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Ganciclovir for injection and preparation method thereof

A technology for ganciclovir and injection, which is applied in the field of ganciclovir freeze-dried powder injection for injection and its preparation, can solve the problem of powder injection skeleton and freeze-dried microstructure collapse, skeleton freeze-dried microstructure Structural collapse, large safety risks and other problems, to achieve the effect of loose and uniform appearance, reduce production costs, and improve product uniformity

Active Publication Date: 2013-04-24
BEIJING WANPENGLANGGE PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The composition of the preparation is complex and contains a relatively high concentration of polysorbate 80, which brings a greater safety risk to clinical application
[0006] CN101711746A discloses a freeze-dried preparation of ganciclovir for injection, which comprises preparing 50-250 parts of ganciclovir and 100-200 parts of hydroxypropyl-β-cyclodextrin into a medicinal solution, and adjusting the pH value to 8.5 ~9.5, freeze-dry the liquid medicine in a freeze dryer, the entire freeze-drying process lasts for 22-26 hours, and the products prepared at the same time do not solve the problem of powder injection skeleton and freeze-dried microstructure collapse
Although this process solves the problems of such drugs such as easy melting, long freeze-drying cycle, collapse of skeleton and freeze-dried microstructure, etc., the dosage of sodium hydroxide contained in the prescription is too much, and the liquid medicine is highly alkaline, which is difficult for clinical practice. The injection is very irritating, and the patient feels very uncomfortable due to pain
Moreover, the product prepared by this process will increase in related substances after long-term storage, and the stability is not high

Method used

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  • Ganciclovir for injection and preparation method thereof
  • Ganciclovir for injection and preparation method thereof
  • Ganciclovir for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The preparation of embodiment 1 ganciclovir freeze-dried powder injection

[0028]

[0029] Preparation: Weigh 2.5kg of ganciclovir and 225g of sodium chloride, add 80-85% of the prescription amount to water for injection cooled to room temperature, stir to dissolve completely, adjust the pH of the liquid to 10.5-11.0 with sodium hydroxide, add water for injection to 25L, stir evenly. Then go through double-stage sterilization filtration with 0.22μm sterile filter membrane, take a sample of the filtrate to detect the content of the semi-finished product, fill a clean vial with a drug solution of about 2.5ml / bottle according to the content, add a rubber stopper halfway, and put it into a freeze-dry Freeze-dried in the machine. The freeze-drying process is as follows, after the freeze-drying is completed, the vacuum plug is pressed, the aluminum cover is rolled out, visually inspected, and packaged.

[0030] Freeze drying process:

[0031] (1) repeated freezing

[...

Embodiment 2

[0037] The preparation of embodiment 2 ganciclovir freeze-dried powder injection

[0038]

[0039]

[0040] The preparation process is the same as in Example 1.

Embodiment 3

[0041] The preparation of embodiment 3 ganciclovir freeze-dried powder injection

[0042]

[0043] The preparation process is the same as in Example 1.

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Abstract

The invention discloses ganciclovir for injection and a preparation method thereof. The preparation is formed by regulating the pH of a solution containing ganciclovir and sodium chloride to 10.0-11.5 by adopting a pH regulator, and freezing and drying repetitively. The freeze-dried powder injection of the ganciclovir for injection has the advantages of high yield, good re-dissolubility, more stable quality and the like; change of related substances during the period of accelerated test is not obvious; and the ganciclovir for injection is safer for clinical application.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a ganciclovir freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Eight types of human herpesviruses have been found. Herpesviruses are mainly transmitted through contact and invade tissues of ectoderm origin (including skin, mucous membranes and nerve tissues). Herpes simplex virus (HSV) is a common pathogen that seriously endangers human health and causes skin diseases and sexually transmitted diseases. In the process of DNA biosynthesis, some specific enzymes induced by herpes virus are different from normal cellular enzymes. People have developed a class of selective antiviral drugs by taking advantage of these differences. Ganciclovir can selectively inhibit the replication of herpes virus. It is the first drug approved in the world for the treatment and prevention of CMV infection. It is recogniz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/522A61K47/02A61P31/22
Inventor 不公告发明人
Owner BEIJING WANPENGLANGGE PHARMA TECH
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