| OBJECTIVE To preparate and evaluate compound Yangjiao soft capsule . Compound Yangjiao soft capsule is made of Yangjiao,Ligusticum chuanxiong Hort,Radix Angelicae dahurica and Raidx aconite.The soft capsule is changed from its pills in the standard of Department of Health. This Chinese traditional medicine could adjust disorders of the liver and the analgesia effect. It is used to treat the migraine, vascular headache,tension headache and neural headache.According to the properties of the herbal medicines and clinical characteristic, this experiment maked the dosage-form improvement. So we systematically researched on the pharmaceutical pharmacy of the soft capsule,mainly including the preparative process,the quality standard and its stability.METHOD (1)Taking the content of ferulic acid and imperatorin as the evaluation indexes,we adopt orthogonal experiment to optimize the extraction process.(2)Taking the viscosity, the volume ratio of sedimentation and the fluidity as the evaluation indexes,we adopt orthogonal experiment to optimize the formula of the soft capsule content.(3)Used TLC to carry on the qualitative distinction of Ligusticum chuanxiong Hort and Radix Angelicae dahurica. Used TLC to carry on the limit test of aconitine in the soft capsule.The HPLC method was developed to determine the content of ferulic acid and imperatorin in the soft capsule. The content of total alkaloid was determined with the acid-dye chromatometry method.(4) According to"Chinese Pharmacopoeia"(2005),the content uniformity and disintegration time were examined.(5) According to "Stability test requests for the new chinese traditional medicine ",inspect on stability of the soft capsules was also carried out. RESULT The more effective way to percolate from Ligusticum chuanxiong Hort,Radix Angelicae dahurica and Raidx aconite was with 8 times amount of 30% alcohol.The percolating rate was 3 ml/min·Kg.According to formula optimization and orthogonal experiment, we confirm the ratio of powdered extract and soybean oil was 1:1, the ratio which the beeswax, Tween - 80, the Gum Arabic occupy the content was 4%, 0.5%,1.5%. The content fluidity of soft capsules was good, the stability of suspend was high.In the identification,the sample displayed the same fluorescence spots as the reference substangt did in the Chromatography,with the negative sample did not. The method was specificity. With limits test of aconitine,the content of aconitine in the sample was in the limit .In the assay, the linear ranges of ferulic acid was 6~60μg/ml, linear regression equation was Y=-79948+61345·X,r=0.9993; the recovery was 100.5% (RSD = 2.23%);the sample solution was stable within 6h (RSD=1.12%); the feruli acid in the soft capsules should not be less than 100μg per gram.The linear ranges of imperatorin was 0.08~0.40μg, linear regression equation was Y=44863 + 3672150·X,r=0.9996;the recovery was 100.3% (RSD = 2.08%) ;the sample solution was stable within 6h (RSD=1.06%); The imperatorin in the soft capsules should not be less than 60μg per gram. The linear ranges of aconitine was 8.4~25.2μg/ml,linear regression equation was Y=0.0054 + 0.03029·X, r=0.9998; the recovery was 99.19% (RSD = 2.31%); the sample solution was stable within 4h (RSD=1.05%); the acontine should not be less than 0.43mg per gram.The examining result of three batches of samples showed that the content uniformity <±10%,and that the disintegration time was in 1h.Through inspection on preliminary stability of this product for 3 months,the character, identification, disintegration time, content determination were no great change.CONCLUSION Through the study of the excration technology and the preparation technology, the reasonable craft parameter were provided for the compound Yangjiao soft capsule; The quality standard could control the quality of preparation, the products was stable.This study has achieved the expect objective.
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