| Sirolimus belongs to macrocyclic lactone produced by Streptomyces hygroscopicu. Now Sirolimus oral solution ,which containing 50mg Sirolimus per 50 ml, has already been used in clinic. It should be preservated between 2-8℃in the refrigerator with darkness.It may develop a slight haze when refrigerated. Meanwhile, bioavailability reduced to about 14%.In an attempt to improve bioavailability and storage condition,solid dispersion technique was introduced in this paper.PEG 6000 mixed with Poloxamer 188 as a carrier, in which sirolimus was amorphous has been established by DSC and X-ray powder diffraction patterns. Ultimately, trituration is considered as the preparative method. Establishment of Analytical Method is also made based on preparation research .In order to study the influencing factors, capsule uncoated was exposed to light(4500lx) and high humidity(92.5%). Stored with ten days, each index of the sample experienced no marked change. It demonstrated the capsule was stable with light and high humidity.However, character changed sharply at high Temperature , eg. 60℃. As a result, content, character, dissolution , related substance s and isomer generate obvious variation. Experiments was carried out at 40℃and show no remarkable change ocuur in content, character, dissolution, related substances and isomer.The stabilities of the capsule were investigated by accelerated experiments and shelf- life test. Results: Storing with six months at 40℃by relative humidity 75 and with twelve months at 25℃by relative humidity 60%, nothing happens in indicators of capsule. Consequently, the preparation with simulating market package, showed good stability.
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