CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 5: 356 - 356-360

DOI: https://doi.org/magtech-2024-10-14-00001

Study on the Determination and Influencing Factors of Hyoscyamine Sulfate and Scopolamine Lactone Content in Vitamin U Belladonna Aluminum Capsules Ⅱ

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  • Liaoning Inspection， Examination and Certification Centre， Liaoning Institute for Drug Control/NMPA Key Laboratory for Quality
         Research and Evaluation of Chemical Drug， Liaoning Shenyang 110036， China

Received date: 2024-10-14

  Revised date: 2025-10-07

  Accepted date: 2025-11-27

  Online published: 2025-12-15

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Abstract

Objective： To establish a method for determining the content of hyoscyamine sulfate and scopolamine lactone in Vitamin U Belladonna Aluminum Capsules Ⅱ， and to investigate the influence of influencing factors. Methods： High performance liquid chromatography was used for detection， with octadecylsilane bonded silica gel as the filler， 0.1 mol·L-1 sodium heptanesulfonate solution as the mobile phase A， methanol as the mobile phase B， gradient elution， flow rate of 1.0 mL·min-1， column temperature of 35 ℃， detection wavelengthes were set at 210 nm (asparagine sulfate) and 344 nm (Scopolamine lactone)， and injection volume of 100 μL. Results： The linear ranges of hyoscyamine sulfate and scopolamine lactone were 4.098-40.980 μg·mL-1 and 0.209 7-2.097 0 μg·mL-1， respectively， and the recovery rates were 100.3% and 100.7%， respectively (RSD of 1.9% and 2.8%， n=6). Hyoscyamine sulfate and Scopolamine lactone were unstable in hot environments， and their contents decreased more significantly with increasing temperature. Conclusion： The established method can accurately determine the content of hyoscyamine sulfate and scopolamine lactone in vitamin U belladonna aluminum capsules Ⅱ， with good specificity and simple pretreatment. The main factors affecting the content of sulfamethoxazole and scopolamine lactone were temperature and time. It was suggested that production enterprises should pay attention to controll the temperature and time of the drying process during the production process， and at the same time， control the storage conditions to avoid excessive temperature in the circulation process， which may cause product quality non-compliance.

Key words： ; font-size:medium; ">Vitamin U belladonna aluminum capsules Ⅱ； Content determination； Amanita sulfate； Scopolamine lactone； Influence factor

Cite this article

ZHANG Di, ZHANG Yaowen, HUANG Hai, XU Wankui . Study on the Determination and Influencing Factors of Hyoscyamine Sulfate and Scopolamine Lactone Content in Vitamin U Belladonna Aluminum Capsules Ⅱ[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(5) : 356 -356-360 . DOI: magtech-2024-10-14-00001

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