Preparation Process and Quality Evaluation of Compound Ligusticum Chuanxiong Whitening Cream
Objective To prepare the Compound Ligusticum Chuanxiong Whitening Cream(LW-C),and to evaluate its quality.Methods A traditional Chinese medicine extract was prepared with a mass ratio of Chuanxiong Rhizoma:Leonuri Herba:Angelicae Dahuricae Radix:Angelicae Sinensis Radix of 4:3:2:1.The optimal concentration of the extract was determined with the inhibition rate of tyrosinase and the clearance rate of 1,1-diphenyl-2-trinitrophenylhydrazine(DPPH)free radicals as evaluation indexes.LW-C was prepared by the mechanical approach.The appearance was observed by the visual inspection method,the particle size was measured by the biological microscope,and the pH of LW-C was measured by the pH meter.The content of ferulic acid was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Elite ODS column(200 mm × 4.6 mm,5 μ m),the mobile phase was methanol-1％glacial acetic acid(30:70,V/V),the flow rate was 1.0 mL/min,the column temperature was 30 ℃,the detection wavelength was 321 nm,and the injection volume was 10 μL.The microbial limits and preliminary stability of the prepared samples were investigated.Results The mass concentrations of traditional Chinese medicine extract in the ranges of 1-50 mg/mL and 1-10 mg/mL were significantly positively correlated with the inhibition rate of tyrosinase and the clearance rate of DPPH free radicals(P＜0.01),respectively.The prepared LW-C was uniform,delicate,glossy texture,moderate hardness,and it was easy to pick up and apply.The particle size was less than 2 μm and evenly distributed.The pH was 6.8.The linear range of ferulic acid was 1.53-30.69 μg/mL(r=0.999 4,n=5).The RSDs of precision,stability,and repeatability test results were all lower than 2.0％.The average recoveries of low-,medium-,and high-concentrations of ferulic acid(88,132,176 μg/mL)were(99.51±0.97)％,(100.08±0.51)％,and(100.97±0.73)％,respectively,with RSDs of 0.97％,0.51％,and 0.73％(n=3).The content of ferulic acid in three batches of samples was 179.63 μg/g,185.38 μg/g,and 179.30 μg/g,respectively.The microbial limit test results showed that the total number of aerobic bacteria in the sample was 20 cfu/g,and no mold or yeast was detected.After the cold and heat resistance tests,the appearance of the LW-C remained uniform and delicate,without oil-water stratification,and there were no coarse particles on the skin when applied.After centrifugation test,there was no significant change in appearance and properties,and there was no oil-water stratification phenomenon.Conclusion The established preparation process is simple to operate,and the quality of the prepared samples is stable.It can be used for the preparation and quality control of LW-C.
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