Double-cavity bag packed cefpirome sulfate injection and preparation method thereof

A technology for cefpirome sulfate and injection, which is used in packaging, packaged food, drug packaging, etc., can solve the problems of time-consuming processes that cannot be air-dropped, dissolved and diluted, and affect product safety, so as to improve effectiveness and safety. The effect of enhancing environmental adaptability and prolonging the validity period of products

Inactive Publication Date: 2012-05-02
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the main preparation forms of this product at home and abroad are: freeze-dried powder injection, aseptic subpackage powder injection, small-volume injection, etc., and the above-mentioned preparations must use appropriate solvents (such as 0.9% chlorine dioxide) before infusion into the patient's body. Sodium chloride injection or 5% glucose injection) can be dissolved or diluted into a solution with a concentration lower than 2mg/ml before intravenous infusion, and the process of dissolving and diluting is relatively time-consuming. Due to the cumbersome dispensing process, rapid intravenous administration is often not possible under certain conditions; the site area of ​​ambulance equipment is narrow and the movement is bumpy, making it difficult to perform dispensing operations or medical errors or accidents such as dispensing errors; air and particle pollution in the ambula

Method used

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  • Double-cavity bag packed cefpirome sulfate injection and preparation method thereof
  • Double-cavity bag packed cefpirome sulfate injection and preparation method thereof
  • Double-cavity bag packed cefpirome sulfate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0039] The samples prepared in Example 1 were put into glass infusion bottles and double-chamber bags respectively, and the stability investigation was carried out after sterilization. It can be found that the samples were investigated for 6 months in the accelerated test at 40°C and in the long-term test at 25°C for 12 months after sterilization. After one month, each index of the sample of double-chamber bag packaging has no significant change, and the stability is obviously better than that of glass infusion bottle packaging samples. (As shown in Table 1)

[0040] Table 1 Product Stability Investigation Comparison Results

[0041]

[0042]

experiment example 2

[0044] Take 10 cefpirome sulfate powder injections (in cillin bottle, specification: 0.5g) and 10 bottles of glucose injection (in glass infusion bottle, specification: 100ml: 5g) respectively, and sterile cefpirome sulfate The powder is transferred to the glucose injection, and it is completely dissolved; another 10 bags of the double-cavity bag sample prepared in Example 1 are taken, the weak welding rod is opened, and the aseptic powder of cefpirome sulfate is completely dissolved by shaking, and the operation process is carried out. comparative study. (As shown in Table 2, the test data is the average value of 10 tests.)

[0045] Table 2

[0046]

[0047] From the comparison results, it can be known that using the existing common packaged cefpirome sulfate preparation, the operation is relatively complicated and the environmental requirements are high (currently large hospitals generally require operation in a clean operating table with laminar flow protection), and in...

experiment example 3

[0049] Get respectively 50 cefpirome sulfate powder injections (penillin bottled, specification: 0.5g) of two manufacturers and 50 bags of double-chamber bag samples prepared in Example 1, and place them under 40°C accelerated test conditions to investigate 6 cases simultaneously. month, all the samples were put upside down, and 10 sticks (bags) were taken out respectively at the accelerated 0, 1, 2, 3, and 6 months, and the aseptic cefpirome sulfate powder was prepared into a 0.1g / ml solution with purified water. degree, observe the clarity of the solution, the results are shown in Table 3:

[0050] table 3

[0051]

[0052] From the investigation data in the above table, it can be known that the clarification of cefpirome sulfate sterile powder is significantly better than that of the currently marketed product in vials for products packaged in double-chamber bags. Therefore, the safety of products packaged in double-chamber bags higher.

[0053] Analyzing the reason, i...

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Abstract

The invention discloses double-cavity bag packed cefpirome sulfate injection. The injection medicinal composition consists of the following Chinese herbal medicines: 0.5 to 2 weight parts of cefpirome sulfate (based on cefpirome) in a powder cavity, and 100 volume parts of glucose injection with 4 to 11 weight parts of glucose or 100 volume parts of sodium chloride injection with 0.8 to 1 weight part of sodium chloride in a liquid cavity. The cefpirome sulfate injection is packed in a double-cavity bag, and cefpirome sulfate sterile medicine powder and a solvent (the sodium chloride injection or the glucose injection) are filled in the two cavities separated by cold joint; and a cold joint isolating bar can be opened only by extruding the medicine bag during use, so that the cefpirome sulfate sterile medicine powder and the solvent can be quickly dissolved and mixed under the closed sterile condition, and full medicine treatment mixed liquid is formed and is directly applied to a patient.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a double-cavity bag-packed cefpirome sulfate injection and a preparation method thereof. Background technique [0002] Cefpirome sulfate chemical name: (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-(6,7- Dihydro-5H-cyclopent[b]pyridin-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxymonosulfuric acid Salt is a fourth-generation cephalosporin antibiotic. It works mainly by blocking the synthesis of peptidoglycan, the main cell wall polymer. Because it can quickly penetrate the cell wall of bacteria and bind with high affinity to the target enzyme (penicillin-binding protein), it can have a bactericidal effect on a wide spectrum of Gram-negative and Gram-positive pathogenic bacteria at a low concentration level. It is used for the treatment of sepsis, lower respiratory tract infection, abdominal cavity and biliary ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/546A61P31/04A61J1/10
Inventor 冉良骥佘佑廷田洪伍邹瑰丽万一龙梁隆王利春
Owner HUNAN KELUN PHARMA
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