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Faropenem sodium freeze-dried powder injection

A technology of faropenem sodium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of unremoved free water, poor solution stability, long production cycle, etc., and achieves a simple and feasible preparation process, high preparation stability, and convenient operation. Effect

Active Publication Date: 2011-07-27
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 freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Faro Peinan sodium 5G

[0022] 100ml of injection water

[0023] The particle size obtained by micro -powder is 5g of sodium powder with a particle size of 75 ~ 100 μm. Add 100ml of injection of water for injection and stir to fully dissolve it. Each 4ML is filled in 10ml Xilin bottle.The frozen dried machine layer layer to -45 ° C. After the filling is over, the Xilin bottle is placed in the frozen dryer and the insulation is 2h.The temperature of the plate layer is heated to -12 ° C, and after 2H, heat the plate to -40 ° C, and continue to keep the insulation for 3h.The plate layer is heated to 20 ° C within 8 ~ 12h; after 8H at 35 ° C, rinse the nitrogen soya, and remove the rolling cover packaging.

Embodiment 2

[0040] [Content measurement] Based on the high -efficiency liquid chromatography method (China Pharmacopoeia 2010 version of the second appendix ⅴ D) determination.

[0041] Chromatographic conditions and system applicability tests are filled with ectopane kel silicone silicone;The ammonium aquatic solution (15: 85: 2) is a flowing phase, and the detection wavelength is 306nm; the number of theoretical tower plates is calculated according to the Fa Luo Peinan Peak not less than 2000.

[0042] The measurement method takes the appropriate amount of this product (about 200mg of Faro Peinan), put it in a 100ml measuring bottle, and dissolve and dilute it to the scale, shake it, filter, and the precision amount is 5ml of 5ml to place 50ml of bottle, add the flow to the flow, add flowingDilute to the scale, shake well as the test product solution, and the precision amount is 20 μL into the liquid chromatography to record the chromatography.In addition, the appropriate amount of sodium c...

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Abstract

The invention relates to a Faropenem sodium freeze-dried powder injection, which comprises only one composition: Faropenem sodium. Preferably, injection water is added into Faropenem sodium powder with the particle size of 75 to 100mum to be prepared into Faropenem sodium solution with concentration of 5-20 percent for drying, thus obtaining a finished product. The Faropenem sodium freeze-dried powder injection is simple and feasible in preparation process, beneficial to operation, and suitable for needs for large-scale industrial production.

Description

Technical field [0001] The present invention involves a kind of Faro Peinan sodium frozen dried powder injection, which is the field of drug preparation technology. Background technique [0002] Faro Peinan is a penicothene antibiotic developed by SUNTORY in Japan. It belongs to the atypical β-lactam antibiotics. In 1986, it obtained a compound patent in Japan. The patent number was JP61, 207387.The American Wyeth-AYERST company obtained the clinical license of the product, and carried out clinical research together. It was first listed in Japan in 1997. The product is named Farom. [0003] Various polymers in β-lactide antibiotics are allergens that cause allergic reactions to allergic allergies. Controlling the content of polymer in the product is the fundamental way to reduce such antibiotic allergic reactions. Especially in the injection, the polymer control the polymerThe content is even more important. At the same time, the endam structure is easy to hydrolyze. To inject ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/431A61P31/04
Inventor 赵志全冯中郝贵周
Owner 鲁南新时代生物技术有限公司
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