Used Excavators

Posts Tagged ‘Pharmaceutical’

Say that Chinese medicine is our national essence, the history of several thousand years, so many people in folk medicine are only a little, but there are many erroneous views, had been repeated the baseless assertion, the become a generally accepted point of view. In Chinese medicine experts, these are misreading of TCM. Not long ago, “Traditional Medicine in China” large-scale scientific propaganda activities, many members of the public consultation in the square question directly let the experts frown, let us reasonable grounds below those common misunderstanding about Chinese medicine.

A misunderstanding of emergency can only select Western

In most people’s minds, Western rapid onset of effect is obvious, so in the case of acute onset, that is, need to see the emergency, surely is to look at Western. However, our hospitals, director of Integrative Medicine, Shaoxing City, the young Chinese Wang Genrong name that, like Chinese medicine can cure acute diseases, such as bleeding, we all know, skin bleeding, with Yunnanbaiyao, this is medicine. If respiratory tract bleeding, hemoptysis symptoms appear, is a heavy fire caused by medicine “under fire” to stop the bleeding. If the cause of hemoptysis is a deficiency, such as tuberculosis, can be nourishing strength to stop the bleeding. Another example of acute diarrhea, Chinese by clearing heat, health transport of drugs to treat stomach, the effect is just fine.

Some acute headache, toothache, the effect of acupuncture is also very good. Wang Genrong say so one thing, university teachers lecture, he mentioned that patients got a bad toothache, 3 days 3 nights no sleep, eat painkillers are not effective. Later, someone suggested he try acupuncture, the results of a needle down, the patient pain immediately disappeared, lying in bed asleep. Now with acupuncture analgesia have been widely used in acupuncture practitioners. Some experts think that in the first aid in the integration technology into the Chinese would make rescue more effective.

Mistakes 2, No toxic side effects of Chinese medicine

In many people the impression that Chinese medicine is without side effects, and many eat it does not matter. However, Wang Genrong physician opinion, this is wrong. Practice of Chinese medicine also has side effects, only side effect size problem. For example tonkinensis, eat on the liver damage, kidney damage on the centipede. Even the traditional Bupleurum, often used as anti-fever drugs may actually eat more damage to the liver. “I Zuozhen rheumatism clinic, many people say bad stomach, so eat Chinese medicine, Chinese medicine can stomach some of the damage is still there.” Dr. Wang cautioned that people should be more careful when taking Chinese medicines.

Mistakes three students to drink ginger in cold sweat

In people’s traditional values, suffering from a cold, boil a bowl of Health and ginger drink, and then covered with thick blanket and covering a cover their out of a sweat enough. This view is wrong. Dr King explained, only cold drink cold ginger students useful condition on Fengreganmao will add. The original, from the perspective of Chinese medicine, cold is divided into many categories, often with wind-heat, cold, Shu Shi, alpine of four, in the spring and autumn, it is because most colds are caused by catching cold cold, but the body in the summer in heat too much, then cold, the more is Shushi type.

Four errors, the best tonic with Ginseng

Dr. Wang introduced, even if the same problem, also need to dialectical therapy, such as LDB, considered to be kidney, but in fact it is the rule Kidney Yin deficiency, if the patient is a yang deficiency, with Liu Wei Di Huang Wan but more with worsen. This is reflected in the tonic on the particular care, such as the Dendrobium is a great tonic, buy a lot of people, but it is slightly cool, if a person with a cold stomach, but taste even worse. Another example of ginseng, some people no matter how appetite, physical good or bad, are using ginseng to tonic, but for some people, eating the ginseng may even have health problems.

Dr. Wang met a patient last year, is a woman nearly 50 years, body good, because good family, usually very particular about diet, health has been good. Honor of her son in law an old wild ginseng, did not think she began eating stool solution not participate, could not sleep at night. To the Department of Gastroenterology, Cardiovascular Division are we not go wrong, or the Chinese to the conditioning was better.

Dr. Wang explained that normally we are talking mainly refers to other direct participation ginseng, ginseng, wild ginseng, etc., of warm, is nourishing vitality, some old and weak or weak constitution, after falling seriously ill people, some of ginseng tonic is good. But those young and healthy or have eczema, fever of the people, but will eat their way to eat ginseng may questions.

“As pharmaceutical excipients on drug quality and safety is important, drug regulatory departments in China have been imposed registration and management, registration management of the Pharmaceutical Excipients play a strict supervision of the industry, an important role in normal development, but there are some, such as high cost and other drawbacks of the executive. “few days ago by the Pharmaceutical and Biological Products of China organized the” 2009 Auxiliaries and Medical Packaging Quality Control Technologies International Forum “, the State Food and Drug Administration drug registration Secretary, said Zhang Wei, China is exploring the implementation of pharmaceutical excipients in DMF (registration and filing of medicinal raw materials) management system, the system is expected to strengthen the preparation manufacturer of the raw materials of the audit responsibility to raise the level of the technical review of the accessories and efficiency.

HC pharmaceutical industry network with map

Accessories in the amount of preparation in many types of complicated auxiliary own safety, uniformity of quality accessories, supplies and accessories and the interaction between the active components of drug interaction between the quality of preparation was obvious. To this end, the State Board to the State Department retains the right accessories to implement registration management. June 2004 the State Council issued “The State Council approved the project Necessary administrative decision of an administrative license” (State Council Decree No. 412), the document legally established practice of pharmaceutical excipients legitimacy of regulatory approval. In 2005, the State Council issued the “Pharmaceutical Excipients registration requirements for disclosure of information”, the new Pharmaceutical Excipients, import medical supplies, medical accessories have national standards, national standards have been Hollow Capsule , Medicinal gelatin capsules with gelatin and supplementary application and re-registration of the six major items of medical supplements standardized requirements for disclosure of information.

“Through the introduction of registration management, China’s pharmaceutical industry continues to standard accessories, and growth of production technology and management continuously improve quality standards continue to improve, greatly promoted the Medicine Development of the industry. But in practice, there are some issues can not be ignored. “Zhang stressed that, above all, blurred preparation excipients used in the audit of corporate responsibility, preparation of production enterprises as the main responsibility of the selected excipients not reflected in the approval system, preparation companies often evade the responsibility for auxiliary enterprises and the implementation of approved manufacturing Drug Administration departments. Second, the accessories manufacturers do not want to detailed technical information to the agent enterprise reporting, and drug departments in the preparation of the review process can not perform a detailed review, can only rely on the approval documents, but not many Pharmaceutical Excipients approval documents. Third, the production site inspections and GMP inspections limited to registered API And the preparation of enterprises and the lack of actual production by the extension of auxiliary materials, raw materials, production processes Drug Quality Impact of poor control, poor drug quality traceability of responsibility. Fourth, hindered the use of new accessories. Accessories manufacturers mostly Chemical industry Enterprise, a small proportion of Pharmaceutical Excipients, businesses time and money do not want to register a higher cost of declaration, it has been registered for approval of supplementary material has been used in China is far less than the accessories. Fifth, the premixed formulation excipients as complex, difficult to implement registration management. In addition, the implementation of administrative examination and approval system for registration costs.

For the establishment of a scientific and effective system of medical material management, the National Bureau in recent years, drawing on experiences of developed countries, based on the attempt to establish, promote and improve the practice of medicine in China for raw materials, management systems registration for the record, that DMF system. DMF refers to active pharmaceutical ingredients, excipients, direct contact with drugs Packaging materials And containers, chemical intermediates manufacturer, in accordance with the provisions of the information requirements and procedures, their production processes, quality standards, process parameters and quality indicators, and all other technical information, voluntarily submitted to the State Food and Drug Administration for drug supervision management and pharmaceutical enterprises in the drug registration process and the production supervision process technology used document management system. Zhang described the drafting of DMF system, since 2002, as China – one of Canada Drug Cooperation, the State Council began to explore the DMF system, and the establishment of the drafting group, the group by the technical review, regulatory authorities, industry associations, etc. form and involves a wide range. Held every year since the relevant seminars, in-depth study technical issues related to DMF. DMF in the international system based on the full study, in March last year, the drafting group completed the first draft of China’s DMF system. Last November 19 and 28, the drafting group meetings were held with business representatives to discuss the work has been completed. DMF system

On the idea of establishing the time, Zhang said, the basic framework of the system, management methods and international standard consistent with the mode, but also adhere to the voluntary reporting, and is divided into public and private parts, no real review and the implementation of approval holder authorizing the use of, the principles of change to be updated. Management includes Medical Packaging, pharmaceutical excipients. Managed all the relevant information the applicant to the drug regulatory departments to voluntarily register for the record, the open part of the preparation of information for enterprises choose to use raw materials, non-public part of the information for the drug regulatory departments in the preparation inspection approval and manufacturers use. DMF system

On the advantages and objectives, Zhang believes that “the most obvious advantage is to strengthen the preparation of raw and auxiliary materials, the use of corporate responsibility.” Agents manufacturing enterprises should be raw and auxiliary materials selected for the real responsibility principal, agent business can be directly referenced DMF file number, so to promote its focus on supplier auditing. In addition, DMF system divided into two parts and private parts, so that technical information can also prevent leakage, ensure that enterprises provide real technical information. Goal of establishing this system is the first technical review services, to improve the technical review of the auxiliary level and efficiency. And then for the on-site inspection and GMP inspection services, increasing the level of variety as the center of the inspection, to establish the true source and the whole process of monitoring the implementation of a real system of inspection, improve the controllability and traceability. Meanwhile, companies choose to meet the requirements for the preparation of raw and auxiliary materials, services, increasing the company as the core of the main agents of responsibility.