Preparation Of Compound Lincomycin Hydrochloride And Spectinomycin Hydrochloride Injection

Lincomycin Hydrochloride and Spectinomycin Hydrochloride were combined,and the Compound Lincomycin Hydrochloride and Spectinomycin Hydrochloride Injection was prepared by orthogonal test in this study.And its preparation process,quality standard,stability and in vitro antibacterial activity and safety inspection,for the clinical application of the injection and provide theoretical basis for further research.1.Preparation and quality controlThe formula composition of Compound Lincomycin Hydrochloride and Spectinomycin Hydrochloride Injection was determined through pre-experiment.The L₉?3³?orthogonal test was used to analyze the factor level by the range method to determine the best prescription.As a prescription for preparing the injection:5 g of Lincomycin Hydrochloride,10 g of Spectinomycin Hydrochloride,0.01 g of disodium edetate,0.2 g of sodium metabisulfite and15 mL of PEG-400 were adjusted to 100 mL with water for injection.According to the requirements of quality control standards,the injection is checked for clarity and pH,which is in compliance with the regulations.2.Establishment of content analysis method and stability testThe content of Lincomycin Hydrochloride in the compound injection was determined by high performance liquid chromatography at 203 nm,and the Lincomycin Hydrochloride showed a good linear relationship in the range of 0.2³.0 mg/mL.The content of Spectinomycin Hydrochloride in the compound injection was determined by high performance liquid chromatography-evaporative light scattering detector method.The concentration of Spectinomycin Hydrochloride was in the range of 0.1⁰.8 mg/mL,showing a good linear relationship.Both methods have high recovery rates,good repeatability and precision.In this study,the effects of light,temperature and long-term accelerated test on drug stability were investigated.Under natural light irradiation,the content of Lincomycin Hydrochloride and Spectinomycin Hydrochloride decreased by 1.28%and 1.34%,respectively.Under the illumination of fluorescent lamps,both The content decreased by1.53%and 1.68%,respectively.Under high temperature conditions,the contents of the two decreased by 1.17%and 1.51%respectively;under low temperature conditions,the contents of the two decreased by 0.98%and 1.28%,respectively.In the long-term accelerated test,the content of the two decreased by 1.26%and 1.61%,respectively.This indicates that the injection is relatively stable.3.Bacteriostatic test in vitroThe MIC of Lincomycin Hydrochloride and Spectinomycin Hydrochloride against five common bacteria was determined by conventional plate counting method.And MBC;using the checkerboard method to determine the combined antibacterial effect of Lincomycin Hydrochloride and Spectinomycin Hydrochloride.The results showed that the MIC of Lincomycin Hydrochloride for the five bacteria were 512,256,0.5,0.125 and 16?g/mL,respectively,and the MBC were:>128,>128,>128,8 and 32?g/mL;The MIC of the three bacteria for the five bacteria were:16,32,32,64 and 16?g/mL,and the MBC were 16,64,64,>128 and 16?g/mL,respectively.The combined susceptibility test results of the two methods showed synergistic effects on Staphylococcus aureus and Streptococcus agalactiae,and additive effects on Escherichia coli,Salmonella and Pasteurella multocida.4.Safety testThe compound LD method was used to determine the LD₅₀ of the Compound Lincomycin Hydrochloride and Spectinomycin Hydrochloride Injection?dose with the sum of Lincomycin Hydrochloride and Spectinomycin Hydrochloride?was 3 548.13 mg/kg,95%of LD₅₀ was credible.The limit is 3 260.08⁴ 027.17 mg/kg,the drug is a low toxicity drug.The injection is non-muscle irritating,pyrogen-free,and safe to use in clinical practice.Conclusion:this study provided theoretical support for the clinical application of Compound Lincomycin Hydrochloride and Spectinomycin Hydrochloride Injection through the formulation,quality control,establishment of content analysis method,stability test,bacteriostatic test in vitro and safety test.