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首页> 外文期刊>Journal of pharmaceutical sciences. >Application of direct crystallization for racemic compound propranolol hydrochloride.
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Application of direct crystallization for racemic compound propranolol hydrochloride.

机译：外消旋化合物盐酸普萘洛尔直接结晶的应用。

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摘要

The application of direct crystallization integrating with chromatography to the resolution of a racemic compound propranolol hydrochloride was studied and the crystallization progression was clearly illustrated in terms of the diagram of solubility and metastable zone widths with different enantiomeric compositions. The solubility and metastable zone widths of propranolol hydrochloride in the mixture of methanol and isopropanol were determined using an in situ Lasentec Focused Beam Reflectance Measurement (FBRM) probe. The direct crystallizations were carried out in an automatic lab reactor (Mettler Toledo LabMax) system. The optical purity of final product crystals was examined using differential scanning calorimetry (DSC), HPLC and PXRD. The crystal size distribution and morphology were analyzed using Malvern Mastersizer and Jeol SEM. It was found that optically pure crystal product could be obtained within certain safe supersaturation limit and there was no evidence of polymorph or solvate/hydrate transformation during the crystallization process. There was no selectivity of crystal growth or nucleation between the pure enantiomer and its racemate when the solution reaches the temperature lower than saturation temperature of the racemate. Hence, the critical supersaturation control of a solution was essential to obtain pure enantiomers from a partially resolved racemate.
机译：研究了将直接结晶与色谱结合用于拆分外消旋化合物盐酸普萘洛尔的方法，并根据不同对映体组成的溶解度和亚稳区宽度图清楚地说明了结晶过程。使用原位Lasentec聚焦光束反射率测量（FBRM）探针确定盐酸普萘洛尔在甲醇和异丙醇混合物中的溶解度和亚稳区域宽度。直接结晶在自动实验室反应器（Mettler Toledo LabMax）系统中进行。使用差示扫描量热法（DSC），HPLC和PXRD检查最终产物晶体的光学纯度。使用Malvern Mastersizer和Jeol SEM分析晶体尺寸分布和形态。发现在一定的安全过饱和限度内可以得到光学纯的晶体产物，并且在结晶过程中没有多晶型物或溶剂化物/水合物转变的迹象。当溶液的温度低于外消旋体的饱和温度时，纯对映体与其外消旋体之间没有晶体生长或成核的选择性。因此，溶液的关键过饱和控制对于从部分拆分的外消旋体中获得纯对映异构体至关重要。

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