The high growth of pharmaceutical industry in Kunming is the list of adverse reactions

Shuanghuanglian injection, Houttuynia cordata and other traditional Chinese medicine injections have exposed serious adverse events, Chinese medicine injections once again become the focus of social concern. In the national drug adverse reaction/incident report (2013) released by the state Food and Drug Administration (FDA), Xuesaitong injection and Blood injection (lyophilized) were all entered the top five of the national drug injection. This time, the brunt of the impact is Kunming Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Kunming Pharmaceutical", 600422.SH) of the products. The company's earnings showed that in 2012, sales of Xuesaitong (freeze-dried) increased by 76%, and in 2013 the Blood Xuesaitong (freeze-dried) of injections increased by 31.49% over a year earlier. At present, only two enterprises nationwide production of injection Blood Xuesaitong (freeze-drying), 2012, Kunming Pharmaceutical Injection of Blood Xuesaitong (freeze-dried) market share accounted for 31%. Guofan, director of CIC's consultancy study, told the China Business newspaper that the above-mentioned report would affect the rapid growth of injection blood Xuesaitong (freeze-dried) products in the base drug market. State Food and Drug Administration said the above-mentioned report, some Chinese herbal injections involved in the primary health care institutions reported a large proportion, suggesting that the use of such drugs at the grassroots level may be a higher risk. Industry insiders said, Kunming Pharmaceutical Blood plug 70% Income from the grassroots hospital market, so Kunming pharmaceutical injection with Blood Xuesaitong (freeze-dried) Gorgeous financial statements, or hidden worries. A single ingredient to the riddle of Chinese herbal injections again the storm. 2013 7 ~ August Analysis of ADR monitoring data in Xishuangbanna, Yunnan province The report shows: 7 ~ August, the state reported adverse drug reactions in 1 cases of death, suspected injection of drugs caused by blood plug, adverse reaction symptoms for chest tightness, dyspnea. Injection of Blood Xuesaitong (lyophilized) is "Notoginseng total saponins" made of prescription drugs, Kunming pharmaceutical products are the original research manufacturers. Kunming brand Xuesaitong Injection (formerly known as Notoginseng Total saponins injection) is the company and the Chinese Academy of Sciences Kunming Plant and other research institutes of the joint research and development of the important results, in 1985, the first market, June 1985 officially named as Blood Plug Tong injection. 1996, the company for the first time the freeze drying technology used in natural drug injection production, developed 37 total saponins lyophilized Powder---xuesaitong (injection blood). Industry insiders said that in December 2007, the State administration of food and drug supervision issued the "Traditional Chinese medicine, natural drug injection basic technical requirements", injection of ingredients should be basically clear. A systematic chemical study of the components in the total solids of the injection agent should be carried out. An injection made from an active ingredient shall contain no less than 90% of the content of a single ingredient, and the content of the structure in a total solid shall not be less than 60%. The main constituents of Blood Xuesaitong (lyophilized) of injection were "total saponins of Notoginseng". Kunming Pharmaceutical Company The invention of the product patent "a 37 saponins Powder injection" claim book, "37 saponins content 50%~99.5%." According to industry insiders, if the single component of this drug to reachLess than the scope of the state, the main will bring two aspects of the problem, one will reduce the efficacy, the second is more drug impurities, the safety of medication will also have an impact. Kunming Pharmaceutical Xuesaitong Injection, injection of Blood Xuesaitong (lyophilized) The content of a single component is how much? Kunming pharmaceutical in response to reporters that "Kunming pharmaceutical production of Xuesaitong injection and injection of Blood Xuesaitong (freeze-drying) content of the National Food and Drug Administration issued the" Chinese Medicine, natural drug injection basic technical requirements and related requirements. "The contents of a single component of Blood Xuesaitong (lyophilized) are vague, and there is no clear answer to the reporter's question. Security risks state Food and Drug Administration The above report indicated that the Chinese medicine injections combined with drug use phenomenon is outstanding, should be vigilant against the drug interaction, but in the 2013 Chinese herbal Medicine injection Adverse reaction report data analysis, the combination of drug use phenomenon has not been effectively alleviated. 2013 the number of adverse reaction/incident reports of Chinese herbal injections in the top 20 drug combination cases, involving 41% of the combined drug use, serious reports involving the use of combined drug accounted for 54.1%. The state Food and Drug Administration report recommends that clinicians, in accordance with the basic principles of clinical use of Chinese herbal injections, the use of traditional Chinese medicine injections, taboo and other drugs compatible use, careful combination of drugs, such as the need for joint use of other drugs, should be considered with the traditional Chinese medicine injection interval time and interaction and other issues. The existing medical literature shows that the combination of blood Xuesaitong (lyophilized) and conventional therapy can improve the clinical efficacy, but the combination of drugs poses a great challenge to the safety of drug use. But the reporter searches the Chinese academic periodical full text data base (CNKI), Wanfang data storehouse and so on, but is difficult to find regarding the injection blood Xuesaitong (freeze-drying) The medical literature which the application alone. In that case, have the blood Xuesaitong (lyophilized) in Kunming Pharmaceutical injection been randomized, controlled, and multicenter clinical trials of individual applications? Kunming Pharmaceutical response to this reporter only said: "Kunming pharmaceutical has been very important to the safety of drugs, since the 90 's, Kunming pharmaceutical in accordance with the national" Drug Clinical Trial Management Code (GCP) "Selected a number of domestic authoritative clinical trial base for clinical trials. "There is also no positive answer to the reporter's question. There is a seemingly xuesaitong contradiction between the efficacy and safety of Blood injection (lyophilized) combined with conventional therapy. Fellow of the Academy of Traditional Chinese Medicine Zhou, executive member of the editorial board of the Chinese People's Republic Pharmacopoeia, said in an interview with the media: "Reliable efficacy is the basic condition of drug listing, we found in the effectiveness of Chinese medicine injections, a lot of Chinese medicine injection efficacy is not accurate to treat infectious diseases of Shuanghuanglian injection as an example, Of the 4,382 research Records found, only 45 (accounting for 1.03%) did not share the antibiotic drugs of western medicine. The clinical effect of Chinese herbal medicine alone, how to improve the clinical efficacy of combined use, is still unknown. "The use of risk risks in primary medical institutions large state food and Drug Administration said the above report, some Chinese herbal injections involved in the primary health care institutions reported a large proportion of the report, suggesting that the basisThere may be a higher risk of using such drugs in the layer. China launched the basic Drug catalogue policy in 2009, according to the Ministry of Health requirements, the county hospital comprehensive reform pilot County level two hospital basic drug sales should reach about 50%. After entering the catalogue of essential medicines, the medicine is equal to the admission ticket of the purchasing system of the primary medical and health institutions. But the blood Xuesaitong (freeze-dried) as the base medicine Chinese Medicine injection variety grows rapidly. Data show that in the first half of 2013, the first ten varieties of Hebei base drug procurement of seven are Chinese medicine injection, Chinese medicine injection of procurement amounted to 240 million yuan, accounting for 23.95% of the total purchase amount, Kunming pharmaceutical injection of blood plug through the purchase amount of 33.74 million yuan. In Jiangsu, 2013, Kunming Pharmaceutical Injection of Blood Xuesaitong (freeze-dried) Jiangsu Province Base Drug Plan purchase amount of 181 million yuan. In the "2014 primary medical and health institutions in Jiangsu Province, the basic drug centralized procurement plan public form", Kunming Pharmaceutical Injection of Blood Xuesaitong (freeze-dried) of the planned purchase amount of 152 million yuan. According to people familiar with the matter, this January, Kunming Pharmaceutical Sales director Lin Jongzhong in a conference call organized by a brokerage, said that 70% of the income from the grassroots hospital. Professor Zhou has said that "the problem with Chinese herbal injections is that the three hospitals with rescue conditions are not very much used, but there is a large number of primary hospitals without rescue conditions." Insiders say because of the condition construction and the restriction of the funds, the basic hospitals do not have the condition guarantee of the big hospital, moreover, because of the restriction of various factors, there is often no good rescue method for adverse events, and lack of emergency experience, which makes the use of Chinese medicine injection more risk. This March, a brokerage firm estimated that the Kunming pharmaceutical leading product blood Xuesaitong is still expected to maintain the growth of 25%~30%, but for the grassroots hospital abuse of injection, all over the introduction of a number of restrictive policies. This January, Anhui Province Department of Health issued a notice, the blood plug injection, Blood Xuesaitong (freeze-dried) powder needles, such as 25 injections into the new agricultural and chemical early Warning management drugs list, the number of drugs to be included in the alert list will be limited, and the excess will not be paid for by the new Farmers ' Fund, and the new agricultural and health insurance does not pay for the early warning drugs. Does this mean that the happy time of Xuesaitong and other Chinese herbal injections will end? What effect does this have on Kunming pharmacy? All this is still unknown.