Objective

2

To improve the current standard of Belladonnae Herba in the 2020 edition of

Chinese Pharmacopoeia

.

Method

2

Taking hyoscyamine sulfate， atropine sulfate and scopoletin as reference substances， and ethyl acetate-methanol-concentrated ammonia（17∶4∶2）as developing solvent， thin layer chromatography （TLC） was applied in the qualitative identification of Belladonnae Herba. The moisture， total ash and ethanol-soluble extract of Belladonnae Herba were determined based on the general principles in the 2020 edition of

Chinese Pharmacopoeia

（volume Ⅳ）. The contents of hyoscyamine sulfate and scopolamine hydrobromide were analyzed by high performance liquid chromatography （HPLC） with mobile phase of acetonitrile-54 mmol·L

-1

phosphate buffer solution （14∶86）， flow rate of 1.0 mL·min

-1

and detection wavelength at 210 nm.

Result

2

The spots in the TLC were clear with good separation and specificity. Hyoscyamine sulfate and scopolamine hydrobromide showed a good linearity with peak area in the range of 0.024 7-0.789 6 g·L

-1

（

r

=0.999 9） and 0.003 9-0.124 0 g·L

-1

（

r

=0.999 9）， the average recoveries of these two ingredients were 100.29% （RSD 1.6%） and 99.04% （RSD 1.4%）， respectively. The limits for moisture， total ash in Belladonnae Herba should be less than 13.0% and the limit for the ethanol-soluble extract should be more than 10.0%. Due to the low content and wide variation of scopolamine hydrobromide， the content of hyoscyamine sulfate should not be less than 0.098%.

Conclusion

2

The established method is simple， specific and reproducible， which can be used to improve the quality control standard of Belladonnae Herba.