| 1. ObjectiveBased on Chinese Traditional Medication decoction pieces, with the application of ultrafine powder technology and patented technology, Dendrobium nobile Lindl. cell-broken powder particle has been developed as a new type of Chinese Traditional Medication decoction pieces.The study will establish technical standards of quality control of Dendrobium nobile Lindl. cell-broken powder particle, and provide theoretical basis for standardized production and the safer use of Dendrobium nobile Lindl; which also helps formation of a series of technical standards for the future development of other varieties of cell-broken powder particle medicine and market accessment for products. The research will further promote the standardization of industry products of traditional Chinese medicine cell-broken powder particle, and make the products of the Dendrobium nobile Lindl. cell-broken powder particle as a safe, effective, controllable and stable product.2 Methods2.1 Fingerprinting of herbal Dendrobium nobile Lindl. and cell-cell-brokenpowder particleUsing the conditions as follows:HPLC-PDA,, Phenomenex prodigy ODS (3) C18 column (250mm×4.6mm,5μm), acetonitrile-0.1%acetic acid gradient elution, column temperature 25℃,flow rate 1.0mL/min, detection wavelength 254nm. Fingerprint of Dendrobium nobile Lindl. cell-cell-brokenpowder particle was analysed.2.2 Safety of herbal Dendrobium nobile Lindl. and cell-broken powder particleUsed to evaluate the maximum tolerated dose acute toxicity test by the maximum tolerated dosage of Dendrobium nobile Lindl. cell-broken powder particle assess the safety, maximum tolerated in mice measured by the amount of tolerance to multiple computing.2.3 Pharmacodynamic of herbal Dendrobium nobile Lindl. and cell-broken powder particleDevelop research of comparison between Dendrobium nobile Lindl. cell-broken powder particle and his decoction pieces in order todetermine the effective dose of Dendrobium nobile Lindl. cell-broken powder particle comparing the raw medicine with application of models of stomach heat card caused by Xin thermal medicine, hyperthyroidism induced by thyroid deficiency model of film, hydrocortisone induced immunosuppression of non-specific immune function, low immune function caused by cyclophosphamide delayed type hypersensitivity, cyclophosphamide amide causes immunosuppression model of humoral immune function.3 Results3.1 Fingerprinting of herbal Dendrobium nobile Lindl. and cell-broken powder particleThe method that with nobile flavonoids and phenolic compounds well separated, is selected based on test results of 10 common peaks, which established the standard ingredients fingerprint of Dendrobium nobile Lindl..3.2 Safety of herbal Dendrobium nobile Lindl. and cell-broken powder particleNo mice death in the acute toxicity experiment, the dose of Dendrobium nobile Lindl. cell-broken powder particle for the mices is 13.5 times that for clinical use of humain, with the same dose (equals dose of raw medecine), the Dendrobium nobile Lindl. cell-broken powder particle has more obvious toxic side effects imposed upon the heart than the conventional slices, however, with less degree of toxic side effect, which ain't menaced the safty of the mices, so use of two doses is safe.3.3 Pharmacodynamic of herbal Dendrobium nobile Lindl. and cell-broken powder particleThe changes of experimental evidence have been reduced accordingly with low, medium and high dose group pathological of Dendrobium nobile Lindl. cell-broken powder particle in the stomach disease and hyperthyroidism experiment; the changes of experimental evidence have been increased accordingly with low, medium and high dose group pathological of Dendrobium nobile Lindl. cell-broken powder particle in low immunity experiment, finally the dose of Dendrobium nobile Lindl. cell-broken powder particle is determined as 1/4 dose.4 Conclusion4.1 Fingerprinting of herbal Dendrobium nobile Lindl. and cell-broken powder particleThe method extablished is easy operation and high repeatability, which can serve as one of the quality control of medicinal Dendrobium nobile Lindl. cell-broken powder particle methods.4.2 Safety of herbal Dendrobium nobile Lindl. and cell-broken powder particleAcute toxicity experiment tells that the clinical use of Dendrobium nobile Lindl. cell-broken powder particle is safe. 4.3 Pharmacodynamic of herbal Dendrobium nobile Lindl. and cell-broken powder particleThe model of stomach disease, hyperthyroidism deficiency and low inmunity correspond to TCM theory can be served as a method for evaluating the resultat of service of Dendrobium nobile Lindl. cell-broken powder particle. |