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Alprostadil emulsions measuring method

A determination method and technology of dil emulsion are applied in measurement devices, preparation of test samples, instruments, etc., which can solve the problems of complicated process, long time and high cost, and achieve simple and easy operation, good reproducibility, and convenience. control effect

Active Publication Date: 2011-01-26
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Generally recorded according to the standard, the test sample volume is 2.5μg / ml, PGA 1 The reference substance is 2.0 μg / ml, calculated according to the current standard limit of 3.0 μg / ml, PGA 1 Equivalent to 120%, the sample is fully converted to PGA 1 All qualified, so this method and limit can't control product quality (the electronic publication issued by the National Center for Drug Evaluation on October 21, 2005, website: http: / / www.cde.org.cn / page / framelimit.cbs?ResName =dzkw)
In addition, the cost of solid phase extraction is high and the inspection period is long, which is not conducive to the control of the production process (intermediate detection)
[0008] Chinese patent CN1823786A adopts the freeze-drying method to demulsify, the process is complicated, the time is too long, it takes 20-50 hours, the energy consumption is large, the cost is high, it is very difficult to measure the content of the sample, the operability is not strong, and it cannot be corrected. production process control
And the general detection units do not have freeze-drying equipment, so this method cannot be used for determination, and the practicability is not strong

Method used

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Experimental program
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Effect test

Embodiment 1

[0034] Embodiment 1 Alprostadil freeze-dried emulsion PGE1 and PGA1 content determination

[0035] 1. Instruments, medicines and reagents:

[0036] Agilent HP1100 liquid chromatograph, Pickering company PCX5200 post-column derivatizer. Alprostadil freeze-dried emulsion: prepared with reference to Chinese patent CN1195990A; the reference substance of alprostadil is provided by Taiwan Yongguang Chemical Industry Co., Ltd., and the content is 99.5%; the reference substance of prostaglandin A1 is the USP reference substance. Acetonitrile, isopropanol, and n-hexane are B&J chromatographically pure; potassium dihydrogen phosphate, potassium hydroxide, and absolute ethanol are analytical alcohols, produced by Chongqing Dongfanghong Reagent Factory.

[0037] 2. Chromatographic conditions and system suitability test

[0038] The chromatographic column is an Agilent XBD-C18 (250×4.0mm, 5 μm) chromatographic column, with 0.02mol / L phosphate buffer (pH4.9) (take 2.72g of potassium dihyd...

Embodiment 2

[0050] Embodiment 2 Alprostadil injection PGE 1 and PGA 1 Assay

[0051] The preparation of need testing solution: precision measures this product appropriate (approximately equivalent to 10 μ g of alprostadil), puts in 10ml measuring bottle, adds 1ml demulsifier (isopropanol: normal hexane=1: 0.3), shakes 2 minutes, Sonicate for 2 minutes, add isopropanol to dilute to the mark, shake well, filter, and obtain.

[0052] All the other are with embodiment 1.

[0053] Measurement result: PGE 1 The content is 110.2%, PGA 1 The content is 5.8%.

Embodiment 3

[0054] Embodiment 3 Alprostadil freeze-dried emulsion PGE 1 and PGA 1 Assay

[0055] Demulsifier is ethanol: normal hexane=1: 0.1, all the other are the same as embodiment 1.

[0056] Measurement result: PGE 1 The content is 105.6%, PGA 1 The content is 2.1%.

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Abstract

The invention discloses an alprostadil emulsion determination method used for determining the content of active ingredients alprostadil and impurities prostaglandin A1. The invention carries on the emulsion breaking by utilizing the alcohol mixed organic solvent, then determines the content of alprostadil and prostaglandin A1 by using a high performance liquid chromatography. The method is simple, convenient, easy operation, breaking completely, and effectively controls the quality of products. Compared with the prior art, the method is more economical, quick, accurate and easy operation. Therefore the invention can be used for determining the alprostadil emulsion quality, also detecting the intermediates in the production process.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for determining the alprostadil emulsion, which is used to determine the active ingredient alprostadil and the impurity prostaglandin A in the alprostadil emulsion 1 content. Background technique [0002] Alprostadil, also known as prostaglandin E 1 (PGE 1 ), English name: Alprostadi (Prostaglandin E 1 ), its chemical name is: 11a, 15(S)-bishydroxy-9-carbonyl-13-reverse prostenic acid. Molecular formula: C 20 h 34 o 5 , whose structural formula is: [0003] [0004] Alprostadil has a wide range of pharmacological activities: it can relax blood vessels, improve peripheral circulation; inhibit platelet aggregation, prevent thromboxane A 2 formation; protection of platelets, inhibition of atherosclerotic plaque formation, expansion of peripheral and coronary vessels and immune complexes; protection of ischemic myocardium, reduction of infarct size; protecti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N1/38G01N30/02
Inventor 谭俊杰
Owner YAOPHARMA CO LTD
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