Abstract

Qingkailing injection (QKLI), a modern traditional Chinese medicine preparation, has been widely used in clinics due to its fast and significant efficacy in treatment of high fever. The free amino acids (AAs) were considered to be the most abundant active ingredients indisputably. So developing an accurate and simple determination method to measure the contents of total free AAs in QKLI is very crucial. In current study, the accurate and simple method of using one single standard AA for simultaneous quantification of multiple AAs (One for M) in QKLI was developed. Particularly, the calculation methods and the robustness of relative correction factors (RCFs) were investigated systematically. No statistically significant difference between these two quantification methods of One for M and classic regression equation was found by the t-test (P = 95%, P > 0.05). The results showed that the precision (RSD < 4.88%), the robustness (RSD < 4.04%), and the average recoveries (94.11%–107.94%) of this newly proposed method all met the requirements for content determination. This One for M method will provide a scientific reference for the quantitative determination of AAs in other traditional Chinese medicines and their preparations owing to its accuracy and simplicity.

Highlights

  • Qingkailing injection (QKL), which is modified from a wellknown classic formulation An-Gong-Niu-Huang pill, has become one of the essential Chinese patent medicines for its wide clinical application in the treatment of liver damage, inflammation, viral infections, and cardiovascular diseases, especially hyperpyrexia [1–5]

  • Developing an accurate and simple determination method of multiple amino acids (AAs) used in production process of Qingkailing injection (QKLI) and quality control to its preparation is imperative

  • We found that the effect of intercept and slope of calibration curve on relative correction factors (RCFs) could not be ignored

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Summary

Introduction

Qingkailing injection (QKL), which is modified from a wellknown classic formulation An-Gong-Niu-Huang pill, has become one of the essential Chinese patent medicines for its wide clinical application in the treatment of liver damage, inflammation, viral infections, and cardiovascular diseases, especially hyperpyrexia [1–5]. In the monograph of Chinese Pharmacopoeia (2010 edition), the Kjeldahl nitrogen determination method, a classic method for analyzing the content of total nitrogen, was used to evaluate the total content of AAs in QKLI indirectly [10]. Some disadvantages of this nitrogen determination method, including time-consuming, complicated operation and the consumption of large amounts of solvents, are not facilitative to accomplish the determination of the total nitrogen. What is more, this Kjeldahl’s method could not distinguish the nitrogen between the free AAs and the binding AAs or the inorganic nitrogen and the organic nitrogen. Developing an accurate and simple determination method of multiple AAs used in production process of QKLI and quality control to its preparation is imperative

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