| Fangfeining Granule is a compound preparation obtained from Angelica sinensis,Radix Paeoniae Rubra act. which has the functions of promoting blood circulation by removing blood stasis,promoting the circulation of qi and reducing phlegm,removing heat from the lung to relieve cough. In clinic, it is used for Radiation pneumonitis (RP), the symptoms are that cough with phlegm,chest distress and breathe hard,thoracalgia or fever act.. Under the guidance of the theories of TCM and according to the characters of the medicament, the studies and the documents of pharmacology and the demands of clinic, the preparation technology, quality standard and preliminary stability of Fangfeining Granule were studied.On the basis of the functions and treatments of the prescription and the characters of the component of the herbs, the optimal preparation process was designed by using the orthogonal experiment as well as quite a few assessing norms to evaluate them comprehensively. The optimum conditions are that extract Herba Cirsii,Salvia Miltiorrhiza,Flos Carthami,Radix Stemonae 2 times, with 8-fold volume of 70% of ethanol,30 minutes each time, then filter it, decompress and reclaim the ethanol, the liquid of the medicament is put back to use. Soak Angelica sinensis,Rhizoma ligustici wallichii and Rhizoma Cyperi for 1 hour with 12-fold volume of water and then distill it for 6 hours, then filter it. The liquid is conserved in other vessel for use. Extractβ-CD four times amount of the oil, make it until saturation in boiling water, add in the oil slowly at the functional temperature of 40℃, then stir it for 30 minutes, refrigerate it at low temperature for 24h, then filter it, dry it in vacuum for 4h at the temperature of 40℃, and put it back for use. Fry and boil the dregs of the decoction which were mentioned above with Radix Paeoniae Rubra,Trichosanthes Bark,Dried rehmannia root,Bitter Apricot Kernel for 1 time, with 12-fold volume of water,2 hours each time, filter it, then combine the solution. Concentrate the solution to eight times amount of the medical prescription dosage, add in 8% part of B before add in 4% part of A of the ZTC1+1Ⅱat the temperature around 70℃. Condense and filter it. Combine the liquid of the medicament obtained after the reclamation of the ethanol, decompress and concentrate it, dry it in vacuum and break it up. Blend the medicinal powder with lactose according to the proportion of 1:1. Add the compound mentioned above, put properly about 95% of the ethanol, dry it at 60℃, then pack it respectively, and the Granule is made finally.In the study of the quality standard, Thin Layer Chromatograph was used to identify all the herbs. Meanwhile, the Thin Layer Chromatograph of Angelica sinensis,Radix Paeoniae Rubra,Herba Cirsii,Rhizoma Ligustici Wallichii,Salvia Miltiorrhiza was taken as the text of the quality standard. The contents of the paeoniflorin were taken as an inherent index to estimate the products and accomplish the systematic methodology (The extraction conditions of the sample, chromatographic conditions, linearity, precision, reproducibility, stability, family recovery, sample determination act.) The results of the experiment were all in accordance with the demands. Therefore, the determination of the content was made as the text of the quality standard. According to the mensuration result of the samples, the Paeoniflorin limitation was made, it was determined for the moment that each bag should contain no less than 30mg of the Paeoniflorin.Preliminary stability research had kept on for 1 month,2 months,3 months, the three samples under the long experiment at room temperature were measured from characters, distinguishment, inspection and the determination of the content. The results indicate that Fangfeining Granule is stable and suitable to the quality standard.Result:This preparation process is reasonable and practical; the quality of the sample is stable and controllable.
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