Study On Method Of Quality Control For Guizhi Fuling Capsules

This research take the Guizhi Fuling capsules as the object of study and has conducted the quality assessment method research to it. The Guizhi Fuling capsules originates Guizhi Fuling pill which was prescriptde in "Golden chamber".Commonly used traditional Chinese medicine to become the side preparation to gather in "the Chinese Pharmacopoeia" in 2005 in version. The present Guizhi Fuling capsules for medicine’s quality specification is not very perfect, "the Chinese Pharmacopoeia" in 2005 in the version only carries on the GC determination of paeonol to the capsule. This research has established in the Guizhi Fuling capsules for medicine at the same time related chemical composition RP-HPLC the content determination method and the GC chromatogram measuring method, simultaneously has established the HPLC chromatograph fingerprint atlas, has conducted the research systematically to the Guizhi Fuling capsules for medicine’s quality control method.To establish a method for the determination of gallic acid, albiflorin and paeoniflorin in Guizhi Fuling capsules by RP-HPLC. The system consisting of a C18 column (250 mm×4.6 mm,5μm) and the gradient elution with a mixture of acetonitrile and 0.1% phosphate acid as the mobile phase was adopted. The linear response ranges were 0.69-6.87μg·mL-1 (r=0.9996),0.88-8.80μg·mL-1 (r= 0.9996) and 2.00-20.00μg·mL-1 (r=0.9995), respectively (n=9). The average recoveries (n= 9) of gallic acid, albiflorin and paeoniflorin were 100.6% (RSD=1.8%),100.4% (RSD= 1.4%) and 99.8% (RSD= 1.6%), respectively. The assay demonstrated that the method had adequate accuracy and selectivity to measure the three chemical constituents in Guizhi Fuling capsules.To establish a method for the determination of benzoic acid, and paeonol in Guizhi Fuling capsules by RP-HPLC. The system consisting of a C18 column (250 mm x 4.6 mm, 5μm) and with a mixture of methanol and 0.1% phosphate acid as the mobile phase was adopted. The linear response ranges were 5.20-52.0μg·mL-1 (r= 0.9999) and 9.60-96.0μg·mL-1 (r= 0.9995), respectively (n= 9). The average recoveries (n= 9) of benzoic acid, and paeonol were 100.0%(RSD= 0.7%) and 99.1% (RSD= 2.1%), respectively. The assay demonstrated that the method had adequate accuracy and selectivity to measure the three chemical constituents in Guizhi Fuling capsules.HPLC fingerprint chromatogram was established for Guizhi Fuling capsules.The condition included Kromasil C18 (250 mmx4.6 mm,5μm) column, the gradient elution with acetonitrile and 0.1% phosphate acid solution. The detection wavelength was 254 nm.10 batches of Guizhi Fuling capsules were studied under this condition. The Guizhi Fuling capsules mutual pattern was established on the basis of the data from 9 batches of Guizhi Fuling capsules. Then the similarity was calculated,respectively.9 batches of sample similarities are more than 0.95. Take Paeoniflorin as in frame of reference, confirmed 9 chemical composition peaks. NO.2 peak (gallic acid) originates from besides Ramulus Cinnamoni other four herbs; NO.8 peak (amygdalin) originates from Semen Persicae; NO.10 peak (albiflorin) originates from Radix Paeoniae and Cortex Moutan; NO.11 peak (paeoniflorin) originates from Radix Paeoniae and Cortex Moutan; NO.14 peak (benzoic acid) originates from Radix Paeoniae, Cortex Moutan and Poria; NO.16 peak (cinnamic acid) originates from Ramulus Cinnamoni; NO.17 peak (benzoylpaeoniflorin) originates from Cortex Moutan and Radix Paeoniae; NO.18 peak (cinnamaldehyde) originates from Ramulus Cinnamoni; NO.19 peak (paeonol) originates from Cortex Moutan and Radix Paeoniae. This method can be validly used to evaluate the quality of Guizhi Fuling capsules.GC/MS chromatogram was established for Guizhi Fuling capsules. Uses DB-1MS(30 m×0.25 mm×0.25μm) the volatile fraction to carry on the analysis to the capsule, altogether has determined 9 peaks. The condition included DB-1 capillary column (30 mx0.25 mmx0.25μm), Inlet temperature was 230℃. the detector temperature was 280℃. and the program was start from 90℃to 220℃by 10℃/min with the FID detection. The linear response ranges were 0.075-0.750μg·mL-1 (r= 0.9997). The average recoveries (n= 9) was 99.0% (RSD= 1.5%) This method can be validly used to evaluate the quality of Guizhi Fuling capsules.