行业组件数据 · 2026

崩解剂

A pharmaceutical excipient that promotes tablet disintegration in the gastrointestinal tract for drug release.

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。

Disintegrants are essential pharmaceutical excipients incorporated into tablet formulations to facilitate rapid breakdown of the compressed tablet into smaller particles or granules upon contact with gastrointestinal fluids. This mechanical disruption increases surface area, accelerating drug dissolution and bioavailability. They function through mechanisms like swelling, wicking, deformation recovery, or gas production to overcome tablet bonding forces.

组件规格

定义
Disintegrants are essential pharmaceutical excipients incorporated into tablet formulations to facilitate rapid breakdown of the compressed tablet into smaller particles or granules upon contact with gastrointestinal fluids. This mechanical disruption increases surface area, accelerating drug dissolution and bioavailability. They function through mechanisms like swelling, wicking, deformation recovery, or gas production to overcome tablet bonding forces.
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
Common materials include: superdisintegrants like crospovidonesodium starch glycolatecroscarmellose sodiumnatural disintegrants like starchmicrocrystalline celluloseand effervescent combinations like citric acid-sodium bicarbonate. Materials must meet pharmacopeial standards for purityparticle size (typically 50-200 μm)and swelling capacity.
Bulk Density
0.3-0.6 g/mL
Swelling Volume
4-10 mL/g
Moisture Content
<10%
Disintegration Time
<5 minutes (USP standard)
pH Range Compatibility
1.2-7.4
Particle Size Distribution
D50: 50-150 μm
标准
ISO 8871USP <701>EP 2.9.1JP 6.09

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

制造该组件的工厂

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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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CNFX Industrial Component Index · 化学制造

数据基础

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初步技术归类
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URN:CNFX:ME:UNIT:DISINTEGRANT