Injection of piperacillin-sulbactum sodium medicine composition injection and preparation method thereof
A technology for ampicillin-sulbactam sodium and ampicillin, which is applied in the field of injection preparations and their preparation, can solve the problems of unsatisfactory dissolution rate, unsatisfactory dissolution rate, and easily fluctuating pH value, and achieves rapid dissolution and guaranteed Stability, good stability
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Embodiment 1
[0030] Example 1 Screening of Ampicillin-Sulbactam Sodium Pharmaceutical Composition Injection Formulation
[0031] The pharmaceutical composition injection of the present invention comprises ampicillin and sulbactam sodium, and one or more of lactose, sodium chloride or sodium dihydrogen phosphate is added respectively, and the drug combination of the present invention is carried out with the dissolution time as an index. Table 1 shows the results of the screening experiment of the drug injection formulation.
[0032] Table 1: Formula screening experiment based on dissolution time
[0033]
[0034] The experimental results in Table 1 show that when the dissolution time is used as an indicator, formula 4 is the best, that is, under the condition that the content of each component added in the formula is the same, the formula is composed of ampicillin, sulbactam sodium, lactose, sodium chloride, phosphoric acid The formulation consisting of sodium dihydrogen required the s...
Embodiment 2
[0035] Example 2 Ampicillin-sulbactam sodium pharmaceutical composition injection and its preparation
[0036] The prescription of pharmaceutical composition injection (1000):
[0037] Ampicillin 500g;
[0038] Sulbactam sodium 250g;
[0039] Lactose 150g;
[0040] Sodium chloride 150g;
[0041] Appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0;
[0042] Dilute to 5000ml with water for injection;
[0043] Preparation:
[0044] Take the above-mentioned amount of ampicillin, sulbactam sodium, lactose, and sodium chloride, dissolve them in water for injection, use an appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0, then dilute to 5000ml with water for injection, and then pass through the filter membrane Filtrate, the pore size of the filter membrane is preferably 0.22um, spray dry, aseptically pulverize, fill, and obtain the ampicillin-sulbactam sodium pharmaceutical composition ...
Embodiment 3
[0045] Example 3 Ampicillin-sulbactam sodium pharmaceutical composition injection and its preparation
[0046] The prescription of pharmaceutical composition injection (1000):
[0047] Ampicillin 1000g;
[0048] Sulbactam sodium 500g;
[0049] Lactose 800g;
[0050] Sodium chloride 800g;
[0051] Appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0;
[0052] Dilute to 5000ml with water for injection;
[0053] Preparation:
[0054] Take the above-mentioned amount of ampicillin, sulbactam sodium, lactose, and sodium chloride, dissolve them in water for injection, use an appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0, then dilute to 5000ml with water for injection, and then pass through the filter membrane Filtrate, the pore size of the filter membrane is preferably 0.22um, spray dry, aseptically pulverize, fill, and obtain the ampicillin-sulbactam sodium pharmaceutical composition...
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