Nowadays, China's pharmaceutical technology industry is in the process of rapid transformation and upgrading, and the consistency evaluation of new product research and development of complex injections and listed products has received unprecedented attention. The high technical threshold is a rare opportunity and a huge challenge for pharmaceutical companies with strength in the fierce market competition.

E Fat Milk injection is a generic drug project developed by Beijing Haiyan Pharmaceutical Research Institute. Fat Milk injection is a high-end preparation. Due to its high requirements for equipment, technology and raw materials in the preparation process, there are few varieties on the market at present. This variety is unstable, with large particle size and wide distribution. Because fat milk is a thermodynamically unstable system, it is easy to stratify and flocculate during placement.

According to the relevant requirements of the Opinions of The State Council on Reforming the Review and Approval System for Pharmaceutical and Medical Devices, we formed a research group spontaneously to solve the physical stability of E fat Milk Injection as the topic, and strive to ensure the stability and quality of the product.

What is the cause of poor product stability? Under the leadership of Dr. Chen Dong from the Institute of Pharmaceutical Research, I consulted literature, summarized experience, and demonstrated and analyzed the problem for many times through brainstorming, and got the end factors affecting the stability of the product.

We use the method of single factor investigation to test, demonstrate and analyze. Single-factor examination means that a large number of trials are needed to identify the causes. In the face of complex test process, we did not hesitate, but more brave, we actively work overtime, give up rest time, only hope to find the main factors affecting product quality as soon as possible!

The light of the laboratory is the brightest night scene of the petrel in Beijing. We continue to experiment, and summarize the experimental results, cross-check and review. On the other hand, the team members used design expert software for the first time and adopted the Box-Behnken-Design response surface optimization method, a new experimental design concept. After repeated exploration, learning and deliberation, we finally successfully combined this method with our experiment, and got the best emulsion preparation process, and the product met all requirements.

In this QC activity, we successfully solved the problem of poor physical stability of E fat milk injection, and won the first prize at the 40th National Pharmaceutical Industry QC Group results Presentation exchange meeting. As the people of Yangzijiang, we uphold the original intention of quality above all, and strive to move forward on the road of drug research and development!