Baiyunshan Ganmaoqing Capsule was recalled

In October, the Chinese patent medicine "Baiyunshan Ganmaoqing Capsule" produced by Guangzhou Baiyunshan Pharmaceutical General Factory was recalled by the Hong Kong Department of Health for the detection of the western medicine ingredient paracetamol (commonly known as "paracetamol"). It is understood that "Baiyun Mountain Ganmaoqing Capsule" is only one of the four "Chinese medicines containing western medicine ingredients" recalled in Hong Kong this year. In Hong Kong, proprietary Chinese medicines are not allowed to add western medicines. Such medicines are legal in the Mainland and are widely distributed in the market.

Baiyunshan denied adding western medicine ingredients

The recalled Baiyunshan Brand Ganmaoqing Capsule contained 0.29 mg/captule of acetaminophen, which was a trace amount. The Guangzhou Baiyunshan Pharmaceutical Factory issued a statement saying that this batch of drugs was processed by the Hong Kong Tat Trading Co., Ltd., and only the packaging process was undertaken. As for why the western drug ingredient was detected in paracetamol, Baiyun Mountain Pharmaceutical Factory And know. It is understood that the prescriptions of “Feng Liang Qing Capsule” provided by Dazhixing Trading Company are all Chinese medicines and do not contain Western medicine ingredients.

According to a preliminary survey conducted by the Hong Kong Department of Health, Tatoshi Trading Co., Ltd. is responsible for the external packaging of imported products. Since the product is not exposed during this process, it is less likely to be contaminated. Although trace amounts of acetaminophen were detected in the product, it is still possible that the product was intentionally added to the product or cross-contamination occurred during the production process.

Du Guanhua, director of the China Pharmacology Society and a researcher at the Institute of Materia Medica, Peking Union Medical College, believes that acetaminophen is a foreign substance and it is almost impossible to mix in due to operational errors. Whether deliberately adding or cross-infecting has become the focus of this issue. The reporter repeatedly called the Guangzhou Baiyun Mountain Pharmaceutical Factory, hoping to get the arguments of the parties, and the other party refused with the “relevant person in charge is not there”.

There are differences in the management of proprietary Chinese medicines

Impure "Proprietary Medicine" Circulates in the Mainland Market

The Baiyunshan Brand Ganmaoqing Capsule was not the first proprietary Chinese medicine that caused “impure ingredients” to “touch the reef” in Hong Kong. In the same month, a proprietary Chinese medicine made in the Mainland was also recalled by the Hong Kong Department of Health for the inclusion of two unlabeled western medicines, losartan and atorvastatin.

Although the Baiyun Mountain Pharmaceutical Factory has been “screaming” during the recall, it is true that the cold clear capsules produced and sold in the Mainland contain western medicine ingredients. On the website of the Guangzhou Baiyunshan Pharmaceutical Factory, the reporter found that in addition to acetaminophen, there are two western medicine components, namely moroxydine hydrochloride and chlorphenylamine maleate.

This "different inside and outside" is rooted in the differences in the standard system for proprietary Chinese medicines in Hong Kong and the Mainland. Hong Kong's TCM standards are far more stringent than in the Mainland, which means that western medicines are not allowed to add western medicine ingredients. In the Mainland, the addition of western medicines to proprietary Chinese medicines is not only allowed but also very common.

In a pharmacy, the reporter scrutinized several proprietary Chinese medicines on the shelves, and found that Chinese medicine containing western medicine ingredients was found. Like Jinling capsule produced by Guizhou Bailing Enterprise Group Tiantaishan Pharmaceutical Co., Ltd., in addition to traditional Chinese medicine ingredients such as honeysuckle and Andrographis paniculata, there are three kinds of western medicine: acetaminophen, amantadine hydrochloride, and chlorphenamine maleate. ingredient. The Chinese medicine that we are most familiar with is a cold Chinese medicine called C Yinqiao tablets. At least, it contains vitamin C, which is a western medicine ingredient. In addition, western medicine ingredients added to this medicine include chlorpheniramine maleate ( Also known as chlorpheniramine), acetaminophen. The difference is that the packaging of the Jingan capsule is clearly marked with “containing two groups of Chinese and Western anti-viral components”, and the content of acetaminophen in each drug is also indicated in the specifications. The Vitamin C Yinqiao tablets did not provide any warning information for the western medicine ingredients.

The biggest hidden concern with western medicine ingredients is not marked

This is actually one of the biggest concerns of Chinese medicine adding western medicine ingredients. Patients are overly superstitious. “Chinese patent medicines are pure Chinese medicine preparations.” Western medicine ingredients in proprietary Chinese medicines are often overlooked, and medicines with overdosed or reused names but with similar ingredients are often overlooked. Cause side effects.

Take Wei C Yinqiao Tablets as an example. According to the adverse drug reaction information bulletin announced by the State Food and Drug Administration in September 2010, in the case of taking 1885 cases of adverse reactions of Vitamin C Yinqiao Tablets, the patients did not use the dosage according to the instructions. Use or combine the use of other drugs that are similar to the drug ingredients, or use drugs that are allergic to the contained ingredients. The paracetamol detected in the "Baiyunshan Ganmaoqing Capsule" has been proven to be harmful to patients with poor kidney function or liver and kidney insufficiency in long-term or large-scale use. Pregnant women are sensitive to this ingredient and need to be careful.

According to the “Manifesto and Label Management Regulations” promulgated by the State Food and Drug Administration, western medicine ingredients containing proprietary Chinese medicines must clearly indicate the ingredients and dosage of Western medicine contained in them. However, there are many unqualified Chinese medicine companies that do not perform labeling. Unconsciously, the patient may be overdosed and cause drug poisoning.

"Mixed" proprietary Chinese medicines count "middle" as "West"?

According to statistics, of the more than 5,000 proprietary Chinese medicines that have been approved for registration by the country, at least more than 200 are proprietary Chinese medicines that contain western medicines. Such proprietary Chinese medicines are collectively referred to as "Chinese and Western medicine compound preparations." However, the current national drug classification is only Chinese medicine, chemical medicine (ie, Western medicine) and biological medicine, and there is no "Chinese and Western medicine compound preparation."

In the packaging of some Chinese medicines containing western medicine ingredients, the reporter noticed that most of the approval numbers for such medicines began with the “Zizi Zhuzi Z”. The director of the Department of Clinical Pharmacy at the Pharmacy Department of Oriental Hospital Affiliated to Beijing University of Chinese Medicine explained to the reporter that the drug approval number has the following provisions in the Drug Registration Administrative Measures: “The format of the drug approval number is: Zhunzi H(Z, S, J) + 4 digits + 4 digits, where H represents chemicals, Z represents traditional Chinese medicines, and S represents biological products."

It is not difficult to see from the drug approval number that "Chinese and Western medicine compound preparations" are demarcated within the scope of Chinese medicine.

Then, can Chinese patent medicines with Western medicine ingredients be counted as traditional Chinese medicine? Zhang Zhuren said that when each new drug application is registered, the State Food and Drug Administration will issue a corresponding drug registration certificate according to the information submitted by the production enterprise in accordance with the “Registration Measures for Drug Registration” after passing the review. If Z is awarded, it means that the drug complies with the relevant regulations of Chinese medicine registration.

However, in the eyes of some Chinese medical experts, there is no theoretical basis for the addition of western medicines to proprietary Chinese medicines. According to Professor Li Yan, the dean of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine and an expert on traditional Chinese medicine, the treatment of traditional Chinese medicine is a process of comprehensive conditioning and correction. The thinking of TCM is macroscopic. A headache may not be the first one. A foot may not necessarily cure the foot. It is concerned with the root causes of internal and external causes of the disease. It may be directly attacking evils in treatment, or it may be through adjustment of yin and yang qi and blood. Dirty balance eliminates the internal and external environment of the disease. Western medicine mostly starts with a microscopic view to find the physical cause of the disease and directly eliminates it as a basic idea. Different ideas are integrated into a prescription, and the best results may not be achieved from the perspective of either Chinese or Western medicine.

Chinese and Western medicine compound preparation is "historical legacy product"

In this case, why does China still allow Chinese and Western medicine compound preparations to exist? Some experts explained that the existence of Chinese and Western medicine compound preparations is "a historical issue." In the 1960s and 1970s, there was a wave of “Western learning and middle school learning” trends in the Chinese medical community. Since there were no national drug administration regulations at that time, various local departments independently approved many Chinese and Western medicine compound preparations and applied them in a wide range of clinical treatments, some of which are still in use today. At present, most of the Chinese and Western medicine compound preparations that have been circulated on the market were approved before the 1980s. In the past 20 years, there have been very few new Chinese and Western medicines. Regarding these “historical legacy products” that have proven to be “a combination of Chinese and Western medicines” that help increase drug efficacy and have unclear drug side effects, according to an expert, the SFDA currently holds a “don't encourage or approve” attitude.

â– Experts say that Chinese and Western medicines are contraindicated

Hong Kong's ban on Chinese and Western medicine compound preparations in the Mainland can not help but raise the question: Does this mean that there is a certain degree of safety in the compatibility of Chinese and Western medicine ingredients?

In this regard, the director of the Department of Clinical Pharmacy at the Department of Pharmacy, Eastern Hospital Affiliated to Beijing University of Chinese Medicine, said that the traditional Chinese and Western medicine compound preparations currently on the market have been scientifically justified, and there is no problem in composition.

"The correct combination of Chinese and Western medicines can have a multiplier effect, and it can receive the effect of treating both the symptoms and the symptoms, synergies, and the reduction of adverse reactions. However, if it is used improperly, it will reduce or eliminate the efficacy, and the This leads to aggravation of the disease and even death. In this regard, doctors may evade prescriptions when prescribing prescriptions. If patients use OTC medicines on their own, they must pay attention to the compatibility of the following Chinese and Western medicines, such as Chinese herbal medicines that contain more tannins, and those containing earthworms. Dijijiao Pills and Qijisan containing catechu should not be used in combination with pepsin mixture, amylase, multienzyme tablets, etc., because the latter contains protein, and the peptide bond or amide bond in the structure binds to tannin. Reaction, hydrogen bond formation and denaturation, causing indigestion, symptoms such as nausea; metal ions containing iron, magnesium, calcium, lead, bismuth and other traditional Chinese medicine and Chinese medicine with some Western medicine, metal ions can be with drugs In combination with the formation of poorly soluble complexes, affect absorption, leading to reduced efficacy; Chinese traditional medicines containing realgar Niuhuang Jiedu Pills, Niuhuangqingxin Pills, and Western medicines containing sulfates and nitrates such as sulfur When ferrous and magnesium sulfate are used in combination, arsenic sulfide, the main component of realgar, will oxidize and increase toxicity; for example, adding Chinese medicine or decoction that has certain corticosteroids, such as licorice and pilose antler, will work against antihypertensive drugs. Therefore, attention should be paid to systemic reactions such as circulation after dosing in clinical practice."