Preparation And Evaluation Of The Compound Nigellae Semen Oil Drops

OBJECTIVE: Rhinitis is a common recurring disease and hard to cure. Rhinitis induce a series of other illnesses threaten human health if the trend continues. In this study an uighur medicine Compound Nigellae Semen Oil Dropswere prepared composed by Nigellae semen and four Chinese herbs e.g. Magnoliae Flos, Centipedae herba, Xanthii fructus and Angelicae dahuricae radix, which had the effect of Tongqiao and anti-inflammatory. We investigated the extraction technology, molding process, quality standard and pharmacological effectof the prepared nose drops in order to get a kind of preparation of anti-rhinitis with mature technology, stable quality and curative effect.METHODS: Orthogonal test was employed to optimize the extractiontechniques of oil fraction of Nigellae semen, volatile oil of Magnoliae Flos and fourChinese herbs respectively. We qualified the nose drops molding process with thecontent of linoleic acid as an index. Qualitative identification of four Chinese herbs ofMagnoliae Flos, Centipedae herba, Xanthii fructus and Angelicae dahuricae radixwere conducted by TLC method. The content of linoleic acid from the Nigellae semenoil fraction was determined by gas chromatography. The ear swelling and local skinirritation experiments were conducted to investigate the effect of treatment andstimulation of the prepared nose drops.RESULTS: The optimized preparation route of the Compound Nigellae SemenOil Drops was as follows: adding10times of petroleum ether into Nigellae semen powder for ultrasonic extraction2times with1hour each time, merging the filtrates,oil was prepared after the solvent retrieved by vacuum.10times of water was addedinto Magnoliae Flos powder, soaked for2hours, extracted for6hours by wetdistillation, acquired the volatile oil. The residue and the filtrate were in reserverespectively. Centipedae herba, Xanthii fructus and Angelicae dahuricae radix wereadded into the residue of Magnoliae Flos powder, boiling for6hours in20times ofwater to obtain their decoction after filtration. The decoction and the water distilled ofMagnoliae Flos powder were merged and concentrated to a relative density of1.15and set aside to cool down. Then added alcohol to make the alcohol content reached60%, overnight, recovering ethanol from the filtrate, liquid reserve. The5mLpolysorbate-80mixed with grease and volatile oil was added into the alcohol depositsolution and then1.5g CMC-Na dissolved in50mL distilled water was added intothe above liquid after fully swelling. Then added4.5g NaCl, adjusted pH to6-7with3%borax solution, then diluted with distilled water to500mL, mixed and frozen for48hours, then subpackage to final preparatoin. TLC results indicated that MagnoliaeFlos, Centipedae herba, Xanthii fructus and Angelicae dahuricae radix of differentbatches of drops and the control herb showed the same spots on the correspondingposition of the plate. Gas chromatography showed that linoleic acid content was noless than2.10mg·mL-1. Ear swelling experiment indicated that the nose drops had agood effect of anti-inflammatory in mice. The rabbit stimulation experiments showedthat this formulation had smaller stimulation effects.CONCLUSION: A series of experiments showed that Compound NigellaeSemen Oil Drops would be a new kind of safe and effective drug for rhinitistreatment with reasonable and reliable extraction and preparation process. The preparation had a comprehensive quality standards and significant curative effect,which was worthy of further clinical studies.