Team:SDSZ-China/Human Practices
Contact with Local Pharmaceutical Companies
In order to get a clearer picture of UDCA-contained drug’s manufacturing circumstance in China, our team visited Tianjin Pacific Chemical & Pharmaceutical Company to interview the experts about current chemical producing methods. According to Mr. Xing Ruwen and Mr. Li Jinlong, the most popular method of producing UDCA-contained medicine in the market mainly focuses on chemical pharmaceutical procedures. Yet this approach has disadvantages including relatively weak efficacy and potential harm to health of the workers. He praises our aim to produce UDCA medic in biopharmaceutical procedure and consider it very promising. Furthermore, he encouraged us to cut off cost so that our method can be accepted by the market and the patients. This suggestion helped us to clarify our future goal.
Mr. Xing Ruwen
Mr. Xing Ruwen is the chief engineer in Tianjin Pacific Chemical & Pharmaceutical Company. He is an experienced manager who has been working on Chemical method of producing UDCA-contained drugs for years.
Mr. Xing introduces us the traditional chemical procedure to manufacture the UDCA-contained drug. Also, he leads us to visit the processing workshop and teaches us many valuable knowledge about drug production.
According to his opinion, chemical method of producing UDCA-contained drug basically has two disadvantages: the first one is its high risk; the second one is related to profit, a factor that influences manufacturing the most. For its potential high risk, Mr. Xing conveys that it comes from the utilization of metal sodium. Sodium is well-known for its highly-reactiveness; it is able react violently with water, which at the same time release large amount of heat and might cause potential safety issue to the workers. He praises our thought of avoiding the dangerousness and very much acknowledges our method.
Mr. Li Jinlong
Mr. Li Jinlong works as the production manager and he also participating in marketing department’s work in Tianjin Pacific Chemical & Pharmaceutical Company.
Mr. Li patiently answers our questions related to marketing. Analyzing its cost, demand and also profit, Mr. Li helps us to determined our minds on trying to solve the problem step by step. He informs that currently the successful UDCA synthesis rate is not hight enough and requires repeating measures to increase its purification ratio. It is very important for us to consider more about the balance between cost and profits if we want to further develop our method. Now, the exported UDCA drugs are highly demanded and we need to find ways to help simplify the production process and to increase the supply of UDCA-contained drugs.
Q：We still have some questions regarding to the market. It would be such a pleasure if you can share some of your ideas or understandings about them.
A : Please ask, I’m very glad to help you.
Q1: Could you please inform us UDCA medicine’s value in market and its efficacy?
A: UDCA is an cholic acid medicine that has choleretic effect to human bodies. It can cure various dan diseases like gallstone as well as hepatopathy including hepatic adipose infiltration. UDCA medicine has stronger healing effect than CDCA medicine while having less side effects in treatment. However, subtracted from bears, UDCA has a relatively high costs. And using UDCA directly converted by CDCA mainly has two benefits: first of all, it requires a lower cost because CDCA is subtracted from poultry like chickens, ducks, and geese; also, use CDCA instead of UDCA can help protect wild animals (bears.) Also, I consulted experts in our marketing department about it and they revealed to me that this approach has very high vendibility that medicines manufactured oversea are in short supply.
Q2: What is the basic principle of this drug design/production?
: First we extract CDCA from the bile of chicken, duck and geese. Then we convert CDCA into UDCA through two steps of redox reaction. These two substance are isomers than differ in their three-dimensional structure only.
Q3: We found out that there are only few factories manufactures UDCA medicine. Is it because the producing process’s complexity? Where is the complexity embodied in specific?
A: In fact, the actual process or technology used is not very complex but the key dangerous factor is the need of sodium, a dangerous, active metal that burns when it meets with water. Moreover, to consider this issue from other perspectives, UDCA medicine’s production copes wth the pressure from people’s safety and environment protection concerns. Therefore there are not too many factories that manufactures UDCA medicine.
Maybe there are only two factories in China that manufactures this active pharmaceutical ingredient (API) officially; one is in Shenzhen and the other is in Suzhou.
……After biliary drainage, it is very likely that bears will suffer from diseases all over their body, which is a torture to them. To resolve this problem, researchers and scientists in our country wish to convert CDCA in order to receive UDCA. Currently, their methods are deeply restrained by the use of sodium due to its danger and difficulty. If you can convert CDCA to UDCA successfully using enzymes, you are making a huge contribution.
Also, there are a lot of problems in the production of UDCA in medical industry. For instance, we need to consider the safety and profits of this drug. Thus, there are still a lot of aspects need to be considered and experiments need to be done when involved in industrial production.
Q: Thank you for your suggestions.
Q4: Could you briefly introduce the issue concerning costs and profits?
A: It is complicated because hydrogen needs to be removed. The chemical composition of UDCA needs to refine repeatedly, which is tricky. For example, a concentration of 70% of UDCA? require three times of refinement at least in order to reach the standard. Also, the raw materials or substances need to be recollected and there will be turnovers and other complex factors during the process. So the profits is limited. And now the biggest issue is that the danger of production overweights its potential profits.
