For pharmaceutical companies, every detail in the production process is related to product quality and safety, even if the small flaws on the packaging bottle can not be negliged.
The ampoule bottle containing injection is thin, and the filling process is easy to generate a broken bottle, glass scrap, which is a problem that has been plaguing the industry.
In order to solve this problem, Shandong Danhong Pharmaceutical Co., Ltd. (step-by-step pharmaceutical subsidiary, hereinafter referred to as Danhong Pharmaceutical) Formulation workshop emergency team, Liang Bang will take the initiative to give up rest time as a group project, lead the topic group At the topic attack.
"Modern pharmaceutical companies should be innovative in ensuring drug safety," Liang Bang will tell reporters that he is maintenance and maintenance work for Danhong injection in fourteen years in fourteen years.
"Danhong injection is red-brown, which is formulated by Chinese medicine salvia, safflower, etc., is a compound preparation extracted by modern special processes. At present, there are two specifications, 10ml and 20ml, clinical application. Cardiovascular disease.
"Liang Bang will say seriously," If the injection of the visible foreign body is hit into the human body, it will cause life.
"This is a major event that is related to the quality of pharmaceutical products, and the key issues that Liang Bang will have to solve before formulation of filling.
In this regard, Director of the Pharmaceutical Department of Beijing University of Traditional Chinese Medicine, Professor Du Shouying said: "The visible foreign matter exists in the injection, ophthalmic liquid preparation and sterile raw materials.
The "National Pharmacopoeia" has been related to the requirements of the injection visible foreign body, and the visible foreign object is unqualified, and the visible foreign body is mainly optimized by improved the process and production environment of the production injection.
"Controlling the source of visible foreign objects is the key and difficult points of the project research.
Liang Banghui and colleagues found that during the production of Danhong injection, the ampoule (glass bottle of Dan red injection) crowded, due to mutual friction, even smashed bottles, and gangmei, the resulting glassbread, Powder and other waste slags entered the ampoule under gas flow, it increases visible foreign matter inside the Danhong injection.
In order to solve this problem, Liang Bang will have repeatedly discussed, studying, researching a slag-residue device (blocking of the plazing of the ampoule produced, the powder, etc.) and the bottle mechanism (fixing the ampoule bottle to reduce friction) ), After determining the design graph of two devices, hand it over to the equipment processing plant for processing. When debugging for the first time, the stainless steel slag unit used in the oven and potting machine connectors, which gives Liang Bang and colleagues confident, but after installing the bottle, let them not think that the ampoule is still Stable.
But at this time, Danhong injection is produced.
The research entered the countdown status, Liang Banghui and colleagues were finding the fate, overtime plus points in the study room, and finally trying to discuss the countermeasures, failed to make a brainstorm, and then try, and finally discovered that it was the bottle mechanism. The spring wire is slightly thick, causing the spring elastic to be large, causing the bottle to be unstable. Find a key point to solve the problem, they immediately communicate with the equipment processing plant, replace the appropriate spring.
After the second installation and commissioning, the bottle is stable, the debugging is successful, the stone hovered in Liang Bang and colleagues finally landed. After the project is successful, the number of broken bottles is effectively guaranteed by the production quality of the drug by more than 10 bobbinning phenomena for the original per batch. "The stainless steel slag devices used in the oven and potting machine" and "ampoules in bottle mechanism" have obtained national patents, effectively improved the clarity and pass rate of Danhong injection. It has been plaguing their "Ampoule Pocket Parametals Visible foreign object". The honor’s acquisition allows Liang Bang and colleagues to taste the sweetness, and the research and development is more enough. In the production process, they continued to innovate and developed the "small pneumatic mixing device" "Improvement of the structure of the ampoule washing machine", and won more than a dozen countries, provinces and municipal innovation prizes.
Further reading: Step of the Pharmaceutical Innovation "Focus on the major disease, cultivation of large varieties", this is Shandong Steps Pharmaceutical Co., Ltd. (hereinafter referred to as step-by-step pharmaceutical) based on cardiovascular and cerebrovascular markets, covering product development in the field of proprietary drugs . Among them, the traditional Chinese medicine injection Danhong injection developed by the step-by-step pharmaceutical investment of billion yuan is the first patent medicine in my country’s first rapidly solving the blood supply and ischemic infarction disease.
At present, the step-by-step pharmaceutical has become a company with the most traditional Chinese medicine patented varieties. As of December 31, 2020, the step-by-step pharmaceutical production of 332 drug production is mainly based on "Danhong Injection", "Danhong Injection" and other 75 exclusive patented varieties (exclusively) 60 varieties, 15 exclusive dosage forms), authorized to 348 patents.
With innovation results, intellectual property declaration protection work is also particularly important.
"I have been working for thirteen years. I witnessed the rapid growth of the company. The company will exceed the development goals every year. This is inseparable from all employees. And the person in charge of the Ministry of Science and Technology must innovate The intellectual property of the project is guaranteed. "Lin Yuli, Manager, Danhong Pharmaceutical Science and Technology Management, said that the department will adjust the company’s intellectual property management architecture according to the relevant policy requirements of the state and Shandong Province, Heze City, and improve the company’s knowledge. The awareness of property rights protection, enhance the capacity of corporate production and operation risk prevention and control.
Going deep into the steps, we can touch the thickness of its innovation: Step-by-step pharmacy has now owned the country’s post-doctoral research workstation, "Study of Biomedical Innovation Pharmaceutical Technology" Academician Expert Workstation, Shaanxi Province Modern Chinese Medicine Innovation Center, Shandong Cardiovascular Cardiovascular Modern Chinese Medicine Engineering Laboratory, Shandong Traditional Chinese Medicine Injection Safety Rematch Engineering Technology Research Center, 42 provincial innovation research platforms; 144 scientific and technological projects, and obtain 47 scientific and technological rewards at all levels.