中国药典和法规未明确，但是国外法规明确了，如下：

1、USP <1151> PHARMACEUTICAL DOSAGE FORMS

Suspensions

A suspension is a biphasic preparation consisting of solid particles dispersed throughout a liquid phase. Suspension dosage forms may

be formulated for specific routes of administration such as oral, topical, inhalation, ophthalmic, otic, and injection.　

Suspensions are generally not injected intravenously, epidurally, or intrathecally unless the product labeling clearly specifies these routes of administration.

Some liposomal drug products are referred to as suspensions because they can settle and require resuspension prior to administration

(see 〈1〉, In Vitro Release Test Methods for Parenteral Drug Preparations 〈1001〉, and Drug Products Containing Nanomaterials 〈1153〉).

Other suspensions can include:

•Lipid nanoparticles (LNP)

•Viral vectored vaccines and gene therapies (e.g., adenovirus and adeno-associated virus, respectively)

因此，在美国，就叫做suspension（混悬液）。

2、Ph.Eur. 5.36 mRNA VACCINES FOR HUMAN USE (Draft)

2-3. FINAL LOT (mRNA-LNP VACCINE)

The mRNA-LNP formulation is a dispersion.

Ph.Eur. 0520 Parenteral preparations

Liquid preparations for injection or infusion are solutions, colloidal dispersions, emulsions or suspensions.

Emulsions for injection do not show any evidence of phase separation.

Suspensions for injection may show a sediment that is readily dispersed on shaking to give a suspension that remains sufficiently stable to enable the correct dose to be delivered.

欧洲药典中说注射液包括四种：solutions（溶液）, colloidal dispersions（胶束分散液）, emulsions（乳状液） or suspensions（混悬液）

也就是说dispersion和suspension还是有区别的，欧洲药典明确 mRNA-LNP制剂叫dispersion，这一点在欧盟上市的mRNA产品说明书上可以得到证实。

3、建议

可以看到中国是不明确的，USP和EP意见不一致，我个人认为dispersion是更贴切的，翻译成中文可能词不达意，可以叫分散体系或分散液。

在中国注册申报，你就叫注射液就行了，在性状描述中可以模糊处理，比如：白色或类白色液体。

1. 乳状液注射剂通常本身形式就是乳剂（两种或两种以上不混溶的油和水组成的胶体系统），如丙泊酚乳状注射液、水包油佐剂等；LNP更接近于两亲性磷脂形成的脂质体，只是没有传统脂质体规整的脂质双分子层结构。

2. 严格来说（微观上），mRNA-LNP并不是一个均一的分散体系，只是没有达到传统上（宏观）可感知的混悬液的程度(如铝佐剂吸附疫苗)。

3. 已上市的几种脂质体注射液说明书中的性状也均为"混悬液"，如盐酸多柔比星脂质体注射液、盐酸米托蒽醌脂质体注射液和盐酸伊立替康脂质体注射液。