Medicinal-composition suspension powder injection with mezlocillin sodium and sulbactam sodium, and novel application thereof

The technology of mezlocillin sodium and sulbactam sodium and mezlocillin sodium is applied in a new application field in the preparation of a drug for preventing postoperative infection after appendicitis, which can solve the problems of poor stability of mezlocillin sodium and sulbactam sodium, and improve the The effect of drug therapeutic index, improved stability and simple production process

Inactive Publication Date: 2010-05-12
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The application of emulsified suspension technology to make powder injection by freeze-drying not only solves the problem of poor stability of mezlocillin sodi

Method used

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  • Medicinal-composition suspension powder injection with mezlocillin sodium and sulbactam sodium, and novel application thereof
  • Medicinal-composition suspension powder injection with mezlocillin sodium and sulbactam sodium, and novel application thereof
  • Medicinal-composition suspension powder injection with mezlocillin sodium and sulbactam sodium, and novel application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 Preparation of Mezlocillin Sodium Sulbactam Sodium Suspension Powder Injection

[0050] Prescription (100 bottles):

[0051] Mezlocillin Sodium 300g

[0052] Sulbactam Sodium 75g

[0053] Tween 80 375g

[0054] Cholesterol 150g

[0055] Sodium deoxycholate 75g

[0056] Mannitol 225g

[0057] Lactose 75g

[0058] Preparation Process

[0059] (1) Add 375g of Tween 80, 150g of cholesterol and 75g of sodium deoxycholate into 5500ml of water for injection, then add 300g of mezlocillin sodium and 75g of sulbactam sodium and mix evenly, heat and stir in a water bath at 80°C until molten;

[0060] (2) Keeping the above liquid at 70-90°C for 10 minutes with a tissue masher to shear and stir at a speed of 10,000 r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0061] (3) Add 225g of mannitol and 75g of lactose to the emulsion, dissolve, filter, subpackage, and freez...

Embodiment 2

[0074] Example 2 Preparation of Mezlocillin Sodium Sulbactam Sodium Suspension Powder Injection

[0075] Prescription (100 bottles):

[0076] Mezlocillin Sodium 200g

[0077] Sulbactam Sodium 50g

[0078] Tween 80 750g

[0079] Cholesterol 400g

[0080] Sodium deoxycholate 500g

[0081] Glucose 500g

[0082] Trehalose 500g

[0083] Preparation Process

[0084] (1) Add 750g of Tween 80, 400g of cholesterol and 500g of sodium deoxycholate into 9000ml of water for injection, then add 200g of mezlocillin sodium and 50g of sulbactam sodium and mix evenly, heat and stir in a water bath at 70°C until molten;

[0085] (2) Heat the above liquid at 70-90°C and use a tissue masher to shear and stir for 20 minutes at a speed of 15000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 4 times to obtain an emulsion;

[0086] (3) Add 500 g of glucose and 500 g of trehalose to the emulsion, dissolve, filter, subpackage, an...

Embodiment 3

[0097] Example 3 Preparation of Mezlocillin Sodium Sulbactam Sodium Suspension Powder Injection

[0098] Prescription (100 bottles):

[0099] Mezlocillin Sodium 100g

[0100] Sulbactam Sodium 25g

[0101] Tween 80 250g

[0102] Cholesterol 125g

[0103] Sodium deoxycholate 150g

[0104] Mannitol 214.3g

[0105] Glycine 85.7g

[0106] Preparation Process

[0107] (1) Add 250g of Tween 80, 125g of cholesterol and 150g of sodium deoxycholate into 4000ml of water for injection, then add 100g of mezlocillin sodium and 25g of sulbactam sodium and mix evenly, heat and stir in a water bath at 90°C until molten;

[0108] (2) The above liquid was kept warm at 70-90°C and was sheared and stirred for 20 minutes with a tissue masher at a speed of 13000r / min to obtain a primary emulsion, which was then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0109] (3) Add 214.3 g of mannitol and 85.7 g of glycine to the emulsion, dissolve, f...

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PUM

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Abstract

The invention belongs to the technical field of medicine, and discloses a medicinal-composition suspension powder injection taking mezlocillin sodium and sulbactam sodium as active components. The injection comprises 4 parts of mezlocillin sodium, 1 part of sulbactam sodium, 5 to 20 parts of Tween 80, 1 to 10 parts of cholesterol, 0.5 to 15 parts of deoxysodium cholate, and 2 to 30 parts of frozen-dried supporting agent. The invention further discloses novel application of the injection in the preparation of medicaments for preventing postoperative infection of appendicitis.

Description

technical field [0001] The invention relates to a suspension powder injection of the mezlocillin sodium sulbactam sodium pharmaceutical composition and a preparation method thereof, and further relates to its new application in the preparation of a drug for preventing postoperative infection of appendicitis. Background technique [0002] Acute suppurative appendicitis is the most common cause of surgical emergency, and surgical resection of the appendix is ​​the treatment of choice. Suppurative appendicitis is usually a mixed infection of Gram-negative bacilli and anaerobic bacteria, and the incidence of secondary infection after surgery is high. If antibiotics are not used during the perioperative period, the postoperative incision infection rate of suppurative or gangrenous appendicitis is 33% to 34.6%. [0003] Mezlocillin (Mezlocilline, Bay1353) belongs to the ureide penicillin, as the most valuable ureide penicillin widely used at home and abroad, it is effective again...

Claims

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Application Information

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IPC IPC(8): A61K31/431A61K31/43A61K9/19A61J3/02A61P31/04
Inventor 王明
Owner HAINAN YONGTIAN PHARMA INST
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