Study On Preparation Process And Quality Standards Of Qinhao Nasal Drops

Objective: To research and develop a kind of traditional Chinese medicinepreparation, which can be used to cure allergic rhinitis(AR), Qinhao nasal drops.Methods：(1)The extraction method of Artemisia Rupestris L in Qinhao nasal drops.Based on the single factor experiments, using comprehensive score of the content ofRupestonic acid and dry extractive material as indexes，adapting orthogonal experimentaldesign to choose the best extraction technology of Artemisia Rupestris L.(2) According tothe “Chinese pharmacopoeia”2010edition a of the provisions of the Scutellariabaicalensis extracts were extracted; According to the “Chinese pharmacopoeia”2010edition a of the provisions of the Licorice extract were extracted.(3)To select the propersolvent of Scutellaria baicalensis extract and Artemisia Rupestris L extract. With ciliatoxicity and rheological properties as the index, to screening Qinhao nasal drops ofthickener; using solubility as index to choose the preservative of Qinhao nasal drops; getthe best prescription of Qinhao nasal drops.(4) Using TLC method for preparation ofbaicalin, Rupestonic acid and glycyrrhizic acid qualitative identification; Check thepreparation appearance, pH value, using the HPLC method to content determination ofbaicalin, Rupestonic acid, glycyrrhizic acid in Qinhao nasal drops. To study the stabilitypreliminary of Qinhao nasal drops. Results:(1) The best extraction technology ofArtemisia Rupestris L were as follows:10-fold of95%alcohol, extracted for three times，0.5hours for each time．(2) The best prescription of Qinhao nasal drops were as follows:Radix Scutellariae, Artemisia Rupestris L., licorice, Carbopol-980, ethylp-hydroxybenzoate;(3) Preparation of Scutellaria baicalensis identification: preparation,lack of reference substance of scutellaria preparations, baicalin, each point in the samepolyamide membrane, with acetic acid as developing agent, and taken out, dried, can beexamined under a UV lamp (365nm), on the same position in the thin layerchromatography shows the same color spots. Preparation of active ingredients a qualitativeidentification of Artemisia Rupestris L preparation, Artemisia Rupestris L referencesubstance, each point in the same silica gel GF254thin layer plate, with petroleum ether (60~90℃boiling range)-ethylacetate-glacial acetic acid (20:10:1) as developing agent, andtaken out, dried, can be examined under a UV lamp (254nm), on the same position in thethin layer chromatography shows the same color spots. Preparation of quality control ofeffective component glycyrrhizic: preparation, lack of glycyrrhiza preparations,glycyrrhetate reference substance, each point in the same silica gel GF254thin layer plate,in ethyl acetate-formic acid, glacial acetic acid-(15:2:2:3) as developing agent, water,remove and dry. can be examined under a UV lamp (254nm). on the same position in thethin layer chromatography show the same color spots. High performance liquidchromatography (HPLC) method was used for determination of the content of baicalin、Rupestonic acid and glycyrrhizic acid. Preliminary stability results show that Qinhao nasaldrops is relatively stable. Formulate quality standard is simple, easy, and can effectivelycontrol Qinhao nasal drops quality. Conclusion：Qinhao nasal drops can be preparedconveniently. The method of quality contral is feasible and sensitive, which can be usedfor the quality control of Qinhao nasal drops.