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Alprostadil freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and alprostadil, which is applied in the field of medicine, can solve the problems of increased related substances, poor product stability, etc., and achieves the effects of low hemolytic activity, increased stability, and good stability

Inactive Publication Date: 2012-09-26
杭州澳亚生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Due to the addition of many types of auxiliary materials in the above method, the related substances of the product increase, the product stability is poor, and there is a potential safety hazard in medication.

Method used

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  • Alprostadil freeze-dried powder injection and preparation method thereof
  • Alprostadil freeze-dried powder injection and preparation method thereof
  • Alprostadil freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0031] The present invention will be explained in detail below in conjunction with the experimental scheme.

[0032] ①Prescription design

[0033] Experiment 1. Effects of different amounts of excipients on the stability of alprostadil freeze-dried powder injection

[0034]

[0035] ②Process design

[0036] 1. The preparation of alprostadil solution: get the alprostadil of prescription quantity, add appropriate amount of medicinal dehydrated alcohol to dissolve, stand-by, be recorded as A solution;

[0037] 2. Preparation of dextran 40 solution: Take the prescribed amount of dextran 40, add an appropriate amount of water around the injection and heat to dissolve, set aside, record as solution B;

[0038] 3. Add 120-160ml of water for injection into the batching tank, add solution B, stir evenly, add the prescribed amount of hydroxypropyl beta-cyclodextrin, stir to dissolve, add solution A, stir while adding, and finally add water for injection to 1000ml, stir evenly, fil...

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Abstract

The invention discloses an alprostadil freeze-dried powder injection and a preparation method thereof. The alprostadil freeze-dried powder injection comprises the following components: alprostadil, hydroxypropyl beta-cyclodextrin and dextran 40, wherein the weight ratio of the alprostadil to the hydroxypropyl beta-cyclodextrin to the dextran 40 is 1:(50-150):70. According to the technical scheme disclosed by the invention, the hydroxypropyl beta-cyclodextrin has an enveloping effect, is low in hemolytic activity, has no irritation to muscles, is capable of enhancing the stability of medicines and can be used for improving the stability and the dissolvability of the alprostadil, and the water solubility of the hydroxypropyl beta-cyclodextrin is greater than 50 percent. The dextran 40 is used for improving the freeze-dried forming characteristics of the alprostadil for injection. The pH value is regulated to be 4.0-4.5, and the alprostadil freeze-dried powder injection is higher in stability within the range of 4.0-4.5. The alprostadil freeze-dried powder injection obtained by adopting the technical scheme disclosed by the invention is safe and stable and is exact in curative effect and high in clinical adaptability of patients.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a freeze-dried preparation of alprostadil and a preparation method thereof. Background technique [0002] Alprostadil is a vasodilator with definite curative effect. It is a human physiological substance that can inhibit platelet aggregation, thromboxane A2 generation, atherosclerotic lipid plaque formation and immune complexes, and can expand peripheral and coronary vessels. It is clinically used for myocardial infarction, thromboangiitis and arteriosclerosis obliterans. In addition, it also has good curative effect on severe hepatitis, erectile dysfunction and ulcer diseases (such as diabetic ulcers and ulcers caused by extremities). [0003] In 1995, our company developed the freeze-dried powder injection of alprostadil for injection (former name: prostaglandin E1 for injection). The implementation standard is the local standard of Zhejiang Province. The standard number is DB33 / WS-114...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/5575A61K47/40A61P7/02A61P9/00A61P9/10
Inventor 陈青连李红菊单天炎邓云娟徐全华
Owner 杭州澳亚生物技术股份有限公司
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