| Compound radix bupleuri decoction is an experience prescription commonly used inclinical treatment of depression and consists of Radix Bupleuri, Fructus Gardeniae,Atractylodes Lancea, Radix Paeoniae Alba, Tuber Fleeceflower Stem and Fried Jujube Kernel.Due to the poor taste, perishableness, inconvenience to carry and insufficient dissolution ofactive fraction during decoction, the dosage form of compound radix bupleuri decoction isrequired to be improved. Synthesizing all the pros and cons of various oral dosage forms, thegranule is determined to be used for preparation of this prescription.Objectives: To optimize the optimal extraction technology of the effective parts which thesix herbs in Compound Radix Bupleuri Granules，and to prepare them into granules andestablish the quality standards of compound radix bupleuri granules.Methods: L9(34) orthogonal test is adopted with saikoside d and gardenoside as theinvestigation indicators; the content of saikoside d is determined by means ofUltraviolet–visible spectroscopy (UV-Vis), and gardenoside is determined by means of Highperformance liquid chromatography(HPLC), so as to determine the optimal extractiontechnology of compound radix bupleuri granules. L9(34) orthogonal test is adopted withunguent weight as the investigation indicators; the volatile oil of rhizoma atractylodis shall beextracted by supercritical CO2extraction method; the volatile oil of rhizoma atractylodis isobtained by means of the optimal extraction technology for volatile oil. L9(34) orthogonal testis adopted with inclusion rate as the investigation indicators to optimize β－CD inclusiontechnology. Wet granulation technology is adopted by means of single factor experiment; thewetting agent and excipient types as well as excipient dosage are investigated with theformability and dissolvability of the granules as the investigation indicators, so as to select theoptimal forming technology for compound radix bupleuri granules. The quality standards ofcompound radix bupleuri granules are established in line with relevant provisions in AttachmentIC “Rules of Preparation for Granules” in Chinese Pharmacopoeia2010. The saikoside d andgardenoside in compound radix bupleuri granules is measured to make its content limits.Results:The optimum extraction technology for Compound Radix Bupleuri Granules is: toadd6times of70%ethanol solution to extract for3times, extracting for1.5h each time. Theoptimum technological condition of supercritical carbon dioxide extraction for rhizoma atractylodis is: extraction temperature45℃, extraction pressure20MPa, separation temperature50℃, separation pressure6MPa, and flow of carbon dioxide22L/h, extraction time4hours.The optimum inclusion technology for Rhizoma Atractylodis Volatile Oil is: the mix proportionof β－CD and Atractylis oil is18:1(g:g), adding3times of water, and then grinding for2hours.The optimal forming technology for compound radix bupleuri granules is as follows: take theextraction of the medicinal materials and add excipient in line with the ratio of powder-milksugar (2:1) and mix it, make the granules by90%ethyl alcohol; dry them at55℃, the entiregranules shall be the wanted granules. The spots of radix bupleuri and Cape Jasmine incompound radix bupleuri granules are clear as identified by thin-layer chromatography, beingnegative without interference. Moreover, the saikoside d in each bag of compound radixbupleuri granules shall not be less than3.0mg, as same as gardenoside shall not be less than34.0mg. Compound radix bupleuri granules comply with the relevant provisions in AttachmentIC “Rules of Preparation for Granules” in Chinese Pharmacopoeia2010.Conclusions: The extraction technology and preparation technology of Compound RadixBupleuri Granules are safe and reliable with good repeatability. The determination method forthe contents is simple with good repeatability. The specificity and repeatability of thin-layerchromatography is good, and the quality inspection complies with relevant requirements. |
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