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        information Center Your current location : Home > R & D > Information Center

        Application of Chinese and western medicine compound preparations requires careful research

        Time: 2011-05-03 Source: China Pharmaceutical News Author: reprint

        At present, it is the season of high incidence of colds. Many people will go to pharmacies to buy medicines by themselves after taking a cold. Few people buy Chinese and Western medicine compound preparations, but few people pay special attention to whether it is a "Chinese and Western medicine compound". Relevant experts pointed out that they do not understand that it contains both traditional Chinese and western medicine ingredients, overdose, and unreasonable combination of medicines, etc., which leads to some potential unsafe factors when people use traditional Chinese and western medicine compound preparations.


        In September last year, the State Food and Drug Administration issued a notice warning the public to pay attention to the safety of Chinese and western medicine compound preparations, Vitamin C Yinqiao tablets, causing heated discussions. In fact, this is not the first time that the compound preparation of Chinese and western medicines appeared in the adverse reaction notification of the State Food and Drug Administration. In 2002, the cold cold tablets (approval document number H, but it contained chlorpheniramine maleate and artificial Bezoar and other Chinese and western medicine ingredients) have also been reported for hematuria.


        Do you know which medicine is a combination of Chinese and Western medicine


        Has the public's awareness of Chinese and western medicine compound preparations improved with the announcement of drug regulatory authorities? The reporter randomly selected four commonly used Chinese and western medicine compound preparations, namely Victoria C Yinqiao Tablets, Fufangganmaoling Tablets, Xiaoke Pills, and Zhenju Jiangya Tablets, and conducted general online and first-line pharmaceutical service personnel without medical knowledge respectively. A small-scale survey.


        Among the 10 ordinary people, 8 people think that the four medicines are pure Chinese medicine, one person thinks that the compound cold cold tablets are western medicine, and one person says that the Vitamin C Yinqiao tablets contain western medicine ingredients; although the 10 first-line pharmaceutical service personnel surveyed knew The four medicines are a combination of Chinese and Western medicines, but the specific ingredients added are inaccurate, or they said they would "look at the instructions" and "check the information" and said that they would not specifically remind consumers during the drug sales process.


        It is understood that there are more than 160 kinds of Chinese patent medicines containing western medicine ingredients approved by the state, all of which are Z-numbered batches. They are mainly concentrated in anti-cold medicine, cough and asthma medicine, gastrointestinal medicine, and some other hypoglycemic drugs. And antihypertensive drugs. The added western medicine ingredients mainly include chlorpheniramine maleate, acetaminophen, ephedrine, diphenhydramine, vitamin C and the like.


        In particular, it should be noted that there are currently about 18 Chinese and Western compound preparations on the cold medicine market, and they are basically over-the-counter (OTC) drugs. They do not require a doctor's prescription, and the public can buy them by themselves. Such as powerful cold tablets, compound cold Lingling tablets (capsules), Sugankang capsules and so on. The added western medicine ingredients are very similar. In addition to the anti-allergic chlorpheniramine maleate and acetaminophen which can relieve fever and analgesia, some also add stimulants such as caffeine.


        Professor Zhou Chaofan, an executive member of the National Pharmacopoeia Committee, pointed out that because such drugs are classified as Chinese medicines at the time of approval, and the drug names are not clearly expressed, it is difficult for ordinary people to understand their ingredients through the names, which may cause repeated drug use and bring potential safety risks.


        Such as Victoria C Yinqiao, from the name it is easy to be confused with its "brother" Yinqiao. But in fact, Yinqiao tablets are pure Chinese medicine composed of honeysuckle, forsythia, mint, nepeta, light tofu, burdock, eustoma, pale bamboo leaves, reed root, and licorice. Vitamin C Yinqiao tablets are added with vitamin C, chlorpheniramine maleate, and acetaminophen on the basis of Yinqiao tablets, so naturally they have the adverse reactions of these western medicine ingredients.


        Another example is the hypoglycemic drug Xiaoke Pill, which is widely used in clinical practice, and is often mistaken for pure Chinese medicine, like Vitamin C Yinqiao Tablets, but it actually contains both traditional Chinese medicine Astragalus, Dihuang, Trichosanthin, and the second-generation sulfonylurea. Glibenclamide, also known as hypoglycemic. Glycemic hypoglycemia may cause hypoglycemia reaction or even hypoglycemia coma; it will aggravate renal insufficiency, ketone body positive and hepatitis patients; it is not suitable for elderly patients with type 2 diabetes with abnormal liver and kidney function.


        The widely used antihypertensive drug Zhenju antihypertensive tablet is composed of pearl layer powder, wild chrysanthemum powder, rutin, hydrochlorothiazide, clonidine hydrochloride. Clonidine hydrochloride is a central alpha receptor agonist, hydrochlorothiazide is a thiazide diuretic, and rutin is a vitamin P. The three medicines have strict dosages and have the following common adverse reactions: lead to water and electrolyte disorders, such as hypokalemia; can reduce glucose tolerance and increase blood sugar; can interfere with renal tubule excretion of uric acid, causing hyperuricemia; It can increase low-density lipoprotein and triacylglycerol levels, reduce high-density lipoprotein and so on.


        Whether 1 + 1 is greater than 2


        "A 67-year-old woman with hypertension who took Zhenju Antihypertensive Tablets for one month, her blood pressure was okay, that is, she felt dry mouth, thirsty, and tiredness. I answered her at the time, which may be a side effect of the drug. Suggestion She returned to check her electrolytes to see if she had hypokalemia. Because Zhenju Jiangya Tablet is a compound preparation of Chinese and western medicine, hydrochlorothiazide is prone to hypokalemia if taken for a long time. "


        This is a case encountered by Pharmacist Wang Shuping in the Pharmacy Department of Huanggang Central Hospital in Hubei Province during a drug consultation. He asked: "If rutin, hydrochlorothiazide, clonidine hydrochloride are not added to Zhenju Antihypertensive Tablets, is there any antihypertensive effect? Does the compound preparation of Chinese and western medicine really have the benefits of" the western medicine cures the symptoms, the Chinese medicine cures the root "?


        In fact, not only Wang Shuping has such doubts, the effectiveness and safety of adding western medicine to Chinese medicine has been controversial in the industry and outside. So, can the traditional Chinese and western medicine compound preparations of traditional Chinese medicine and western medicine achieve the effect of "1 + 1 greater than 2"?


        Zhou Chaofan said that the addition of western medicine ingredients to Chinese medicine originated in the 1950s and flourished in the late 1970s, mainly produced by some southern manufacturers. Due to the low quality and standard at that time, it was basically a simple 1 + 1 form, and no corresponding efficacy and safety studies were conducted. Therefore, after the implementation of the "Measures for the Administration of Drugs" in 1985, the state strictly enforced the drug approval system, and has eliminated a number of quality and ineffective compound Chinese and Western medicine preparations, but some varieties have remained.


        The reporter found in the interview that it is precisely the practitioners of traditional Chinese medicine who oppose the compound preparations of Chinese and Western medicines, and specifically oppose the classification of such drugs as Chinese medicine management. A clinical Chinese pharmacist said: "The so-called traditional Chinese medicine should be a drug applied under the guidance of traditional Chinese medicine theory. Western medicine ingredients are added to the compound preparations of traditional Chinese and western medicine. Traditional Chinese medicine theory cannot be used to guide the application, not traditional Chinese medicine."


        "I would rather prescribe soup medicine for patients." Yang Xiaohui, chief physician of the Oriental Hospital of Beijing University of Traditional Chinese Medicine, is an endocrinologist who has research on diabetes. He said that although the compound Chinese and western medicine preparations had played an active role in certain historical periods, the related basic research was relatively weak, and many problems were difficult to explain at present, which brought certain difficulties to the rational application of clinicians. However, since many of these drugs are OTC varieties, the amount is still large.


        "I personally think that this kind of medicine is not very valuable, because doctors can prescribe two medicines, instead of fixed ingredients and fixed proportions." Professor Lu Feng of the Department of Pharmaceutical Analysis, Second Military Medical University believes that the ingredients are separate Or compared with new medicines with western medicine ingredients, the combination of Chinese and Western medicine has higher requirements for research and development. He said that this is not a simple one-to-one or one-to-two problem. Rather, it is necessary to study both the efficacy and safety of western medicine ingredients, as well as the efficacy and safety of traditional Chinese medicine ingredients. The curative effect is greater than that of using the medicine alone, and can at least reduce the occurrence of toxic and side effects. It is also necessary to explain the synergy between these traditional Chinese and western medicine ingredients and other traditional Chinese and western medicines. Such R & D requirements are currently difficult to meet.


        Re-evaluation of Chinese and western medicine compound preparations should be carried out


        At present, there are very few reports on the adverse reactions of Chinese and western medicine compound preparations. According to relevant experts, because the main body of this kind of drugs is OTC varieties, and 80% to 90% of adverse reactions in China are provided by medical institutions, not pharmaceutical companies and ordinary patients, so there are not many related studies.


        In February 2009, the article "A Literature Analysis of 36 Cases of Severe Hypoglycemia Induced by Xiaoke Pills" published by "Chinese Journal of Pharmacovigilance" was one of the few literatures that summarized and analyzed the application of such drugs. This article analyzed 36 cases of severe hypoglycemia caused by Xiaoke Pills retrieved from the Chinese Journal Full-text Database from 1994 to 2008. Among them, there were 28 cases of hypoglycemic coma, 7 cases of death caused by severe hypoglycemia, and 1 case of severe hypoglycemia.


        Xiaohui Yang has also been concerned about the safety of Xiaoke Pills. He pointed out that many of the adverse reactions were caused by the public's lack of knowledge of the western medicine ingredients, overdose, and repeated application of similar western medicines. The article "Adverse Reactions and Reasonable Application of Xiaoke Pills", published by the "Chinese Pharmacovigilance" magazine in March 2006, and other scholars, believed that the adverse reactions of the drug were mainly related to the following factors: The chemical drug glibenclamide is the main cause of hypoglycemia; the clinical use is unreasonable, and the response to hypoglycemia is not timely; the patient lacks sufficient knowledge of the drug formula and is not used strictly under the guidance of a doctor.


        Zhou Chaofan believes that it is necessary to be cautious about the combination of Chinese and Western medicine, and neither rush to affirm or rush to deny it, but to summarize the pros and cons of the combination of Chinese and western medicine in a timely manner from the clinical reality. As a way of drug innovation, the combination of Chinese and western medicine is also a research direction. The key is to improve basic and clinical research. It has been confirmed that such preparations can achieve a clinical efficacy of 1 + 1 and greater than 2, and can reduce toxic and side effects.


        "Any drug has an adverse reaction. The occurrence of an adverse reaction does not mean that the safety of the drug cannot be guaranteed. The same is true for the Chinese and Western medicine compound preparations. The public should treat it as a guest. In the current situation where the basic research on the Chinese and Western medicine compound preparations is relatively weak, It is necessary to evaluate the Chinese and western medicine compound preparations after they are marketed, "said Yang Xiaohui.


        Some people in the industry also said that manufacturers of Chinese and Western medicine complexes should take the initiative to assume social responsibilities instead of covering up. First of all, product specifications, packaging and labeling should be improved, and relevant safety information should be added to remind doctors and patients which drugs are Chinese and western medicine compound preparations. Secondly, re-evaluation of drugs after marketing is launched to promote clinical rational and safe application.

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