Industry calls for new drugs for Chinese medicine more protection
With the rapid development of biotechnology, peptide and protein drugs are emerging. There are now 35 important therapeutics on the market, and the development of biotechnology and biopharmaceutical companies is becoming increasingly global. Biotechnology drug research focuses on the application of DNA recombinant technology to develop peptides, proteins, enzymes, hormones, vaccines, cell growth factors and monoclonal antibodies that can be used in clinical applications. According to Parexl's Pharmaceutical R&D Statistical Source Book, there are currently 723 biotech drugs under FDA review (including phase â…° to iii clinical and FDA evaluation), 700 drugs are in early stage (research and preclinical). More than 200 additional drugs are in the final stage of approval (Phase iii clinical and FDA evaluation). The basic dosage form of biotech drugs is lyophilized. Although the efficacy of conventional preparations has long been clinically proven, they need to be injected frequently for a long time due to their short half-life, which is difficult to accept from the perspective of psychological and economic burden on patients. To this end, scholars around the world mainly from two aspects to study and develop convenient and reasonable drug delivery approaches and new preparations: (1) embedment agent and sustained-release injection. â‘¡ Non-injectable dosage forms, such as respiratory inhalation, rectal administration, nasal administration, oral administration and transdermal administration, etc. Injectable preparations of sustained-release biotechnological drugs are new dosage forms with promising applications. Some of them, such as microsphere injections of luteinizing hormone releasing hormone (LHRH) analogues which can be sustained-release for 1 to 3 months, have been on the market. This paper focuses on this kind of preparations.Main types of peptides and protein drug sustained-release preparations The research and development of peptides and protein drug sustained-release preparations can be divided into two types, namely, embedment agent and microsphere injection, from the perspective of development process and dosage form. The shape of the implant is a hollow micro-fine rod, one end is closed, the other end is open, and the rod material is non-biodegradable polymer such as ptfe. The lumen was filled with a mixture of drugs and silica gel (silastic, polydimethylsiloxane). The implant is embedded under the skin, and the drug is released slowly through the opening of silica gel matrix. The American Physicians' Handbook (PDR) contains a product called Norplant? Levo-18 ethyl norethinnes, used in family planning. The preparation, each with a diameter of 2.4 mm and a length of 34 mm, is surgically implanted in the inner side of the patient's upper arm with 6 thin rods. The drug can be released in the body in zero-grade mode for up to 5 years, and then removed by surgery after release,1.1.2 Micro-osmotic pump embedding agent The United States Alza company in the 1970s developed an embedding agent shaped like a capsule, which is embedded in the skin or other parts. The body fluid can penetrate through the shell, dissolve the interlayer electrolytic layer, make the volume expansion of the interlayer pressure to the plastic inner cavity, and promote the drug solution from the opening of the fixed speed release. Many biomolecular drugs, such as insulin, heparin and nerve growth factor, have been reported as model drugs in vivo and in vitro. Implants have positive significance for the treatment of chronic patients who need long-term medication, but it has the following defects: â‘ must be surgically implanted. â‘¡ The skeleton material of the preparation is non-biodegradable polymer, which needs to be removed by surgery after release. â‘¢ The preparation has irritation and discomfort in local tissues. Evaluation methods for polypeptide protein drugs: 1. Liquid chromatography 2. Spectroscopic 3. Solvent-based versions are easy to use, but need to be kept at low temperatures (2-8 degrees Celsius). medicine peptides high,Peptide injections,buy medicine peptides high,medicine peptides for bodybuilding,medicine peptides for hgh Shaanxi YXchuang Biotechnology Co., Ltd , https://www.peptide-nootropic.com
It is understood that there are more than 100,000 pharmacists in national pharmacies, less than 20,000 in licensed pharmacists, and less than 10% in pharmacies with licensed pharmacists. There are 17 licensed pharmacists in Henan Jishi Pharmaceutical Co., Ltd., which is known for researching and producing traditional Chinese medicine Donglingcao. Zhang Hai, chairman of the company, said, “They did not choose to go to the grass-roots pharmacy to work, but chose to work in a better environment and have a large room for growth. The hospital or the Chinese medicine factory works because the pharmacy has a low salary."
The new version of the GSP stipulates that those who are engaged in the inspection and acceptance of Chinese herbal medicines and Chinese herbal medicines shall have a technical secondary school education or above, or have a professional title of Chinese medicine or above, and shall be engaged in the maintenance of Chinese herbal medicines and Chinese herbal medicines. If the above academic qualifications or have professional titles of junior and senior professional titles in Chinese medicine, and the direct purchase of real estate Chinese herbal medicines, the inspection and acceptance personnel shall have professional title of professional titles of Chinese medicine or above.
According to Wang Guobao, deputy general manager of Beijing Heiantang Pharmaceutical Co., Ltd., Chinese medicine shops are traditional industries, and it is difficult to gather talents. Most of the staff of TCM shops have received secondary education and belong to the low-income class. Their salaries are generally between 1,000 and 2,000 yuan. Some pharmacy staff may not have five insurance and one gold. These treatments will not attract professional pharmacist certificates and professional titles with intermediate or higher titles. Technical talents.
"It is very difficult for such pharmacies to rise within three years of attracting the operating standards of licensed pharmacists. If these pharmacies leave the market, it will be very inconvenient for ordinary people to buy drugs on holidays or in the evening," said Wang Guobao.
It is understood that the state requires that each pharmacy must have a licensed pharmacist in the store. The prevailing situation now is that the pegs are not linked to people, and many pharmacies are not licensed to practise pharmacists, but are a local training certification. Long Yan, chairman of Beijing Times Qianfang Pharmacy Co., Ltd., said: “The current situation in pharmacies is that some pharmacists have experience with drugs but it is difficult to obtain certificates. It is suggested that alternative methods, such as organizing training, should be provided to allow these to have Pharmacists with experience in medicine obtain certificates."
The wholesale enterprises under the county level cannot cancel the new version of the GSP. The management requirements for the quality of business operations have been significantly improved. In particular, the ability to control drug quality risks in circulation has been enhanced. The State Food and Drug Administration estimates that only 30% of wholesale enterprises can pass this strict certification. Many companies face the fate of delisting.
It is understood that China currently has 13,000 pharmaceutical wholesale companies. "There are 3,000 pharmaceutical wholesale companies in the country that are sufficient, even if only 1,000 will not affect the market supply." Li Guoqing introduced the media.
Regarding the issue of a large surplus of wholesale companies, Wang Guobao thinks this is a product of the planned economic impact in the past. The degree of marketization in the field of pharmaceutical circulation in China is not high, and wholesale companies do not have sufficient market competition. In such circumstances, the survival of the fittest will restrict the overall industry development.
However, if the new regulations increase market barriers and improve hardware facilities, a large number of Chinese medicine wholesalers will be delisted. This standard should not be "one size fits all". “Small-scale wholesale enterprises with county-level units are indispensable. Drug distribution with county units is in line with China’s national conditions, and large pharmaceutical groups cannot deliver county and township health centers. If these wholesale enterprises are cancelled, only 3000 Home wholesale companies, then the drug is difficult to timely, safe and cheap to benefit the people of the township below the county level.†Zhang Hai believes.
The new regulations have increased the requirements for storage and transportation of refrigerated and frozen pharmaceuticals. The new version of the GSP stipulates that when refrigerated or frozen pharmaceuticals arrive, they should be inspected and documented the quality control of their transportation methods, transportation temperatures, and transportation time. Do not meet the temperature requirements should be rejected. This standard should also take into account the actual situation, for example, "My plant produced Chinese medicine Donglingcao syrup is required to sell at a temperature below 25 degrees Celsius, summer pharmacies and wholesale companies is difficult to achieve, for the county-level wholesale companies like this The transport requirements are even more difficult to achieve. It is recommended that such drugs can be considered to be added with preservatives." Zhang Hai said.
It is necessary to give consideration to the development of small and medium-sized Chinese medicine companies. The industry believes that the current development of Chinese medicine companies is in good shape. The introduction of this policy is in line with the adjustment of the country's major industrial policies. The modern facilities of small-sized enterprises cannot keep up with the software and are automatically eliminated. Large enterprises are made bigger by strict management. Strong. However, the implementation of the new regulations is a double-edged sword. It may also cause monopolies in large companies and squeeze the development of small and medium enterprises.
“To say that the new regulations have caused the pharmaceutical circulation industry to face reshuffling is somewhat alarmist. In fact, the reshuffle of an industry is the result of the natural development of the market, and the production enterprises of Chinese medicine and circulation companies are all striving for their own living space in the market. "The survival of enterprises is to be bigger and stronger because of their unique features and differentiated competition. My company is not big. It belongs to medium-sized Chinese medicine companies, but the traditional Chinese medicine, Donglingcao, is our specialty and specialty. Zhang Hai believes that the ability of small companies to manage their business is not necessarily worse than that of big companies. Small companies in Switzerland can make products worldwide.
“The new regulations have increased the requirements for storage and transportation equipment for refrigerated and frozen medicines and increased the requirements for hardware facilities such as information management. This is not difficult for big companies to realize. Large enterprises have financial advantages, such as China Resources Group, etc. It will be very difficult for the pharmaceutical companies to realize them. The new regulations will take root, and the relevant agencies shall provide the SMEs with the necessary funds and technical support.†Wang Guobao said that to upgrade the company’s modern hardware facilities, the purchase of hardware facilities must follow the market rules. The premise of increasing the extra burden on the company is to avoid third-party interests and prevent new corruption chains.