| 摘要 |
The present invention discloses a method for preparing a Camellia nitidissima Chi lipid-lowering and hypoglycemic agent. Active components such as tea polysaccharides, tea polyphenols, and flavones are extracted from Camellia nitidissima Chi and purified, which are then mixed with pharmaceutical excipients such as hydroxypropyl methyl cellulose, polyvinylpyrrolidone, and triethyl citrate to prepare various pills, tablets, capsules, granules, etc. including sustained release agents and controlled release agents. Thereby, clinical or health care medicine effects of the Camellia nitidissima Chi lipid-lowering and hypoglycemic agent are improved, a dosing frequency is reduced, interference of impurities with the medicine effect is eliminated, relative bioavailability and safety of the active components of the Camellia nitidissima Chi lipid-lowering and hypoglycemic agent in a human body are enhanced, and compliance of a patient is improved. |
| 主权项 |
1. A method for preparing a Camellia nitidissima Chi lipid-lowering and hypoglycemic agent, comprising steps of:
1) Extracting and separating tea polysaccharides: the fresh leaves of Camellia nitidissima Chi is smashed by high-speed tissue homogenizer after being cleaned, then the smashed leaves are placed into the triangular flask and fixed on reactor, the ultrasonic drug processor is started to perform extraction under solid to liquid ratio of 1:45-55, 75-85° C., 0.8-1.2 h, ultrasonic frequency of 53.2 kHz, and centrifugation is performed to the extract under 8000 r/min for 15 min, so the obtained supernatant is the crude extract of Camellia nitidissima Chi polysaccharide. 95% ethanol is added into the crude extract for 2-4 times to precipitate Camellia nitidissima Chi polysaccharide, then the obtained Camellia nitidissima Chi polysaccharide precipitation is dissolved by distilled water and constant volume can be performed, Camellia nitidissima Chi polysaccharide is prepared by recrystallization for 1-4 times, and phenol-sulfuric acid method is used to determine the contents of total sugar. 2) Extracting and separating tea polyphenols, comprising steps of: the Camellia nitidissima Chi is smashed and screened through mesh size of 30, then dipped into 30% ethanol for 20 min, microwave extraction is performed for 20 min, the extract via hollow fiber membrane is separated by concentration with rotary evaporation and extraction with macro porous resin of XDA-200, water elution is performed to remove the impurity, 10% ethanol elution is also performed to remove impurity, in the successive step, 30% ethanol gradient elution is performed, the eluent is concentrated by rotary evaporation respectively, after freezing and drying, the dried powder is obtained; finally, the tea polyphenols are prepared by three-time recrystallization; the content of tea polyphenols is determined based on detection method of tea polyphenols and catechins content of tea in GB/T 8313-2008, that is, the content of tea polyphenols=tea polyphenols quality in powder specimen/powder specimen quality)*100% 3) Extracting and separating flavonoid substances in camellia nitidissima: 10 g obtained Fe3O4 magnetic particles-PAMAM nano composites are added into 2.0 L Camellia nitidissima Chi leaves extract, ultrasonic extraction is conducted under 400 W, after extraction, the Fe3O4 magnetic particles-PAMAM nano composites together with the extraction of flavonoid substances are separated through magnetic separation, the separated Fe3O4 magnetic particles-PAMAM nano composites adsorbed with flavonoid substances are extracted for 3-5 times by ethanol, the extract is mixed and the flavonoid substances in Camellia nitidissima Chi will be obtained by rotary evaporation, and flavonoid substances with higher purity can be obtained by three-time recrystallization, the ultraviolet spectrophotometer is used to determine the content of flavonoid substances. One or combination of tea polysaccharides, tea polyphenols, and flavonoid substances are mixed with pharmaceutical excipients to prepare various ordinary pills, granules, powders, tablets, capsules etc. |
