Preparation Of Gaoyuanshu Granula

Altitude sickness is refer to the body hypoxia syndrome caused by low oxygen environment when the human body removes from plain to highland(elevation above 3000 meters). It is divided into acute altitude sickness and chronic altitude sickness and does harm to breathing and cardiovascular systems, and common symptoms include difficulty breathing( sometime accompanied by a cough and hoarseness), heart palpitations, dizziness, chest tightness and fatigue,etc. Along with the development of the western region, a large number of construction workers blend into the northwest, more and more passengers go to enjoy the unique landscape of the plateau at the same time,which make an increased trend of altitude sickness. Western medicine has the characteristics of obvious effects and strong pertinence, but its side effect are also great, so it is not applicable to act as preventative drugs. As a result, it is Extremely essential to develop safe, effective, and convenient drugs to prevent Altitude sickness. Our laboratory selected a Chinese medicine compound consist of Sibiraea angustata, Chinese angelica and Astragalus on the basis of studying Tibetan medicine Sibiraea angustata in earlier stage, we got the best extraction technology through yield and the content of ferulic acid of compound extract, we selected excipient and wetting agent to determine the optimal preparation process, and researched the quality standard of Gaoyuanshu granula, at last we observed the pharmacological effects and acute toxicity experiment of the compound in order to ensure the efficacy and safety. The main results are as follows:1.Mice swimming test was used to observe the 10 designed compound, we got the best compound ratio : Sibiraea angustata : Chinese angelica : Astragalus = 10:3:7.2.Liquid-solid ratio, extraction time and extraction times were acted as the main influence factors,then designed orthogonal test. We got the best extraction technology through yield and the content of ferulic acid of compound extract. The best extraction technology: liquid-solid ratio was 10,extraction time was 1 hour, extraction times was 2 times.3.By selecting excipient and wetting agent, loss rate of granula, appearance, solubility, shaping rate, water content were acted as the standard to select the optimal preparation process of granula,we got the optimal preparation:drug powder: dextrin : mannitol =1:0.5:0.5, 95% ethanol was wetting agent.4.We have researched the quality standard of Gaoyuanshu granula, and Sibiraea angustata, acts as sovereign drug, was identified by TLC, the main content of granula included appearance, particle size and dissolubility, etc. And Content determination is the determination of ferulic acid.5.To reflect the anti-fatigue and anti-hypoxic effects by experiments of hepatic glycogen, serum urea, blood lactate and load swimming, At the same time, we adopted the rhodiola as a positive control, result showed that Gaoyuanshu granula had obvious effects of anti-fatigue and anti-hypoxic.6.The acute toxicity test of mice showed that giving the maximum dosage to mice(equivalent to26 times of clinical dose) would not appear poisoning symptoms or other pathological changes, so Gaoyuanshu granula has high security.