Since the birth of traditional Chinese medicine injection in the 1940s, after long-term development, it has made great contributions to the protection of patients' life and health, and has become an indispensable category for clinical use. However, in recent years, drug damage incidents related to traditional Chinese medicine injections have occurred frequently. Houttuynia cordata, Acanthopanax senticosus, Shuxuening, Yinzhihuang, Shuanghuanglian... This series of events has made many people safe for Chinese medicine injections. Sexuality has raised suspicions. In individual hospitals in Beijing, Chinese medicine injections have even been cleared out of pharmacies. At the same time, many people in the industry have pointed out that the key to the safety of traditional Chinese medicine injections is to regulate the use.

Traditional Chinese medicine injection adverse reaction is lower than western medicine

Referring to the adverse reactions of traditional Chinese medicine injections, Wang Yaoxian, dean of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, gave two sets of data.

*The data of the group is the statistical data of the Beijing Municipal Center for Adverse Drug Reaction Monitoring. This data shows that among the adverse drug reactions in Beijing last year, 86.7% of chemical drugs and 11.9% of Chinese patent medicines (71.9% of them are Chinese medicine injections) Biopharmaceuticals accounted for 1.4%. Wang Yaoxian said that this group of data shows that the incidence of adverse reactions of traditional Chinese medicine injections is far lower than that of chemical drugs.

The second set of data given by Wang Yaoxian is the statistical data on the use of Chinese medicine injections and the occurrence of adverse reactions in Beijing Dongzhimen Hospital. There are 26 varieties of traditional Chinese medicine injections used in Dongzhimen Hospital. The use rate of traditional Chinese medicine injections in hospitalized patients has reached 51%, and even 90% in individual departments such as respiratory departments, and only 40 cases of adverse reactions related to traditional Chinese medicine injections per year. Left and right, and mostly mild allergic reactions. For example, Qingkailing injection, used more than 1,400 patients last year, the amount of nearly 30,000, only 3 cases of adverse reactions, and only a slight rash, headache and other symptoms. Shuxuening injection, the hospital used a total of 1357 patients last year, the amount of up to 95,000, but no adverse reactions occurred. Wang Yaoxian said that this group of data indicates that the safety of traditional Chinese medicine injections is guaranteed.

Wang Yaoxian said that the analysis of drug damage incidents related to traditional Chinese medicine injections in recent years can be found that the occurrence of these events has little to do with the quality and safety of the drugs themselves, and is more important than the special constitution of patients. It is caused by irrational use of drugs and other reasons. For example, the acanthopanax senticosus incident was caused by contamination of the drug during storage; the Shuanghuanglian injection event was caused by the combination of Shuanghuanglian injection with various antibiotics such as cephalosporin and lincomycin; the Yinzhihuang incident was Because of the erroneous use of drugs for the treatment of hepatitis jaundice in newborns, and the use of adult doses. Not long ago, the National Center for Adverse Drug Reaction Monitoring notified the safety of Chuanhuning and Yanhuning. The investigation showed that it was also caused by overdosage.

"It can be seen that most of the adverse events of traditional Chinese medicine injections are caused by human factors and can be avoided. Therefore, the rational use of traditional Chinese medicine injections is very important." Wang Yaoxian pointed out.

Mao Zhenbin, Food and Drug Inspection Commissioner of the National Bureau, said that the quality control of the production process and the correct use of the drug in the use phase are closely related to the safety of traditional Chinese medicine injections. The theory of traditional Chinese medicine is profound and profound, but the level of doctors at all levels is uneven. However, traditional Chinese medicine injections are used more in medical institutions in rural areas and in remote areas. Due to the limitations of the professional level of grassroots medical staff, the phenomenon of irrational drug use is relatively high. Damage events associated with traditional Chinese medicine injections are more common in primary care institutions.

In addition, a considerable part of traditional Chinese medicine injections are used by Western medicine, and many Western medicines lack sufficient understanding of Chinese medicine theory, which also brings hidden dangers to the safety of Chinese medicine injections.

In the interview, the reporter learned about such a case: the vice president of a hospital in Henan suffered from upper respiratory tract infection, and took the drugs such as virus spirit, cephalosporin, and Qingkailing injection to let the nurse give him intravenous infusion, two and a half hours. After that, the vice president died. According to investigations by relevant departments, the cause of the incident was the combination of unreasonable multi-drugs.

Shenwei Pharmaceutical is a company that takes Chinese medicine injection as its leading product. Li Zhenjiang, chairman of the group, told reporters that Chinese medicine injection has outstanding advantages such as curative effect, rapid action and no drug resistance, and expands the use of traditional Chinese medicine in the treatment of critical illness, viral infectious diseases, cardiovascular and cerebrovascular diseases, tumors, etc. It is widely used in modern and frequently-occurring diseases, especially in the treatment of incurable diseases. It has become a clinically essential drug.

Mao Zhenbin also said that since the birth of traditional Chinese medicine injections, it has played a significant role in the treatment of critically ill and severe diseases. Especially for the treatment of patients with cardiovascular diseases, traditional Chinese medicine injections have an irreplaceable role. Therefore, they should be active. Support its development.

The production process is strictly controlled to ensure quality.

In the imagination of many people, Chinese medicine manufacturers may still be small workshops that are hand-operated. In fact, with the development of science and technology, the production of traditional Chinese medicine has already been modernized. In the traditional Chinese medicine production enterprises, various advanced production equipment and production technologies have been applied to production, and the level of scientific research has also been continuously improved.

The reporter saw in Zhengda Youthbao Pharmaceutical Co., Ltd. that in the spacious and bright production workshop, the production of traditional Chinese medicine injections has completely realized automation, and advanced program-controlled extraction equipment such as double-effect concentrators are readily available. It is understood that Chinese medicine injection is the main dosage form of the company. Over the years, the company has invested 500 million yuan in its production process, quality control, basic and clinical research, Chinese medicine extraction and separation, production equipment, etc. The modern production process of “automatic extraction of raw liquid, mechanization of packaging and packaging, and pipeline transportation of liquid medicine”.

In the quality control of traditional Chinese medicine injections, Wang Zhi, vice president of Zhengda Youthbao, put forward the concept of “compact process control”. Wang Zhi said that looking at the differences between traditional Chinese medicine injections and chemical injections, in terms of production control, chemical injections are constantly being dosed as intermediates. Therefore, it is a step, stop, adjust, and then go It is a superposition of a plurality of short-term "schedules" in a solid state and a liquid state, and the traditional Chinese medicine injection is dosed once according to the prescription amount, and therefore, it is like a "marathon" long-distance running in a liquid state. From the results, the results of traditional Chinese medicine injections will certainly be greater than the chemical injections, that is, the "intermediate control" of Chinese medicine injections is more difficult and important than chemical injections. In terms of the characteristics of the drug itself, most of the chemical injections are “not afraid of microorganisms” and even have “antibacterial” effects. Even if they are contaminated by microorganisms, they only add a little heat load, but the Chinese medicine injection is the largest. Most of them are good "medium". Once contaminated by microorganisms, they will cause unqualified products and cause phytotoxicity. For the above reasons, the quality of stable Chinese medicine injections should be "compact process control", that is, to reduce the liquid state of the Chinese medicine injection manufacturing process in each process.

So, what is the purpose of implementing "compact" control? Wang Zhi said that the first is to reduce the incubation time of bacteria in the liquid state to reduce the pyrogen load in the final product of zui; the second is to reduce the unknown chemical reaction in the liquid state. In order to achieve "compact process control", the company began a series of measures from the process, equipment, personnel and other aspects. For example, in order to ensure the uniformity of the quality of raw materials, the company fixed the raw material production area, set up a fully automatic Chinese medicine extraction workshop, basically eliminated the artificial operation error; and introduced advanced injection water production equipment.

Li Zhenjiang said: "The production of traditional Chinese medicine injection has 'five high', high threshold, high standard, high quality requirements, high quality of staff, high management level. It is a complex craft in all Chinese medicine varieties, high technical content, high quality, and quality requirements. Strict variety. One needle is two lives, one is the life of the patient, and the other is the life of the enterprise."

The quality of Chinese herbal medicines is the basis of the quality of traditional Chinese medicine injections. Shenwei Pharmaceutical always adheres to the principle of “original purchase, direct purchase, and access to goods”, and directly purchases medicines from local production sites. For the Chinese herbal medicines with a large amount of use, Shenwei Pharmaceutical has established a planting base, which is planned and constructed in strict accordance with the GAP standard, from the ecological environment, breeding and planting of the medicinal materials planting to the harvesting, processing, transportation and storage. , are included in the standardized management. Suppliers are required to regulate the harvesting and processing of Chinese herbal medicines and eliminate some bad processing methods. Suppliers are required to perform initial processing and storage according to the company's standards. For example, Banlangen should go to the head, red ginseng and yam must be stored in a cool storage. In the inspection of medicinal materials, Shenwei Pharmaceutical has established internal control standards that are higher than national standards. On the basis of national standards, quality control projects such as mid-infrared spectroscopy, fingerprints, heavy metals, sulfur dioxide, and pesticide residues have been added to ensure the use of enterprises. It is a high quality Chinese herbal medicine. The company collected thousands of genuine, fake and defective samples of medicinal materials as the standard for acceptance of medicinal materials, and hired famous Chinese medicine experts in Hebei Province to check the purchase of Chinese medicinal materials and prevent the entry of counterfeit medicinal materials. Shenwei Group also carried out irregular inspections on suppliers and eliminated them in time for unqualified suppliers.

Shenwei Pharmaceutical has an advanced automatic control production line for the extraction of traditional Chinese medicine. This production line uses industrial integration and automatic control technology to apply the combination of dynamic countercurrent extraction, supercritical extraction, macroporous resin adsorption and other processes to the extraction process of traditional Chinese medicine. And using computer distributed control technology, set the production process parameters such as temperature, pressure, time, liquid level and concentration for different effective parts of different medicinal materials and medicinal materials, and complete the corresponding actions by computer, thus realizing the extraction and purification of the whole Chinese medicinal materials. , Concentration, separation of the automation of the production process, to ensure the stability of the production process, the product quality between batches is uniform, zui greatly reduce man-made pollution and errors.

Li Zhenjiang said that Shenwei Pharmaceutical has set internal control standards higher than the national standards for the Chinese herbal medicines, the semi-finished products and the finished products. For example, the inspection of visible foreign matter in the injection liquid, the national standard is that if one of the 20 defects is unqualified, the whole batch of products is judged to be unqualified, and Shenwei Pharmaceuticals stipulates that if one of the 200 is unqualified, the whole batch of products is judged as unqualified. , 10 times higher than the national standard.

Improve the standard and use reasonably

In recent years, Chinese medicine injection manufacturers have paid more and more attention to scientific research investment. For example, Zhengda Qingbao and Zhejiang University have cooperated for more than 10 years, and jointly undertaken the national “Ninth Five-Year” scientific and technological key project “Shenmai Injection Modernization Demonstration Research”, focusing on chemical substance foundation, process optimization, fingerprint, quality standards. He has carried out a series of technical research and development on traditional Chinese medicine injections such as Shenmai injection; jointly undertaken the national “10th Five-Year” scientific and technological research project “Fingerprint Application Demonstration Research” and “70 kinds of traditional Chinese medicine injection fingerprint research and technology” A series of scientific research projects such as the establishment of the platform, the major scientific and technological specialties of Zhejiang Province, the quality evaluation of Chinese medicines and the quality monitoring of production processes, and the research on the quality control technology of Danshen injection have achieved fruitful results. For the first time, their research has clearly defined the chemical substance basis of Shenmai injection, and developed a quality control method combining chromatographic fingerprint and content determination. The relevant research results won the second prize of National Science and Technology Progress Award in 2004.

Shenwei Pharmaceutical invested 100 million yuan to improve the quality standards of traditional Chinese medicine injections, and cooperated with research institutes such as Peking University, Tsinghua University, Second Military Medical University, China Pharmaceutical University, Military Medical Academy, Shanghai Pharmaceutical Institute, etc. Conduct research on material foundation, pharmacy, toxicology, and clinical safety and efficacy. Fingerprint technology is an important means of quality control of traditional Chinese medicine injections. Shenwei tests the fingerprints, heavy metals and pesticide residues of all the medicinal materials, intermediates and finished products involved in all batches of traditional Chinese medicine injections, and establishes medicinal materials, intermediates and finished products. Liquid fingerprinting.

Some insiders pointed out that in order to achieve long-term development of the Chinese medicine injection industry, in addition to the work of production enterprises to improve scientific research and standards, it is also very important to use the clinic reasonably.

"Because most of the ingredients of traditional Chinese medicine injections are complex, in the process of use, special attention should be paid to rational application," Wang Yaoxian said.

According to Wang Yaoxian, traditional Chinese medicine injections should follow the principle of “dialectical medicine”. The use of traditional Chinese medicine injections is inseparable from the guidance of traditional Chinese medicine theory. It is a "dialectical treatment" rather than a "disease treatment", such as Qingkailing injection, adapted to heat syndrome fever, if used for cold syndrome, it violates The principle of medication used in traditional Chinese medicine is prone to adverse reactions. The use of traditional Chinese medicine injections should avoid combination, overdose and long-term use. Long-term use of traditional Chinese medicine injections can easily lead to adverse reactions of drug components accumulating in the body, especially drugs with certain toxicity or slow metabolism in the body. In addition, the operation of the drug configuration time, drip speed and other aspects must be standardized, otherwise it may also cause damage.

The State Food and Drug Administration has attached great importance to the safety of traditional Chinese medicine injections. In January this year, the Notice on the Safety Re-evaluation of Traditional Chinese Medicine Injections was issued. On July 20 this year, the State Food and Drug Administration held a video conference on the safety re-evaluation of traditional Chinese medicine injections, and mobilized and deployed the safety re-evaluation of traditional Chinese medicine injections. The meeting pointed out that the safety re-evaluation of traditional Chinese medicine injections will focus on the core of ensuring drug safety, and will carry out work from three levels: risk investigation, comprehensive evaluation and improvement of standards. On the basis of the comprehensive investigation of the risk of production and quality control links in the production enterprises, the National Bureau will organize the risk and benefit evaluation of key varieties in stages and in batches. At the same time, the National Bureau will use Chinese medicine injection as a key area of ​​the standard improvement plan and accelerate the improvement of the national standard for Chinese medicine injections. In line with the principle of a batch of mature batches, the national standards for Chinese medicine injections were announced in batches. For varieties that have not been produced according to national standards due to problems such as the base of medicinal materials and medicinal materials, long-term non-produced varieties and varieties with high safety risks will be eliminated. The meeting requested that the safety and quality controllability of traditional Chinese medicine injections be further improved through re-evaluation. Traditional Chinese medicine injection manufacturers and drug supervision and administration departments at all levels should attach great importance to doing relevant work. At the same time, encourage production enterprises to cooperate with research institutions, universities and colleges to carry out research, encourage Chinese medicine injection manufacturers to cooperate in research, strengthen cooperation and common development.

In addition, the relevant state departments are also very concerned about the rational use of traditional Chinese medicine injections, the Ministry of Health issued the "Basic Principles for the Clinical Use of Traditional Chinese Medicine Injections" to ensure the rational use of traditional Chinese medicine injections. The health departments in some areas have also conducted training on the popularization of Chinese medicine knowledge among Western doctors in order to improve the level of rational use of traditional Chinese medicine injections by Western doctors to ensure the health and safety of patients.

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