Antiviral Dropping Pills Developed

The anti-viral capsule is composed by the Radix isatidis, gypsum, Radix Rehmanniae, Pogostemon cablin, Fructus Forsythiae, Rhizoma Phragmitis, Radix Curcumae, Acorus tatarinowii Scllott and Anemarrhena asphodeloides Bge, admitted in departmental standard. Its clinical applications have proved the great beneficial effect in the treatment of patients with viral diseases such as the flu, cold due to wind-heat, upper respiratory tract infection. But the anti-viral capsule also has exhibited some disadvantages that the administration dosage is big and the effects is slow, so based on the pharmacology experiment foundation, we purifies the crude extract of anti-viral capsule, reduce the administration dosage, made Drop Pills into a better bioavialability and quicker onset of action. The present paper studies deeply its preparation, quality standard, biological evaluation and preliminary stability. Several studies are included in the thesis:At first according to the physicochemical properties and pharmacological action of the active ingredients of every kind of chinese herbal medicine in Prescriptions, a rational process route has been determined. the volatile oil extraction processes of Pogostemon cablin,Radix Curcumae,Acorus tatarinowii Scllott was established with orthogonal test and single factor experiments. the ethanol extracting technology of Fructus Forsythiae,Anemarrhena asphodeloides Bge, and the water extracting and ethanol precipitating technology of the Radix isatidis,gypsum,Radix Rehmanniae,Fructus Forsythiae, have been determined. then crude extract process was established. On the basis of the pharmacological experiment, the Antiviral effective parts was prepared by purifying the crude extract. The process conditions to make preparation of antiviral Dropping Pills were optimized in terms of spherical degree by studying single factor and orthogonal design test. The the results showed that the drug effect of effective parts purified with 90% ethanol, is superior to the capsule dosage form. The optimized process was as follow: the matrix contained PEG4000: PEG6000(1:1); the refrigerant was methyl-silicon oil; the ratio of limonene to matrix was 1:3 and the temperature of limonene was 80℃; the intemal and extemsl diameter of burette was 2.0mm and 2.4mm, respectively; the burette was 4cm above the surface of refrigerant; drug was dropped into refrigerant of 5℃at 30 drops per minute. In the studie of the antiviral drop pills quality evaluation, a thin layer chromatography method for qualitative distinguishing Radix isatidis,Anemarrhena asphodeloides Bge,Fructus Forsythiae and Pogostemon cablin in prescription medicine were developed, and the contents of forsythin in Fructus Forsythia was determined by HPLC, the Method has good specificity. At the same time, other regular check related to drop pill have been done, the result indicated that Antiviral Droping pills made in this process has good appearance and disintegrate rate, with low weight coefficient of variation, this process is suitable for quality control. The bioevaluation indicate that, Compared with the anti-viral capsule, the anti-viral drop pill has strongly inhibitory action in vitro behind less densities to virus's, under in vivo less dosage, it may has the more effective suppress virus pneumonia, be able obviously to reduce body temperature, has obvious antithermic action, the analgesia function and the anti-inflammation function. Anti-viral drop pill has less dotage, plays the effect quickly, has longterm of effect time, but has not obvious poisonous side effect, continuously, gives the medicine safely to be reliable for a long time.The investigation of the anti-viral drop pill will provide a novel idea for developing traditional Chinese medicine (TCM) compound by using the proposed dosage form.