| Traditional Chinese medicine injections(TCMI)should have safety,effectiveness,stability and controllability,while quality controllability is the prerequisite and basic guarantee for the security and validity of the TCMI.In this paper,investigations on the improvement in quality standard of Hongjingtian injection were performed to effectively reflect HPLC chemical fingerprint for the main chemical composition of Hongjingtian injection for quality control(QC),establish the determination method of the main chemical components in this product,and perform the limited control of 5-hydroxymethyl furfural(5-HMF),a harmful substance prone to induce in the production of TCMI.Firstly,this paper established the fingerprint chromatographic conditions of Hongjingtian injection by investigating the different types of chromatography column and different conditions of gradient elution proportion.The methodology study indicated that the analytical method for fingerprint chromatography of Hongjingtian injection was reliable and stable,and could be used for the QC analysis of the Hongjingtian injection.The standard chromatogram was established using the similarity evaluation software for Chinese medicine chromatographic fingerprint which was based on the analysis of the fingerprints of Hongjingtian injection from different regions and different batches.The similarity between different batches of injection showed that similarity for all 27 batches was above 85%.Methods for the determination of p-hydroxybenzoic acid and p-coumaric acid are established through investigating different chromatographic conditions.The methodology study indicated that the content determination methods for fingerprint chromatography of p-hydroxybenzoic acid and p-coumaric acid were accurate,reproducible and could be used as a analysis method for the determination of effective components content in Hongjingtian injection.This paper further investigated the limited control of 5-HMF,a harmful substance prone to introduce in the production process of TCMI.Chromatographic conditions for the limit test of 5-HMF was established through investigating different chromatographic conditions.The methodology study indicated that the limited determination methods for fingerprint chromatography of 5-HMF were stable,reproducible and could be used for limited determination of 5-HMF in Hongjingtian injection.The results of the limited determination of 5-HMF in different batches of Hongjingtian injection indicated that the each batch of injection was limited under the standard.In this paper,the correlations of medicinal materials of Herba Rhodiolae,intermediate during production and quality control of Hongjingtian injection were studied through the establishment of chromatographic fingerprint analytic methods.The results showed that the chromatographic fingerprint of medicinal materials of Herba Rhodiolae,intermediate during and Hongjingtian injection showed good correlation.This method effectively reflected the transition process of main effective components from original herb to intermediate then to injection production as well as the changes of relative content in this process and therefore,could be applied for quality control during Hongjingtian injection production. |
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