Even Spend Fang Powder Injection Preparation Process And Quality Standards Study

Objective: Influenza is a kind of virus epidemic which has not beenthoroughly controlled until recent times. Due to the virus` continuousaberrance and transformation, it is hard for compound chemical medicinesto cope with that just in time. Therefore, National governments have paiedclose attentions on effective anti-influenza medicines by means of TCMfeaturing low toxin content. In our research of TCM composite formulasfor clearing away heat and toxic material, Chinese empirical prescriptionLianhuafang No.1 and No.2 filtered out. Here, No.1 is mainly for relievingexterior syndrome and No.2 subduing internal heat. And it is demonstratedthat both are anti-virus, anti-bacteria as well as anti-inflammation, andaffect markedly in reducing fever and subduing pains. Especiallyinjections in small doses can still perform remarkably well. Hence thedissertation will focus on the basic research of sterilized powder forinjection of Lianhuafang No.1 and No. 2, and hopefully, make contributionsto TCM innovations in the way of exerting the technology of sterilizedpowder for injection on TCM composite formula.Methods: (1) Study on process technology: Optimum extraction factors forchoosing the most effective parts of herbals were determined by crossingdesigns and comparative experiments. The macro absorption resins wereapplied to separate and purify the effective part. In order to enhancethe solubility of oleum menthae dementholatum ,it was prepared into aHP-β-CD by means of CD technology. Lianhuafang sterilized powder forinjection. were made by the freeze-dried technic and the finished productswere selected by pharmaceutical procedure according to their color,dissolvability, clarity and forms. (2) The study on quality specification:By using HPLC we have made quantitative analysis on Phillyrin,Forsythiaside, Arctiin, Gardenoside, Baicalin,Chlorogenic acid; By usingTLC we have made qualitative analysis on each constitute of Lianhuafang.(3) The preliminary stability investigation: through observing the remainspecimen ,we studied the properties, contents, sanitation and then chooseagain on the basis of stability results.Results:(1) Through procedure selection, the best processing method toprepare the effective part of honeysuckle was determined. It has greatlyAbstract Ⅴincreased the solubility of oleum menthae dementholatum when prepared intoa HP-β-CD by means of CD technology and also offer a possibility to prepareinto sterilized powder for injection.Through procedure selection, theeffective part of Lianhuafang No.1 and No.2 can be prepared into sterilizedpowder for injection by means of freeze-drying technics and the propertiesof finished products are of good quality. (2) The quality specificationof Lianhuafang sterilized powder for injection: the method is mature,sensitive, accurate, repeatable and specific. The finished productsaccord with the requirements of TCM injections in common terms. The overallcontent of No.1 and No.2 is 36.67% and 29.73% respectively. (3) Thepreliminary stability investigation shown: the both Lianhuafang No.1 andNo.2 are stable in their quality and can meet the quality that clinicalmedicine required.Conclusion: According to the research of pharmacy, it was proved to befeasible to prepare the effective part of Lianhuafang No.1 and No.2 intosterilized powder for injection by means of freeze-drying technics. Italso supplies a valuable reference for other TCM empirical prescriptionsand lays the foundation for the future development of TCM composite formulaand TCM pharmaceutical research.