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Fasudil salt injection for improving stability and preparation method thereof

A technology of fasudil and injection, which is applied in the field of fasudil salt injection preparations, can solve the problems of not considering the unstable factors of drug ingredients, achieve the effect of large industrial application value and prolong the shelf life

Inactive Publication Date: 2011-04-13
广东中润医药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

) In addition, Chinese patent CN1729985A also provides a preparation method of Fasudil hydrochloride injection, but this method does not consider the unstable factors of the drug components, and does not adopt appropriate methods to investigate the stability of the drug

Method used

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  • Fasudil salt injection for improving stability and preparation method thereof
  • Fasudil salt injection for improving stability and preparation method thereof
  • Fasudil salt injection for improving stability and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 prepares Fasudil hydrochloride injection

[0029] Get 30.0g of Fasudil hydrochloride, 10.0g of medicinal sodium chloride, and water for injection to 2000ml, and make 1000 sticks altogether, that is, each stick is 30mg / 2ml.

[0030] The preparation method is as follows:

[0031] 1. Bottle washing: The bottle washing post is a clean area, the cleanliness should meet the 100,000-level standard, and the bottle area has 100-level laminar flow protection. The glass ampoules for injection are sorted and enter the ultrasonic bottle washing machine, washed with purified water in turn, dried with compressed air, washed with water for injection, and dried with compressed air. The outer body of the bottle is sprayed, cleaned and dried with circulating water, water for injection and compressed air in order to complete the whole cleaning process.

[0032] 2. Tunnel oven sterilization: The air cleanliness of the cleaned glass ampoules for injection (infrared) room shoul...

Embodiment 2

[0037] Embodiment 2, the impact of oxygen content in the injection on the stability of the preparation

[0038] In order to test the effect of the oxygen content in Fasudil Hydrochloride Injection on the stability of the injection, injections with different oxygen contents were first prepared, and then the changes of impurity content in the injection were detected under different high temperature and light conditions.

[0039] The experiment was carried out in the following way:

[0040] 1, the preparation of different oxygen content solutions of the test: first prepare the solution that is used for the production of injection according to embodiment 1 fasudil hydrochloride injection, then adopt the method for ultrasound and negative pressure pumping to remove the gas in the injection, Oxygen is introduced to increase the oxygen content in the solution to prepare injections with different oxygen content.

[0041] The following injections with different oxygen concentrations wer...

Embodiment 3

[0048] Embodiment 3, the impact on the stability of Fasudil hydrochloride injection preparation after being filled with inert gas

[0049] In order to test the influence of inert gas such as nitrogen, helium, carbon dioxide gas on the stability of injection in the Fasudil Hydrochloride Injection, at first the Fasudil Hydrochloride Injection of Embodiment 1 is carried out ultrasound or / and pumping Negative pressure degassing, and then injecting different gases to prepare injections containing different gases (nitrogen, helium or carbon dioxide gas), and then detecting the change of impurity content in the injections under different high temperature and light conditions.

[0050] The experiment was carried out in the following way:

[0051] 1. Preparation of solutions containing different inert gases (helium, nitrogen, carbon dioxide): first prepare a solution for the production of injections according to Example 1 Fasudil Hydrochloride Injection. Then, the gas in the injection...

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Abstract

The invention provides a fasudil salt injection for improving stability. The injection consists of the following components based on a weight ratio: the fasudil salt and medical sodium chloride are blended with water to 2,000ml according to a ratio of 100:1 to 1:100 to prepare 1,000 injections. The stability of the fasudil salt injection to light and heat is improved by reducing the oxygen content in the injection and introducing inert gas, so that the preserving period of injection products can be prolonged, and the injection has higher industrial application value. The invention provides a preparation method.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a fasudil salt injection, in particular to a new fasudil salt injection preparation with better stability. Background technique [0002] Fasudil hydrochloride (1-5-isoquinolinesulfonyl) homopiperazine hydrochloride is a new and highly effective vasodilator, which can effectively relieve cerebral vasospasm and improve the prognosis of patients with subarachnoid hemorrhage. The product was jointly developed by Nagoya University and Asahi Kasei Pharmaceutical Co., Ltd., and was first launched in Japan for clinical treatment in 1995, and was later approved for marketing in China and other places. Since the product has been on the market for more than ten years, it has been widely recognized clinically due to its clear curative effect and few side effects, and has become the drug of choice for the treatment of ischemic chronic cerebral vasospasm. The vasodilator effect of Fasudil hydro...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/551A61K47/02A61K47/04A61P9/10
Inventor 魏林华魏林友晏文利
Owner 广东中润医药有限公司
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