The Pharmaceutical Research Of QBPF Granule

Chronic obstructive pulmonary disease(COPD)is a not fully reversible airflow characterized by chronic disease,accompanied by lung to noxious granule or gases abnormal inflammatory response.COPD has a high morbidity and mortality,and has a great harm,late diagnosis,poor efficacy characteristics,its number of patients and mortality is huge,disease progression was slow,seriously affect the ability to work and quality of life of patients。COPD is one of the important diseases harmful to human health,whether in urban or rural areas.Elderly patients is more common,and prevalence increases with age.In recent years,worldwide COPD morbidity and mortality continue to rise,resulting in a staggering economic burden,it has become an important public health problem.According to WHO statistics,in the next 20-30 years,it will become the worldwide diseases,which disability and death rate is the fastest rising.QBPF granule prescription based on long-term clinical practice,is composed of Panax ginseng,Astragalus,chuanxiong,schisandra,Tinglizi,xiebai and earthworm.It treats COPD,hasing clinical applications for many years and a significant effect.The issue conducted the research of pharmaceutical literature,quality standard,preparation technology,and stability of prescription,in accordance with the of traditional Chinese medicine research guidelines.1.QBPF granule preparation process studyThrough literature review,develop a different process routes,according to the relevant pharmacodynamic screening optimum route,and research on extraction,concentration,drying preparation intermediates research,molding technology to obtain the best technology,and pilot scale study.Process routes Filters:According to Chinese medicine theory,the nature of each herbs active ingredients,we design the formulation process routes,and fliter the process routes,with related pharmacodynamic evaluation as an indicator.Intermediate Preparation Process Study:With Ginsenoside Rg1 + Re,Ginsenosides Rb1,Astragaloside A and ferulic acid as index,the preparation process of optimal exctraction,concentration,drying technology parameters were obtained by single factor and orthogonal experiments.The last process is as follows:Panax ginseng and Astragalus was extracted for 2 times and 2 hour for each with 8 times 70%ethanol,filtered,combined extracts,filtrate and concentrated the filtrate to relative density 1.25～1.30(50 ℃),spared.Panax ginseng,Astragalus dregs and Chuanxiong、schisandra,Tinglizi,xiebai and earthworm,was extracted for2 times and 2 hour for each with 8 times water,filtered,combined extracts,filtered,and concentrated the filtrate to relative density 1.20～1.25(50 ℃).Take the above thick paste were dried under reduced pressure,pulverized.Process of Forming Study:Taking melting,molding rate,angle of repose,the percentage of moisture as index to study the molding process,select lactose as excipients,adding an appropriate amount of lactose,mixing,dry granulation.Pilot scale study:According to a preferred process conditions conduct three batches of pilot study,results show that preferred process conditions stable and feasible.2.QBPF granule quality standard researchAccording to The 2015 edition of Chinese pharmacopoeia to examine the granules,the quality standards for QBPF granule is formulated.Taking a reference or the reference drug as comparison,using thin layer chromatography,established qualitative identification method of Astragalus and chuanxiong、schisandra and xiebai.Ginsenoside(Rg1+Re),ginsenoside Rb1,Astragaloside A were measured simultaneously by HPLC,and develop appropriate content limit.This product bag containing ginseng ginsenoside Rg1(C42H72014)and ginsenosides Re(C48H82O18)the total amount of not less than 1.1 mg;ginsenoside Rbl(C54H92O23)dollars,not less than 0.60mg,Astragalus Astragalus A glycosides(C41H68O14)dollars,not less than 1.0mg.Establish a quantitative analysis of multi-components with a single-marker(QAMS)method for the determination of the eight components in QBPF Granule.Ginsenosides Rg1,Re,Rf,Rb1,Rc,Rb2,Rd,and astragaloside had good relations respectively.The QAMS method is feasible and credible,and could be used to determine the multiple components in QBPF Granule3.QBPF granule stability studyPilot batches of products were in October,January,February,March,June accelerated stability test(40℃±2℃、RH 75%±5%),and in October,March,June,September,December,18 month long-term stability test(25 ℃±2℃,RH 60%±10%),results show that the index of goods in during the review period are in line with quality standards,better stability.