Study On The Improvement Of The Quality Standard Of Panlongqi Tablets

Panlongqi tablets is composed of 29 Chinese herbal medicines such as Polygoni milletii Rhizoma,Acanthopanacis cortex,Eucommia ulmoides Oliver,Angelica sinensis Radix,Gentianae macrophyllae Radix,etc.It is used to treat rheumatic diseases,lumbar muscle strain and fractures.It is currently the exclusive product of Shaanxi Panlong Pharmaceutical Group Co.,Ltd.It was once included in the "Medicine Standards for Prescriptions of Traditional Chinese Medicines”of the Ministry of Health"(Volume 20 of 1998 Edition),and the current standard is"National Standards for Prescriptions of Chinese Medicines”WS3-B-3998-98-1,Because the original standard cannot fully reflect the composition of prescription drugs and the quality of drugs,in order to formulate a complete and simple quality standard system for Panlongqi Tablets,the following six aspects of research have been carried out in this subject.1.In this study,under the guidance of the Chinese Pharmacopoeia,the sample powder was fixed by the smear method with chloral hydrate test solution.Completed the microscopic identification of 8 kinds of original medicinal powders of Salvia miltiorrhiza,Angelica sinensis Radix,Eucommia ulmoides Oliver,Carthamus tinctorius,Aucklandia lappa,Achyranthes bidentata,Acanthopanacis cortex,Gentianae macrophyllae Radix in Panlongqi tablets and 15 batches of Panlongqi tablets powder.The results showed that Panlongqi tablets powder had the same microscopic characteristics as the eight kinds of raw powder used as medicinal materials.2.Study on thin-layer identification of Panlongqi tablets.This research filled up the vacancy of the original standard non-thin-layer identification,taking Gentianae macrophyllae Radix,Salvia miltiorrhiza,and Angelica sinensis Radix as the research objects to establish a thin-layer identification method.The detection wavelength of Gentianae macrophyllae Radix is 254 nm,and ethyl acetate-methanol-water(10:2:1)was used as the developing agent.The results showed that 15 batches of Panlongqi tablets have the same color spot as gentiopicroside and Gentianae macrophyllae Radix in the corresponding positions.Through the investigation of the developing agent system of the thin-layer identification method of Salvia miltiorrhiza,the developing agent system is finally determined to be trichloromethane-ethyl acetate-toluene-formic acid-methanol(6:8:4:4:1)and toluene-ethyl acetate(19:1).The detection wavelength is 365 nm,and the control medicinal material and the preparation chromatogram showed the same fluorescent spot at the same position.The developing agent of Angelica sinensis Radix thin-layer method is n-hexane-ethyl acetate(9:1).The above method and other impurity spots have good resolution,and the negative control is not disturbed.3.The character and inspection study of Panlong tablets.In this study,the properties of Panlongqi tablets were investigated.They were sugar-coated tablets in accordance with the original standard.They were gray-brown after removing the coating,and tasted bitter and slightly sweet.Then the weight difference,disintegration time limit,and hardness were investigated,and the results all met the inspection of the tablets under the pharmacopoeia standards.4.Study on the content determination of Panlongqi tablets.There is no content determination item in the original standard,in this study,the detection methods of gentiopicroside,ligustilide,geniposide acid and costanolide were established respectively.And passed the verification of specificity,precision,linearity,repeatability,stability,accuracy and chromatographic adaptability test methodology.With regard to gentiopicrin,the optimal extraction method and chromatographic conditions were determined by investigating the extraction solvent,time and method,and the content of gentiopicrin in 15 batches of Panlongqi tablets was determined to be 0.467 mg/tablet～0.784 mg/tablet.After ultrasonic treatment with 70%methanol for 30 min,the mobile phase is acetonitrile and 0.01%trifluoroacetic acid aqueous solution,and the detection was performed at 324 nm.The content of ligustilide in 15 batches of Panlongqi tablets was measured in the range of 0.198 mg/tablet～0.333 mg/tablet.The content of geniposide and costanolide ranged from 31.174 μg/tablet to 55.332 μg/tablet and 34.349 μg/tablet to 57.448 μg/tablet,respectively.5.Study on the fingerprint of Panlongqi tablets.In this study,HPLC technology was used to establish the fingerprint of Panlongqi tablets,and the fingerprint similarity evaluation system was used to analyze and process the data,and the common peaks were calibrated.The similarity analysis results showed that the similarity of 10 batches of Panlongqi tablets was not less than 0.936.By comparing with the fingerprints of single medicinal materials and reference substances,the source of the chromatographic peaks of some medicinal materials was determined,and the main chromatographic peaks in the fingerprints were further accurately identified by liquid mass spectrometry technology.6.Research on the safety of toxic medicinal materials.In this experiment,the content of the toxic medicinal materials such as Aconitum carmichaelii Radix and Aconitum kusnezoffii Reichb.in Panlongqi tablets was determined by HPLC,in order to control the content limit range of aconitine compounds,so as to ensure the safety of drugs.