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安宁(甲丙氨酯)片为一安定药,在原生产工艺中,制颗粒时必须采用两次投料的方法来减少淀粉浆的用量以改善崩解度。该工艺操作繁琐,且空气中用丙氨酯粉尘浓度大,严重影响操作工人的健康、药片质量不稳定,时有崩解超限的现象,片子的硬度一般只有3—4公斤。为了解决以上问题,我们在安宁片的处方中使用了(新型药用辅料—低取代羟丙基纤维素LS-HPL)。按使用方法和数量、设计了六种工艺处方、各处方中主药甲丙氨酯均采用一次投入的方法。处方设计和质量测定结果见表一。
Tranquilization (mephedrine) tablets for a stable medicine, in the original production process, the system must be used when making pellets feeding two methods to reduce the amount of starch slurry to improve the disintegration. The process is cumbersome, and the concentration of acrylamide dust in the air is large, seriously affecting the health of workers, unstable tablet quality, when the phenomenon of collapse overrun, the film hardness is generally only 3-4 kg. In order to solve the above problems, we used the prescription of An Ning Tablet (new medical excipient - LS-HPL). According to the method of use and quantity, six kinds of process prescriptions were designed. The main drug methylacridine in each prescription was put into one method at a time. Prescription design and quality determination results in Table 1.