Quality Assurance品質管制

Quality control tests

  1. 1. General Inspections
  2. 2. Species Authentication
  3. 3. Sulfur Dioxide Detection
  4. 4. Essential Oil Detection
  5. 5. TLC Identification
  6. 6. Aflatoxins Detection
  1. 7. Aristolochic Acid Detection
  2. 8. Heavy Metals Detection
  3. 9. Pesticide Residuals Detection
  4. 10. Mark Substance Detection
  5. 11. Microbial Test

1. General Inspections

The quality of Chinese herbs shall be tested based on the specifications in Chinese Pharmacopoeia Taiwan.

  1. Loss on Drying:To measure the moisture content in the Chinese herbs. The moisture content will affect the storage stability of herbs. If the moisture content is too high, the herbs are vulnerable to mold.
  2. Determination of ash & acid-insoluble ash:To measure the amount of non-volatile inorganic salt in the Chinese herbs, and could be used as a reference to determine the cleanliness of the herbs.
  3. Dilute ethanol-soluble extract:To measure the content of fat-soluble constituents in the Chinese herbs.
  4. Water-soluble extract:To measure the content of water-soluble components in the Chinese herbs.

2. Species Authentication

The species of Chinese herbs are complex due to the herbs are derived from natural plants, animals and minerals. The incidents of misuse of inauthentic herbs, mistaken identification or the substitution of imitation herbs are always happened because of the similarity of herbs. Therefore, species authentication is a very crucial process to determine the correct species, origin and quality of Chinese herbs.
Ko Da performs the following methods of authentication on raw herbs:

  1. Appearance:Identify based on the appearance including form, size, colour, texture, fracture, gross internal structures, odour/smell, taste, and other relevant information of raw herbs.
  2. Microscopic analysis:Observe the plant tissues of Chinese herbs.
  3. Physical/Chemical identification:Test on color reaction, gas-forming reaction, etc.
  4. Impurity analysis:Analyze the non-medicinal part and other impurity contents of the herbs.
  5. Thin-layer chromatography (TLC):It's a qualitative determination process to authenticate if the herb contains mark substance or the consistency of mark substance among the sample herb and reference standard of herb.
  6. Chemical fingerprinting:Build the fingerprint and content of mark substance of the herbs via HPLC.

3. Sulfur Dioxide Detection

There are many Chinese herbs are fumigated with sulfur-based vapors, in order to prevent moldy, halt decay from insects, color bleaching, and acting as a chemical preservative. The application of sulfur dioxide, however, alters the very nature of the herbs and will remain on the raw herbs during sulfur fumigation process. Therefore, many countries had regulated the limit of sulfur dioxide on the common herbs, i.e. Dioscoreae (Shan Yao), Nelumbinis (Lian Zi), Bulbus Lilii (Bai He), etc. As sulfur dioxide can jeopardize the quality and safety of the herbal products, Ko Da takes many precautions to keep sulfur fumigation from its herbs, i.e. herbs planting field leasing projects in China, cooperating with Chinese farmers, etc. Besides, Ko Da employs the method of alkali titration to analyze herbs from sulfur dioxide.

4. Essential Oil Detection

Essential oils are the essence of many traditional Chinese medicines. It is very important to detect the content of essential oil on the herbs. Ko Da formulates the essential oil detection method and specification in accordance with Taiwan Chinese Pharmacopoeia and Chinese Pharmacopoeia (P.R.C.). Essential oil can be detected by using GC and GC/MS/MS.

5. TLC Identification

TLC is a qualitative detection method to authenticate the species identity of raw herbs. It could be applied to authenticate if the herb and finished product contains mark substance. Ko Da formulates the specifications of TLC identification of each raw herb in accordance with Taiwan Chinese Pharmacopoeia and Chinese Pharmacopoeia (P.R.C.).

6. Aflatoxins Detection

The fungus can be grown and produce Aflatoxin on some seed foods, i.e. peanuts, corn, grain and some Chinese herbs, especially before and after harvest, during shipping or storage environment with warm temperature and high humidity. This could harm human health as it is toxic and possibly carcinogenic. Currently, Ministry of Health & Welfare, Taiwan had regulated that the total limit of Aflatoxin should be lower than 15ppb on 15 high risk Chinese herbs and single herb product, i.e. Corydalis (Yan Hu Suo), Jujube (Da Zao), Corni (Shan Zhu Yu), etc. Other countries (U.S., Europe, Japan etc.) have even stricter regulations on the limits of Aflatoxin.

There are four kinds of Aflatoxins are determined by researchers nowadays and they have been classified into categories B1, B2, G1 and G2. In order to meet the international regulation standards, Ko Da enforces the stricter specifications on Aflatoxin detection by testing total Aflatoxin (B1, B2, G1, G2) and also the individual Aflatoxin (B1).

7. Aristolochic Acid Detection

The major components of Aristolochic Acid are aristolochi acid I and II, which can be found in aristolochiaceae plant family, i.e. Guan Mu Tong, Guang Fang Ji, Qing Mu Xiang, Tian Xian Teng, Huai Tong, Xun Feng Gu, etc.

Ministry of Health & Welfare, Taiwan has restricted the use of 5 Chinese herbs and medicines that contain Aristolochic Acid in 2004, which include Guang Fang Ji, Qing Mu Xiang, Guan Mu Tong, Ma Dou Lin, and Tian Xian Teng. The authority also published the safety regulations on the Chinese herbs and medicines that contain Asarum (Xi Xin), which the Aristolochic Acid shall not be detected by HPLC/UV method according to Japan Pharmacopoeia 14th edition. Due to safety concern, Ko Da performs the stricter analysis method which is LC-MS/MS analysis to further distinguish the authentic herbs from the common substitutes and maintain an inflexible, uniform policy forbidding any ingredients tainted with the presence of aristolochic acid.

8. Heavy Metals Detection

Today's development of industry has brought us the life convenience, but also the industrial waste and pollutants. These industrial waste and chemical pollutants can pollute the planting environment and add dangerous chemicals to natural herbs, such as heavy metals and other trace elements in Chinese herbs. Along with industry's growth, the danger of heavy metals in herbs has become an acute concern. Ministry of Health and Welfare (Taiwan) has regulated the limits of heavy metals respectively on more than 91 types of Chinese herbs, and also on Chinese medicine preparations with limits of Pb<10ppm, As<3ppm, Cd<0.5ppm, Hg<0.5ppm.

Ko Da detects the heavy metal content in herbs according to the method outlined in Taiwan Chinese Pharmacopeia, and the results could meet the stricter requirements of heavy metals of different export countries.

9. Pesticide Residuals Detection

Large-scale cultivation of Chinese herbs could easily lead to cross infections of pests. Therefore, the use of high efficiency and economic chemical pesticides cannot be avoided during cultivation process. Moreover, the persistent nature of pesticides might be broken down and can remain in the herbs long after use in the past. Thus, the pesticide residuals on the herbs must be controlled very strictly. Ministry of Health & Welfare, Taiwan has regulated the pesticide residual limits of BHC, DDT, and PCNB on many Chinese herbs and medicine preparations.

Due to the safety concern of the medicines, Ko Da has invested heavily in gas chromatograph/mass spectrometry (GC-MS/MS) and liquid chromatography/mass spectrometry (LC-MS/MS) to test for pesticides. These devices have the features of higher selectivity, higher sensitivity, lower demand of test samples volume and more precise and reliable results.

10. Mark Substance Detection

  1. Mark substance detection on raw herbs
    Chinese raw herbs are mostly the natural plants with uncontrollable factors. In order to ensure its quality and stability, a quantitative analysis method could be applied on the raw herbs. Ko Da's lab detects the herbal substance on raw herbs according to the methods outlined in Taiwan Chinese Pharmacopoeia and Chinese Pharmacopoeia (P.R.C.), to enhance the stability and efficacy of the products.
  2. Mark substance detection on Chinese herb medicines
    To ensure the homogeneity and stability of the finished product, a quantitative analysis on 2 or more mark substances should be performed in the same medicine preparation. Ministry of Health & Welfare, Taiwan has regulated the quantitative methods and its specifications on 20 Chinese herbal formulas, as well as the mark substance detections on 13 Chinese herbal formulas in the draft.

11. Microbial Test

Chinese herbs mostly are plants, animals and minerals which naturally contain large number of microbes, impurities and eggs. Microbes can rapidly grow if the humidity and temperature are suitable, especially when harvesting, storing or shipping. This is the main reason of microbial contamination on Chinese herbs. There are some possibilities of microbial contamination on Chinese medicines during the manufacturing process, i.e. excipients, appliances and equipments, production environment, water, operating staffs or packaging materials. Therefore, microbial test is essential to ensure the cleanliness and safety of products. Ministry of Health & Welfare, Taiwan has regulated the limits of total microbial amount, E. coli and Salmonella on Chinese herbal concentrated preparations and some traditional Chinese preparations. Besides the required microbial tests by Taiwan, Ko Da also tests on Yeast & Mold, Enterobacteria & other gram negative bacteria, Pseudomonas aeruginosa, and Staphyloccocus aureus, based on the requirements by different countries.

科達製藥股份有限公司

科達製藥股份有限公司 地址:32459桃園市平鎮區工業三路20-1號
電話:03-469-6105 營業處專線:03-469-1388 傳真:03-469-0546

KO DA Pharmaceutical Co,Ltd. No. 20-1, Gongye 3rd Rd., Pingzhen Dist., Taoyuan City 324, Taiwan R.O.C. 版權所有 ⓒ 2015 KO DA Pharmaceutical Co,Ltd. All Rights Reserved.