Beijing Haiyan Pharmaceutical "Morning Bell" QC team was established in 2008, for many consecutive years to participate in the national pharmaceutical industry quality management (QC) group results publication activities, all won the first prize. Looking back on the psychological journey of growing up with the QC team, my heart is surging and I am filled with emotions, there are hardships and joys, and there are frustrations and gains.


Endless improvement


As the exclusive variety of Beijing Haiyan, Suhuang Zhike capsule is the only recommended Chinese medicine for the treatment of cough after cold and cough variant asthma, and the total effective rate of clinical efficacy ingredients is more than 87%.


It is understood that the similarity of fingerprints of proprietary Chinese medicines collected in the 2015 edition of Chinese Pharmacopoeia can reach the requirement of more than 0.9. Through the search of relevant literature, the Morning Bell team found that the fingerprints have the characteristics of integrity, characteristics and quantification, which can improve the quality of Suhuang Zhike capsule. The team set the goal as "to establish a method for the detection of non-volatile components of Suhuang Zhike capsule".


After the group leader announced the topic, all members of the Morning Bell group began to work on it. From the initial goal setting to the final summary, it took a year. Looking at the successful completion of the project, recalling the little bits and pieces of the year, all the sweat is worth it.


Unite and fight to create quality


In July 2019, when the project was continuing, the Morning Bell group hit the biggest bottleneck: "Investigation of mobile phase elution gradient."


The elution gradient of the mobile phase is extremely important in the liquid phase test, which directly affects the chromatographic peak separation of the sample and the sample analysis time. However, in the experiment process, the mobile phase ratio could not achieve the best effect after adjustment again and again, and everyone in the group was frowning for a time. At this time, Liu Xiaoqing, the director of the laboratory, first stood up to reassure everyone, do not be afraid of failure, we can start again. We encourage each other, analyze the reasons, all the holidays, weekends and spare time are used up, through reading, surfing the Internet, access to information constantly "charging", after a study and practice, finally summed up a more suitable elution gradient, after testing, separation results basically meet the expected requirements.


But the team members in the spirit of "quality, miss is as good as a thousand miles", still do not give up, continue to carry out precision experiments, stability experiments, repetitive experiments. In the final target examination, the similarity of 30 batches of samples was between 0.976 and 0.997, which proved that liquid chromatography as a method to detect the fingerprint of non-volatile components of Suhuang Zhike capsule was feasible, and the team goal was successfully achieved! And the project won the first prize and the best presentation award at the 41st National Pharmaceutical Industry Quality Management (QC) group results presentation.


As a treasure of the Chinese nation, we young people should continue to explore traditional Chinese medicine to make it understandable, acceptable, quantifiable and verifiable. To carry forward Chinese medicine is the collective mission of our generation of pharmaceutical workers, and it is also the unremitting pursuit of the goal of the Morning Bell Group.