Dissolving ultrafiltration-spray drying-molecule dispersion coating-hydration palletizing-freeze drying method for preparing liposome combination medicine

Abstract

The invention relates to a dissolving ultrafiltration-spray drying-molecule dispersion coating-hydration palletizing-freeze drying method, which can industrially prepare both liposome medicine-carrying injections and liposome medicine-carrying oral preparations by utilizing uniform prescriptions, technologies and devices. The invention provides a mole-ratio prescription of various components and materials for preparing liposome medicine-carrying preparations, and provides a technology for preparing nanoliposome lyophilization injections and liposome oral preparations. The invention also provides 20 embodiments for preparing liposome medicine-carrying preparations: an embodiment for preparing anti-gastric-ulcer liposome medicine-carrying preparations, an embodiment for preparing antibiosis and anti-fungus liposome medicine-carrying preparations, an embodiment for preparing anti-tumor liposome medicine-carrying preparations, an embodiment for preparing anti-viral liposome medicine-carrying preparations, an embodiment for preparing anti-emetic liposome medicine-carrying preparations, an embodiment for preparing nutrition-supplement liposome medicine-carrying preparations and an embodiment for preparing anti-diabetics and cardio- and cerebro-vascular drug liposome medicine-carrying preparations.

Description

technical field [0001] The present invention relates to a kind of preparation method of large-scale industrial production liposome combination medicine, it is characterized in that, the subject of the invention is to use dissolving ultrafiltration-spray drying-molecular dispersion coating-hydration granulation-freeze-drying method, with unified formula, The process and equipment can not only produce liposome drug injections in a large industrial scale, but also can produce liposome drug oral preparations in a large industrial scale. Background technique [0002] 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 20 years behind the international advanced level. At present, a large number of second-generation common preparations are produced, while third-generation su...

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;

[0005] 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;

[0006] 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;

[0007] 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;

[0008] 6. The number and size of insoluble particles in the injection exceed the standard;

[0009] 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;

[0010] 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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