The Study Of Safety Evaluation Of Clinical Application Of Cooked Aconite

ObjectiveThrough the analysis of the clinical use of aconite summarized in our hospital, determination the toxicity of Fuzi ingredients and active ingredient content, using the method to evaluate the quality and safety of medicinal aconite,clinical dose safety, decocting time safety, compatibility attenuated and other factors, to clarify the aconite toxicity reducing medication principle. To provide a theoretical basis for the clinical use of aconite is safe and effective, and provide experience for the rational clinical use of aconite.Methods1. The study of literatureExplored literature, analysis of effective ingredients and toxic components of aconite, Processing technology,decoction processes, the latest research progress in dosage and compatibility, to provide a reference for the development of feasible experimental program.2. Clinical prescription analysisReorganize and analysis the aconite use situation of our hospital in a quarter of year by the retrospective analysis method, included four aspects were the source of aconite, decoction, dose, and compatibility.3. According to the analysis of prescription, to determine the content of raw and cooked aconite, establish the HPLC and UV to the 6 alkaloids of aconite(HA, MA, AC, BHA, BAC, BMA), reference 2015 edition of Chinese Pharmacopoeia limited provisions and related literature report, to comparative study of decoction, dose, source of the evaluation of raw and cooked aconite.4. Explore the connotation of cooked aconite "reducing toxicity and increasing efficiency"Aconite and dried ginger,Aconite and Glycyrrhiza,Aconite and honey compatibility, Sini decoction processed,by the conventional standard decoction, used the above content determination method, determination the dissolution rate of the active ingredients and toxic components in decoction, and established HPLC chromatogram of compatibility before and after, from the aspect of chemical composition, evaluation of the connotation of "reducing toxicity and increasing efficiency" of dried ginger, licorice and honey compatibility on cooked aconite.Result1.The amount of raw aconite in our hospital from April 2015 to June 2015 was 93.75kg, and the amount of cooked aconite was 1158.75kg.The amount of aconite roots was 31.25kg, and the cookde aconite was 386.25kg every month. During the course of the patients did not appear moderate poisoning reaction. Different doses of aconite decoction need different time, the decocting time of aconite roots were more than 2h, decoction cooked aconite time need 1h. The amount of each agent commonly used in prescription aconite roots is 3-60g, the usual dose of cooked aconite was 3-30g. Aconite and dried ginger, aconite and glycyrrhiza, aconite and honey were commonly used for medicine compatibility.2. Respectively measured the raw content determination results show that, the toxic components of Unprocessed Radix Aconiti Lateral is was higher, content of toxic components of heishunpian and paofupian were lower, paofupian alomost without diester alkaloids, accord with the Pharmacopoeia Limited. But the content difference of the Mono ester type alkaloid was great, aconite roots was 0.0030-0.0056mg/g, heishunpian was 0.3035～1.3948mg/g, paofupian was 0.0990～0.2135 mg/g.3. Screening out of the heishunpian in 5,10,15,20,30,45,60,90g 8 dose group, decocted 1h, content of single and double ester alkaloids in black were all meet the requirements of Pharmacopoeia by HPLC, diester alkaloids were disappeared after decocting,different doses of mono ester alkaloids have different dissolution rate, the dissolution rate decreased with the increase of the dose, the total soluble dose was positively correlated with the dose. Compared with the single decoction,the dissolution rate of Mono ester type alkaloid were all have increased in the same dose of sini decoction, that the compatibility could increase the dissolution rate of alkaloids.High dose 45g heishunpian decoction with time prolonging, content of monoester alkaloids in the decoction decreased gradually, after boiling 2.5h, the dissolution rate for decoction was 20.26%, the dissolution amount of decoction was 12.7170mg, its Single ester type alkaloid dissolution was same as the 15g heishunpian Decoction lh, when boiling 3.5h,its content was gradually disappearing, to prove that extended decoction time could reduce the toxicity of aconite.4. Double ester aconitine dissolution quantity fluctuation in the process of raw aconite decoction, and the dissolution of the three alkaloids were obviously different. The appropriate consumption of Unprocessed Radix Aconiti Lateralis was 30～120g, The clinical use of aconite roots was in line with the situation of our hospital. The dissolution rate of aconitine was constantly increase with time prolonging decoction, maximum value reached at 4h, mesaconitine and hypaconitine had the similar dissolution, with the increase of time, its content has a downward trend. And the content of hypaconitine decreased significantly, the highest dissolution rate was at 0.5h, minimum at 4h.5. After compatibility cooked aconite and dried ginger, licorice, honey, the content of mono ester type alkaloids and total alkaloids increased. To explain that cooked aconite and dried ginger, licorice, and honey were reasonable. The compatibility of aconite with honey decoction effect was not prominent.ConclusionDetection on the market of different sources of ripe monkshood, it was concluded that the total single ester type alkaloids in the heishunpian were in accordance with the Pharmacopoeia, the paofupian for two batches of unqualified phenomenon. The content of toxic components is relatively low in heishunpian and paofupian, because The processed products of common monkshood on the market has already been processed,the toxic components contained in the test were low, safe use of drugs. Double ester type alkaloid content is higher in Aconite roots,so in the use of the process should pay attention to the decocting time and the dose,in order to avoid poisoning. The toxicity of Aconite Decoction cooked disappear after one hour, and effective component dissolution to reach the maximum value. Diester aconite roots in the decocting process of aconitine dissolution rate fluctuations, and the dissolution of the three alkaloids were obviously different, recommended dosage of raw aconite is 30-120g is appropriate, so as not to cause waste and large dosage of herbal medicine, because the increase in the dose of its alkaloid content and did not increase but decrease. Licorice, ginger can increase the content of the total alkaloids and alkaloids, so as to improve the dissolution rate of alkaloids, and honey has less influence on the alkaloid content. Therefore, ginger, liquorice cooked aconite is scientific, the combination can make the play better the effect of ripe monkshood. However, licorice, dried ginger, honey on whether it has the role of attenuated, but also for pharmacological research. The Sini Decoction as the experimental group, compared with the same effect of aconite decocted Decoction on its alkaloid contents, experimental results point out, the content of mono ester type alkaloids and total alkaloids were large, further confirmed the rationality of the compatibility of drugs, whether the aconite was decocted first certain science, further research on pharmacology and toxicology is needed.