Study On The Quality Control Of Gardenia Jasminoides In Naoxuening Injection

Naoxuening injection is a traditional Chinese medicine prescription, which is composed of the Cornu Saigae Tataricae, the mouton root bark, the Fructus Gardeniae and the Acorus tatarinowii. It is used primarily to the treatment of the apoplexy caused by hypertension. We studied on the method of quality control of Gardenia jasminoides in this prescription. First, the content of geniposide in Gardenia jasminoides from three different origins was determined. We chose the Gardenia jasminoides with the highest content of geniposide as the crude drug of Naoxuening injection. Then we established the HPLC fingerprints of crude Gardenia jasminoides and its intermediate by HPLC according to the technical requirements of the fingerprints of Chinese traditional medicine, which provides a basis for controlling the quality of Naoxuening injection.The dissertation is summarized as followed:1. Study on quality contrast in three origins of Gardenia jasminoidesWe chose Gardenia jasminoides from Hunan, Jiangxi and Hubei to do the contrast in identification. And a method for the content determination of geniposide was established. First we put the extract fluid of gardenia into pillar which was adsorbed with alumina, then washed it by 50% methanol. The content of geniposide was determined by HPLC at 238nm detection wavelength with methanol-water(70:30) as mobile phase. The calibration curve was linear in the range of 53.94～89.90μg for geniposide, correlation coefficient (r=0.99996). The average recovery was 101.56%(n=6).2. Study on fingerprint of Gardenia jasminoides in Naoxuening injectionWe established the HPLC fingerprints of Gardenia jasminoides in Naoxuening injection. The chromatographic separation was performed on a phenomenex C18 column(4.6mm×250mm,5μm)with a mobile phase consisting of methanol-water, gradient eluent, at the flow rate of 0.8mL/min. The detection wavelength was 238nm and 440nm, and the column temperature was 30℃. The fingerprints of Gardenia jasminoides in Naoxuening injection was established, fourteen common peaks in the chromatogram were marked with the parameter according to the technical requirements of the fingerprints of Chinese traditional medicine. The fingerprints of Gardenia jasminoides from three different places indicated that the ratio of common peak areas was different in the fingerprints of Gardenia jasminoides from different places.3. Study on fingerprint of intermediate of Gardenia jasminoides in Naoxuening injectionWe did laboratory simulation according to the method which enterprise used to prepare intermediates of Gardenia jasminoides in Naoxuening injection. The extracted intermediates of Gardenia jasminoides were analysied with the program which was the same as the HPLC fingerprints of Gardenia jasminoides. Then the fingerprints of intermediates were established. Twelve common peaks in the chromatogram were marked with the parameter according to the technical requirements of the fingerprints of Chinese traditional medicine.4. Study on the heavy metals of the intermediateAnd the heavy metals of the intermediate was examined. The content of Pb was less than 10ppm.