四百五十三章 鉴定材料(1 / 1)

碘普罗胺样品是制备出来了,可这鉴定材料该怎么写呢?以单酯酸制备为例,专利上介绍双酯水解的路线,把所有可能的溶剂全给以化学通式给罗列进去了,如水及水与各种醇、酮、二氧六环等等可与水相溶的有机溶剂,介绍碱时同样把氢氧化钠,氢氧化钾,氨水,碳酸钠等等碱性物质包含在内,浓度上来一句从百分之零到百分之一百,我们现在的工艺条件落在它的工艺保护范围内。另外,各步条件都不成熟,中间体的质量指标也没有建立,特别是树脂分离的工艺,收率只有百分之五十多一点儿,收率也落在报道资料范围,成本偏高,与产业化有太大的差距。

陈法学陈总与王近之商量了好久,感觉难以下笔,写碘海醇时可以说打破国际垄断,降低国产制剂成本,因为这药在国内医院CT检查时大量使用,一句话就引起评委的共鸣,可碘普罗胺制剂在国内并无市场。写改进工艺,占领世界市场的份额,出口创汇,目前成本绝对偏高,没有市场竞争力。

王近之绞尽脑汁,想到了一条理由,对陈总说:“碘普罗胺产品中有个甲基,脂溶性比碘海醇等要好,我们可以从这方面着手,说明原料药与制剂一起联合开发后的社会意义。”

“造影剂是一个系列,我们把它与碘海醇等一起论述,套用上一次碘海醇的社会意义,评委们会感兴趣的。”陈总把碘海醇鉴定的话略作修改,引到序言中,接着说道:“明天我们一起上浙大,听一听老师们的意见,他们多次充当评委。身经百战,项目又是双方合作的。”

胡老师看了看陈总与王近之拟的鉴定材料初稿说:“你们这个是演说稿,给政府官员与专家作口头汇报很好,但是,与鉴定材料的侧重点是不同的,鉴定材料要的是依据,每条理由有权威部门的数据说明,验收结论与立项一一对应,如质量指标,立项里是达到欧美药典的质量标准,那么,你们就得叫第三方机构出具报告,写明你的检测结果,并在企业标准上收严,至少有一项比药典规定的质量标准更好。

专家评审特别地强调创新点,但参数优化绝对构不成创新,其它创新点如纳滤浓缩、特种型号的树指吸附等等,必需得有查新资料证明这几个点以前国内外从没有资料报道或专利介绍。

还有,你们这里预估的产值与经济数据缺少,我们双方产学研的成果转化就无法以数据化的形式体现出来了。”

其它事情好说,浙大与各个科研机构的关系铁,根据胡老师的意见补充就行了,可经济数据实在不好说,一方面是产品没有投产,另外一方面,目前的中试树脂分离收率不高,产业化以后,能否大幅度提高完全是个未知数,因为得选择到适合的树脂才有可能,这是完全没底的事,现在,把收率写得很高,并把将来几年的产量写得很大,不是摆明着吹牛吗?王近之有些担心地问:“万一这几年无法产业化呢?我不是欺骗政府了?”

陈总拉了拉王近之的衣袖,王近之会意,连忙住口,陈总接过话题说:“查新与出具证明之类还得胡老师给我们指点一下。”

浙大的分析仪器与图书资料在全国都是处于领先地位的,要拿这材料不难,可是,这次产学研的合作方之一就是浙大,不能既作选手又当裁判,在胡老师的介绍下,检测与查新证明出具都转移到了其它科研机构与省图书馆。

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