Preparation method of clindamycin phosphate powder injection

Abstract

The invention relates to a method for preparing clindamycin phosphate powder filling agent, including: adding and dissolve clindamycin phosphate in alcohol solution; adding in activated charcoal to make decolorization, then roughly filtering, finely filtering, and placing to crystallize, filtering to eliminate supernatant and obtaining clindamycin phosphate crystal; then making transfer-solution for the second time, recrystallizing once, filtering and obtaining the recrystallized clindamycin phosphate crystal; drying and crushing, making split charging, capping and packaging in aseptic condition and making it. In the preparing course, it needs no high temperature treatment, need not add in additive, and its powder has good fluidity, high purity, few impurities, high bio-capability and good stability. It has no anaphylaxis and hemolysis and has no stimulation to blood vessels by intravenous injection. It adds a new clinic form of clindamycin phosphate, meeting clinic requirement.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and particularly relates to a preparation method of a preparation for treating infectious diseases caused by Gram-positive bacteria and infectious diseases caused by anaerobic bacteria. Background technique [0002] Clindamycin Phosphate is a derivative of lincomycin, which is produced by clindamycin through a semi-synthetic method. This product was first successfully developed by Magerlein in 1966. It has no activity in vitro and is rapidly hydrolyzed after being injected into the body. As clindamycin, it exerts pharmacological effects, and its mechanism of action is to inhibit bacterial protein synthesis. This product has the same antibacterial spectrum, antibacterial activity and therapeutic effect as clindamycin. It mainly has antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus, pneumococcus and hemolytic streptococcus and most anaerobic bacteria. ...

AI Technical Summary

Problems solved by technology

[0004] Clindamycin phosphate is a lactone compound, which is easy to degrade in water, and its hydrolyzed products are more toxic than clindamycin phosphate, and the structure and pharmacological properties of many other degradation products are not clear, which may affect medication safety

The aqueous solution of clindamycin phosphate used in reported dosage forms such as clindamycin phosphate aqueous injection and large infusion has many deficiencies: the phosphate group in the chemical structure of clindamycin phosphate has a certain amount in the aqueous solution. The degree of hydrolysis reduces the stability; Clindamycin Phosphate Water Injection is administered through intramuscular injection, although it is well absorbed and has a quick effect, it is highly irritating locally and difficult for patients to tolerate; A large amount of additives such as isotonic agents, PH value regulators, antioxidants, etc., the product needs to be sterilized at high temperature, which increases the degradation of clindamycin phosphate, reduces the safety of the product, and affects the stability of the product