| Chaihu Lougu Decoction was recored in Oncology of TCM which has the effect of restore liver function,dispersing stagnated hepatoqi and dispersing stasis.It is used in the treatment of breast cancer with pattern of liver depression and phlegm coagulation.It has been proved that the preion is safe and effective after long-term clinical application.The preion is composed of11 traditional Chinese medicines which include Bupleuri radix,Citri reticulatae Pericarpium viride,Tangerine leaf,Curcumae radix,Angelicae sinensis radix,Paeoniae radix alba,Poria,Atractylodis macrocephalae rhizoma,Cremastrae pseudobulbus pleiones pseudobulbus,Trichosanthis fructus,Angelicae dahuricae radix.There are many inconveniences in the preparation and use of decoction.This study is guided by tcm theory,which uses the Extraction Separation Technology of chinese medicinal materials and the efficient technology of solid dosage forms.Objective to investigate the methods to extraction technology,the rudiment stability test,quality standard and the forming process study of the Chaihu Lougu decoction in order to study the Chaihu Lougu-solid pellet.This experiment can lay the foundation for industrial production.First,it need to determine the best extraction process.Examined the abstraction rate by single factor experiment to study the extraction technology of Tangerine leaf,Citri reticulatae Pericarpium viride and Curcumae radix.The results show that the best volatile oil extraction technology is using water,twelve-fold the amount of the three ingredients and 6 hours of distillation once.Due to the characteristic of easily volatile and unpleasant smell of volatile oil,the studies through the β-Cyclodextrin and saturated water solution method and orthogonal experimental method was used to screen the technological process.By orthogonal experiment,three factors: the ratio of material to liquid,inclusion temperature and time were reviewed.The best condition of inclusion complex was that the ratio of volatile oil and β-Cyclodextrin was1: 6,the temperature of inclusion is 60 ℃ and the inclusion time is 1.5 h.At the same time,the study determined the immersion time of medicinal materials was 90 mins in the process of optinization of water extracting technology.Then,put the medicinal materials into 10 times amount of distilled water,2 h of total decocting time and reflux extraction for 3 times to get extract.Secondly,the study of formulation process to be continued.Take a proper amount of dry extract powder of Bupleurum and Trichosanthes,add microcrystalline cellulose and dextrin as auxiliary materials.The optimized technology is that the proportion of extract powder:microcrystalline cellulose: dextrin is 2:1:1,the concentration of wetting agent ethanol is 85%,the proportion of powder and ethanol is 25:1,the seasoning agent aspartame is 1%,the drying temperature is 60℃,and the drying time is 2 hours.Thirdly,the quality evaluation in particles of Chaihu Lougu Decoction was evaluated.Bupleuri radix,Angelicae sinensis radix,Paeoniae radix Alba,Poria,Atractylodis macrocephalae rhizoma,Trichosanthis fructus in compound were identified by TCL.The TLC spots were highly clear without the interference of negative control.A simple,sensitive and workable method for the determination of saikosaponin a,saikosaponin d,ferulic acid and paeoniflorin in compound by HPLC was reported.It is suggested that the content of saikosaponin a,ferulic acid and paeoniflorin should not be less than 0.06%,0.10% and 0.07% respectively.Finally,the stability of Chaihu Lougu Decoction was studied under high temperature.Under condition of high temperature,humidity,accelerated（40±2℃,RH75%±5%）and long-term（25℃±2℃、RH60%±10%）.The preliminary stability of the product was investigated,the stability results indicated that particles of Chaihu Lougu Decoction had excellent stability.To sum up,the results shown that the preparation procedure which fitted to the standard of China Pharmacopoeia is scientific and quality control method is reliable,stable and feasible. |
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