Chapter 203 The difference between Chinese medicinal materials
Hearing Feng Gang’s words, Zhang Yang couldn’t help but smile.
Chinese patent medicines, as the name suggests, are medicines made from Chinese medicinal materials or their extracts as the main raw materials and processed through certain processes.
Compared with Western medicine, that is, chemical drugs, which have a scientific evaluation system of research and development, verification, and clinical evaluation for nearly a hundred years, Chinese patent medicines have not yet established their own verification methods.
Even saying that I don’t know how to establish a relatively scientific evaluation system.
Traditional Chinese medicine emphasizes the importance of the king becoming the assistant, the strengthening of the foundation and the adjustment of the yuan, and the emphasis on solving problems at the root by regulating human body functions.
So, in the process of traditional Chinese medicine treatment, it is difficult for you to find one or several reasonable quantitative indicators to evaluate the drug treatment effect like Western medicine.
A simple analogy:
For example, the most common chronic gastritis causes abdominal distension, abdominal pain, indigestion and even vomiting.
In Western medicine, there is a common drug for treating gastric problems called "domperidone tablets", and its popular name is domperidone.
When you have stomach pain, nausea, regurgitation, or vomiting, taking one pill can quickly relieve stomach discomfort.
The drug principle is to inhibit the release of acetylcholine during gastrointestinal motility by stimulating the dopamine D2 receptors in the central nervous system, thereby enhancing the peristalsis and tension of the upper gastrointestinal tract and improving the symptoms of functional indigestion.
At the same time, domperidine can also increase the threshold of the vomiting center by stimulating 5-hydroxytryptamine receptors in the central nervous system, thereby exerting an anti-emetic effect.
During this process of taking the medicine, the drug concentration of domperidone reaches the peak in about 2 hours.
Through clinical trials, it can be monitored that the concentration of acetylcholine in the human body decreases, and the concentration of acetylcholine in the stomach Peristalsis increased significantly and the patient's vomiting decreased.
But what if you take traditional Chinese medicines that are commonly used to treat stomach problems?
For example, for the common "Weikangling Capsules", "Xiangsha Yangwei Pills" and "Baohe Pills", you cannot monitor obvious index fluctuations through clinical trials and double-blind tests.
Why?
Because the effects of traditional Chinese medicine come slowly, so slowly that you cannot even use specific biochemical indicators to measure its effects.
Let’s talk about it in detail.
From the beginning to the end, traditional Chinese medicine has always emphasized the need for thousands of people to make the same prescriptions. Even the most experienced traditional Chinese medicine doctors still need to adjust the dosage and traditional Chinese medicine according to the different conditions of the patients through the method of "seeing, hearing, asking, and feeling".
This is true for top veteran Chinese medicine practitioners. It is difficult for Chinese patent medicines to standardize the treatment of a certain disease.
It is more difficult to pass clinical trials established by Western medicine standards with obvious quantitative data.
Even the well-known Suxiao Jiuxin Pills could not pass the FDA's Phase III clinical trials in the United States.
Thinking of this, Zhang Yang gradually put away his thoughts.
It is precisely because of this situation that the State Food and Drug Administration is relatively loose in its review of the marketing of proprietary Chinese medicines. As long as it is determined that there are no major toxicological problems with the drug,
as long as it does not cause obvious drug poisoning by eating dead people, most of the Chinese All prescriptions for patent medicines can be approved.
Because of this, many domestic pharmaceutical companies have also focused their main efforts on the research and development of proprietary Chinese medicines compared to the rigorous, complex, and high-investment research and development of new drugs.
After all, there are few things to do, a lot of money, and there is no need to determine the exact curative effect. You only need to find a few ancient prescriptions in ancient books and slightly improve them to make money on the market. Who would want to make innovative drugs?
This time Zhang Yang purchased the patent of a traditional cold granule, and then donated the medicinal ingredients to treat "T14 protein" to be hidden in the cold granule, and he also took advantage of this loophole.
"Director, you can't speak so unfavorably of traditional Chinese medicine. To put it bluntly, traditional Chinese medicine still has a lot of merits." At the mature stage, I believe that traditional Chinese medicine can shine again in the future. ”
Of course Feng Gang just complained a few words casually. He laughed immediately when he heard this:
"Zhang Yang, your speaking skills are really high!"
"Okay. Well, I hope that in a few years I can see that our thousands of years of traditional Chinese medicine can be carried forward again.”
After speaking, he paused and introduced the topic to "Feiduqing Granules".
"Having said so much, would you like to take a look at the clinical trial results of the 'Feiduqing Granule'?"
"Okay!"
Zhangdiandiandian Head, did not continue to talk about the topic of Chinese patent medicine.
He quickly walked to Feng Gang's computer and began to carefully check the clinical data of "Feiduqing Granules" in the past two months.
Sure enough, almost as Feng Gang said, after two months of nearly 200 clinical trial data, this "Feiduqing Granule" did not show obvious therapeutic effects in the biochemical indicators related to colds and coughs.
In other words, in the double-blind test, it is impossible to tell which is the experimental group and which is the control group, and the effect is not significant.
This is one of the reasons why it is difficult for almost all Chinese patent medicines to pass double-blind testing.
As for the clearance index of "T14 protein", just like last time, you can see obvious differences at a glance. You can tell at a glance which patients are in the control group and which are in the experimental group.
Zhang Yang nodded and began to look at more data in more detail.
Data results show that patients with common viral colds, that is, those who have colds and coughs but have not yet caused pneumonia, only need to take "Feiduqing Granules" for two days to completely eliminate the "T14 protein" in their bodies.
Those patients who have caused pneumonia can still detect the "T14 protein" in their bodies after three days of taking it because of the large number of "pneumonia viruses". However, they only need to continue taking it until the symptoms of "pneumonia infection" disappear. "T14 protein" will also be completely eliminated.
Seeing this, Zhang Yang felt reassured.
Although "Feiduqing Granules" are mediocre in treating colds and coughs, its effect in clearing "T14 protein" is very powerful and achieved the effect I wanted!
That's enough!
After a moment, he looked up at Feng Gang and said:
"Director Feng, you are right. Although the clinical trial data is mediocre, it is enough to pass the clinical trial!"
"I'm just going to end it The bed test has been carried out, please help me submit the data to the review center."
Feng Gang immediately waved his hand and said with a smile:
"It's just me who said it was troublesome! ”
"Then I will sort out the clinical data for you and submit it to the review center!"
"Well, thank you."
Zhang Yang ended the clinical trial process and then submitted the clinical data to the review center.
Soon, he returned to Qingshan Pharmaceutical from the Third People's Hospital of Chengdu
Sitting in the office and thinking for a while, he decided to call Secretary Zhou Hai and inform "Pulmonary "Duqing Granules" has completed clinical trials and has been submitted to the review center.
The last time they met, he left Secretary Zhou's phone number, and the call was answered after a while.
"Secretary Zhou, I am Zhang Yang from Qingshan Pharmaceutical."
"Hello, Mr. Zhang, I noted your name, I know."
"Yeah."
Zhang Yang was not too polite and went straight to the topic:
"Secretary Zhou, we have developed the drug that removes the 'T14 protein' that I mentioned to you before, and have completed clinical trials."
"Judging from nearly 200 clinical data in two months, The drug has good effects on the body's The clearance rate of 'T14 protein' is very high. I will send you all the clinical data soon. Can you take a look?"
"Thank you very much, Mr. Zhang!" Secretary Zhou said on the phone. Zhang Yang didn't feel surprised that he didn't show any surprise.
Presumably when I applied for clinical trials of "Fei Du Qing Granules", someone in the capital began to pay attention to the clinical data of this drug, and Secretary Zhou must have heard about the relevant data.
After hanging up the phone and placing the phone on the desk, Zhang Yang suddenly exhaled heavily.
After first hearing the news about the rising incidence of "lung adenocarcinoma" from Director Dai, and then discovering the secret of "T14 protein" that can cause "lung adenocarcinoma" in the simulator,< br>
In the past few months, he has been worried and troubled about the "T14 protein".
It’s finally fine now!
After submitting for clinical trial approval, with state intervention, there is a high probability that "Feiduqing Granules" will be approved soon.
Once approved for marketing, it also means that the "T14 protein" remaining in the lung tissue will also have a treatment plan.
Even if patients are infected with the pneumonia virus in the future, they will only need to take 2-3 days of lung cancer. Duqing Granules can completely remove "T14 protein", so you don't have to worry about it anymore!
As for how to let patients infected with the pneumonia virus take "Fei Du Qing Granules" without causing severe social impact as much as possible, Zhang Yang no longer wants to think about it!
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Anyway, I have already reported this matter, and developed a drug to remove "T14 protein". I have done everything that needs to be done, and the rest is for the country to consider.
Zhang Yang was finally free and relaxed. Taking advantage of the rare rest time, he and Zhou Xiaomei watched a few movies together and had two hot pot meals together.
After a few days of relaxation, news suddenly came from the Food and Drug Administration Approval Center.
The proprietary Chinese medicine "Feiduqing Granules" submitted by Qingshan Pharmaceutical has passed the clinical trial approval and entered the production approval process.
This was so fast that even Director Feng Gang who notified Zhang Yang was surprised, but Zhang Yang knew very well that it was people from the capital who were behind the rapid push.
Think about it. Infection with the "T14 pneumonia virus" can induce "lung adenocarcinoma", which is completely considered a matter of public safety. If it is listed as soon as possible, then the top management will be much more calm in dealing with it.
Since "Feiduqing Granules" quickly passed the clinical trial approval, Zhang Yang could not continue to be idle. Early the next morning, he personally came to Hehua Pharmaceutical, the long-term partner of Qingshan Pharmaceutical.
At this time, He Ping, the boss of Hehua Pharmaceutical, had been waiting in the office for a long time. A pot of refreshing tea was brewed and placed on the coffee table.
Seeing Zhang Yang walking into the office, He Ping was all smiles:
"Mr. Zhang, you are here. Sit down quickly. The tea has been made for you."
Zhang Yang had informed He Ping in advance on the way here. As the real financial backer of Hehua Pharmaceutical, he was not polite and sat down directly on the sofa.
After taking a sip of the fragrant new tea, he put down the tea cup and got down to business:
"Old He, I told you before that we are developing a 'Fei Du Qing Granule'. You understand the situation.”
“Clinical trial review now. The approval has been passed. The next step is to trouble you with the production approval document and OEM production."
"Oh, Mr. Zhang, you are so polite!"
"You said. What's the trouble? Serving you is what we should do!"
The smile on He Ping's face became even wider. After finishing speaking, he paused and said:
"Don't worry, we have a stable production line of proprietary Chinese medicines and our quality control is very strict!"
>"After you mentioned last time that a Chinese patent medicine is being developed, , I have set up a separate production line for you in the past two months, and I am waiting to apply for the production license at any time!”
“Don’t worry! There is no problem in passing the approval!”
"Yeah!"
Zhang Yang nodded, he was relieved that Lao He could do this.
But after a moment, He Ping suddenly said again:
"Mr. Zhang, there is one more thing... you were too busy before and I didn't communicate with you properly."
"This time our 'Feiduqing Granules' are no more chemical than other innovative drugs before. There are strict fixed purity requirements in the production process!"
"For example, the purity of a certain compound must be purified to 99.9 % or more!”
"The Feiduqing granules this time are Chinese patent medicines. What grade do we use for the Chinese medicinal materials? Do you have any specific requirements?"
Zhang Yang was stunned for a moment and responded quickly. come over.
There is another obvious difference between chemical drugs and Chinese patent medicines, and that is the selection of drug materials.
The essence of Western medicine, or chemical medicine, is to obtain a compound substance with high purity through chemical means, by synthesizing or extracting compounds.
The higher the purity, the fewer drug impurities, and in a sense, the better the effect.
Therefore, in the process of producing chemical drugs, there are strict standards for the purity of drug ingredients.
But Chinese patent medicines are different.
Traditional Chinese medicinal materials do not have such strict standards and are generally divided into top grade, medium grade and low grade.
The quality of the same type of medicine may vary greatly depending on the place of origin and year of growth, such as astragalus, which is very common in Chinese medicinal materials.
The functions of astragalus are to replenish qi and raise yang, stabilize the surface and stop sweating, and reduce water and swelling.
Therefore, astragalus will be used when the body is weak and needs to replenish yang energy, or when people are prone to sweating during long-term sleep, and some patients with kidney disease.
However, the real high-quality astragalus requires at least 3-4 years of growth, but the vast majority of astragalus used in Chinese patent medicines on the market is only 1-2 years old.
Astragalus plants that are one to two years old are still growing and adapting to the environment, and their effective ingredients such as astragalus polysaccharide and astragaloside IV are obviously insufficient, so the efficacy is inferior to that of astragalus that is 3-4 years old. many!
Of course, the price will naturally be different depending on the age.
This is also the reason why there are many Chinese patent medicine granules on the market that everyone uses to treat coughs and colds, but some brands and manufacturers are much more expensive.
In addition, yam, white chrysanthemum, finished products, and Coptis chinensis are also divided into origins. For example, most Coptis chinensis from Sichuan Province is exported to Japan, and very few are domestically produced.
Zhang Yang thought for a moment.
Although the main effect of "Fei Du Qing Granules" this time is not to treat colds, it is the brand of Qingshan Pharmaceutical after all, and the sign cannot be ruined.
"Old He, if you didn't tell me, I would have forgotten about this!"
"All the Chinese medicines in our 'Fei Du Qing Granules' should be made of top-grade medicinal materials!"
After the words fell, He Ping was a little surprised!
"Mr. Zhang, all the top-grade medicinal materials are used, how much do you want to sell a box for?!"
(End of this chapter)