Study On The Parameter System For The Product Quality Control Of Chinese Midicine Qizhi Weitong Particles

Aim:27batch of Qizhi Weitong Particles (QWPs) were analyzed in order to establish asystem of identifying the multi components and quality control parameters of the nonstandard Chinese materials.Method:According to the official standard, detection of QWPs properties, volume difference,moisture, particle size, solubility, TLC method for identification of tetrahydropalmatine,paeoniflorin, using high performance liquid chromatography method for the determinationof paeoniflorin.Using thin layer chromatography of QWPs of bupleurum, Fructus aurantii, cyperusand Radix Glycyrrhizae were identified; using high-performance liquid chromatographyand diode array detector (HPLC-DAD) for simultaneous determination of Radix PaeoniaeAlba medicine glycosides, paeoniflorin, licorice glycoside, naringin and neohesperidin5component content, and method verification; using high performance liquidchromatography (HPLC) determine the content of tetrahydropalmatine, andmethodological validation; taking a type of sugar and sugar free all2batches of sampleswere accelerated stability test (temperature:40℃±2℃, humidity is70%±5%), placed0,1,2,3month after determination.Using HPLC to QWPs for atropine sulfate, sodium diclofenac, ibuprofen3chemicalsand antibiotic norfloxacin1illegal check; using inductively coupled plasma atomicemission spectrometry (ICP-AES) for magnesium, aluminum ion determination.Establishment of TLC, HPLC, step by step (sensitivity, accuracy and continuouslyimprove) detection method, to study in a sample of Corydalis medicinal raw materials the existence of auramine O industrial dye residues. Application of atomic fluorescencespectrometer (AFS) for lead, cadmium, arsenic, mercury, copper determination of harmfulelements.Result:1．All of the physical parameters, appeara, content uniformity, moisture, granularityand solubility，of the27batch of QWPs were coincide with the provisions of SFDA.Tetrahydropalmatine and paeoniflorin could be detected by thin layer chromatography.The contents of paeoniflorin and sugar free paeoniflorin were15.52～24.71mg/bag and18.07～24.90mg/bag, repectively.2．The thin-layer chromatogram of QWPs showed obvious principal spots correspondto the control of radix bupleuri, rhizoma cyperi, α-cyperus ketone, fructus aurantii,naringin, neohesperidin, liquiritin and so on.Results from HPLC-DAD indicated that the contents of albiflorin, paeoniflorin,liquiritin, naringin and neohesperidin were5.29～13.27mg/bag,16.15～24.56mg/bag,1.74～4.25mg/bag,8.75～16.78mg/bag, and5.84～10.48mg/bag, respectively. However,contents of the sugar free type glycosides were4.80～9.94mg/bag,17.49～24.81mg/bag,1.72～3.10mg/bag，5.68～13.54mg/bag and3.98～8.43mg/bag, respectively.Results form HPLC analysis indicated that the content of tetrahydropalmatine in the27batch of product were0.12～0.26mg/bag （0.12～0.23mg/bag in sugar free type）。Accelerated stability was tested at the special time points of0.0,1.0,2.0,3.0months.No specific difference was demonstrated between the drug concentrations.3．The chemicals of atropine sulphate, diclofenac sodium, ibuprofen and norfloxacinwere not detectable in all of the27batch of QWPs. By the Step checking test, noamishdriving instructorne was found.Conclusion:1．All of the27batch of QWPs tested with the drug administration regulations andare acceptable products with higher quality.2. The methods established in the present study to identify and test the componentswere simple, practicable, stable，reliable and repeatable. These methods can be regarded asstandard test of the tetrahydropalmatine, paeoniflorin, radix bupleuri, fructus aurantii,rhizoma cyperi and liquorice in the products of QWPs. 3. The27batch of QWPs did not join the functional chemicals. Magnesium andaluminum ions for raw materials into, non-human add. Products are the detection of heavymetal and harmful elements, but all did not exceed the standard. Tips and preparationprocess control good quality of Chinese medicinal materials.