| Traditional Chinese medicine(TCM)is the material basis of disease prevention and treatment in the medical system with Chinese characteristics.It is widely used in clinical diagnosis,treatment and prevention of diseases.But chinese herbal pieces are take time and energy in the process of decocting and take high dosage.Meanwhile,the quality of TCM is easily affected by producing,processing,storage conditions and other factors.With the development of modern science and technology,the formula granules of TCM rose gradually,which became a useful supplement to the TCM.It not only preserves the pharmacodynamics of the original decoction pieces,but also avoids the traditional decocting process of TCM.So it has huge market potential.At present,the national management of formula granules is not very sound.Because there is not relatively perfect and standardized national quality standards to the TCM formula granules.In order to standardize clinical medication and improve clinical efficacy,it is an urgent task for us to establish a scientific and perfect quality standard of the TCM formula granules.In this paper,peach kernel formula granules are taken as the research object.The whole process quality control is studied from Chinese herbal decoction pieces to standard decoction and then to formula granules,which provided reference for the standardization of the production of Chinese herbal formula granules.The main research contents are as follows:(1)Study on fingerprint of peach kernel.The 16 batches of peach kernel fingerprints were detected by high performance liquid chromatography.Eight common peaks were identified,and five chemical constituents were analyzed by UPLC-Q-TOFMS.(2)Study on peach kernel decoction pieces.There are two main aspects: 1)Study on processing technology.The optimum processing parameters of processing peach kernels were determined by multi-index comprehensive scoring method were boiling water for 3 minutes,cold water for 1 minute,peeling,drying for 4 hours at 60?;The fried peach kernels optimum processing parameters was based on the appearances,content of amygdalin and the sum of peak area of fingerprint characteristics was 10 minutes.2)Study on storage conditions.With the sum of appearance,amygdalin content,acid value,peroxide value and common peak area of fingerprint as the detection index,the changes of components of peach kernel decoction pieces(raw,processing,stir-baked)were studied in different storage environments.The results showed that the quality of peach kernel decoction pieces changed under the conditions of high temperature,high humidity and light storage.(3)Study on the quality standard of peach kernel standard decoction.The methods of TLC identification,content determination and fingerprint of peach kernel standard decoction were studied.And a draft quality standard for peach kernel standard decoction is established.(4)Study on the quality standard of peach kernel formula granules.The methods of TLC identification,content determination and fingerprint of peach kernel formula granules were studied,and the draft quality standard of peach kernel formula granules was established.The uncertainty theory was used to evaluate the determination results of Amygdalin in peach kernel formula granules.It was found that the volume of sample solution contributed most to the uncertainty of the results,which proved the accuracy and reliability of the determination results.Conclusion In this paper,peach kernel formula granules were studied in quality control from Chinese medicine to granule.To achieve the quality control in the whole production process of peach kernel formula granules.The processing parameters and storage conditions of peach kernel decoction pieces were determined,and the quality standard draft of peach kernel formula granules was formulated,which provided a reference for the standardization of enterprise production. |
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