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
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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
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[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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