行业组件数据 · 2026

崩解剂

繁體:崩解劑

崩解剂是片剂配方中的关键药用辅料,用于促进片剂在胃肠液中快速崩解为小颗粒或颗粒,增加表面积,加速药物溶出和生物利用度。

技术定义与适配语境
典型 崩解剂 会按材料、尺寸公差、适配关系和失效风险在 化学制造 中评估。

崩解剂是片剂配方中必不可少的药用辅料,其作用是在与胃肠液接触时,使压缩片剂快速崩解为较小的颗粒或颗粒。这种机械性崩解增加了表面积,从而加速药物溶出并提高生物利用度。崩解剂通过溶胀、毛细管作用(wicking)、变形恢复或产气等机制,克服片剂内部的粘结力。 崩解剂主要通过毛细管作用(wicking)发挥作用,即吸收液体并溶胀,产生内压使片剂基质破裂。次要机制包括变形恢复(压缩颗粒恢复原状)和化学反应(如泡腾崩解剂产生气体)。颗粒间键的破坏使溶出介质能快速渗透至药物核心。

组件规格

定义
崩解剂是片剂配方中必不可少的药用辅料,其作用是在与胃肠液接触时,使压缩片剂快速崩解为较小的颗粒或颗粒。这种机械性崩解增加了表面积,从而加速药物溶出并提高生物利用度。崩解剂通过溶胀、毛细管作用(wicking)、变形恢复或产气等机制,克服片剂内部的粘结力。

崩解剂主要通过毛细管作用(wicking)发挥作用,即吸收液体并溶胀,产生内压使片剂基质破裂。次要机制包括变形恢复(压缩颗粒恢复原状)和化学反应(如泡腾崩解剂产生气体)。颗粒间键的破坏使溶出介质能快速渗透至药物核心。
工作原理
Disintegrants work primarily through capillary action (wicking) where they absorb liquid and swell, creating internal pressure that fractures the tablet matrix. Secondary mechanisms include deformation recovery (where compressed particles return to original shape) and chemical reaction (e.g., effervescent disintegrants producing gas). The disruption of interparticulate bonds allows rapid penetration of dissolution media to the drug core.
材料
常用材料包括:超级崩解剂如交联聚维酮、羧甲淀粉钠、交联羧甲纤维素钠天然崩解剂如淀粉、微晶纤维素以及泡腾组合如柠檬酸-碳酸氢钠。材料必须符合药典标准涉及纯度、粒径(通常为50-200 μm)和溶胀能力。
Bulk Density
0.2–0.5g/mL
Swelling Volume
5–15mL/g
Moisture Content
≤5.0% w/w
Disintegration Time
≤15min
pH Range Compatibility
1–8pH
Particle Size Distribution
50–200μm
Temperature during processing
20–40 °C
Relative humidity during storage
30–60 % RH
Compression pressure
5–20 kN
Mixing time with other excipients
5–15 min
标准
USP <616>USP <701>USP <786>USP <921>

行业分类与别名

崩解剂 的常用贸易名称、技术标识和检索关键词。

上级产品

该组件会出现在以下整机或工业产品中。

FMEA · 风险与缓解

诱因 → 失效模式 → 工程缓解

Inadequate disintegrant concentration or improper distribution->Prolonged disintegration time (>30 minutes)->Optimize concentration (2-8% w/w), use granulation techniques for uniform distribution, conduct disintegration testing during formulation development
Moisture absorption during storage->Premature disintegration or reduced tablet hardness->Use moisture-resistant packaging, incorporate desiccants, select low-hygroscopic disintegrants like crospovidone
Chemical interaction with API or other excipients->Reduced drug potency or altered dissolution profile->Conduct compatibility studies, select chemically inert disintegrants, adjust formulation pH

工业生态与工程逻辑

0
Over-swelling causing tablet cracking
1
Moisture sensitivity affecting shelf life
2
Incompatibility with certain APIs
3
Variable performance with formulation changes

合规与检测

tolerance
Disintegration time must meet pharmacopeial limits (typically <15-30 minutes depending on monograph). Tablet weight variation ≤5%, friability <1%
test method
USP <701> Disintegration Test: Six tablets tested in basket-rack assembly immersed in 37±2°C fluid, observed for complete disintegration without residue

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制造商列表用于前期研究和供应商能力理解,不代表认证、排名或交易担保。

采购评估维度

不是客户评论,也不是实时热度。以下维度用于前期 RFQ 准备和供应商评估。

技术文档
4/5
制造能力
4/5
可检验性
5/5
供应商透明度
3/5

这些分值是采购评估维度示例,不代表真实客户评分、具体国家买家反馈或实时询盘。

相关组件

常见问题

What is the difference between superdisintegrants and traditional disintegrants?

Superdisintegrants (e.g., crospovidone) provide faster disintegration at lower concentrations (1-5% w/w) through superior swelling or wicking, while traditional disintegrants (e.g., starch) require higher concentrations (5-15% w/w) and work primarily through swelling.

How does disintegrant concentration affect tablet properties?

Excessive disintegrant (>10% w/w) can reduce tablet hardness and increase friability, while insufficient amounts (<1% w/w) may prolong disintegration. Optimal concentration balances disintegration time with mechanical strength.

Can disintegrants affect drug stability?

Yes, some disintegrants may interact with APIs through moisture absorption or chemical incompatibility. Proper selection and moisture-controlled environments are critical for stability.

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