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Method for preparing ceftizoxime powder injection for injection and use thereof

A technology for ceftizoxime sodium and injection, which is applied in the field of preparation of ceftizoxime sodium powder injection preparations for injection, can solve the problems of reduced stability, high oxygen content in the bottle, influence and the like, and achieves increased stability of the finished product, The effect of improving product stability and reducing oxygen content

Inactive Publication Date: 2009-10-28
HAIKOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Ceftizoxime sodium is a special product that is very sensitive to relative humidity. It is necessary not only to control the range of the labeled content of the product, but also to control the purity of the product. Any change in any parameter may have a negative impact on the purity of the product, reducing the Its stability, such as the existing powder injection sub-packaging technology uses nitrogen flushing at the same time after sub-packaging, the nitrogen flushing tube cannot be extended into the vial, so that the oxygen content in the bottle after nitrogen filling is relatively high, affecting the stability of the sample

Method used

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  • Method for preparing ceftizoxime powder injection for injection and use thereof
  • Method for preparing ceftizoxime powder injection for injection and use thereof
  • Method for preparing ceftizoxime powder injection for injection and use thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] In this example, the ceftizoxime sodium powder injection preparation method is used in the preparation method of the ceftizoxime sodium powder injection preparation method provided by the present invention to prepare the ceftizoxime sodium powder injection preparation by means of airflow. The specific steps are described in detail as follows.

[0039] 1) Wash the bottles with purified water through a bottle washer and blow them dry, then enter the laminar flow sterilization tunnel and be sterilized and cooled at a high temperature above 300°C. Check the purified water for visible foreign matter before cleaning the bottle and rubber stopper, and use it only after passing the inspection.

[0040]2) Clean the rubber stopper, rinse the rubber stopper with purified water and water for injection, and after passing the inspection according to the quality standard, use RXH-1 hot air circulation oven (Macofar, Italy) for dry heat sterilization at 122±5℃ for 4 hours, standby .

[004...

Embodiment 2

[0048] In this example, the ceftizoxime sodium powder injection preparation is prepared by the method of screw sub-packing in the preparation method of the ceftizoxime sodium powder injection preparation provided by the present invention. Except for the sub-packaging method, the other specific steps are the same as in Example 1.

[0049] Check the purified water for visible foreign matter before cleaning the bottle and rubber stopper, and use it only after passing the inspection. Wash the rubber stopper, after passing the inspection according to the internal control quality standard, dry heat sterilization for 4 hours. The aluminum plastic cover is sterilized by dry heat. Wash the bottle. The cleaned bottles shall be sterilized after passing the inspection according to the internal control quality standard.

[0050] Raw materials are pre-packed; bottles and rubber stoppers are before and after sterilization; related items (such as visible foreign matter, clarity, color of raw mate...

Embodiment 3

[0054] In this example, the stability of the ceftizoxime sodium powder injection preparation prepared by the preparation method of the ceftizoxime sodium powder injection preparation provided by the present invention was carried out. The specific determination method refers to the national drug standard YBH02832004.

[0055] Take trial samples (30 bottles, 1.0g / bottle), and place them under the conditions of temperature 25℃±2℃ and relative humidity 60%±10% for long-term stability test. At the end of the 3rd, 6th, 12th, 24th, and 36th months, each survey item was tested according to the survey method, and compared with the results in 0 months. The content determination was calculated according to the external standard method, and the calculation of related substances was based on self-control. According to the calculation method, the polymer is the impurity specified in the standard. The results are shown in Table 1.

[0056] Table 1 Long-term test results of ceftizoxime sodium for...

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Abstract

The invention provides a method for preparing ceftizoxime powder injection for injection and use thereof. The method for preparing ceftizoxime powder injection for injection provided by the present invention includes steps of filling ceftizoxime raw material powder into bottle, filling nitrogen, fastening plug and rolling cover, and the method is carried out under condition that humidity is less than 40%, and the nitrogen filling operation is carried out under multistage nitrogen-filling protection. Because environmental relative humidity is successfully controlled in the preparation process, preparation humidity is less than 40%, product stability is insured, and by employing multistage nitrogen-filling protection, problem of easy oxidation and decomposition of the product is solved, and expiry date is prolonged. The ceftizoxime powder injection prepared by the method has moisture content less than 8.0%. The method for preparing ceftizoxime powder injection can stability control preparation humidity, reduce oxygen content in finished product, and increase stability of the finished product, and safety of packaged clinic medicament.

Description

Technical field [0001] The invention relates to a preparation method of a powder injection preparation, in particular to a preparation method and application of a ceftizoxime sodium powder injection preparation for injection. Background technique [0002] Ceftizoxime Sodium (Ceftizoxime Sodium) is a third-generation cephalosporin developed by Fujisawa Pharmaceutical Co., Ltd. in Japan in the 1980s, and its trade name is Yibao Shiling. [0003] The chemical name of this product is [6R-[6(,7((Z)]]-7[[2,3-dihydro-2-imino-4-thiazolyl)(methoxyimino)acetyl] Amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, its structural formula is as follows: [0004] [0005] This product is a third-generation cephalosporin synthesized from cephalosporin and aminothiaxamic acid. It is white or gray-yellow crystalline powder, almost odorless, with a melting point of 227°C (decomposition). It is easily soluble in water, slightly soluble in methanol, and almost insoluble ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B65B31/04B65B31/02B65B1/16B65B1/12B65B55/10B65B55/06B65B55/02A61K9/14A61K31/546A61P31/04
Inventor 张志兰庄欣李晋峰王莉
Owner HAIKOU PHARMA FACTORY
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