| Objective and meaning: Polygala Tenuifolia Wild. is commonly used for clinical. If used improperly, it may lead to some adverse reactions, such as guttural stimulus, nausea, distension and allergic reaction. It has been confirmed that Crude Radix P will lead to animal deaths, gastric mucosal injury, stomach wall thinner and gastrointestinal motility inhibition by excessive or prolonged use. Honey-stir-baked Radix P. has the minimum toxicity with good effect among processed products. Main on subjective judgment, the existing honey-fried techniques lacks unified standards, impacting on clinical drug efficacy and safety directly by weak controllability and instability of products. By various means, this study avoids interference of single experimental results, through a multi-level research, optimizes safe and effective Honey-stir-baked Radix P, provides scientific basis for clinical reasonable selection of safe and effective; It also standardizes the honey-fried process, reveals scientific content of detoxification with reserved effect. It has great academic and practical value with far-reaching social significance with rare research currently.Methods: By processing, toxicological pharmacological experiments combining fingerprint analysis, we did the following researches.①By orthogonal experimental design, we chose time, temperature, honey volume, set three levels, processed 9 samples (No.1,2,3,4,5,6,7,8,9).②We got the honey-stir-baked Radix P with relatively smaller toxicity and better effect, optimized honey-fired process by acute toxicity, gastric emptying of methyl orange colorimetry, intestinal movement of carbon promotion, mice autonomic activities counting, mice pentobarbital sodium collaborative test, trachea phenol red expectoration and antitussive activities of the cough times induced by ammonium hydroxide in mice.③We observed rats' gastric morphology and gastric mucosal, compared to the effect of stomach by optimized Honey-stir-baked Radix P and Crude Radix P.④We established fingerprints map of decoction for optimizing Honey-stir-baked Radix P by HPLC.Results:①We got Honey-stir-baked Radix P (No.1, 2, 3, 6) with relatively small toxicities from 9 samples, comparing them by acute toxicity experiments with same dosage. It shows No.1,2,3 have smaller toxicities, relatively safer than Crude Radix P.②The inhibition of intestinal propulsion can be decreased remarkably by No.3, comparing with Crude Radix P.③No.1,2,3,6, and Crude Radix P can significantly reduce mice autonomic activities, increase tracheal phenol red excretion. No.3 and Crude Radix P significantly increased pentobarbital sodium-induced sleeping mice.④There is significant difference of rat gastric mucosal injury between No.3 and Crude Radix P.⑤It matched fingerprint testing fingerprint sample No.3 of 10 batches of Honey-stir-baked Radix P.Conclusion:①The optimized processing technique is: Crude Radix P: honey volumn: water volumn (g/g/ml) is 10:3:2, moistening:3h, and to be fried 9min in 60℃.②Honey-stir-baked Radix P No.3 decreased acute toxicity and gastrointestinal target organ toxicity:inhibitions of small intestine propulsion movement and gastric emptying, injuries of gastirc morphology and gastric mucosal; it can still tranquilize the mind (the effect of sedation and hypnosis), remove phlegm and antitussive with no affected, indicating that the way of honey-fried is the way of detoxification with reserved effect.③We established HPLC fingerprint of Honey-stir-baked Radix P No.3, made testing standards and corresponding technical parameters of fingerprint, indicating the stable quality, provided scientific parameters for quality control standards of this processed product. |
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