RESUMO
Objective: To establish a method of quantitative analysis of multi-components by single marker (QAMS) for determining the flavonoids in Epimedii Herba and improve the level of quality control of Epimedii Herba by applying multi-index components control. Methods: To detect a relative correction factor (RCF) of epimendin A, epimendin B, epimendin C, and icariin at detection wavelength of 270 nm by HPLC in the range of a linear, to investigate the reproducibility of RCF in different chromatographic columns and different instruments as well, to consider icariin as an internal standard, to calculate the contents of epimendin A, epimendin B, and epimendin C in Epimedii Herba by using RCF; Meanwhile, to analyze the content of the four components in 100 Epimedii Herba by external standard method (ESM) and verify the accuracy and scientificalness of QAMS. Results: The RCF had a good reproducibility, which were 1.352, 1.384, and 1.340. The values of RSD were less than 5%; No significant differences were found in the quantitative results of epimendin A, epimendin B, and epimendin C determined by using RCF and ESM. Conclusion: This method could be accurate and reliable, simple and feasible, which could save the reference and costs of testing. It further validates that this approach can be used as a quality control method for the determination of multi-component index in Epimedii Herba.
RESUMO
Objective: To prepare and evaluate bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules, composed of Epimedium flavonoids as drug, snail enzyme as hydrolase and common formulation accessories, which is in favor of in vivo real-time enzymolysis and real-time absorption of Epimedium flavonoids. Methods: The UV method and single factor experiment were applied to investigating the effects of key factors such as filling agents species and dosage, disintegrating agents species and dosage, wetting agents species and drying temperature on the cumulative release degree of Epimedium flavonoids. Response surface method was used to optimize the prescription for bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules, and the enzymatic process of the four Epimedium flavonoids (icariin and epimendin A, B, C) was also evaluated by HPLC. Results: The optimal formulation for the bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules was composed of 100 mg Epimedium flavonoids extract, 68 mg snail enzyme, 65 mg α-lactose, and 11.7 mg low-substituted hydroxypropyl cellulose. This enteric-coated capsules showed a cumulative Epimedium flavonoids release rate of 85.43% within 45 min in simulated intestinal fluid and a complete enzymolysis within the intestine emptying time (3-6 h). Conclusion: The bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules show an advantage in improving hydrolysis and anti-osteoporosis efficacy of Epimedium flavonoids, providing some research ideas for improving the oral bioavailability of other flavonoids.