| Acute mountain sickness(AMS) is an illness that can affect mountain climbers, skiers, travelers,or troops at high altitude (typically above 2,400 meters). AMS is brought on by the combination of reduced air pressure and lower oxygen concentration that occur at high altitudes. Symptoms can range from mild to life-threatening, and can affect the nervous system, lungs, muscles, and heart.Medical measures are used to prevent and treat AMS including giving enough oxygen , using medicines such as acetazolamide and dexamethasone. Many researches indicated that some Chinese traditional medicines have good effects in AMS through improving organism function, and without side effects of western medicines. Hangqitianma capsule which in this study is a compound preparation of traditional chinese drug. It is made up of Radix Astragali, Rhizoma Gastrodiae, Rhizoma Gastrodiae, Semen Ziziphi Spinosae and so on. The Chinese medicine is purposed to prevent and treat acute AMS. This study is on its preparation process and quality standards.1.Study on the preparationPrescription of the herbs and the dosage capsules selection is according the need of the clinics. Research on technology of the optimal extraction is as follows: an orthogonal test was used for studying the effects of alcohol concentration, volume, extraction time and times. The contents of Gastrodin, AstragalosideⅣand solid were selected as indices of appraisal. Data processing was carried out with the multiple guidelines grading method for optimizing the extraction condition. The optimal extraction process is as follow: 10 times of 60% alcohol, 2 times of extraction and 1.5 hours for each extraction. Research on technology of forming pharmaceutics is as follows: The properties of the powdered extract with different auxiliary components is assessmented by the comparing hygroscopicity and angle of repose. The result of moulding preparation shows that the moisture absorption of the powdered extract can be limited in a properly extent and has a good fluidity when mixing microcrystal cellulose, and the critical relative humidity is about 67 % .2.Study on quality standardAccording to the addenda general rule of the capsule in the 2005 part 1 of Chinese Pharmacopoeia, a series of quality studies about Hangqitianma capsule performed as: character, distinguish, heavy metal, arsenic salt, weight differential and microorganism limit ssay. Radix Astragali, Radix Ginseng, Rhizoma Gastrodiae, Rhizoma Chanxiong, Radix Rehmanniae were identified by thin layer chromatography. The separation of the stains is apparent, and the negative contrast showed no disturbed. We used high performance liquid chromatography to determine gastrodin which filler is octadecylsilane chemically bonded silica. The detection was performed with the mobile phase of Methyl Cyanides-water (4:96), the detection wavelength of 221nm,flow velocity of 0.8mL·min-1. Method study indicated that this method is strong specializated,and easy to operate. Finally, the quality standards draft of the Huangqitianma capsule is completed through the quality studies.In summary, the preparation process of Huangqitianma capsule can remain most active components like Gastrodin and AstragalosideⅣ, and the process has advantage of easy handle; Quality standards that was formulated in this study has the propertises of high specificity and reproducibility, and it is suit for the qualitative control of Huangqitianma capsule. Researche in this study is a good basis for the development of new drug Huangqitianma capsule.
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