Method for detecting volatile components in pharmaceutical preparation

Abstract

The invention provides a method for detecting volatile components in a medicinal preparation, which adopts an HS-GC / MS (headspace-gas chromatography / mass spectrometry) method to simultaneously detect22 material components including methyl eugenol, safrole, 3, 5-dimethoxytoluene, 1, 2, 3-trimethoxy-5-methyl benzene, myristyl ether, elemenin, 2-Undecenal, 9-decenal, tetradecanoic acid, borneol, isoborneol, palmitic acid, oleic acid, beta-sitosterol, triundecane, 2,3-dihydro-3,5-dihydroxy-6-methyl-4-hydropyrone, 1-iodododecane, caryophyllene, caryophyllene oxide, isopsoralen, tonic Osteostatin,bakuchiol. The detection method can achieve the effect of comprehensively detecting the internal quality of the medicine, so that the safety and effectiveness of the medicine use of the product are ensured.

Description

technical field [0001] The invention relates to the field of detection and analysis of pharmaceutical components, in particular to a detection method for volatile components in pharmaceutical preparations. Background technique [0002] The pharmaceutical preparation of the present invention is composed of red ginseng, epimedium, psoralen, medlar, ephedra, asarum, salvia miltiorrhiza and leeches. The pharmaceutical preparation is a marketed product, and the manufacturer is Shandong Buchang Pharmaceutical Co., Ltd. The name of the marketed product is Shenxian Shengmai Oral Liquid. It is used for yang-deficiency and delayed pulse. Symptoms include delayed pulse, pulse knot, palpitation, and chest tightness. , chills, cold limbs, weak waist and knees, shortness of breath, fatigue or dizziness, dull tongue or scalloped tongue, or ecchymosis or petechiae on the tongue, which is equivalent to mild to moderate sinus node bradycardia (heart rate> 50 beats) And mild sick sinus syn...

AI Technical Summary

Problems solved by technology

At present, the implementation standard of this product is the State Food and Drug Administration standard WS 3 -065(Z-010)-2003(Z), but its quality testing method is thin layer identification (TLC) of red ginseng, ephedra, psoralen, epimedium and salvia miltiorrhiza, and the single index component of ginsenoside molecular formula Quality control, the method is simple and elementary, and the detection components are few, so the existing detection can not achieve effective evaluation of the internal quality of the traditional Chinese medicine of the present invention, and more in-depth research is needed

[0003] Gas chromatography is a chromatographic technique that can gradually separate complex chemical components in Chinese patent medicines, but its ability to characterize and identify structures is poor; when combined with mass spectrometry, it has a strong ability to identify unknown compound structures, with high sensitivity and rapid detection , but mass spectrometry itself has the disadvantage of being unable to separate complex compounds, so high-purity samples are required for the identification of unknown compounds

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