药物制剂的稳定性
2016-12-08 11:21:31 0 举报仅支持查看
AI智能生成
药物制剂的稳定性是指在规定的条件下,保持其物理、化学和微生物学性质的能力。这包括药物的活性成分、辅料和制剂工艺的稳定性。稳定性是药物制剂质量的重要指标之一,直接影响到药物的使用效果和安全性。药物制剂的稳定性受多种因素影响,如温度、湿度、光照、氧气、金属离子等。为了确保药物制剂的稳定性,需要对其进行严格的质量控制和检测,包括长期稳定性试验、加速稳定性试验等。同时,药物的储存条件和方法也对其稳定性有很大影响,因此在使用和储存药物制剂时,应遵循相关的规定和建议,以确保药物的安全性和有效性。
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<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:Arial;
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">研究目的</span></p>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
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text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">考察原料药及其制剂的性质在温度、湿度、光线等条件下随时间的变化规律,为药品的生产、包装、贮存、运输条件和有效期的确定提供科学依据,以保障临床用药安全有效</span>
分支主题
影响制剂中药物降解的因素及增加稳定性方法
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:仿宋_GB2312;
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">处方因素对制剂中药物稳定性的影响及增加稳定性方法</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:"Times New Roman";mso-ascii-font-family:"Times New Roman";
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<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">广义酸碱催化的影响</span></p>
<div>溶剂的影响</div><div><br></div>
<div>离子强度的影响</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">表面活性剂的影响</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">处方中基质或赋形剂的影响</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:仿宋_GB2312;
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">外界因素对制剂中药物稳定性的影响及增加稳定性方法</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">温度的影响</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">光线的影响</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">空气(氧)的影响</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">金属离子的影响</span></p>
<div>湿度和水分的影响</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">包装材料的影响</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:仿宋_GB2312;
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">增加制剂中药物稳定性的其它方法</span></p>
<div>改变药物的结构</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">制成固体制剂</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">采用粉末直接压片或包衣工艺</span></p>
<div>制成微囊、微球或包合物</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:Arial;
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">药物稳定性的加速试验研究方法</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">经典恒温法</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:"Times New Roman";mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
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text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">t0.9</span><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">法</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">活化能估算法</span></p>
<div>温度系数法(Q10法)</div><div><br></div>
<div>线性变温法</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:Verdana;
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">概念</span></p>
<font color="#000000" face="仿宋_GB2312">化学稳定性</font>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
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text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">是指药物的化学变化,如水解、氧化、光解等</span>
<div>物理稳定性</div><div><br></div>
<span class="Apple-tab-span" style="white-space:pre"> </span>是指物理变化,如固体药物的溶出、晶型变化;溶液的澄清度、色泽的变化;混悬液的沉降、粒度的变化;乳剂的分层、破裂的变化等
<font color="#000000" face="仿宋_GB2312">微生物学稳定性</font>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
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text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">是指微生物学变化,如药物的腐败、霉变等</span>
药物稳定性的化学动力学基础
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:Verdana;
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">概念</span></p>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
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12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">半衰期</span>
<span style="font-family:"Times New Roman";mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
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text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%"> 将反应物降解一半所需的时间称为半衰期,记作</span><span style="font-family:"Times New Roman";mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
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mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">t1</span><span style="font-family:"Times New Roman";mso-ascii-font-family:"Times New Roman";
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mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">/2</span>
<font color="#000000" face="仿宋_GB2312">十分之一衰期</font>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
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text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">降解</span><span style="font-family:"Times New Roman";mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:en-US;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">10%</span><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">所需的时间,称为十分之一衰期,记作</span><span style="font-family:"Times New Roman";mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:en-US;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">t0.9</span><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">,通常定义为有效期</span>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:Verdana;
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">制剂中药物的化学降解途径</span></p>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">水解</span>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">酯类药物的水解</span>
<div>酰胺类药物的水解</div><div><br></div>
<div>其它药物的水解</div><div><br></div>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">氧化</span>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">酚类药物</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">烯醇类药物</span></p>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">其它类药物</span></p>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">光降解</span>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">光能激发氧化反应,加速药物分解,其速度与系统的温度无关</span></p>
<span style="font-size: 13.3333px; font-family: 仿宋_GB2312; color: black;">它</span><span style="font-size: 13.3333px; font-family: 仿宋_GB2312;">其</span><span style="font-size: 13.3333px; font-family: 仿宋_GB2312;">反应</span>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">异构化</span>
<div>聚合</div><div><br></div>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">脱羧</span>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">脱水</span>
<div>与其它药物或辅料的作用</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:Verdana;
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">药物稳定性的试验方法</span></p>
<div><div style="font-size: 13.3333px;">影响因素试验</div></div><div><br></div>
<div>高温试验</div><div><br></div>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">高湿度试验</span>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">强光照射试验</span>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
仿宋_GB2312;mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">加速试验</span>
<div>是将拟上市包装的样品在超常试验条件下对药物的化学或物理稳定性进行考察,并初步预测样品的长期稳定性</div><div><br></div>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
仿宋_GB2312;mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">长期试验</span>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:"Times New Roman";
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">是在接近药品的实际贮存条件下进行,是确定有效期和贮存条件的最终依据</span></p>
<div>固体药物制剂的稳定性特点</div><div><br></div>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:仿宋_GB2312;
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">固体药物与固体剂型的稳定性特点</span></p>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">固体药物一般分解较慢,需要较长时间和精确的分析方法</span>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">固体状态的药物分子相对固定,不像溶液那样可以自由移动和完全混合,因此具有系统的不均匀性,含量等分析结果很难重现</span>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">一些易氧化药物的氧化作用往往限于固体表面,而内部分子被保护起来,以致表里变化不一</span>
<p style="margin-top: 4.32pt; margin-bottom: 0pt; margin-left: 0.5in; text-indent: 0in; direction: ltr; unicode-bidi: embed; vertical-align: baseline;"><span style="font-family:仿宋_GB2312;mso-ascii-font-family:仿宋_GB2312;
mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;mso-bidi-theme-font:
minor-bidi;color:black;mso-color-index:3;mso-font-kerning:12.0pt;language:zh-CN;
mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:text2;
mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">固体药物制剂的降解反应途径</span></p>
溶剂催化
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">氧化</span>
<span style="color: rgb(0, 0, 0); font-family: 仿宋_GB2312; font-size: 13.3333px;">光解</span>
<span style="font-family:仿宋_GB2312;mso-ascii-font-family:
"Times New Roman";mso-fareast-font-family:仿宋_GB2312;mso-bidi-font-family:+mn-cs;
mso-bidi-theme-font:minor-bidi;color:black;mso-color-index:3;mso-font-kerning:
12.0pt;language:zh-CN;mso-style-textfill-type:solid;mso-style-textfill-fill-themecolor:
text2;mso-style-textfill-fill-color:black;mso-style-textfill-fill-alpha:100.0%">热解反应</span>
姓名:谭畅
班级:制药升14级
学号:2016520461
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