POLYQUATERNIUM-10
化妆品中 聚季铵盐-10 (POLYQUATERNIUM-10) 的全球法规限值与配方应用标准是什么?
聚季铵盐-10(标准 INCI: POLYQUATERNIUM-10,CAS 号: 81859-24-7)是化妆品配方中主要用作抗静电剂, 成膜剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(未列管)及欧盟 CosIng(未列管)等 6 大法域法定标准监管,常规建议添加量为 0.2–0.6%(最佳稳定窗口 pH 4–8)。
全球 7 轨官方全成分标签名称对照表
严格采用各国政府官方目录原名 · 严禁机器翻译| 法域与监管轨道 | 官方公告全成分标准名称 | 一键复制 |
|---|---|---|
| ① 韩国 (MFDS 化妆品标准名称) | POLYQUATERNIUM-10 (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | POLYQUATERNIUM-10 | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | POLYQUATERNIUM-10 | |
| ⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC) | — (非美国 OTC 专论活性成分 / 普通化妆品原料) | — |
| ⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名) | 聚季铵盐-10 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | POLYQUATERNIUM-10 (标准 INCI 参照) |
Layer 1 — 全球 6 大法域法定限值与监管状态
| 法域 | 监管状态 | 法定限值 | 适用条件与法定依据来源 |
|---|---|---|---|
| 韩国 (MFDS) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 已使用/准用 | GMP | IECIC Entry #3906 |
| 日本 (MHLW) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 东盟 (ACD) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剂型常规配比指南与理化配伍性
| 剂型分类 | Min – Q1 – Median – Q3 – Max (%) | 配方作用与机理 | Source ID |
|---|---|---|---|
| 剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露 | 0.2% · 0.2% · 0.25% · 0.3% · 0.6% | Rinse-off cleanser & surfactant system modifier | Global Starter Formulation Library Statistical Distribution (n=19, EVONIK 17 · ELEMENTIS 1 · SEPPIC 1) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。
学术与毒理综合摘要
Tier 1 Synthesis本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。
关联同行评审文献 (NIH PubMed) (3)
Ocular biocompatibility of polyquaternium 10 gel: functional and morphological results. [PMID: 25631258 · 2015]
This paper deals with the characterization study of topical and intraocular biocompatibility and toxicity of cationic hydroxyethylcellulose Polyquaternium 10 (PQ10). It also evaluates the rheological properties of gels. The cytotoxicity assays were done in two cell lines: HEp-2 and VERO (human larynx epidermoid carcinoma cell and African green monkey kidney cells respectively). For the in vivo study, New Zealand albino rabbits were used. The in vitro cytotoxic activity of PQ10 shows no statistically significant differences in relation to the control of hydroxypropylmethylcellulose (HPMC) in any of the cell lines used in this study. Similarly, the signs of inflammation observed after treatment showed no significant difference between the groups of animals treated with the polymer compared to the control group. Normal histological characteristics were seen in both groups with no histological inflammatory reaction. After 1 month of the intracameral application of 2% PQ10 (treatment group) or 0.3% HPMC (control group), electroretinograms showed similar levels of a- and b-waves latencies and amplitude. In summary, PQ10 gel was well tolerated in these experiments, with proper monitoring, it could stand as a new alternative in the development of ophthalmic viscosurgical devices.
Detecting Levels of Polyquaternium-10 (PQ-10) via Potentiometric Titration with Dextran Sulphate and Monitoring the Equivalence Point with a Polymeric Membrane-Based Polyion Sensor. [PMID: 28018490 · 2016]
Polymeric quaternary ammonium salts (polyquaterniums) have found increasing use in industrial and cosmetic applications in recent years. More specifically, polyquaternium-10 (PQ-10) is routinely used in cosmetic applications as a conditioner in personal care product formulations. Herein, we demonstrate the use of potentiometric polyion-sensitive polymeric membrane-based electrodes to quantify PQ-10 levels. Mixtures containing both PQ-10 and sodium lauryl sulfate (SLS) are used as model samples to illustrate this new method. SLS is often present in cosmetic samples that contain PQ-10 (e.g., shampoos, etc.) and this surfactant species interferes with the polyion sensor detection chemistry. However, it is shown here that SLS can be readily separated from the PQ-10/SLS mixture by use of an anion-exchange resin and that the PQ-10 can then be titrated with dextran sulphate (DS). This titration is monitored by potentiometric polyanion sensors to provide equivalence points that are directly proportional to PQ-10 concentrations.
Dialdehyde cellulose nanofibrils/polyquaternium stabilized ultra-fine silver nanoparticles for synergistic antibacterial therapy. [PMID: 39322171 · 2024]
Dialdehyde cellulose nanofibrils (DACNF) and Polyquaternium-10 (PQ: chloro-2-hydroxy-3-(trimethylamino) propyl polyethylene glycol cellulose) have become increasingly favored as antibacterial substances due to their advantageous characteristics. DACNF exhibits exceptional mechanical properties and biocompatibility, whereas PQ demonstrates a positive charge that enhances its antibacterial activity. Combined in a DACNF/PQ mixture, they provide an excellent template material for preparing and stabilizing ultra-fine (~ 10.3 nm) silver nanoparticles (AgNPs) at room temperature. Here, the dialdehyde group of DACNF functions as a reducing agent, while the quaternary ammonium of PQ and carboxylate groups of DACNF synergistically helped in-situ generation of AgNPs uniformly. The synthesized nanocomposites, namely PQ@AgNPs, AgNPs@DACNF, and AgNPs@DACNF/PQ, were subjected to comprehensive characterization using various advanced analytical techniques. The films containing AgNPs@DACNF and AgNPs@DACNF/PQ, fabricated via vacuum filtration, exhibited excellent mechanical properties of 9.78 ± 0.21 MPa, and demonstrated superior antibacterial activity against both Escherichia coli and Staphylococcus aureus. Additionally, the silver ion leaching from the prepared composite films was well controlled. The fabricated nanocomposites also effectively inhibited bacterial biofilm formation. It was also found to be highly biocompatible and non-toxic to human skin fibroblast cells. Furthermore, the nanocomposites exhibited enhanced migration of human dermal fibroblasts, suggesting their potential in facilitating wound healing processes.
常见问题解答 (FAQ)
- Q1. 聚季铵盐-10 (POLYQUATERNIUM-10) 在全球 7 大法域的官方全成分标签名称是什么?
- 中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 '聚季铵盐-10',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'POLYQUATERNIUM-10',日本 JCIA 表示名称为 'POLYQUATERNIUM-10'。
- Q2. 聚季铵盐-10 (POLYQUATERNIUM-10) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
- 6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): none,欧盟(EU): none,美国(US): none,日本(JP): none,东盟(ASEAN): none。
- Q3. 聚季铵盐-10 (POLYQUATERNIUM-10) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
- 在代表性剂型 (cleanser_rinse) 中常规添加量为 0.2%–0.6%(中位数 0.25%),最佳稳定 pH 范围为 4–8。
- Q4. 聚季铵盐-10 (POLYQUATERNIUM-10) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL;配伍禁忌注意:Verify phase compatibility under extreme pH or high electrolyte loads。