The Preparation And Quality Standard Research Of The Compound Chuanxiong Rhizoma Gel Paste

Objective:The prescription is consist of three drugs, Rhizome Chuanxiong, Rhizoma Cyperi and Radix Paeoniae Alba, having the migraine treatment of primary dysmenorrhea because of qi stagnation and blood stasis. In order to avoid the disadvantage of degrading in the gastrointestinal tract and poor taste of oral medicine, and make a better curative effect, then making them in gel paste. The topic makes research on the preparation process, molding process and quality standard, to provide the reference for developing new drugs to treat primary dysmenorrhea in the future.Methods:Through single factor and orthogonal test method, investigating the extraction process of volatile oil in Rhizoma Chuanxiong with the ligustilide content and volatile o il rate as indicators, investigating the extraction process of phenolic acids in Rhizoma C huanxiong with the ferulic acid content and dry paste rate as indicators, investigating the extraction process of Rhizoma Cyperi with the a-cyperone content and volatile oil rate as indicators, investigating the extraction process of Radix Paeoniae Alba with the paeon iflorin content and dry paste rate as indicators; Using single factor test to investigate the macroporous resin purification process of the ferulic acid and paeoniflorin; Investigating the molding process with the initial adhesion force, morphic characteristics and compreh ensive sensory evaluation as the index; Using TLC to identify Rhizoma Chuanxiong, Rhi zoma Cyperi and Radix Paeoniae Alba, using HPLC to makecontent determination and methodology investgation on the ligustilide, ferulic acid, a-cyperone, paeoniflorin; Using accelerated test and long-term test to investgate the stability of the preparation.Result:The extraction process of ligustilide:Rhizoma Chuanxiong added through 40 me sh screen, adding 8 times amount of water, soaking for 2 h, extracting for 4 h, collectin g volatile oil, retaining water extraction liquid and solid; The extraction process of feruli c acid:taking a moderate amount of water extraction solid, adding 8 times amount of 6 5% ethanol, reflux extracting twice,80 min each time, collecting alcohol extraction liqui d, after reduced pressure recovery of ethanol, merging into the water extraction liquid w hich is from the extraction process of ligustilide; The extraction process of a-cyperone: Rhizoma Cyperi added through 40 mesh screen, adding 7 times amount of water, soakin g for 2 h, extracting for 10 h, collecting volatile oil; The extraction process of paeonifl orin:adding 70% ethanol, reflux extracting 3 times,3 h every time, adding 8.3 times c ontent of alcohol for the first time, and the alcohol quantity for the second and third ti me is 8 times; The purification process of the ferulic acid:enriching the extraction liqui d to per mL containing 0.5g original crude drugs, making centrifugal process for 30 min at the speed of 5000 r per minute, taking the supernatant, adjust pH of 3.0, as the col umn liquid, going through prepared HPD-300 macroporous resin at the speed of 3 BV/h, after being completely adsorbed, using 3 BV distilled water to wash, abandoning, then using 6 Bv 70% ethanol with the elution velocity of 3-4 BV/h, collecting the eluent; T he purification process of paeoniflorin:after reduced pressure recovery of ethanol to no alcohol taste, enriching the extraction liquid to per mL containing 0.2g original crude dr ugs, making centrifugal process, taking the supernatant as the column liquid, going throu gh prepared AB-8 macroporous resin with the elution velocity of 5 mL/min, after being completely adsorbed, using 2 BV distilled water to wash, abandoning, then using 5 Bv 80% ethanol with the elution velocity of 4 BV/h, collecting the eluent; The enrichment process:measuring preciously prescriptions of Rhizoma Chuanxiong purification liquid an d Radix Paeoniae Alba purification liquid, blending, concentrating the mixture liquid unti l the relative density is about 1.20 under the condition of temperature 50℃ and vacuum 0.08 MPa; Drying technology:taking the moderate amount of the compound Rhizoma Chuanxiong cream for spray drying, the inlet temperature of 120～130℃, the outlet tem perature of 60～70℃, the flow rate about 8.0 mL/min, going through 6 screen, receivin g the compound Rhizoma Chuanxiong extract powder; Molding process:the prescriptions of compound Rhizoma Chuanxiong extract powder and volatile oil, adding 1.5% gelatin, 4% polyacrylic acid sodium,9% kaolin,2% glycerol,4% Polyethylene glycol-400,0. 3% sorbic acid and suitable amount of distilled water, prepared through melting method; Quality standard:during the TLC method to identify Rhizome Chuanxiong, Rhizoma C yperi and Radix Paeoniae Alba, negative samples are without interference, theseparation i s good, the ligustilide content of the product shall not be less than 1.37 mg each piece, the ferulic acid content of the product shall not be less than 2.17 mg each piece, the a-cyperone content of the product shall not be less than 1.66 mg each piece, the paeoni florin content of the product shall not be less than12.81 mg each piece.Conclusion:The preparation process of the compound Chuanxiong Rhizoma gel paste is stable, reliable, feasible, and worthy of promoting.