尼莫地平作为钙通道阻滞剂，可以通过减少蛛网膜下腔出血，严重的颅脑损伤和急性中风后出现的缺血性缺损的发生率和严重程度来改善神经系统预后。尼莫地平还可以有效预防脑动脉痉挛和改善脑血流量。尼莫地平亲脂性很强而水溶性极差，属于BCS-II类药物。尼莫地平口服生物利用度仅有5~15%，提高其溶解度和溶出速度是使尼莫地平被快速利用并发挥药效的关键。

本文以尼莫地平为模型药物，探讨不同载体材料对尼莫地平溶解度、溶出程度以及稳定性的影响，制备了固体分散体。本文以喷雾干燥技术进行制备，并对该方法进行参数逐个优化。分别使用PVP K30、S630、Soluplus 和HPMCAS为载体材料，按照药物与载体材料1：2、1：3和1：4的比例制备尼莫地平固体分散体，并经偏光镜扫描、偏光显微镜观察（PLM）、差示扫描量热法（DSC）、粉末X射线衍射（XRD）和傅里叶红外光谱（FTIR）、动力溶解度实验、稳定性试验等进行系统性表征。结果显示，在所有的固体分散体中，尼莫地平均以无定形的形态均一分撒于载体材料中，且与载体材料间存在不同程度的氢键作用。动力溶解实验以原为溶出技术进行考察，结果显示载体材料对尼莫地平溶出的最大增大效果由高到低排列为PVP K30＞Soluplus＞S630＞HPMCAS，且在同一载体材料组中，当药物与载体材料比为1：3时，增溶效果达到最佳。在40℃、75%RH加速条件下考察固体分散体的稳定性，结果显示以PVP K30为载体材料时，药物在90.27℃、96.10℃和94.48℃出现热吸收峰，以S630为载体材料时，药物在90.27℃、96.10℃和94.48℃出现热吸收峰，即此时药物晶体析出，稳定性差；而在以HPMCAS和Soluplus为载体材料时均未出现新的热吸收峰，即尼莫地平在这两种载体材料中的表现较好的稳定性。

用Soluplus为载体材料的固体分散体制备尼莫地平固体分散体片剂。在片剂中，以微晶纤维素为稀释剂，交联聚维酮为崩解剂，所制备的片剂硬度和脆碎都表现良好，不发生粘冲现象且易于包衣。同时放置6个月稳定性，数据表明自制与尼膜同质量均未发生显著变化。表明采用Soluplus为载体制备尼莫地平固体分散体制剂拥有较高的溶出度且稳定性良好。

Nimodipine, as a calcium channel blocker, can improve the neurological prognosis by reducing the incidence and severity of ischemic defects after subarachnoid hemorrhage, severe head injury and acute stroke. Nimodipine can also effectively prevent cerebral artery spasm and improve cerebral blood flow Nimodipine has strong lipophilicity and poor water solubility, and belongs to the BCS-II class of drugs.The oral bioavailability of nimodipine is only 3-12%. Improving its solubility and dissolution rate is the key to enabling nimodipine to be used quickly and exert its efficacy.

In this paper, using nimodipine as a model drug, the effects of different carrier materials on the solubility, dissolution and stability of nimodipine were discussed, and solid dispersions were prepared. The spray drying technology is used for preparation, and the parameters of the method are optimized one by one. With PVP K30, S630, Soluplus and HPMCAS as carrier materials, nimodipine solid dispersions were prepared according to the ratio of drug and carrier material of 1:2, 1:3, and 1:4, and were scanned by a polarizing lens and observed under a polarizing microscope (PLM), Differential Scanning Calorimetry (DSC), Powder X-ray Diffraction (XRD) and Fourier Infrared Spectroscopy (FTIR), dynamic solubility test, stability test, etc. for systematic characterization.

The results show that in all the solid dispersions, Nimodine is uniformly dispersed in the carrier material in an amorphous form, and there are varying degrees of hydrogen bonding with the carrier material. The kinetic dissolution experiment was conducted with the original dissolution technology, and the results showed that the maximum increase effect of the carrier material on the dissolution of nimodipine was arranged from high to low as PVP K30>Soluplus>S630>HPMCAS. In the same carrier material group, when the ratio of drug to carrier material is 1:3, the solubilization effect is the best. The accelerated testing showed that when PVP K30 was used as the carrier material, the drug showed heat absorption peaks at 90.27℃, 96.10℃ and 94.48℃. When S630 is used as the carrier material, the drug has heat absorption peaks at 90.27°C, 96.10°C and 94.48°C, that is, the drug crystals are precipitated and the stability is poor. However, when HPMCAS and Soluplus are used as carrier materials, there is no new heat absorption peak, which means that nimodipine has better stability in these two carrier materials.

The solid dispersion tablets of nimodipine were prepared with the solid dispersion of Soluplus as the carrier material. In the tablet, with microcrystalline cellulose as the diluent and cross-linked povidone as the disintegrant, the prepared tablets have good hardness and friability, no viscous phenomenon and easy coating.The stability data for 6 months showed that the quality of the self-made tablets did not change significantly, indicating that the nimodipine solid dispersion prepared by soluplus possessed with good dissolution and stability.