AbstractBotanical Source: Sophora alopecuroides L.
Other names: Baptitoxine, Sophorine
Part Used: Seeds
CAS No.: 485-35-8
Molecular Formula: C11H14N2O
Molecular Weight: 190.24
Appearance: White or slightly yellowish crystalline powder
Specification: 98%, 99% Cytisine by HPLC
Description:Cytisine, also known as baptitoxine and sophorine, is a toxic alkaloid that occurs naturally in several plant genera, such as Laburnum and Cytisus of the family Fabaceae. Cytisine is a nicotinic acetylcholine receptor agonist, and as a pharmaceutical preparation it is available for the treatment of nicotinism. That is, Cytisine substance has a mechanism of action similar to the effect of nicotine, but with rather low toxicity. It can substitute nicotine substance, which shortens the period of interaction of nicotine with the respective receptors and hence leads to a gradual reduction and elimination of existing psychic nicotine dependence in smokers.
Functions:
It can substitute nicotine action, reducing and eliminating the smokers dependence on nicotine to achieve the Purpose of smoking cessation.
With a respiratory stimulant and booster effects on the cerebral circulation;
With the function of pharmacological, such as anti-arrhythmia, anti-microbial, anti- infection, anti-ulcer, elevated white blood cell;
Has strong anti-cancer activity;
With significant regulating activity on plant growth;
With the function of expectorant and antitussive, it shows good effect on treating elderly patients with chronic.
| Analysis Items | Specifications | Results | Methods used |
| Identification | Positive | Conforms | TLC |
| Appearance | White to slightly yellow crystal powder | White crystal powder | Visual test |
| Odor & Taste | Characteristic | Conforms | Organoleptic test |
| Solubility | Soluble in water | Conforms | Visual |
| | | | | | | | |
| Assay(Dry base) | NLT 99% | 99.31% | HPLC |
| Related substances | NMT 0.25% N-Methylcytisine | Not detected | / |
| NMT 0.25% N- Formaldehydecytisine | Not detected | / |
| NMT 0.10% Other Impurity | Not detected | / |
| NMT 0.50% Total related substances | Conforms | / |
| Loss on Drying | NMT 0.5% | 0.39% | 5g /105ºC /2hrs |
| sulphated ash content | NMT 0.1% | 0.05% | 2g /525ºC /3hrs |
| Sulphates | NMT 400ppm | Conforms | / |
| Melting range( °C) | 154 ~ 157 | 154.3 ~ 156.7 | / |
| Specific rotation[α]20(°) | -118.0 ~ -125.0 | -122.3 | / |
| Extract Solvents | Acetone NMT 5000ppm | 220ppm | GC |
| Ethanol NMT 5000ppm | Not detected | GC |
| | | |
| | | | | | | | |
| Heavy Metals | NMT 20ppm | Conforms | Atomic Absorption |
| Arsenic (As) | NMT 2ppm | Conforms | Atomic Absorption |
| Lead (Pb) | NMT 2ppm | Conforms | Atomic Absorption |
| Cadmium (Cd) | NMT 1ppm | Conforms | Atomic Absorption |
| | | | | | | | |
| 666 | NMT 0.1ppm | Conforms | USP-GC |
| DDT | NMT 0.5ppm | Conforms | USP-GC |
| Acephate | NMT 0.2ppm | Conforms | USP-GC |
| | | | |
| Parathion-ethyl | NMT 0.2ppm | Conforms | USP-GC |
| PCNB | NMT 0.1ppm | Conforms | USP-GC |
| | | | |
| | | | | | | | |
| Microbiological Data | Total Plate Count< 1,000cfu/g | < 200 cfu/g | GB 4789.2 |
| Total Yeast & Mold< 100cfu/g | < 50 cfu/g | GB 4789.15 |
| E. Coli to be absent | Absent | GB 4789.3 |
| Staphylococcus to be absent | Absent | GB 4789.10 |
| Salmonella to be absent | Absent | GB 4789.4 |
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