualdehyde and trans-nerolidol; the preparation takes the finished product amount equal to drug amount used daily as unit, and each unit of drug amount comprises not less than 1.4mg of salvianic acid A sodium (C9H9O5Na), not less than 0.12mg of salvianolic acid B (C36H30O16), not less than 0.019mg of salvianolic acid A (C26H22O10), and not less than 0.14mg of protocatechualdehyde (C7H6O3); and in 1000ml of the preparation, the trans-nerolidol (C15H26O) is not less than 5mg. The quality control method can effectively improve the quality of the compound injection liquid and achieve safe and effective quality control of effective components really.

Description

technical field [0001] The invention belongs to the technical field of injection quality control, and in particular relates to a quality control method for a compound injection with the effect of promoting blood circulation and removing blood stasis. Background technique [0002] Traditional Chinese medicine has a long history of thousands of years. It not only has a complete set of theories, methods, prescriptions and medicines, but also has been made into dozens of dosage forms for clinical use. Restricted by historical conditions and technology, before the founding of the People's Republic of China, traditional Chinese medicine preparations remained at the level of decoctions, pills, powders, pastes, and dans. The only injection preparations were Bupleurum Injection, which was developed by the Anti-Japanese Base in 1938. After the founding of the People's Republic of China, the pace of research and development of traditional Chinese medicine injections accelerated. From t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/537A61P9/10G01N30/36G01N30/02
Inventor 沈志滨唐春萍尹永芹杨超燕
Owner GUANGDONG PHARMA UNIV
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