Abstract
Sheng-Mai-San is a multi-component traditional Chinese herbal preparation. Due to the fact granulated additives, such as starch, carboxymethyl cellulose, lactose and raw herbal powder may alter the content of the bioactive markers in the herbal products, a developed ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) method was used to measure the herbal biomarkers of ginsenoside Rb1, Rb2, Rc, Rd, Re, Rg1, Rh1, compound K, ophiopogonin D and schizandrin from the Sheng-Mai-San herbal formulation. Besides, scanning electron microscopy (SEM) was used to observe the morphology of the herbal granular powders. Light microscopy with Congo red and iodine-KI reagent staining was used to identify the cellulose fiber and cornstarch added to pharmaceutical herbal products. The swelling power (SP), water solubility index (WSI), and crude fiber analysis were used to determine the contents of cellulose fiber and cornstarch in pharmaceutical herbal products. In this study, we developed a novel skill to assess the quantification of appended cornstarch in pharmaceutical herbal products using Aperio ImageScope software. Compared with the traditional cornstarch analysis, our analysis method is a rapid, simple and conversion process which could be applied to detect the percentage of added cornstarch in unknown powder products. The various range of the herbal content for the five pharmaceutical manufacturers varied by up to several hundreds-fold. The physical examination reveals that the morphology of the herbal pharmaceutical products is rough and irregular with sharp layers. This study provides a reference standard operating procedure guide for the quality control of the Chinese herbal pharmaceutical products of Sheng-Mai-San.
Highlights
Traditional Chinese herbal medicine is one of the most important forms of complementary and alternative medicine (CAM) used for health care in the world
Analytes were quantified in selective reaction monitoring (SRM) mode: ginsenoside Rb1, m/z 1131.78 [M + Na]+ → m/z 789.41 (CE 56 eV); ginsenoside Rb2, 1101.78 [M + Na]+ → m/z 789.40 (collision energy (CE) 54 eV); ginsenoside Rc, 1101.78 [M + Na]+ → m/z 789.46 (CE 58 eV); ginsenoside Rd, 969.65 [M + Na]+
The results demonstrate that, among the samples obtained from pharmaceutical manufacturers A–E and the decoction powder, the contents of ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rc, ginsenoside Rd, ginsenoside Re, ginsenoside Rg1, ginsenoside Rh1, ophiopogonin D, and schizandrin were 9.44 to 346 μg/g, 6.57 to 277.6 μg/g, 6.53 to 544.8 μg/g, 19.58 to
Summary
Traditional Chinese herbal medicine is one of the most important forms of complementary and alternative medicine (CAM) used for health care in the world. Recent studies have shown its effectiveness in the treatment of heat-stroke and cardiovascular diseases. Molecules 2016, 21, 1159 ginseng), Fructus schisandrae (Chinese herbal name: wu-wei-zi) and Radix ophiopogonis (Chinese herbal name: mai-men-dong). Shenmai injection, a botanical pharmaceutical product comprising an alcoholic extract of Panax ginseng and Ophiopogon japonicus, has been used for the treatment of chronic pulmonary heart disease [1,2,3,4]. Due to its injection formulation, the quality control of herbal pharmaceutical products in terms of safety and activity is an important concern. Ginseng is a popular nutrition supplement and well-known traditional herbal medicine. Ginseng herbal extracts have been used as tonic, sedative, anti-fatigue, and anti-gastric ulcer drugs for thousands of years in
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