| Ache is the common symptom of many diseases in clinic.At present,most of the analgesics used in clinic therapy have addiction and obvious drug adverse reaction,so it is significant to find a high-effect and low-toxicity analgesic.Armadillidiam Vulgare is the whole dried body of Latreille of Armadillidiidae.The concents of reducing sugar and glycogen in Armadillidiam Vulgare vary with the growth period.Its polysaccharides contain chondritin A or C or hyaluronic acid.Other concents contain different kinds of fat,cholesterol,and may be have formic acid.For analgesia,Armadillidiam Vulgare mainly has protein and formic acid . Documents recorded that Armadillidiam Vulgare has many Pharmacological effects, such as breaking blood , diuresis , detoxication and analgesia.At present,the clinic applications of Armadillidiam Vulgare include therapies on hemorrhoids,verruca,cancer pain,stomatitis,tonsillitis,chronic bronchitis,postoperative pain,liver cancer and so on.It is reported in china that Armadillidiam Vulgare alleviates pain of liver cancer at advanced stage and its effect lasts longer than Sauteralgyl.For utilizing thoroughly traditional Chinese drug resources of our country,and meeting demands of development Modernization of Traditional Chinese Medicine.We studied on the Pharmaceutics of Armadillidiam Vulgare in this paper on the basis of clinical reports.At first,we studied the extraction method of Armadillidiam Vulgare.Using the analgesia inhibitory rate of acetate-induced pain in mice as indicators, the analgesia substances of Armadillidiam Vulgare was extracted by water decoction. The optimization technics obtained by orthogonal experiment was liquid ratio 1:8,extraction time 8h and one time.We also studied the technics of water decoction and ethanol precipitation.The concentration of ethanol precipitation was 50%.The result of the acute toxicity of the water extracts of Armadillidium Vulgarem shows that the water extracts of Armadillidium Vulgarem are safe and non-toxic.LD50 is not detected.MTD of water extracts from Armadillidium Vulgarem is 120g /kg.The prescription and preparation technic of armadillidium vulgarem dropping pills and dispersible tablets are identified by using single factor selection and orthogonal design.The Armadillidiam Vulgare pills was evaluated by appearance and disintegrating time.We selected the type of matrix, the matrix ratio,the ratio of the drug and matrix.In the shaping process of Armadillidium Vulgarem dropping pills,with the spherical degree,hardness,tailing degree,colour and disintegrating time as the evaluation quota using orthogonal test to decide the best experimental methods.The best moulding technical conditions: the rate of drug to matrix is 1:1,P188 content is 15%, the temperature of drug is 70～75℃.In the dropping process,the best dropping condition using orthogonal test for the conficient of heavy variation of the dropping pills is the temperature of liquid condensate 1～4℃,drop-nozzle temperature 27～30℃,the internal and external diameter of burette is 4.1mm and 4.6mm,drop speed 20d/min.By investigating different disintegrants,fillers,granulating solvents and drug loading on the influence of disintegration time of dispersible tablets,screening result was PVPP as disintegrants,calcium sulfate as the filler,water as wetting agent,the drug loading of 5%~10%.The effect of drug loading, the amount of disintegrants and lubricants on the disintegration time is investigated by using L9(34) orthogonal experiment.The best prescription is 17.5% PVPP as disintegrant,73% calcium sulfate as filler,drug loading of 7.5%,1% steviosin as sweetener,water as wetting agent,1% magnesium stearate,talcum powder and micro-powder silica gel as lubricants.We also established quality standards of two agents.The main characters we measured include the detection of character,identification,examination and content determination.The protein and Borneol in Armadillidium Vulgarem pills and dispersible tablets is identificatied by the ninhydrin, biuret color reaction and thin-layer chromatography.It mainly measured the content,precision,stability and rate of recycling of Armadillidium Vulgarem protein and borneol by using lowry and GC method.The method is accurate and quick.This detective index could be used to control the quality of Armadillidium Vulgarem dropping pills and dispersible tablets.The results of stability of two agents show that the characters,identification,examination and content determination of Armadillidium Vulgarem pills and dispersible tablets have not changed during the 6 months at room temperature.The Armadillidium Vulgarem pills and dispersible tablets are stable in the present testing period.Finally,the pharmacology and toxicology of Armadillidium Vulgarem pills and dispersible tablets are studied . It is proved that half lethal dose (LD50) of Armadillidium Vulgarem pills is 21.70g/kg,95% confidence interval (95% CI) is 19.3~24.5g/kg.The maximal tolerance dose of Armadillidium Vulgarem dispersible tablets is 30.00g/kg,equivalent to 1090 times clinical dosage(3.3g/day/person).The result shows that the maximum dosage of Armadillidium Vulgarem dispersible tablets in mice is greater than 30.00g/kg,non-toxic reactions,oral administration safely.To study the principal pharmcodynamics of armadillidium vulgarem pills and dispersible tablets,methods of acetic acid-induced writhing,hot-plate test and xylene-induced ear edema in mice are used to study the analgesic effect and anti-inflammatory effect.The results show that Armadillidium Vulgarem pills and dispersible tablets have significant effect of improving the pain threshold and inhibition rate of writhing reaction.Moreover,Armadillidium Vulgarem pills has significant effect of anti-inflammatory.
|
PDF Full Text Request