Compound The Wind Particles Preparation Process And The Preparation Of Quality Standards

On the treatment of drug detoxification, the current internationally accepted the methods of opioid receptor agonists and non-opioid receptor agonist symptomatic treatment, or awareness deprivation of narcotic drugs. However, great potential for addiction, side effects, low acceptance rates, low maintain rates and low patient compliance is also the great problems. So, safe and effective opiate addiction withdrawal is currently a pressing medical problem to solve. Traditional Chinese medicine has a lot of advantages as multi-system, multi-target, safe and effective, short course, wok quickly, few side effects, economic. So the topic choose the clinical experience prescription, and use the modern scientific and technological means, to make an ideal non-side effects and non-dependence reaction drug of traditional Chinese medicine preparations. The preparation composed of Saposhnikoviae Radix, baked Rhizoma Zingiberis, Pericarpium Citri Reticulatae, Hawthorn Fruit (coke), Herba Cistanchis (wine). It can promote blood flow, neutralize poison, rest the wind, relieve pain, invigorate the kidney and spleen. Clinical use of acute withdrawal period of opioid addiction with appearance of poison congestion stasis, insufficient of kidney and spleen, cold-heat complicated syndrome. The researches used the method of treatment according to traditional Chinese medicine and combined with modern research results. To optimize the technology of manufacture of the praeparatum, use the method of orthogonal experiment, to formulate the quality standards of preparation according to the requirements of "The Chinese Pharmacopoeia". And we also carried out the research of accelerated stability tests and long-term stability tests.The main conclusions are as follows:1. Saposhnikoviae radix, baked Rhizoma Zingiberis, pericarpium citri reticulatae were extracted by wet distillation for 8hrs, with 6 times the weight of water soaked 2hr. Collecte the volatile oil. The residues continue extracted by boiling water for 2 times, each time lhr, and each with water volume of 4 times the weight. Herba Cistanchis, Fructus Crataegi, Radix Codonopsitis, etc. were extracted with boiling water for 4hrs, and two times, each time 1.5hrs, 8 times and 6 times the weighy of water. The volatile oil was wraped withβ-CD bying stiring, with the ratio of the volatile oil:β-CD=1:4, stiring 15min, at 30±1℃. The filtrate was concentrated to the relative density of 1.04 (60℃), high-speed centrifugation, the supernatant was concentrated to the relative density of 1.20 (60℃). At the ratio of Thick paste : wraped volatile oilβ-CD and dextrine mixture=4.3:1, fluidized spray granulation. 2. According to "Chinese Pharmacopoeia" General granule preparation, checking items on the compound particle size wind, water, melting resistance, load difference, microbial limit has been studied and qualified; using TLC method to Cimicifuga glycosides and 4'-O-beta-Glucopyranosyl-5-O-Methylvisamminol qualitative identification of the wind were to Codonopsis control medicines to control the qualitative identification of Codonopsis, ginger ale, medicine to control the qualitative identification of the Baojiang to Orange glycosides for the qualitative identification of Citrus control; using HPLC to determine the Cimicifuga glycosides and 4'-O-beta-Glucopyranosyl-5-O-Methylvisamminol, and tentatively the total amount was not less than 20mg per bag.3. The research of 3 batches of finished compound accelerated stability test and long-term stability test shows that the preparation packaging products in plastic, aluminum composite film for packaging materials, sealing under normal temperature conditions, will be valid for 24 months.