Party Construction
Open the road of research
2021-07-30Return list
I am a graduate student graduated from the chemistry. Since 2016, I entered the Queen National Medicine Company Quality Technology Center. After several years of work practice, I have been able to work with drug testing, project declaration and registration. This year, the department is re-adjusted to my work, I began to participate in the actual production problem of the company's products, and optimize the process parameters.
For the first time, I changed the most basic knowledge of the principal of the cephalakenine capsule, understanding the most basic knowledge of their prescription and role, process trial system, the work is successfully completed under the guidance of departmental supervisors, let me first taste the joy of success, I feel The process is not difficult.
However, the next chloramphenicol capsule trial system, the departmental supervisor allows me to do the project person in charge, and I am fully responsible for work, this is the real challenge I have encountered. The difficulty of this work is how to fill the particles into 2 # capsules, 2 # capsules are small, the particles are large, and they can't install the dissolution and content, I have no ideas, a fog. After guiding Ni Haifeng, I have mastered the relationship between capsule filling and material stack density, liquidity, and initially identify basic ideas, first solving filling problems, second makes it eligible.
How to solve filling problems? The first step is to study the characteristics of raw materials. By determining the retention density of the raw material and the number of reactors, grain weight, the difference between the two, the nature of the raw materials determines whether it cannot be directly filling, must granary. In the second step, the granulation process is performed. In order to grasp the progress, use dry, wet synchronous trial. Through a series of experiments such as different binders, ratios, screening purposes, the wet method cannot reach the grain weight design requirements of 2 # capsules, and the granulation process is complex and the process is long. The process of dry method is relatively simple. With the cooperation of the manufacturer, we finally solve the filling problem by continuously granulation, prescription adjustment and testing, and the material is successfully filled into 2 # capsules in accordance with the design plan. After the filling problem is solved, it is necessary to solve the problem with lower dissolution. By comparing the reference preparation, the disintegrant is screened, and the adjustment of the amount of the amount of carboxymethyl starch sodium sodium is filled with the amount of the amount of the amount of the sample, and the dissolution of the sample is ultimately exceeded by 70% of the BP standard.Since these two difficulties, I solve one by one, which makes me grateful.
After this trial, I realized that the design of the process must be carried out around the workshop production equipment or level, and the literature information can be drawn, but only the situation in combination with the workshop is king. I sincerely thank the company to give me this opportunity to exercise, supervisors and colleagues to help me, will make me benefit for life. Whether the road in front is good, I am not very clear, but I am confident for myself.
Cao Yajuan
