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Aspartic acid lomefloxacin powder and preparing method thereof

A lomefloxacin aspartate and powder technology, which is applied in powder delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve problems such as lax drawing and sealing, excessive color of injection, crystallization, etc., to achieve The effect of reducing troubles and improving the yield of finished products

Inactive Publication Date: 2005-12-14
YANGPU HG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After being launched on the market, lomefloxacin aspartate injection satisfies the needs of acute and critically ill patients and patients who are not suitable for oral administration. The product quality has produced side effects: the clarity of the finished injection solution exceeds the standard, and the injection solution is prone to crystallization during storage and other quality problems; during storage in winter, the phenomenon of excessive color and crystallization of the injection solution is more serious
Moreover, in the sales and use of lomefloxacin aspartate injection, due to the defects of the liquid preparation itself, it is inconvenient to transport. In the industrial production of small needles, the average yield of finished products is only 80% due to the easy damage of the ampoule and the lax sealing of the wire drawing. ~90%

Method used

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  • Aspartic acid lomefloxacin powder and preparing method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017]According to the dosage of 1000 vials of product specifications of 0.1g / item, the prescription in Table 1 is set as 50mg / ml in terms of lomefloxacin. Now choose glucose as excipient to prepare lomefloxacin aspartate powder, namely: under aseptic conditions, take lomefloxacin aspartate and glucose in the prescription amount in Table 1, place them in a sterilized container, add Appropriate amount of water for injection, stir to dissolve, add water for injection to the full amount, stir well; add 0.02% activated carbon for injection and stir for 5-10 minutes, decarbonize with a sterile filter, filter with a 0.45 μm microporous membrane, and finally 0.22 μm microporous Filter through a pore filter, and after the filtrate is qualified, it is divided into molded bottles, and each bottle with a specification of 0.1g is filled with 2ml, and vacuum freeze-dried: pre-freeze below -30°C for about 2 to 3 hours, and the temperature of the condenser Drop below -45°C → start the vacuum...

Embodiment 2

[0023] According to the dosage of 1000 sticks of product specifications of 0.1 / g stick, the prescription in Table 2 is set as 50 mg / ml based on lomefloxacin. Now select mannitol as excipient to prepare lomefloxacin aspartate powder, that is: under aseptic conditions, weigh lomefloxacin aspartate and mannitol in the prescription amount in Table 2, and place them in a sterile container , add an appropriate amount of water for injection, stir to dissolve, add water for injection to the full amount, and stir well; add 0.02% activated carbon for injection and stir for 5 to 10 minutes, decarbonize with a sterile filter, filter with a 0.45 μm microporous membrane, and finally 0.22 μm microporous membrane filtration, after the filtrate is qualified, it is divided into molded bottles, each bottle with a specification of 0.1g is filled with 2ml, vacuum freeze-drying: pre-freeze below -30°C, and condense after about 2 to 3 hours The temperature of the device drops below -45°C → start the...

Embodiment 3

[0029] 1. Bacterial endotoxin test

[0030] 1) Test product

[0031] The pharmaceutical powder of the present invention has sample numbers 20000401, 20000402, and 20000403, and the specification is 0.2g / bottle.

[0032] 2) Reagent

[0033] Limulus reagent 0.1ml / tube, sample number: 0012132, sensitivity 0.125EU / ml, produced by Zhanjiang Andus Biological Co., Ltd.; 0.1ml / tube, sample number: 010701, sensitivity 0.125EU / ml, produced by Fuzhou Xinbei Biochemical Industry Co., Ltd. , and the sensitivity checks are in compliance with the regulations. Bacterial endotoxin test water 2ml / cartridge, sample number 0103060, produced by Zhanjiang Andus Biological Co., Ltd.

[0034] 3) Standard substance:

[0035] Bacterial endotoxin working standard, each containing 70 units, sample number 2001-3, China Institute for the Control of Pharmaceutical and Biological Products.

[0036] 4) Vortex mixer XW-80A, Shanghai Medical University Instrument Factory; bacterial endotoxin tester, Tianji...

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Abstract

The invention relates to a lomefloxacin aspartate powder and a preparation method thereof, characterized in that: the powder comprises lomefloxacin aspartate and an excipient, and the excipient is a water-soluble carbohydrate , aldehydes, ketones, and alcohols with n hydroxyl groups; the carbon numbers of the aldehydes, ketones, and alcohols are m=3-8, and n=(m-2), (m-1) or m. The invention provides a lomefloxacin aspartate powder with stable physical and chemical properties of a dosage form, which can reduce the preparation links in clinical application, and is convenient for storage / transportation, and a corresponding preparation method for preparing the lomefloxacin aspartate powder. process method.

Description

【Technical field】 [0001] The invention relates to a western medicine antibiotic, in particular, the invention relates to a dosage form and a preparation method of a piroxacid antibacterial drug. 【Background technique】 [0002] Lomefloxacin is the third-generation piroxacin antibacterial drug that has been on the market in recent years. It not only has the characteristics of broad antibacterial spectrum, strong antibacterial effect, and less toxic and side effects shared by piroxacins, but also has a long half-life. Theophylline has advantages such as no interaction. Lomefloxacin aspartic acid is a water-soluble salt formed by aspartic acid and lomefloxacin. It has the characteristics of good body adaptability, good water solubility, small toxic and side effects, strong and wide antibacterial effect, etc., June 18, 1998 Approved by the Ministry of Health as a national fourth-class new drug, according to the common name of aspartic acid in the Chinese Pharmacopoeia 2000 editi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/496A61P31/04
Inventor 郭德
Owner YANGPU HG PHARMA
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