| More than 80% of Spiramycin produced by Tianfang Pharmaceuticals is sold to European markets.When exporting to European markets,the product quality must meet the requirements of local and local pharmaceutical regulations.At the same time,high temperature and high humidity environment are encountered during export shipment.Affected product quality and sales.In accordance with the requirements of the European market,this paper conducts spiramycin-related substances and residual solvents in laboratories in accordance with EP 9.0(European Pharmacopoeia 9.0)and ICH Q3C(Guidelines for the International Technical Counselling of Technical Requirements for the Registration of Human Drugs: Residual Solvents).The establishment of testing methods and method validation;At the same time in accordance with the ICH Q1(human drug registration technical requirements of the International Coordinating Committee: Stability)stability study;newly established European Code Spiramycin detection method system,mainly used in product quality testing And stability inspection,in addition to the stability of different packaging drugs inspection and process optimization.The results of this study are as follows:1.Established a system for the detection of spiramycin related substances and organic residues.The quantitative limit of the relevant material detection method was 0.0006 mg/ml,and the relative standard concentration was 0.06%;the detection limit was 0.0002 mg/ml,and the relative standard concentration was 0.02%.The linearity was good in the range of 0.0006mg/ml to 1.2 mg/ml.The organic residue detection method has a quantitation limit of 7.5μg/ml and 15 ppm;the detection limit is 2.2 μg/ml and 5 ppm.The measurement range was good within the range of 0.0075 mg/ml to 3.5 mg/ml.This method is characterized by strong specificity,high sample precision,good reproducibility,lower limit of quantitation concentration than the neglected limit,good linearity,and suitable for the detection of spiramycin-related substances and organic residues,so that the quality of spiramycin conforms to European pharmaceutical practice.Claim.2.During the investigation of the stability test,it was confirmed that spiramycin accelerated the reduction of the effective components of the product in a high-temperature and high-humidity environment,and the impurities changed significantly;under the preset test conditions,the overall stability of the quality indicators of the aluminum foil packaging was excellent.In the polyethylene bag packaging samples,the long-term total component stabilization trend cycle can increase 7.98%,confirming the use of packaging materials sold to the European market.3.The detection method studied in this paper has been applied to the quality control of the European Codex spirulina production.The production plant used the method system to detect the process optimization index during the process of the process project.Through the optimization of the feeding process in the fermentation process,the output loss and disqualification caused by the adjustment of p H due to impurities in the fermentation broth components are eliminated,and the product qualification rate reaches 100%;after the activated carbon adsorption process is optimized,the total yield is higher than the original process.Increased 2.6% and production costs decreased by 3.78 yuan/kg.In 2017,Tianfang Pharmaceutical Europe Code Spiramycin produced about 120 tons of annual output,and its export value was nearly 180 million yuan.The spirulina detection method system studied in this paper not only ensures that the product quality conforms to the European pharmaceutical standards,but also applies to the change of packaging materials and workshop process optimization,and initially studies the causes of spiramycin-related substances,bringing huge economic benefits to the company.Provide reference for export drug testing. |
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