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Adulteration and Contaminants in Chinese Patent Medicines
Summary
Chinese Patent Medicines
Adulteration and Contamination Issues: An Introduction
Chinese herbs are often consumed in what are called proprietary or patent medicines. Patent medicines from China have many inherent problems, some reminiscent of the patent medicines used in America at the turn of the twentieth century. This summary will introduce some of the important documented problems.
• patent medicines toxicity concern: The use of patent medicines from mainland China is inadvisable under any circumstances, unless one is trained in Chinese herbal product identification and the products have clear indications of having been produced in accordance with GMP quality control standards.
For a discussion of the issues involving Stephania, Aristolochic Acid and Chinese Herb Nephropathy see that topic.
See also Chinese Herbs: Toxicity and Interactions Issues in Chinese Herbal Medicine
patent medicines toxicity concern: Heavy metal contamination.
• A number of products have been found to have heavy metal contamination, including lead and mercury. The possible sources of lead and mercury can be accidental contamination from processing machinery used in China or accumulation during cultivation from soil contamination. Some formulae actually contain lead or mercury containing ingredients, such as minim or cinnabar. Finally, the coating of traditional pills called "dan" is often made from cinnabar, a mercury containing substance. Responsible modern practitioners no longer use such ingredients in their prescriptions. However, they still may appear as ingredients or contaminants in illegal patent medicines from China. Several instances of poisoning from heavy metals are noted in the medical literature.
(Zhang ZW, et al. Sci Total Environ 1998 Sep 18;220(2-3):137-145; Kang-Yum E, Oransky SH. Vet Hum Toxicol 1992 Jun;34(3):235-238; Tie B, et al. Chung Kuo Chung Yao Tsa Chih 1990 Oct;15(10):602-604, 639; Chan TY. Vet Hum Toxicol 1994 Jun;36(3):238-240; Fratkin J. Oriental Medicine Journal. Vol. 6, No. 3-4, Fall/Winter 1997.)
patent medicines toxicity concern: Pharmaceutical adulterants.
• A number of products have been found to have been adulterated with pharmaceutical drugs. According to a study by the Taiwanese FDA, these products may include drugs such as acetaminophen, aminopyrine, caffeine, chlormezanone, chloroxazone, diazepam, diclofenac, ethoxybenzamide, hydrochlorothiazide, ibuprofen, indomethacin, ketoprofen, mefenamic acid, papaverine, phenylbutazone, piroxicam, prednisolone and salicylamide. 25-30% of herbal formulae sold in East Asian herbal stores and Chinese medicine clinics for the treatment of asthma, pain and arthritis were found to contain drugs.
• It has been suggested the situation in the U.S. is not much better than that in Asia. The popular cold and sinus remedies Yin Chiao Chieh Tu Pian, Bi Yan Pian, Pe Min Kan Wan, Gan Mao Ling, Zhong Gan Ling contain decongestants, analgesics or antihistamines. The Black Pills for Arthritis may contain phenylbutazone, hydrochlorothiazide, indomethacin, aminopyrine and acetaminophen, depending on manufacturer and batch. Diazepam is present in most samples. Most of these are prescription or discontinued drugs and have dangerous, even fatal consequences. Other arthritis products of concern include Vine Essence Pills and Ox Head Brand Tong Shu
i Wan. Some patent medicines, reputedly beneficial for heart disease, contain drugs such as toad venom (Seven Flower Pills). Quite a few creams for skin complaints contain cortisone or antibiotics. Cortisone is often labeled as "unguentum flourocortisoni acetatis."
(Dharmananda 11/99; Huang WF, et al. J Clin Pharmacol 1997 Apr;37(4):344-350; Fratkin JP. Oriental Medicine Journal. Vol. 6, No. 3-4, 1997; Ries CA, Sahud MA. JAMA 1975 Jan 27;231(4):352-355.)
• herbal toxicity concern: Most nontoxic herbs require substantial dosages to exert any effect at all in pill form. If a patent medicine exerts a strong effect of any kind from a small dosage, one should immediately suspect drug adulteration.
patent medicines toxicity concern: Single active compound isolates.
A number of products are not herbs per se, but single isolated constituents, effectively making them unapproved drugs, most notably the now banned Jin Bu Huan. Others include Qi Ye Lian, Yan Hu Suo Tong Zhi Pian and Saloton. Jin Bu Huan was the cause of a number of serious problems. A single, acute ingestion in children rapidly produced life-threatening neurologic and cardiovascular manifestations, while long-term Jin Bu Huan use in adults was associated with hepatitis. The active ingredient, levo-tetrahydropalmatine, is potent and potentially dangerous, as it acts directly on the central nervous system. Jin Bu Huan has been banned in California and other jurisdictions.
(Dharmananda 11/93; Picciotto A, et al.J Hepatol 1998 Jan;28(1):165-167; Horowitz RS, et al. Arch Intern Med 1996 Apr 22;156(8):899-903; Woolf GM, et al.Ann Intern Med 1994 Nov 15;121(10):729-735; MMWR Morb Mortal Wkly Rep 1993 Dec 3;42(47):920-922; MMWR Morb Mortal Wkly Rep 1993 Aug 27;42(33):633-636.)
patent medicines toxicity concern: Toxic herbs.
A few products contain poisonous herbs and should not be consumed under any circumstances. In almost all known cases of poisoning from Chinese herbs, the toxic components came from preparations containing aconitine, podophyllin or anticholinergics, except for the preparations containing dangerous pharmaceutical drugs or heavy metals, as mentioned above or isolated cases that are probably due to allergic hypersensitivity.
(Chan TY, Critchley JA. Hum Exp Toxicol 1996 Jan;15(1):5-12; Chan TY, et al. Hum Exp Toxicol 1995 May;14(5):434-436; Chan TY, et al. Vet Hum Toxicol 1994 Oct;36(5):452-455; Chan TY, et al. Aust N Z J Med 1993 Jun;23(3):268-271; But PP.J Trop Med Hyg 1994 Dec;97(6):371-374; Ferguson JE, et al. Br J Dermatol 1997 Apr;136(4):592-593.)
Herbs
Contamination Data: Chinese Patent Medicines
The following medicines were found to contain toxic levels of arsenic, mercury, or lead, or had the addition of western pharmaceuticals. This list is not all-inclusive of The Compendium of Asian Patent Medicines (California Department of Health Services, Food and Drug Branch. 1997) compiled by Richard Ko, Pharm.D., Ph.D. and Alice Au, Ph.D. This list focuses on those products that are commonly used by practitioners, and that pose a significant health risk. The USP lists toxic levels of lead at >10 ppm, and mercury or arsenic at > 3 ppm. Bear in mind that doctors of traditional Chinese medicine in China can and will justify the inclusion of mercury or arsenic as a necessary therapy for heat toxins, fever, or disturbed shen when done in a supervised manner and for short periods of time. High levels of mercury and arsenic, however, are unacceptable, and the conscientious practitioner should become aware of products posing a health risk.
(Reproduced, with permission, from Fratkin JP. Toxic Contaminants in Chinese Patent Medicines. Oriental Medicine Journal. Vol. 6, No. 3-4, Fall/Winter 1997.)
The problem of adulterants and contaminants in Chinese patent products, as well as the rapid appearance of a significant number of counterfeit products, has been exacerbated in recent years by the emergence of increased entrepeneurial activity and non-governmental manufacturing facilities in the Peoples Republic of China.
Please note the particular manufacturer of a contaminated product. Other factories may use the same or similar English name for a contaminated product listed below, when in fact they may be pure.
• An Gong Jiang Ya Wan, Beijing Tung Jen Tang, Beijing.
Application: High blood pressure.
Contaminants: Arsenic 192 ppm.
• An Kung Niu Huang Wan, Beijing Tung Jen Tang, Beijing.
Application: High fever.
Contaminants: Lead 184 ppm, Arsenic 46,400 ppm, Mercury 1450 ppm
Comment: An extremely toxic level of arsenic.
• Ansenpunaw, Chung Lien Drug Works, Hangzhou.
Application: Insomnia, palpitation.
Contaminants: Arsenic 60 ppm, Mercury 3590 ppm.
Comment: A very toxic level of mercury.
• Chin Koo Tieh Shang Wan, Tianjin Lerentang Pharmaceutical Factory, Tianjin.
Application: Trauma.
Contaminants: Lead 11 ppm, Arsenic 35 ppm.
Comment: These are low levels of contamination, but they may cause a problem if taken over a period of time. Plum Flower offers a non-contaminated version.
• Ching Chun Bao: Recovery Of Youth Tablets, Hangzhou Chinese Medicine Factory.
Application: Geriatric tonic.
Contaminants: Arsenic 20 ppm.
Comment: This is a low level of contamination. As a tonic, however, long term usage can cause an accumulative affect.
• Compound Prescribed Water Melon Frost, Guilin Chinese Medicines Pharmaceutical Factory, Guilin.
Application: Sore throat.
Contaminants: Arsenic 1360 ppm, Mercury 1230 ppm.
Comment: Arsenic and mercury levels are high. Please note that the following versions are uncontaminated: Compound Watermelon Frost, Guilin Chinese Medicine Factory; Water Melon Frost, Fei Shan United Manufactory.
• Ding Xin Wan, Min-Kang Drug Manufactory, Yichang.
Application: Insomnia, palpitation.
Contaminants: Lead 77 ppm, Mercury 1750 ppm.
Comment: This is a high level of mercury.
• Du Huo Jisheng Wan, Min-Kang Drug Manufactory,Yichang.
Application: Lower back pain.
Contaminants: acetominophen*
Comment: Plum Flower offers the same product in a non-contaminated version.
• Fargelin For Piles, United Pharmaceutical Manufactury, Guangzhou.
Application: Hemorrhoids.
Contaminants: Arsenic 20,200 ppm.
Comment: This is a very toxic level of arsenic.
It should not be confused with High Strength Fargelin For Piles, United Pharmaceutical Manufactury; Guangzhou.
• Gan Mao Qing Capsules, Bai Yun Pharmaceutical Factory, Guangzhou.
Application: Common cold or flu.
Contaminants: Acetaminophen, chlorpheniramine*.
Comment: There are many similar formulas without western pharmaceuticals.
• Ganmao Pien, Tianjin Drug Manufactory, Tianjin.
Application: Common cold or flu.
Contaminants: Lead 241 ppm.
Comment: This is a moderately toxic level of lead. Also, there are many similar formulas without heavy metals.
• Guanxin Suhe Jiaonang, Jing Xi Tang Pharmacy, Guangzhou.
Application: Coronary heart disease, angina.
Contaminants: Arsenic 74 ppm.
Comment: This is a moderately toxic level of arsenic.
• Hong She Pills, Chung Lien Drug Works, Wuchang (Hubei).
Application: Bi syndrome, arthritis, rhuematism.
Contaminants: Mercury 181 ppm, strychnine, ephedrine.
Comment: This has a moderate level of mercury. Strychnine is found in the Chinese herb Strychnos Ma Qian Zi, and ephedrine is found in Ephedra (Ma Huang).
• Huang Lien Shang Ching Pien, Tientsin Drug Manufactory, Tianjin.
Application: Bacteriaol infections of the throat, gums or eyes.
Contaminants: Pugelone, phenacetin*.
Comment: Plum Flower offers the same product in a non-contaminated version.
• Hui Chun Dan, Kwong Tong Fushan Pharmaceutical Manufactory, Fushan.
Application: Pediatric fever.
Contaminants: Lead 56 ppm, Arsenic 32 ppm, Mercury 50 ppm.
Comment: Not commonly available.
• Kai Yeung Pill: Trisnake Itch-Removing Pill, Wuzhou People's Pharmacy, Guangxi.
Application: Skin itching.
Contaminants: Lead 5 ppm, Arsenic 51 ppm.
Comment: Safer versions are available from Hanyang Pharmaceutical Works; Hubei, and from Plum Flower.
• Kang Gu Zeng Sheng Pian, United Pharmaceutical Manufactory, Foshan.
Application: Vertebral calcification.
Contaminants: Arsenic 21 ppm, Mercury 35 ppm.
Comment: These are low but significant levels of contamination.
• Lu-Shen-Wan, Shanghai Chinese Medicine Works, Shanghai.
Application: Sore throat.
Contaminants: Lead 40 ppm, Arsenic 82,000 ppm, Mercury 3850 ppm, resibufogenin.
Comment: Very toxic level of arsenic and mercury.
• Nan Bao, Tianjin Li Sheng Pharmacy, Tianjin.
Application: Male impotence or poor sexual function.
Contaminants: Lead 68 ppm.
Comment: This is a moderate level of lead contamination.
• Niu Huang Chieh Tu Pien-Bezoar Antipyretic Pills, Peking Tung Jen Tang.
Application: High fever.
Contaminants: Arsenic 59 ppm.
Comment: Taiwan also found this product contaminated with mercury, as well as a product by the same name manufacturered by Tientsin Drug Manufactory, Tianjin.
• Niu Huang Ching Hsin Wan, Tientsin Drug Manufactory, Tianjin.
Application: High fever.
Contaminants: Arsenic 4520 ppm, Mercury 2080 ppm.
Comment: These are very toxic levels of arsenic and mercury.
• Pe Min Kan Wan, United Pharmaceutical Manufactory, Fushan.
Application: Sinus congestion.
Contaminants: Chlorpheniramine*.
Comment: There are many clean versions of this product by other manufacturers, including Fo Shan Herbal and Yu Lam Medicine Factory. Plum Flower also offers it in a non-contaminated version.
• Ren Shen Zai Zao Wan, Kwong Tong Fushan Pharmaceutical Manufactory, Foshan.
Application: Wei syndromes, post-stroke, trembling of limbs.
Contaminants: Mercury 827 ppm.
Comment: This is a toxic level of mercury.
• San She Dan Chuan Bei Powder, United Pharmaceutical Manufactory, Guangzhou.
Application: Cough.
Contaminants: Arsenic 148 ppm.
Comment: This is a significant level of arsenic contamination. Do not confuse it with the glass vial liquid, San She Dan Chuan Bei Ye.
• Shu Kan Wan: Hepatico-Tonic Pills, Lanchow Chinese Medicine Works, Lanzhou.
Application: Liver-stomach dysharmony.
Contaminants: Arsenic 49 ppm.
Comment: Plum Flower offers the same product in a non-contaminated version.
• Tao Chih Pien (For Babies), Tientsin Drug Manufactory, Tianjin.
Application: Pediatric fever.
Contaminants: Arsenic 26 ppm.
• Ta Huo Lo Tan, Beijing Tung Jen Tang; Beijing.
Application: Bi and Wei syndromes, arthritis.
Contaminants: Arsenic 30,900 ppm.
Comment: This is an very toxic level of arsenic.
• Tian Wang Bu Xin Wan, Min-Kang Drug Manufactory, Yichang.
Application: Insomnia, Shen disturbance.
Contaminants: Lead 5 ppm, Mercury 1580 ppm
Comment: This is a high level of mercury contamination. Plum Flower offers the same product in a non-contaminated version.
• Tien Wang Pu Hsin Tan, Lanchow Chinese Medicine Works, Lanzhou.
Application: Insomnia, Shen disturbance.
Contaminants: Mercury 2290 ppm.
Comment: A high level of mercury contamination. This is a confusing entry, because an identical looking package, Tien Wang Pu Hsin Tan, Lanzhou Foci Pharmaceutical Factory; Lanzhou, had no contaminants. This product (above) may in fact be a countefeit. Plum Flower offers the same product in a non-contaminated version.
• Tin Tzat To Chung Pills, Shan Sai Hang Lam Medicinal Manufactory.
Application: Bi syndrome, arthritis and rheumatism.
Contaminants: Lead 62 ppm.
Comment: This is a moderate level of lead contamination.
• Tsai Tsao Wan, Tientsin Drug Manufactory, Tianjin.
Application: Wei syndromes, flaccid paralysis, trembling of limbs.
Contaminants: Mercury 204 ppm.
• Tung Shueh Pills (Cow's Head Brand), Ta Ang Pharm Co; Kaohsiang, Taiwan.
Application: Bi syndrome, arthritis and rheumatism.
Contaminants: Diazapam, chlorzoxanone, caffeine, chlormezanone*.
• Yen Shun Zai Zao Wan, Fushan United Med. Fact. Guangzhou
Application: Wei syndromes, post-stroke, trembling of limbs.
Contaminants: Lead 51 ppm, Mercury 1500 ppm.
Comment: These are high levels of lead and mercury contamination.
• Zhong Gan Ling, Meizhou City Pharmaceutical; Guangdong
Application: Viral cold or flu.
Contaminants: Mercury 22 ppm; chlorpheniramine, dipyrone*.
Comment: This formula is available in a non-contaminated version by Golden Flower.
In addition to the material published in The Compendium, the American-based Chinese herbal product manufacturer and distributor, Mayway USA sent patent medicines out for laboratory analysis, and reports the following contaminants. Parts per million (ppm) of heavy metals, or amounts of other additives, were not reported. The information however, is important to practitioners and again, caution is advised in using the following medicines.
• Bi Tong Pian, Guangzhou Medicine and Health.
Application: Sinus congestion.
Contaminants: Chlorpheniramine*
• Bi Yan Pian, Chung Lien Pharmaceutical Works.
Application: Sinus congestion.
Contaminants: Acetaminophen*.
Comment: Plum Flower offers the same product in a non-contaminated version.
• Farfunpeiminkam Wan, Foshan United Pharmaceutical Co., Foshan.
Application: Sinus congestion.
Contaminants: Chlorpheniramine*.
• Gan Mao Ling, United Pharmaceutical, Guangzhou.
Application: Cold, flu, respiratory viral infection.
Contaminants: Acetaminophen, caffeine*.
Comment: Plum Flower offers the same product in a non-contaminated version.
• High Strength Yin Chiao, United Pharmaceutical, Guangzhou.
Application: Cold, flu, respiratory viral infection.
Contaminants: Acetaminophen, pulegone*.
• Margarite Acne Pills, Foshan United Pharmaceutical Manufactory.
Application: Asthma.
Contaminants: Sophoridane*.
Comment: Plum Flower offers the same product in a non-contaminated version.
• Niu Huang Chiang Ya Wan, Tianjin Pharmaceutical Manufactory.
Application: High blood pressure.
Contaminants: Mercury, Lead.
• Niu Huang Chiang Ya Wan, Peking Tung Jen Tang, Beijing.
Application: High blood pressure.
Contaminants: Mercury, Lead.
The following pharmaceutical drugs are prohibited for use in these products by the FDA:
• Acetaminophen (analgesic, e.g., Tylenol®).
• Chlormezanone (tranquilizer).
• Chlorpheniramine (antihistamine).
• Chlorzoxanone (antispasmodic).
• Diazapam (tranquilizer, trade name: Valium®).
• Dipyrone (analgesic).
• Phenacetin (analgesic and antipyretic).
• Pulegone (promotes menstrual flow).
• Resibufogenin (cardiotonic).
• Sophoridane.
The following list of products were reported in The Compendium as being uncontaminated, or having heavy metals within USP acceptable levels (specifically, lead below 10 ppm). This represents a test done on a single sample of the medicine, and may not be true for all batches. Also, even if the product is uncontaminated, it still may be banned in California due to Category 3: "Making claims on the labeling for the treatment or prevention of serious medical conditions/diseases for which a person should seek professional medical help."
• Alopecia Areata Pill, China National Chemicals Import-Export Corp, Guangdong.
• An Shen Bu Xin Wan, Shanghai Native Medicine Works, Shanghai; also available as:
An Sheng Pu Shin Wan, Shanghai Native Medicine Works, Shanghai.
• Bu Shen Pill, Sing-Kyn Drug House; Guangzhou.
• Dendrobrium Moniliforme Night Sight Pills, Tientsin Drug Manufactory, Tianjin.
• Eight Flavor Tea, Lanchow Chinese Medicine Works; Lanzhou; also available as:
Chih Pai Di Huang Wan, Lanzhou Foci Pharmaceutical Manufactory, Lanzhou
Zhi Bai Ba Wei Wan, Lanzhou Foci Pharmaceutical Manufactory, Lanzhou
Zhi Bai Di Huang Wan, Lanzhou Foci Pharmaceutical Manufactory, Lanzhou.
• Eight Treasure Tea, Lanchow Chinese Herb Works, Lanzhou; also available as:
Ba Zhen Wan, Lanzhou Foci Pharmaceutical Factory, Lanzhou
Nu Ke Ba Zhen Wan, Lanzhou Foci Pharmaceutical Factory, Lanzhou
Women's Precious Pills, Lanzhou Foci Pharmaceutical Factory, Lanzhou.
• Gui Pi Wan, Lanchow Foci Herb Factory; Lanzhou; also available as:
Angelicae Longana Tea, Lanchow Chinese Medicine Works, Lanzhou
Kwei Be Wan, Lanchow Chinese Medicine Works, Lanzhou.
• Gejie Nourishing Kidney Pills, Yulin Pharm. Factory; Yulin; also available as:
Gejie Bu Shen Wan, Yulin Drugs Manufactory, Yulin
Gejie Bu Shing Wan, Yulin Drugs Manufactory, Yulin.
• Golden Book Teapills, Lanzhou Foci Herb Factory; Lanzhou; also available as:
Sexotan, Lanchow Chinese Medicine Works, Lanzhou.
• Kai Kit Pill, Hanyang Pharmaceutical Works, Hanyang.
• Lien Chiao Pai Tu Pien, Tianjin Drug Manufactury; Tianjin
• Liu Wei Di Huang Wan, Lanzhou Fo Ci Pharmaceutical Manufactory; also available as:
Six Flavor Tea, Lanzhou Foci Pharmaceutical Manufactory, Lanzhou
Six Flavor Teapills, Lanzhou Foci Herb Factory, Lanzhou.
• Prostate Gland Pills, Wai Yeung District Medicine Company, Guangdong.
• Sea Horse Genital Tonic Pills, Tianjin Drug Manufactory; also available as:
Sea Horse Herb Tea, Tianjin Drug Manufactory; Tianjin.
• Specific Drug Passwan, Mai Yun Shan Pharm. Manufactory, Guangzhou
• Tabellae Suan Zao Ren Tang, Sing-Kyn Drug House, Guangzhou.
• Tian Wang Bu Xin Dan, Lanchow Foci Pharm. Factory, Lanzhou; also available as:
Emperor's Tea, Lanchow Foci Pharmaceutical Factory, Lanzhou
Tien Wang Pu Hsin Tan, Lanchow Foci Pharmaceutical Factory, Lanzhou.
• Tzepao Sanpien Pills, Yantai Pharmaceutical Works, Yantai.
• Wuchaseng Tablet, Harbin Chinese Medicine Factory; Harbin
• Yeuchung Pills, United Pharmaceutical Manufactory, Szechuan.
• Yu Quan Thirst Removing Pills, Xinkang Pharmaceutical Factory, Beijing. |
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