Pefloxacin mesilate liposome medicine composition

A liposome and composition technology, which is applied in the directions of liposome delivery, inactive components of polymer compounds, antibacterial drugs, etc., can solve the problems of increasing leakage rate, loss of medicinal value, and troublesome production process, etc. The effect of improving the therapeutic index

Inactive Publication Date: 2011-06-15
邓学峰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

High-pressure homogenization method and ultrasonic method can control the particle size, but high-energy crushing will damage the raw material medicine; the latter four methods cannot control the particle size, and the particle size distribution is not concentrated, organic solvent residues, leakage, precipitation, coagulation, Quality problems such as phospholipid corruption;
[0006] 3. The existing liposome preparation method makes the encapsulation efficiency of the liposome-combined drug carrier not reach 100%, and each batch fluctuates and changes greatly; the leakage rate is large, and the significance of the liposome-combined drug is lost;
[0007] 4. The production process is troublesome, energy-consuming and time-consuming, equipment investment is large, the prescription and process are not reliable and immature, resulting in uncontrollable, unstable and poor reproducibility of the preparation quality;
[0008] 5. Improper methods of sterilization and depyrogenation, it is difficult to guarantee

Method used

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  • Pefloxacin mesilate liposome medicine composition
  • Pefloxacin mesilate liposome medicine composition
  • Pefloxacin mesilate liposome medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] The raw material drug is a liposome combination drug with strong fat solubility. The molar ratio of each raw material component of the standard is as follows:

[0058] 1. The raw materials are alprostadil and indapamide

[0059] Mole number 1:30 composition 0.03

[0060] 2. Phospholipid raw materials are hydrogenated soybean lecithin and egg yolk lecithin

[0061] 2.5:1 molar composition 0.45

[0062] 3. The antioxidant is a combination of reduced glutathione and vitamin C with a molar ratio of 1:1 0.01

[0063] 4. The molecular diluent of phospholipid membrane is dimercaprol 0.90

[0064] 5. Liposome drug-loaded dispersant and excipient

[0065] It is a composition of xylitol and sodium glutamate molar ratio 5:1 0.90

[0066] 6. Surfactant is sodium dehydrocholate 0.01

[0067] 7. Ethanol 90% (v / v) (when dry, evaporate to the fullest) appropriate amount

[0068] 8. Phosphate buffer solution for injection 0.01M pH value 5.0-8.0 appropriate amount

[0069] 9. Two...

Embodiment 2

[0072] The raw material drug is a liposome combination drug with strong fat solubility. The molar ratio of each raw material component of the standard is as follows:

[0073] 1. The raw materials are alprostadil and indapamide

[0074] Mole number 1:30 composition 0.10

[0075] 2. Phospholipid raw materials are hydrogenated soybean lecithin and egg yolk lecithin

[0076] Molar ratio 2.5:1 composition 1.20

[0077] 3. The antioxidant is a combination of reduced glutathione and vitamin C with a molar ratio of 1:1 0.07

[0078] 4. The molecular diluent of phospholipid membrane is dimercaprol 1.50

[0079] 5. The liposome drug-loaded dispersant and excipients are xylitol and sodium glutamate

[0080] Molar ratio 5:1 composition 3.00

[0081] 6. Surfactant is sodium dehydrocholate 0.07

[0082] 7. Ethanol 90% (v / v) (when dry, evaporate to the fullest) appropriate amount

[0083] 8. Phosphate buffer for injection 0.03M pH 5.0-8.0 appropriate amount

[0084] 9. Two-thirds of ...

Embodiment 3

[0087] The raw material drug is a liposome combination drug with strong fat solubility. The molar ratio of each raw material component of the standard is as follows:

[0088] 1. The raw materials are alprostadil and indapamide

[0089] Mole number 1:30 composition 0.03

[0090] 2. Phospholipid raw materials are hydrogenated soybean lecithin and egg yolk lecithin

[0091] Molar ratio 2.5:1 composition 1.20

[0092] 3. The antioxidant is a combination of reduced glutathione and vitamin C with a molar ratio of 1:1 0.01

[0093] 4. The molecular diluent of phospholipid membrane is dimercaprol 1.50

[0094] 5. Liposome drug-loaded dispersant and excipient

[0095] It is a composition of xylitol and sodium glutamate molar ratio 5:1 0.90

[0096] 6. Surfactant is sodium dehydrocholate 0.037

[0097] 7. Ethanol 95% (v / v) (when dry, evaporate to the fullest) appropriate amount

[0098] 8. Phosphate buffer solution for injection 0.02M pH value 5.0-8.0 appropriate amount

[0099]...

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Abstract

The invention is characterized in that uniform formula, process and equipment are used for industrial production of pefloxacin mesilate liposome medicine composition in the forms of injection and oral preparation by using a molecular dispersion method. The invention provides the mole ratio of the components in a formula of the pefloxacin mesilate liposome medicine composition. The invention also provides steps, methods and specific embodiments for preparing the pefloxacin mesilate liposome medicine composition in the forms of lyophilized injection and oral preparation. The pefloxacin mesilate liposome medicine composition can be used for resisting bacteria.

Description

[0001] This application is an application enjoying domestic priority. The country of the earlier application is China, the application number of the earlier application is 201010248597.3, the application date is August 9, 2010, and the name is "Large-scale Industrial Production of Liposome Combination Drugs by Molecular Dispersion Method". technical field [0002] The invention relates to a method for preparing a liposome combination medicine in large-scale industrial production. Production of oral formulations of liposomal combination drugs. Background technique [0003] The gap between my country's pharmaceutical technology and raw material drug preparation technology and the international advanced level is only within 5 years, and some have reached or exceeded the international advanced level, and the preparation technology is 10-20 years behind the international advanced level. At present, a large number of second-generation common preparations are produced, while third...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/496A61K47/24A61K47/42A61P31/04
Inventor 蔡海德刘会梅张连印
Owner 邓学峰
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