Formula, preparation method and application of pantoprazole sodium liposome composite medicament

Abstract

The invention relates to a pantoprazole sodium liposome composite medicament which is characterized by comprising the raw materials in mole ratio. The invention also provides a large-scale industrial preparation method of the liposome composite medicament. The invention is characterized in that the pantoprazole sodium liposome composite medicament is made into a freeze-dried injection, oral liquid, spraying agent or suppository according to the pharmaceutically acceptable dosage. The invention is characterized in that the pantoprazole sodium liposome composite medicament is used for resisting gastric ulcer.

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 201010240184.0, the application date is July 29, 2010, and the name is "dissolving ultrafiltration-spray drying-molecular dispersion coating-hydration granulation-freeze drying to produce fat Plastid Combination Drugs. technical field [0002] The present invention relates to a large-scale industrialized production of liposome combination drug formula and preparation method, characterized in that the subject of the invention is to use dissolution ultrafiltration-spray drying-molecular dispersion coating-hydration granulation-freeze-drying method, with a unified The formula, process and equipment can be used for large-scale industrial production of liposome drug injections and large-scale industrial production of liposome drug oral preparations. Background technique [0003] The gap between my country's ph...

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, phospholipids Corruption and other quality issues;

[0006] 3. The existing liposome preparation method makes the encapsulation rate of the liposome drug carrier not reach 100%, and each batch fluctuates and changes greatly; the leakage rate is large, and the meaning of liposome 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 the aseptic and pyrogen-free operation throughout the whole process, and the lack of a high degree of sterility concept for liposome drugs leads to corruption of liposome drugs under bacterial erosion, decreased encapsulation efficiency, and leakage rate increases, the validity period is extremely short, and almost loses its medicinal value;

[0009] 6. The number and size of insoluble particles in the injection exceed the standard;

[0010] 7. Most raw materials, phospholipids, excipients, and solvents are selected without national drug quality standards, and new drug certificates and production approval documents cannot be approved even if they have patents. Registration is very difficult and takes a long time;

[0011] 8. Breaking away from the real situation in China, it took nearly 10 years and more than 20 million yuan from the development to the approval of liposome new drug production. Even the best drug invention patents, most companies dare not invest in development

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