Traditional Chinese Medicine Analysis and Testing

Material Analysis 百检检测 2024-05-23

With the continuous development of the traditional Chinese medicine industry、 the quality and safety issues of traditional Chinese medicine have become increasingly important. With the implementation of new policies and standards、 traditional Chinese medicine enterprises need to prepare durable response plans and standardize production and operation. As consumers increasingly value the safety of traditional Chinese medicine、 they need to ask suppliers to demonstrate the quality and safety of their products. Traditional Chinese medicine includes traditional Chinese medicine、 prepared slices of traditional Chinese medicine and traditional Chinese patent medicines and simple preparations. The Chinese Pharmacopoeia stipulates that the detection of heavy metals and harmful elements、 toxic ingredients、 residual solvents、 mycotoxins and biosafety should be strengthened. There are many testing items for traditional Chinese medicine、 mainly in terms of chemistry、 physics、 microbiology、 etc. The completeness of testing items helps to ensure the quality of traditional Chinese medicine. Test scope of traditional Chinese medicine: traditional Chinese medicine includes traditional Chinese medicine、 Chinese medicine decoction pieces、 traditional Chinese medicine preparations、 traditional Chinese patent medicines and simple preparations. Functional classification: surface relieving medicine、 heat clearing medicine、 phlegm resolving、 cough relieving and asthma relieving medicine、 liver calming and wind calming medicine、 wind dampness removing medicine、 blood activating and stasis removing medicine、 qi activating medicine、 hemostatic medicine、 aromatic dampness removing medicine、 digestion medicine、 diuretic and moisture removing medicine、 sedative medicine、 deficiency tonifying medicine、 purgative medicine、 etc. Test items of traditional Chinese medicine: physical and chemical tests: color、 odor、 pH value、 purity、 clarity Content uniformity、 impurities、 moisture、 ash、 acid value、 peroxide value、 iodine value、 density、 solubility、 melting point determination、 burning residue、 drying weight loss、 evaporation residue、 potassium permanganate consumption、 appearance characteristics、 and characteristics of traditional Chinese medicine. Microbial testing: bacteria、 mold、 yeast、 Escherichia coli、 Salmonella、 Pseudomonas aeruginosa、 Staphylococcus aureus、 bacterial endotoxin、 and sterility testing Detection of heavy metals such as initial contaminating bacteria: Detection of various auxiliary materials such as lead、 chromium、 mercury、 arsenic、 copper、 etc β- Detection of Western medicine components such as cyclodextrin and cross-linked povidone: cyclophosphamide、 ceftriaxone、 cefoperazone、 and cefotaxime polymer in injection properties detection: identification of appearance properties、 traditional Chinese medicine properties、 etc. Detection: thin layer chromatography identification、 paper layer chromatography identification、 gas chromatography identification、 liquid chromatography identification、 infrared spectroscopy identification、 microscopic identification of traditional Chinese medicine、 etc Biological test for microscopic identification of traditional Chinese patent medicines and simple preparations (each kind of medicinal material、 chemical identification reaction): allergy test (histamine test)、 hemolysis test (blood cell test、 ultraviolet spectrophotometry)、 pressor or depressor substances (cat method)、 abnormal toxicity test (mouse method) methodological verification: methodological verification、 drug related substances detection、 drug related substances identification、 drug impurity identification、 drug impurity structure detection、 pharmaceutical intermediates methodological verification Validation of raw material drug formulas、 identification of impurities、 etc. Raw material drugs: Confirmation of raw material drug structure、 analysis of raw material drug structure、 inspection of raw material drug、 analysis of raw material drug components: total saponins、 total flavonoids、 matrine、 oxymatrine、 inositol、 ginsenoside、 salidroside、 aloe vera、 paeoniflorin、 lovastatin、 L-carnitine、 proanthocyanins、 grape polyphenols、 soybean isoflavones、 chondroitin sulfate、 crude polysaccharides、 10 hydroxyl groups- α- Decanoic acid、 allicin、 puerarin、 lycopene、 geniposide (geniposide)、 chromium picolinate、 cordycepin、 silymarin、 triterpenoids、 melatonin、 sorghum ginger extract、 baicalin、 lotus leaf alkaloid、 adenosine、 tetrahydropalmatine、 crude polysaccharide、 superoxide dismutase (SOD)、 Ganoderma lucidum polysaccharide、 Ganoderma lucidum triterpenoid、 caffeine、 aconitine、 chlorogenic acid、 tanshinone IIA、 gastrodin、 emodin and chrysophanol、 vitamins Quantitative and Qualitative Analysis of Minerals and Other Ingredients: Content Detection of Designated Components、 Other Chemical Component Analysis: Fingerprint Detection、 Traditional Chinese Medicine Fingerprint Detection、 Peptide Fingerprint Detection、 etc.: 1. Quantitative Analysis of Indicative Components: such as Polysaccharides、 Saponins、 Catechin、 Triterpenes、 etc... 2. Aristolochic acid 3. Aflatoxin B1、 B2、 G1、 G2、 ochratoxin、 and mycotoxins 4. Preservatives (benzoic acid、 hexanoic acid、 dehydrated acetic acid) 5. Sulfur (sulfur dioxide、 SO2) and other bleaching agents 6. Minerals and heavy metals? Essential minerals for the human body: sodium (Na)、 potassium (K)、 calcium (Ca)、 magnesium (Mg)、 iron (Fe)、 zinc (Zn)、 phosphorus (P)、 etc? Analysis of harmful heavy metals: arsenic (As)、 lead (Pb)、 cadmium (Cd)、 mercury (Hg)、 copper (Cu)、 etc. 7. Pesticide residues? Qualitative analysis: Organic phosphorus、 carbamate? Quantitative analysis: Organophosphorus、 carbamate、 organochlorine 8. Steroids、 hormones 9. Antibiotic residues 10. Water content、 water-soluble extract content、 alcohol soluble extract content、 acid insoluble ash content、 total ash content、 essential oil content、 etc. Test standard: GBZ/T 160.79-2004 Method for Determination of Pharmaceutical Compounds in the Air of Workplace GB 21906-2008 Emission Standard of Water Pollutants for the Pharmaceutical Industry of Traditional Chinese Medicine GB/T 30219-2013 Traditional Chinese Medicine Dispensing Machine GB/T 31773-2015 Coding Rules and Codes of Traditional Chinese Medicine Prescriptions GB/T 31774-2015 Coding Rules and Codes of Traditional Chinese Medicine GB/T 31775-2015 Coding and Representation of Traditional Chinese Medicine in Supply Chain Management GB/T 32237-2015 Traditional Chinese Medicine Extract spray Dryer GB/T 32239-2015 Traditional Chinese Medicine Pill Making Machine GB/ Z 35038-2018 Code for Operation and Management of Traditional Chinese Medicine (Sanqi) Industry Projects GB/Z 35039-2018 Code for Operation and Management of Traditional Chinese Medicine (Chuandangshen) Industry Projects

Function of testing report:

1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report

2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms

3. Used as a sales report: issuing legally effective testing reports to make consumers more confident

4. Papers and research: Provide professional personalized testing needs

5. Judicial services: providing scientific、 fair、 and accurate testing data

6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problems

inspection and testing process:

1. Telephone communication and confirmation of requirements

2. Recommend solutions and confirm quotations

3. Mail samples and arrange testing

4. Progress tracking and result feedback

5. Provide reports and after-sales service

6. If urgent or priority processing is required

Testing and testing characteristics:

1. The testing industry is fully covered、 meeting different testing needs

2. Fully cover the laboratory and allocate localized testing nearby

3. Engineers provide one-on-one services to make testing more accurate

4. Free initial testing、 with no testing fees charged

5. Self service order delivery for free on-site sampling

6. Short cycle、 low cost、 and attentive service

7. Possess authoritative qualifications such as CMA、 CNAS、 CAL、 etc

8. The testing report is authoritative and effective、 and is generally used in China

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