| Acanthopanax senticosus and Schisandra chinensis have a long history of application.The two drugs alone have the function of regulating nerve and improving sleep.The clinical research confirmed that the combination of two drugs hung up for two cases of deficiency of the heart and spleen,deficiency of spleen and kidney,insomnia,dreaminess,forgetfulness,fatigue,lack of appetite,and other symptoms.Studies have shown that the two drugs are not simply the accumulation of drug components,but through synergistic effect to enhance the efficacy.At present,the product developed on the market is compound acanthopanax syrup,which is mainly an oral preparation made by the combination of the extract of Acanthopanax senticosus and the extract of Schisandra chinensis plus honey and other excipients.Compound Acanthopanax senticosus syrup due to the addition of honey and other causes of high sugar content in the preparation,people suffering from diabetes disease should not be taken,such as crude extract and other medicine,large dosage,oral taste is bitter,sour,inconvenient to carry and not easy to store,there are still a series of problems in the transportation process,such as easy to be damaged.Therefore,it is imperative to develop new Chinese medicine preparations.In this study,the effective parts of Acanthopanax senticosus and Schisandra chinensis were refined and combined to produce soft capsules,which are convenient to carry and have high bioavailability.First of all,Acanthopanax senticosus and Schisandra chinensis were extracted by reflux extraction.The optimum extraction process was selected by single factor experiment and orthogonal experiment.The optimum extraction process of Acanthopanax senticosus was 1:8g/m L of feed-liquid ratio,60% ethanol at extraction concentration,extraction for 3 times and extraction for 1 hour each time.The optimum extraction process of Schisandra chinensis was1:12 g/m L,85% ethanol,3 times and 1 hour each time.Further,macroporous resin was used to refine the total glycosides in Acanthopanax senticosus and total lignans in Schisandra chinensis.The best purification technology of total glucosides of Acanthopanax senticosus is not more than 5.13:1（medicinal material quantity g/macroporous resin quality g）,the speed of sample is 2BV H-1,the volume of eluent is 5times the volume of column,and the concentration of eluant is 55%.The optimum refining process for total lignans of Schisandra chinensis was that sample solution with concentration of 1.5 mg/m L was loaded into macroporous resin at a loading rate of 2 BV h-1,and the loading amount was not more than 9:1（total lignan mass mg/macroporous resin mass g）,and eluent volume was 8 times column volume,and eluent concentration was 95%.Secondly,orthogonal test was used to study the preparation process of Ciwujia Wuweizi soft capsule.The total glucosides of Acanthopanax senticosus and lignans of Schisandra chinensis were 5.4% and 11.7%,respectively.Soybean oil 67.1%,beeswax 4%,Tween-800.5%,1,2-propanediol 1%,water 10%,nipagin ethyl ester 0.3%.gelatin: glycerin: purified water = 1.0:0.35:1.0,standing for 24 hours.The preparation process of the soft capsule is as follows: the temperature of the feed port is 50 ℃,the speed ratio is 1.75:1,and the drying time is 6h.Thirdly,the quality of Acanthopanax senticosus soft capsule was evaluated.The color of capsule shell of soft capsule is pale yellow,the content is yellow,the granules of soft capsule are complete and smooth,without bonding,deformation and leakage,and a few cases of capsule shell damage.The difference of loading capacity and disintegration time meet the relevant requirements of the Chinese Pharmacopoeia.The TLC identification method for compound Acanthopanax senticosus and Schisandra chinensis was studied.Results the TLC spots were clear and the negative control was not interfered.The content of syringin,schisandrin,schizandrin A and schizandrin B were determined by HPLC.It is suggested that the content of syringin should not be less than 1.13 mg,and the total amount of schisandrin,schizandrin A and schizandrin B should not be less than 4.70 mg.Fourth,a preliminary study on the stability of Acanthopanax senticosus and Schisandra chinensis soft capsules was carried out,and the preliminary stability of the products was investigated in the different disintegration time limit of the character identification and the content determination,respectively,with good results.In conclusion,the preparation process of Acanthopanax senticosus and Schisandra chinensis soft capsules is reasonable,which meets the requirements of Chinese Pharmacopoeia for soft capsules,and the quality is controllable and stable. |
PDF Full Text Request