Research On The Quality Control Of Shaji Extract Embodying The Characteristics Of Tibetan Medicine

Shaji extract (Tibetan name "dabukan za") is customarily used for Tibetan, and Shaji extract has heat-clearing, cough-stopping, blood-activating and stasis-resolving and ulcer-healing effects, cures bronchitis, dyspepsia, gastric ulcers, amenorrhea, and so on. Shaji extract has been widely used in clinical. Shaji extract was recorded in the Tibetan medicine classics, such as Yue Wang Yao Zhen, Si Bu Yi Dian, and Jing Zhu Ben Cao. Shaji extract’s quality standard was recorded in Ministry of Public Health’s Quality Standard (1995version, Tibetan medicine I) and appendix Ⅲ of Chinese Pharmacopoeia (2010version, Volume I), and there are only simple description of preparation method, character, keeping and so on, so they can’t control Shaji extract’s quality effectively. Therefore, it’s necessary to improve the quality standards.Combining with pre-fieldwork and literature, the fruits of Hippophae rhamnoides and Hippophae tibetana (Tibetan name Sadaer) always be used to preparate Shaji extract, so this paper research on the quality standards of Hippophae tibetana Schlechtend, in order to provide an experimental basis for establishing scientific and reasonable Shaji extract quality control standards embodying the characteristics of Tibetan medicine.Purposes1. To investigate the traditional used methods in Tibetan areas and related literature of Shaji extract;2. To establish the quality standards of Sadaer to ensure the stability of Shaji extract’s quality.3. To improve and establish Shaji extract’s quality standards in order to ensure the effectiveness and safety of Shaji extract’s clinical usage.Methods 1. Using literatures research and field study’s methods to research Shaji extract;2. Using the methods of microscopy to identificate Sadaer, and using TLC to identificate Sadaer and Shaji extract;3. Using single-factor test and orthogonal experimental method to optimize the best preparation method of Shaji extract;4. In accordance with the Chinese Pharmacopoeia (2010Edition) method for determining the moisture, total ash and acid insoluble ash, alcohol-soluble extract content of Sadaer, determining the total ash, moisture, insoluble in water of Shaji extract;5. Using HPLC method to research fingerprint of Shaji extract;6. Using UV-Vis method to determinate content of total flavonoids in Shaji extract;7. Using HPLC method to determinate contents of quercetin, kaempferol and isorhamnetin of Sadaer and Shaji extract.Results1. The textual research show that many species of Hippophae can be used as Hippophae Fructus, Tibetan people usually choose a large amount of local resources varieties of Hippophae to prepare Shaji extract. This paper supposed that we should base on the traditional preparation method of Shaji extract, with modern methods to make a preparation which process parameters can be quantified.2. Definite the characters and microscopic identification features of Sadaer; Established the TLC methods; Determinated the moisture, total ash and acid insoluble ash, alcohol-soluble extract content of10Sadaer and made the definition (moisture≤10.0%, total ash≤4.0%, acid insoluble ash≤0.30%, alcohol-soluble extract content≥30.0%); Established the HPLC methods of Sadaer and made the definition (quercetin≤0.025%, kaempferol≥0.028%, isorhamnetin≥0.063%).3. Optimized the best preparation method of Shaji extract, that is take Hippophae Fructus (meal), plus15times the amount of water, boiling twice,2hours each, filtered, combined filtrate, the filtrate was concentrated to thick paste which relative density of1.30～1.40(60℃) at60℃.4. Definite the characters of; Established the TLC、fingerprint (similarity≥0.850) methods; Determinated the moisture, total ash and insoluble in water of Shaji extract and made the definition(moisture:≤56.0%, total ash≤9.0%, insoluble in water≤11.0%); Established the UV-Vis and HPLC methods of Shaji extract and made the definition(total flavonoids≥0.55%; quercetin≥0.010%, kaempferol≥0.003%, isorhamnetin≥0.021%).Conclusions1. Established the quality standards of Sadaer, so that to ensure the stability of the quality of Shaji extract.2. Established the quality standards of Shaji extract and ensure the effectiveness and safety of clinical medicine.