Stability Research On Ultra Micro Powder Of Qi-Ling Medicament

AstragalosideⅣand ActractylenolideⅢwere the main indexes in this study. Effect-factors test was used to Analyze the factors affecting the stability of ultra micro powder of Qi-Ling medicament, and to search appropriate packaging, and cheap and effective drugs stabilizer and antioxidant for ultra micro powder of Qi-Ling medicament. The validity period of medicament of Qi-Ling ultra micro powder was determined by accelerated stability test. The results are as follows:1 A test method by ELSD-HPLC for AstragalosideⅣin ultra micro powder of Qi-Ling medicament was established. AstragalosideⅣwas extracted with methanol, then purified by liquid-liquid extraction from ultra micro powder of Qi-Ling medicament. The optimal conditions of separation and detection were achieved on a C18 analytical column with an mobile phase consisting of acetonitrile-water (30:70). The column temperature was maintained at 25℃. The content of AstragalosideⅣin ultra micro powder of Qi-Ling medicament was 545.79μg·g -1.2 A test method by DAD-HPLC for ActractylenolideⅢin ultra micro powder of Qi-Ling medicament was established. ActractylenolideⅢwas extracted with methanol, then purified by SPE from ultra micro powder of Qi-Ling medicament. The optimal conditions of separation and detection were achieved on a C18 analytical column with a mobile phase consisting of methanol-acetonitrile-water (30:30:40) at the flow-rate of 1mL·min-1. The detection wavelength was 220nm. The column temperature was maintained at 30℃. The content of ActractylenolideⅢin ultra micro powder of Qi-Ling medicament was 97.14μg·g -1.3 Effect-factors test⑴High-temperature test: Ultra micro powder of Qi-Ling medicament was put in the conditions of 60oC for 10 days, sampled and measured timing. The results showed that, the temperature seriously effected the stability of ultra micro powder of Qi-Ling medicament. The content of AstragalosideⅣdeduced to 66.54%, and the content of ActractylenolideⅢdecreased to 12.68% within 10 days.⑵High-humidity test: Ultra micro powder of Qi-Ling medicament was put in the conditions of 25oC, RH90%±5% for 10 days, sampled and measured timing. The results showed that: High-humidity extremely effected the stability of ultra micro powder of Qi-Ling medicament. The content of AstragalosideⅣdeduced to 47.50%, the content of ActractylenolideⅢdeceased to 79.80%.⑶High-intensity light test: Ultra micro powder of Qi-Ling medicament was put in the conditions of 4500±500XL for 10 days, sampled and measured timing. The results showed that: the light exceedingly effected the stability of ultra micro powder of Qi-Ling medicament. The content of AstragalosideⅣdeduced to74.20%, the content of ActractylenolideⅢdecreased to 65.43% within 10 days.4 The choice of packaging, stabilizer and antioxidant⑴Packaging choice: Different bulk product of ultra micro powder of Qi-Ling medicament was put in the condition of 60oC for 10 days, and sampled and measured at the 5th, the 10th.The results showed that the effects of vacuum-packed and sealed package were no significantly different; PET-Al-PE Strip Packaging was superior to LDPE nylon Strip Packaging.⑵Stabilizer and antioxidant choice: Ultra micro powder of Qi-Ling medicament with different stabilizer and antioxidants was put in the condition of 60oC for 5 days, sampled and measured. The results showed that PVP could effectively inhibit brown of ultra micro powder of Qi-Ling medicament, and the content of AstragalosideⅣand ActractylenolideⅢchanged; D-Sodium isoascorbiate could effectively inhibit ultra micro powder of Qi-Ling medicament browning, inhibit content of ActractylenolideⅢchanged. D-Sodium isoascorbiate was befittingly appended in 2%～5% and PVP was befittingly appended in 3%～5%, determined by stabilizer optimal experiment.5 Accelerated stability testUltra micro powder of Qi-Ling medicament with 2% D-Sodium isoascorbiate, 3% PVP, packaged by PET-Al-PE Strip Packaging was put the accelerated condition of 40oC, RH75% for 6 months. The content of AstragalosideⅣdeduced to about 89% and the content of ActractylenolideⅢdecreased to about 93% at the 6th month. Therefore, using AstragalosideⅣand ActractylenolideⅢas the main indexes, the validity period of ultra micro powder of Qi-Ling medicament was about 24 months.