回复第一个问题、 盲法试验中安慰剂做对照药需要满足的条件主要从以下几方面考虑：

1. 伦理方面，与是否设盲无关；通常只有在无法使用活性对照药的情况下采用安慰剂对照的设计，如所研究疾病目前无有效治疗措施并且使用安慰剂不会给受试者带来额外的风险。

- Placebo may be used as a comparator without providing the established effective intervention to participants only if:

•      there are compelling scientific reasons for using placebo; and

•      delaying or withholding the established effective intervention will result in no more than a minor increase above minimal risk to the participant and risks are minimized, including through the use of effective mitigation procedures.”

《Placebo and drug kits in clinical trial design》, WHO Drug Information Vol. 31, No. 2, 2017}

2. 满足试验盲态的要求，即安慰剂与试验药物需在外形、气味、包装、标签和其他特征上均应一致 （中国GCP 2003年版本，第五十七条）

此外，可参照《Placebo and drug kits in clinical trial design》, WHO Drug Information Vol. 31, No. 2, 2017：

-        Placebos typically consist of the ingredients employed in the medicinal product under study minus the active ingredient, making them inert. The inactive ingredients (excipients) employed in a pharmaceutical product must be “generally recognized as safe”1 for use in humans, otherwise a medicinal product would not be authorized for use.

3. 对试验用药物的一般要求：安慰剂属于试验用药物，需遵循《药品生产质量管理规范》的通用原则。

参见《临床试验用药物生产质量管理规范》征求意见稿：

 第三十条  如采用安慰剂作对照，应当确定安慰剂的处方、生产工艺和质量标准，检验合格方可放行用于临床试验。安慰剂生产所用物料应当符合相应给药途径的质量要求，不得添加对试验药物安全性及有效性产生干扰的物质。

此外可参考ICH guideline E6:

5.13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s).

回复第二个问题、 不确定第二个问题的背景，回答如下。安慰剂需与试验药物一样有进行合适的稳定性研究，遵循GMP原则进行检测放行，遵循GCP/方案设计/GMP进行标签与包装过程。与其他试验用药物同等管理，常规情况下无需提供稳定性数据资料给伦理委员会。