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Oct 07

Raw TCM herbs (EU GMP, GAP) | SINOPHYTO

Sinophyto

About SinoPhyto – Buy Raw TCM Herbs now – EU GMP, GAP

TCM – TRADITIONAL CHINESE MEDICINE IS OUR PURE PASSION

SinoPhytoMed represents TCM remedies of the highest quality and purity.

To the quality of our TCM remedies to guarantee from field to patients uncompromising, we founded a private joint venture operating in China. We built on the implementation of our Qualitätsanprüche high personal commitment and long-standing commitment to an operation according to European standards. Our continuous technical, cultural and human exchanges enabled us to create a bridge between China and Germany. This is the basis for us going forward.

Rely on our years of experience with remedies and our pharmaceutical and medical expertise.

VERIFY THE IDENTITY AND PURITY

Through our extensive identity determination, we ensure that neither corruption nor confusion of Chinese medicinal agent present. We achieve this by macroscopic, microscopic and organoleptic tests in our own laboratory with experienced and qualified staff. Analytical purity and content determinations (water content, Extrakgehalt, eth. Oil content, …) are provided for each drug daily laboratory practice. The foregoing and further analyzes are carried out to Prüfzertifikaterstellung also commissioned laboratory. Only then can we ensure we have set quality standards. Extent of identity analysis in accordance with the current Chinese Pharmacopoeia (CP 2005) and further leading Chinese original literature · macroscopic characteristics · organoleptic characteristics (appearance, smell, taste) · Microscopic Features · physical and chemical detection methods · chromatographic methods (HPLC and TLC) scope of the purity analysis of the current Chinese Pharmacopoeia (CP 2005) · Stranger ingredients · water content (loss on drying at 105 ° C) · Normal ashes · Acid-insoluble ash scope of content analysis (corr. monograph request CP 2005) · Extract (aqueous, alcoholic) · essential oil · quantitative determination of plant-specific ingredients *)_______________________________________ *) Authentic reference substances of TCM drugs are hardly available in Germany. Through our close collaboration with the pharmaceutical faculty of the University of Yantai (China) are our Chinese laboratory these pure substances for comparative analysis.
EXAMINATION OF HARMFUL STRAINS
The technically sophisticated analysis of pollutant loads are performed in contract laboratory. Due to modern equipment, the absolute compliance with the statutory limit and reference values ​​can be ensured. The following tests are carried out there: – heavy metals – pesticides – aflatoxins – Microbiology – toxin levels (eg aristolochic acid, aconitine)

Heavy metals

The levels of heavy metals lead, mercury, cadmium, arsenic and copper are studied in complex analysis methods with ICP-MS equipment. For herbal infusions with the limits of the maximum residue amount Regulation (iF the correction of 19th Amendment Regulation of 8 October 2007) and the reference values ​​of Kontaminantenempfehlung heavy metals of 17 October 1991 apply.

Heavy metal Limit value in mg / kg
Lead (Pb) 5.0
Mercury (Hg) 0.1
Cadmium (Cd) 0.2
Copper (Cu) 40.0


Pesticides

The pesticides are detected with highly sensitive HPLC instruments. The fingerprints obtained are compared with an extensive database. Our contract laboratory studied organochlorine and organophosphorus compounds, dithiocarbamates, pyrethroids and piperonyl butoxide, and polychlorinated biphenyls. The compounds listed below are in the laboratory for residue and trace analysis with the Modular Multi method for the determination of pesticides in food according to §35 LMBG L 00.00-34 ( Advanced recast DFG Method S 19) detected. Notes: the organochlorine pesticides marked with * are determined by the method according to Murphy (sulfuric acid cleaning; Journ AOAC, 1972, 55 (6), 1360- 1362nd) detected; the bold pesticides are in the design monograph “2.8.13. Pesticide residues “(Pharm Europe, Vol. 18, No. 4, October 2006) indicated. All other pesticides are listed in the MRLs Regulation (RHmV). The detection limits are given in mg / kg (based WKF Business Association herbal and fruit eV, Hamburg).

1. organophosphorus
Acephate 0.05
Azinphos-ethyl 0.05
Azinphos-methyl 0.1
Bromophos-ethyl 0.02
Bromophos (methyl) 0.02
Carbophenothion (ethyl) 0.05
Chlorfenvinphos 0.03
Chlormephos 0.02
Chlorpyrifos (ethyl) 0.02
Chlorpyrifos-methyl 0.05
Chlorthiophos 0.02
Crotoxyphos 0.05
Cyanofenphos 0.05
Cyanophos 0.02
Dialifor 0.05
Diazinon 0.02
Dibromo (naled) 0.1
Dichlofenthion 0.02
Dichlorvos 0.02
Dicrotophos 0.02
Dimefox 0.02
Dimethoate and omethoate 0.02
Dioxabenzophos
Dioxathion 0.05
Disulfoton 0.02
Ditalimfos 0.02
EPN 0.02
Ethion 0.02
Ethoprophos 0.02
Etrimifos 0.02
Fenamiphos 0.02
Fenchlorphos and isomers 0.02
Fenchlorphos,
Fenchlorphos-oxon
Fenitrothion 0.02
Fensulfothion and isomers 0.03
Fensulfothion
Fensulfothion-oxon
Fensulfothion-oxonsulfon
Fensulfothion sulfone
Fenthion and isomers 0.02
Fenthion
Fenthion-oxon
Fenthion-oxonsulfon
Fenthion-oxonsulfoxid
Fenthion sulfone
Fenthion sulfoxide
Fonofos 0.02
Formothion 0.02
Iprobenfos (IBP) 0.02
Isocarbophos 0.02
Isofenphos 0.02
Jodfenphos 0.03
Leptophos 0.05
Malathion and malaoxon 0.03
Mecarbam 0.02
Mephosfolan 0.02
Methacrifos 0.02
Methamidophos 0.02
Methidathion 0.03
Mevinphos 0.02
Monocrotophos 0.08
Parathion (ethyl) and paraoxon-ethyl 0.03
Parathion-methyl and paraoxon-methyl 0.03
Phenkapton 0.05
Phenthoate 0.02
Phorate 0.02
Phosalone 0.05
Phosmet 0.05
Phosphamidon 0.05
Pirimiphos-ethyl 0.02
Pirimiphos-methyl u. Isomers 0.02
Pirimiphos-methyl
N-desethyl pirimiphos-methyl
Profenofos 0.02
Prothiophpos 0.02
Pyrazophos 0.05
Pyridaphenthion 0.02
Quinalphos 0.02
Sulfotep 0.02
Tetrachlorvinphos 0.02
Thionazin (zinophos) 0.02
Tolclofos-methyl 0.02
Triamiphos 0.05
Triazophos 0.02
Trichloronat 0.02
Trichlorfon 0.05
2. organochlorines
Alachlor 0.05
Aldrin and dieldrin * 0,005
Benfluralin 0.01
Bromopropylate 0.02
Chlorbenzide 0.05
Chlordane and isomers * 0,005
cis, trans, oxy-chlordane
Chloroneb 0.05
Chlorthal-dimethyl 0.01
Chlorothalonil 0.03
Cyanazine 0.05
DDT and isomers * 0.01
o, p-DDD, o, p-DDE, o, p-DDT,
p, p-DDD, p, p-DDE, p, p-DDT
Dichlobenil 0.01
Dichlofluanid 0.02
Dicloran 0,005
Dicofol 0.05
Dichlobenzophenon
Endosulfan and isomers 0.01
α- and β-endosulfan, endosulfan sulphate
Endrin * 0.01
Fenarimol 0.02
Fenson 0.02
Folpet 0.1
HCH and isomers *
α-HCH 0,005
β-HCH 0.01
δ-HCH 0,005
ε-HCH 0.01
Heptachlor and isomers * 0,005
Heptachlor, cis, trans-heptachlor epoxide
Hexachlorobenzene * 0,005
Iprodione (Glycophen) 0.03
Isodrin * 0.01
Lindane (γ-HCH) * 0,005
Methoxychlor 0.02
Metolachlor 0.05
Metribuzin 0.05
Mirex * 0.01
PCB 28 * 0.01
PCB 52 * 0.01
PCB 101 * 0.01
PCB 138 * 0.01
PCB 153 * 0.01
PCB 180 * 0.01
Pendimethalin 0.02
Pentachloroanisole 0.01
Pentachlorobenzene 0.01
Pentachlorophenol 0.01
Procymidone 0.02
Profluralin 0.01
Quintozene and isomers * 0.01
Quintozene, pentachloroaniline, pentachlorophenol (methylsulfanyl) benzene
S421 0.02
Tecnacen * 0,005
Tetradifon 0.01
Tetrasul * 0.02
Trifluralin 0.01
Vinclozolin 0.01
3. pyrethroids
Bifenthrin 0.05
Cyfluthrin and isomers 0.02
λ-cyhalothrin and isomers 0.02
Cypermethrin and isomers 0.02
Deltamethrin 0.02
Fenpropathrin 0.01
Fenvalerate and isomers 0.01
Flucythrinate and isomers 0.01
t-fluvalinate and isomers 0.01
Permethrin and isomers 0.02
4. Other plant treatment products
Dithiocarbamates **
Sum parameter CS 2 0.05
Piperonyl butoxide 0.1
Pyrethrins ** 0.5
Cinerin I and II
Jasmolin I and II
Pyrethrin I and II
Bendiocarb 0.02
Bromide 1.0
5. shell treatment agents **
Biphenyl 0.1
Imazalil 0.02
ortho-phenylphenol 0.02
Thiabendazole 0.1
** Not in routine analysis

Stand: 01.03.2008

Aflatoxins

An aflatoxin can be caused by the infestation of a TCM drug by fungi. One differentiates approximately 20 naturally occurring aflatoxins, of which the aflatoxin B1 is considered the most dangerous to humans. Even at low concentrations it acts hepatotoxic and can even be carcinogenic.
For this reason, we consider it our duty, mushroom-prone TCM remedies (eg platycladi Semen, Corydalis Rhizoma and others) to check for Aflatoxinfreiheit and at the slightest complaint immediately from circulation draw.
The regulation on mycotoxin limits in foodstuffs (mycotoxin maximum quantity regulation, MHmV) as amended on 2 May 2003 and the Prohibition Ordinance on the use of aflatoxin-contaminated materials in the manufacture of medicines (aflatoxin Ban Ordinance) of 19. July 2000 (valid from 1.2.2001), the legal basis for this. Accordingly, the following limits apply for foods and drugs:

Aflatoxin Limit in ug / kg
B1 2.0
Sum of B1, B2, G1, G2 4.0

Microbiology

As natural products may be contaminated with bacteria, mold and manure (feces), this study is very important.
Here are the approximate values ​​of the European Pharmacopoeia (Ph. Eur.) In accordance with section 5.4.1 Kat. 4A binding (Kat . 4A: Microbiological quality of pharmaceutical preparations of herbal medicinal products, which consist only of one or of several herbal drugs; Herbal medicine, where boiling water is added before use, decoction).

designation Limit in CFU / g or CFU / ml
Aerobic bacteria Max. 10 7
Mushrooms Max. 10 5
Escherichia coli Max. 10 2
CFU: colony forming unit

Toxins

Unilateral and partly incorrect reports in the media about “toxicity of Chinese medicines” create confusion among the population. And Western – – In fact, a few herbal remedies are for the human organism poisonous and must be tested for toxins (poisonous substances) in order to avoid harmful side effects or overdoses. In China it lowers for over 2000 years the toxin content of this remedy by traditional ” detoxification methods “in special operations. In SinoPhyto we review these procedures in the laboratory, in order to supply our customers with only clearly defined remedies. For this purpose we determine the Eisenhut the content of aconitine and its esters chemically. The content may thereby a certain threshold does not exceed in order to be therapeutically effective.Pyrrolizidinhaltige remedies we perform only in our range, if they meet the current requirements in Germany limits by BfArM: 100 ug Pyrrolizidinalkaloide PA per day for external application, 10 micrograms in decoction and 1 ug Pyrrolizidinalkaloide PA per day in direct oral administration (granules, tablets, etc.). In addition, we have also in compliance with these limits on an application period of a maximum of 6 weeks per year out. We pay particular attention to the aristolochic acid, a natural component of aristolochiaceae that acts potentially nephrotoxic and kancerogen. We will only use medicinal plants that they do not contain. To avoid confusion with similar species, besides the exact determination of identity of the drug, the absence of aristolochic acid by HPLC-UV detection is tested in accordance with DAC. With stringent quality checks and strict laboratory tests we give you the security, effective and non-toxic to the patient drugs obtain.

DAO DI – MEDICINAL HERBS FROM TRADITIONAL REGIONS

Every medicinal plant has its preferred location and growing region. The Chinese tradition combines a spiritual significance for the healing process to the original source of the medicinal herbs. The term for remedies from their authentic region is Dao Tu We believe in Dao Tu, because our analyzes confirm the above-average drug levels of these plants.

GOOD AGRICULTURAL PRACTICE

Basically as “Good Agricultural Practice” GAP (“Good Agricultural Practice”) is referred to one of the farmers in their land use einzuhaltendes ecological approach. In this way, very high quality, unencumbered agricultural products can be produced. The “Good Agricultural Practice” includes the Integrated Crop (IPB) and the Integrated pest management (IPM). The main principles of “good agricultural practices” are: · Location Adapted management · Cleanliness water, air and earth · preservation of the natural features of the usable space · Documentation on the use of fertilizers and pesticides and adherence to their limits the moment there are about 12 companies in China, which are recognized as GAP farms. Through our TCM pharmacists we have contact with them and buy there a preferred when the extract content meets our high quality criteria.