Suspension powder-injection preparation of amoxicillin sodium and flucloxacillin sodium medicinal composition and new application thereof

A technology of amoxicillin sodium flucloxacillin sodium and amoxicillin sodium, applied in amoxicillin sodium flucloxacillin sodium pharmaceutical composition suspension powder injection and its new application field, can solve the problem of amoxicillin sodium flucloxacillin sodium Poor sodium stability and other problems, to achieve the effect of improving drug therapeutic index, simple production process, and reducing drug side effects

Inactive Publication Date: 2010-05-26
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] After long-term and arduous research, the present inventors have found unexpectedly that the application of emulsified suspension technology to make powder injection by freeze-drying not only solves the problem of poor stabilit

Method used

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  • Suspension powder-injection preparation of amoxicillin sodium and flucloxacillin sodium medicinal composition and new application thereof
  • Suspension powder-injection preparation of amoxicillin sodium and flucloxacillin sodium medicinal composition and new application thereof
  • Suspension powder-injection preparation of amoxicillin sodium and flucloxacillin sodium medicinal composition and new application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of Amoxicillin Sodium Flucloxacillin Sodium Suspension Powder Injection

[0035] Prescription (100 bottles):

[0036] Amoxicillin Sodium 25g

[0037] Flucloxacillin Sodium 25g

[0038]Egg yolk lecithin 48.2g

[0039] Poloxamer 188 26.8g

[0040] Polyglycerol ester 60g

[0041] Sucrose 61.5g

[0042] Sorbitol 38.5g

[0043] Preparation Process

[0044] (1) Add 48.2g of egg yolk lecithin, 26.8g of Poloxamer188 and 60g of polyglycerol ester into 900ml of water for injection, then add 25g of amoxicillin sodium and 25g of flucloxacillin sodium and mix evenly, heat and stir in a water bath at 70°C until molten;

[0045] (2) Keep the above liquid at 70-90°C for 20 minutes with a tissue masher to shear and stir at a speed of 12000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 4 times to obtain an emulsion;

[0046] (3) Add 61.5 g of sucrose and 38.5 g of sorbitol to the emulsion, di...

Embodiment 2

[0056] Example 2 Preparation of Amoxicillin Sodium Flucloxacillin Sodium Suspension Powder Injection

[0057] Prescription (100 bottles):

[0058] Amoxicillin Sodium 50g

[0059] Flucloxacillin Sodium 50g

[0060] Egg yolk lecithin 257.2g

[0061] Poloxamer 188 142.8g

[0062] Polyglycerol ester 200g

[0063] Glucose 156.2g

[0064] Mannitol 343.8g

[0065] Preparation Process

[0066] (1) Add 257.2g of egg yolk lecithin, 142.8g of Poloxamer188 and 200g of polyglycerol ester into 6000ml of water for injection, then add 50g of amoxicillin sodium and 50g of flucloxacillin sodium and mix evenly, heat and stir in a water bath at 80°C until it melts;

[0067] (2) Keeping the above liquid at 70-90°C for 10 minutes with a tissue masher to shear and stir at a speed of 15,000 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;

[0068] (3) Add 156.2 g of glucose and 343.8 g of mannitol...

Embodiment 3

[0079] Example 3 Preparation of Amoxicillin Sodium Flucloxacillin Sodium Suspension Powder Injection

[0080] Prescription (100 bottles):

[0081] Amoxicillin Sodium 100g

[0082] Flucloxacillin Sodium 100g

[0083] Egg yolk lecithin 353.6g

[0084] Poloxamer 188 196.4g

[0085] Polyglycerol ester 220g

[0086] Sucrose 544.5g

[0087] Sorbitol 155.5g

[0088] Preparation Process

[0089] (1) Add 353.6g of egg yolk lecithin, 196.4g of Poloxamer188 and 220g of polyglycerol ester into 7000ml of water for injection, then add 100g of amoxicillin sodium and 100g of flucloxacillin sodium and mix evenly, heat and stir in a water bath at 90°C until it melts;

[0090] (2) Heat the above liquid at 70-90°C and use a tissue masher to shear and stir for 15 minutes at a speed of 13000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0091] (3) Add 544.5 g of sucrose and 155.5 g of sorbit...

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Abstract

The invention provides a suspension powder-injection preparation of an amoxicillin sodium, and flucloxacillin sodium medicinal composition and new application thereof, and particularly discloses a suspension powder-injection preparation of an amoxicillin sodium and flucloxacillin sodium medicinal composition and a method for preparing the same. The suspension powder-injection preparation comprises the following components in part by weight: 1 part of amoxicillin sodium, 1 part of flucloxacillin sodium, 2 to 18 parts of emulsifier, 0.5 to 12 parts of auxiliary emulsifier and 3 to 20 parts of freeze-dry supporting agent. Furthermore, the invention relates to the application of the suspension powder-injection preparation in the preparation of medicaments for treating pelvic inflammatory diseases.

Description

technical field [0001] The present invention relates to a new dosage form of amoxicillin sodium flucloxacillin sodium pharmaceutical composition, in particular to amoxicillin sodium flucloxacillin sodium pharmaceutical composition suspension powder injection and its preparation method, and further relates to its preparation and treatment of pelvic infection new applications in medicine. Background technique [0002] Pelvic inflammatory disease mostly occurs in women, and the incidence rate has remained high in recent years and has an increasing trend. The main high-risk factors include: infection after intrauterine surgery; lower genital tract infection, mainly sexually transmitted diseases of the lower genital tract; direct spread of clinical organ inflammation. The common pathogens that cause the disease are: aerobic bacteria, anaerobic bacteria, sexually transmitted pathogens, viral infections, etc. Clinically, due to the acute onset and serious condition, it is often t...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/431A61P31/04A61P15/00A61K31/43
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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