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Faropenem sodium powder injection

A technology of faropenem sodium and powder injection, which is applied in the field of western medicine preparations, can solve the problems of difficult to control the filling amount, poor solution stability, long production cycle and the like, and achieves the effects of stable filling amount, good stability and high preparation stability.

Active Publication Date: 2013-05-29
鲁南新时代生物技术有限公司
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AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN100536843C discloses a pharmaceutical composition containing faropenem or an acceptable salt or hydrate thereof, which contains antioxidants and amino acids or dipeptides, and also contains stabilizers, bacteriostats, pH regulators One or more, the preparation adopts terminal sterilization or filter freeze-drying to sterilize; this invention still does not investigate the polymer, does not investigate the stability of the injection, the content of the polymer increases significantly during storage, and the solution The stability is poor, and a variety of additives are added at the same time, so the safety is difficult to guarantee
It is mentioned in the invention that for sterile preparations for injection, it is relatively stable when the molecule of faropenem sodium contains 2.5 crystal waters. At this time, the moisture content of the raw material is about 15%. The filling process is difficult to control; and the large water content of raw materials is used to directly pack sterile powder for injection, and the stability of the preparation is difficult to guarantee, so faropenem sodium is not conducive to the preparation of sterile powder for injection; but the preparation Freeze-dried powder injection has a long production cycle. Faropenem sodium has poor stability in aqueous solution and is also degraded. In addition, after freeze-drying, faropenem sodium in the product will either lose part or all of the crystal water, or there will be free water that has not been removed, which is difficult to obtain. Ensure that the final product contains exactly 2.5 crystal waters of faropenem sodium. In both cases, the stability of the main drug is reduced
[0008] To sum up, the prior art has certain limitations in controlling the polymer formation and inhibiting hydrolysis of faropenem sodium injection preparations. Chinese patents CN1843354A, CN100536843C and CN101904822A fail to ensure that faropenem sodium injections are compatible with The problem of water degradation; although the Chinese patent CN1236814C adopts aseptic sub-packaging technology, it adds antioxidants, so the safety is difficult to guarantee

Method used

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  • Faropenem sodium powder injection
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preparation example Construction

[0018] Preparation of control solution Take an appropriate amount of faropenem sodium reference substance (approximately equivalent to 20mg of faropenem), weigh it accurately, put it in a 100ml measuring bottle, add water to dissolve and dilute to the mark, and shake well.

[0019] Assay Take an appropriate amount of this product (approximately equivalent to 50mg of faropenem), weigh it accurately, put it in a 100ml measuring bottle, add water to dissolve and dilute to the mark, shake well, immediately accurately measure 100μl, inject it into a liquid chromatograph, and use mobile phase A The mobile phase was used for determination, and the chromatogram was recorded; in addition, 100 μl of the control solution was accurately measured, injected into the liquid chromatograph, and the mobile phase B was used as the mobile phase, and the same method was used for determination. According to the peak area calculation by the external standard method, the faropenem-containing po...

Embodiment 1

[0021] Faropenem sodium (calculated as faropenem) 100g

[0022] --------------------------------------

[0023] Make 1000 pieces

[0024] Preparation Process:

[0025] 1. Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer at 320°C, and then sent to the filling room for later use.

[0026] 2. Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is steam-pressurized at 121°C for 20 minutes, and dried for later use.

[0027] 3. Control the humidity of the packaging environment below 50%, fill each vial with powder containing faropenem sodium, add a rubber stopper, and crimp the cap.

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Abstract

The invention relates to a Faropenem sodium powder injection, which comprises only one composition: raw Faropenem sodium powder without any additive. As raw Faropenem sodium is solid powder and in isolating state, the oxidization and hydrolyzation are hard to carry out; in addition, as a current filling machine can be forcibly filled, the filling amount is stable. Particularly, when the humidity of a split charging workshop is controlled under 30 percent, the stability of the Faropenem sodium powder is better.

Description

technical field [0001] The invention relates to a faropenem sodium powder injection, which belongs to the technical field of western medicine preparations. Background technique [0002] Faropenem is a penem antibiotic developed by Suntory Company of Japan. It belongs to atypical β-lactam antibiotics. It obtained a compound patent in Japan in 1986, and the patent number is JP61, 207387. In 1990 and 1992, Japan’s Yamanouchi Pharmaceutical Company and Wyeth-Ayerst Company of the United States respectively obtained the clinical license of the product and jointly conducted clinical research, and it was first listed in Japan in 1997 under the trade name of Farom. [0003] Various types of polymers in β-lactam antibiotics are allergens that cause immediate allergic reactions. Controlling the content of polymers in products is the fundamental way to reduce allergic reactions to such antibiotics, especially in injections. Content is more important, and at the same time, the lactam ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/431A61P31/04
Inventor 赵志全郝贵周冯中
Owner 鲁南新时代生物技术有限公司
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