 Enteric empty capsule |
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Enteric empty capsule is a capsule made from pharmagel and enteric coating. Neither crack nor disintegration occurs within two hours in juice gastric.But it disintegrates and releases the content in intestinal juice
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| within 30 min.its appearance and burst strength can compare with those of common Packing-purpose capsule.It is usually used as a special packing material for the drug or health food generating irritation to stomach or unstable as encountering acid,and needing to solve and act in bowel.Target-oriented administration may reduce possible undesirable effects and be convenient to administrate at the same time to reinforce curative effect of a drug or reduce dose.Furthermore,It may be used for providing an optimal absorbed place for oral peptide family drugs and health food to avoid their degradation. |
 Physiochemical quality |
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Item
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Quality standard
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Density(granula)
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≤ 2 |
Fragility(granula)
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≤ 15 |
Collapsing duration (minute)
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≤ 10 (broken capsules allowed) |
Sulfite(as to So2 %)
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< 0.02 |
Chlorohydrin (PPm)
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< 25 |
Drying loss (%)
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12.5 - 17.5 |
Residue on ignition(% )
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Transparent< 2.0 |
| Semi-transparent, half transparent, half opaque < 3.0 |
| Half semi-transparent, half opaque< 4.0 |
| Opaque< 5.0 |
Heavy metal(PPm)
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≤ 50 |
| Viscosity( mm 2 /s ) |
≥ 60 |
Total count of bacteria colonies(each/g)
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< 1000 |
Total count of mould(each /g)
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< 100 |
Escherichia coli
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No result |
Acarid
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No result
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Freezing strength(g )
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> 180 |
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| Physiochemical quality of enteric empty capsule |
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Item
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Quality standard
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Density(granula)
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≤ 3 |
Fragility(granula)
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Test in stomach dissolving liquid≤ 15 |
Collapsing duration (minute)
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In gastric juice = 120 |
| In enteric juice ≤ 45 |
Sulfite(as to So2 %)
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< 0.02 |
Chlorohydrin (PPm)
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< 25 |
Drying loss (%)
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12.5 - 17.5 |
Residue on ignition ( % )
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Transparent< 2 |
| Semi-transparent, half transparent, half opaque< 3 |
| Half semi-transparent, half opaque< 4 |
| Opaque< 5 |
Heavy metal( PPm )
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≤ 50 |
| Total count of bacteria colonies(each/g) |
< 1000 |
Total count of mould(each /g)
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< 100 |
Escherichia coli
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No result |
Acarid
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No result |
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