| The dissertation includes three parts: 1.The development of drugs for curing AD. 2. Studies on the preparation technology of Nao Zhi Qing tablet. 3. Studies on the quality criteria of Nao Zhi Qing tablet.1. The development of drugs for curing Alzheimer disease (AD).It is reported by WHO lately that there're 20 million patients of AD all over the world, and it will beyond 100 million by 2050, including 68 million in developed countries. The patients suffer from AD who lose their capabilities of memory and live alone bring heavy economic burdens to their families and society. In USA AD became the forth"killer"disease causing death which following cardiovascular disease, cancer and apoplexy. The survey of AD in our country shows that the incidence of the disease approaches that in western countries, the number of AD patients is about 5 million, and it is more in fact. So speeding up the research of drugs which can be used in prevention and cure of AD has been a urgent problem of health to deal with in our country, and meanwhile, it also indicate the powerful potential of the market of the drugs for curing AD.2. Studies on the preparation technology of Nao Zhi Qing tablet.It is a new drug so that the study of the interaction between drug and adjuvant is required. The drug and adjuvant are mixed at different proportion, and then treated respectively with high illumination (4500±500Lx), high temperature (60℃) and high humidity (RH75%) for ten days. At the same time the content and related substances were determined by HPLC to check the change. The results showed that the change was few so that the lactose, carboxymethyl starch sodium, condensability starch sodium, stearic magnesium and starch can all be used as adjuvant of this preparation. Besides, based on physical chemistry character of the drug and the result of pharmacology experiment, we confirmed the oral dose of the preparation as 4 mg per tablet, and chose the tablet as dosage form of this drug. The technology of recipe and preparation have been confirmed by the results of single reason tests of which evaluate guide lines are appearance, the shape of granule, rigidity, disintegrable time and dissolution.3. Studies on the quality criteria of Nao Zhi Qing tablet.Based on the perfect and stable technology of preparation, the research on the quality criteria is proceed, it's mainly about the determinations of impurity, dissolution, uniformity of dosage units and content, as well as the elementary research of stability.A reversed-phase high-performance liquid chromatographic (HPLC) method has been developed and validated for the impurity test of the novel drug Nao Zhi Qing. The process was performed on a C18 column。with acetonitrile—0.05 M triethylamine, pH 3.0 (13:87) was adjusted by formic acid as the mobile phase. The flow-rate was 1.0 ml·min-1 and eluent was monitored at 268 nm. The result showed that the dosage of impurity was less than 1.0%.The UV Spectrophotometry was used in the determinations of content, dissolution, uniformity of dosage units. The equation of the linearity relation is as follow: A = 0.0492 C + 0.0026, r = 0.9998, which shows that the content of the drug display a good linearity relation in the range of 5.0～15.0μg·mL-1 and the rate of callback is between 98 and 102%., the RSD is 0.89%. The RSD in the test of precision is 0.16%, which shows that this method adapts to the requirement of the determination and holds a good emersion, high precision and can be used in controlling the quality of production. Ultimately, the elementary research of stability is as follow: the test of accelerating was under the condition of enwrapping the pack of coming into the market (40℃, RH 75%), and after 6 months long-term test, the results of every standard examined were all eligible, which showed the good stability of this drug.The result of the whole experiment shows that this drug holds a reasonable, feasible technology of preparation and a steady, controllable quality.
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