Abstract

Pneumonia mixture was formulated and is available to treat children acute pneumonia and acute bronchitis in our hospital for nearly forty years, but there are few studies of its quality evaluation or control. In this paper, a new strategy for quality evaluation of pneumonia mixture was explored and verified through qualitative and quantitative analyses of multicomponents by single marker (QAMS) by UPLC-MS/MS. Baicalein was selected as an internal reference, and the relative correction factors (RCFs) and the relative retention time (RRT) of (R, S)-goitrin, amygdalin, chlorogenic acid, pseudoephedrine hydrochloride, ephedrine hydrochloride, ammonium glycyrrhizinate, and baicalin were established. The robustness and durability of the QAMS method were investigated. RCF values calculated by the average (AVG) method and linear regression (LRG) method had good repeatability and were acceptable for quantitative analysis, and the RTT combined with the exact masses of precursor and fragment ions and their abundance could be adopted for accurately positioning the chromatographic peak of the eight constituents. The consistency and feasibility of the QAMS method were verified by comparing the contents of the seven components calculated by a classic and validated external standard method (ESM) with those of the QAMS method, which reduces analytical cost and time of detection and avoids the problem of the diversity and large quantity of reference standards. The results demonstrated that the QAMS method developed in this paper could provide a new, alternative, and promising method to comprehensively and effectively determine multicomponents and control the quality of pneumonia mixture or even a group of similar medicines.

Highlights

  • Pneumonia, usually caused by virus, bacteria, mycoplasma, chlamydia, or multiple pathogens, is a menace to the healthy growth of children around the world. e major pathogens are bacteria, including Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis, Escherichia coli, and Klebsiella pneumoniae. e main clinical symptoms of the disease are cough, expectoration, asthma, and fever [1,2,3]

  • For further investigation on the robustness of quantitative analyses of multicomponents by single marker (QAMS) method, the mixed standard solution should be analyzed under different condition. e relative correction factors (RCFs) and RTT of the other target peaks to internal reference standard (IRS) were calculated in different flow rates, column temperatures, and columns using the AVG method and assessed by relative standard deviation (RSD, less than 5%) [39]. e flow rate was set at 0.3/0.4/0.5 mL/min with temperature maintained

  • With the results of RCFs, the content of eight constituents except IRS in the samples could be indirectly calculated by AVG and linear regression (LRG) method according to (5) and (7), respectively. e concentrations of eight constituents calculated through QAMS method were compared to the calculative concentration of sample solution through the classic external standard method (ESM) to assess the similarity of QAMS method and ESM and to verify the feasibility of QAMS by F-test using SPSS 17.0 and standard method difference (SMD)

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Summary

Introduction

Usually caused by virus, bacteria, mycoplasma, chlamydia, or multiple pathogens, is a menace to the healthy growth of children around the world. e major pathogens are bacteria, including Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis, Escherichia coli, and Klebsiella pneumoniae. e main clinical symptoms of the disease are cough, expectoration, asthma, and fever [1,2,3]. Modern pharmacological and clinical studies showed that each medicinal material in the prescription possessed a variety of biological activities, such as diminishing inflammation, antipyretic effect, expectorant effect, antimicrobial activity, and relieving cough and asthma [14,15,16,17,18,19,20,21] It seems like the choice of those multiple compounds to be controlled in each drug is highly dependent on the drug composition, desired pharmacological effect, and the availability of the standards. In Chinese Pharmacopoeia [22], the index components of each medicinal material in the prescription for determination are pseudoephedrine hydrochloride, ephedrine hydrochloride, amygdalin, baicalein, baicalin, (R, S)-goitrin, chlorogenic acid, and ammonium glycyrrhizinate, which can be used as the quality control standards of pneumonia mixture. Our findings offer a suitable and efficient approach for assessing the quality of pneumonia mixture or even a group of similar medicines

Materials and Methods
Method Validation
Conclusion
Conflicts of Interest
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