{"id":9297,"date":"2026-02-02T11:23:35","date_gmt":"2026-02-02T03:23:35","guid":{"rendered":"https:\/\/www.packqc.com\/applications\/bloom-strength-of-soft-gelatin-capsule\/"},"modified":"2026-03-16T10:56:29","modified_gmt":"2026-03-16T02:56:29","slug":"bloom-strength-of-soft-gelatin-capsule","status":"publish","type":"applications","link":"https:\/\/www.packqc.com\/cs\/applications\/bloom-strength-of-soft-gelatin-capsule\/","title":{"rendered":"Testov\u00e1n\u00ed pevnosti m\u011bkk\u00fdch \u017eelatinov\u00fdch kapsl\u00ed v rozkv\u011btu"},"content":{"rendered":"

M\u011b\u0159en\u00ed s\u00edla rozkv\u011btu m\u011bkk\u00e9 \u017eelatinov\u00e9 tobolky<\/strong> m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro kontrolu kvality l\u00e9\u010div. P\u0159\u00edmo odr\u00e1\u017e\u00ed mechanickou integritu a konzistenci \u017eelatinov\u00e9ho materi\u00e1lu a zaji\u0161\u0165uje, \u017ee tobolky spl\u0148uj\u00ed po\u017eadavky na regula\u010dn\u00ed normy<\/strong> a o\u010dek\u00e1v\u00e1n\u00ed spot\u0159ebitel\u016f. Tento \u010dl\u00e1nek se zab\u00fdv\u00e1 z\u00e1klady pevnosti v\u00fdkv\u011btu, zp\u016fsoby jej\u00edho testov\u00e1n\u00ed a d\u016fvody, pro\u010d si vybrat spolehliv\u00e9 za\u0159\u00edzen\u00ed, jako je nap\u0159. CHT-01 Tvrdom\u011br \u017eelatinov\u00fdch kapsl\u00ed<\/strong><\/a> od spole\u010dnosti Cell Instruments je pro spolehliv\u00e9 v\u00fdsledky z\u00e1sadn\u00ed.<\/p>\n\n\n\n

Porozum\u011bn\u00ed s\u00edle kv\u011btu v \u017eelatinov\u00fdch kapsl\u00edch<\/h2>\n\n\n\n

S\u00edla kv\u011btu<\/strong> je m\u011b\u0159\u00edtkem pevnosti nebo s\u00edly \u017eelatiny, kter\u00e1 p\u0159\u00edmo ovliv\u0148uje pru\u017enost, odolnost proti prasknut\u00ed a chov\u00e1n\u00ed p\u0159i rozpou\u0161t\u011bn\u00ed. m\u011bkk\u00e9 \u017eelatinov\u00e9 kapsle<\/strong>. Term\u00edn poch\u00e1z\u00ed z Bloomova testu, kter\u00fd m\u011b\u0159\u00ed hmotnost v gramech pot\u0159ebnou ke stla\u010den\u00ed povrchu \u017eelatinov\u00e9ho gelu o 4 mm standardn\u00edm p\u00edstem za ur\u010dit\u00fdch podm\u00ednek (obvykle p\u0159i 10 \u00b0C po 17-18 hodin\u00e1ch \u017eel\u00edrov\u00e1n\u00ed).<\/p>\n\n\n\n

V kontextu m\u011bkk\u00fdch \u017eelatinov\u00fdch tobolek znamen\u00e1 vysok\u00e1 pevnost v\u00fdkv\u011btu obecn\u011b pevn\u011bj\u0161\u00ed a pru\u017en\u011bj\u0161\u00ed obal tobolky, co\u017e p\u0159isp\u00edv\u00e1 k lep\u0161\u00ed stabilit\u011b v\u00fdrobku, mechanick\u00e9 odolnosti b\u011bhem balen\u00ed a lep\u0161\u00ed kontrole uvol\u0148ov\u00e1n\u00ed l\u00e9\u010diva.<\/p>\n\n\n\n

V\u00fdznam testov\u00e1n\u00ed pevnosti kv\u011btu p\u0159i kontrole farmaceutick\u00e9 kvality<\/h2>\n\n\n\n

The s\u00edla rozkv\u011btu m\u011bkk\u00e9 \u017eelatinov\u00e9 tobolky<\/strong> mus\u00ed b\u00fdt d\u016fsledn\u011b sledov\u00e1ny z n\u00e1sleduj\u00edc\u00edch d\u016fvod\u016f:<\/p>\n\n\n\n

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  • Zaji\u0161t\u011bn\u00ed kvality produktu<\/strong>: Zaji\u0161\u0165uje struktur\u00e1ln\u00ed integritu kapsle.<\/li>\n\n\n\n
  • Soulad s p\u0159edpisy<\/strong>: Spl\u0148uje l\u00e9kopisn\u00e9 normy USP a EP.<\/li>\n\n\n\n
  • Stabilita slo\u017een\u00ed<\/strong>: Identifikuje odchylky v \u0161ar\u017e\u00edch surov\u00e9 \u017eelatiny.<\/li>\n\n\n\n
  • Bezpe\u010dnost spot\u0159ebitel\u016f<\/strong>: Zaji\u0161\u0165uje, aby se tobolky neroztrhly p\u0159ed\u010dasn\u011b nebo se nerozpou\u0161t\u011bly p\u0159\u00edli\u0161 pomalu.<\/li>\n<\/ul>\n\n\n\n

    Tato krit\u00e9ria kvality jsou obzvl\u00e1\u0161t\u011b d\u016fle\u017eit\u00e1 pro l\u00e9ky citliv\u00e9 na teplotu nebo vlhkost.<\/p>\n\n\n\n

    Pou\u017eit\u00e9 n\u00e1stroje: Zkou\u0161ka pevnosti m\u011bkk\u00fdch \u017eelatinov\u00fdch kapsl\u00ed v rozkv\u011btu<\/h2>\n\n\n\n

    Bloom Tester - m\u011b\u0159en\u00ed gelov\u00e9 s\u00edly \u017eelatiny<\/h3>\n\n\n\n

    A tester kv\u011btu<\/strong> hodnot\u00ed mechanickou pevnost \u017eelatinov\u00e9ho gelu, kter\u00e1 \u00fazce souvis\u00ed s v\u00fdkonem tobolek. Tato zkou\u0161ka zahrnuje:<\/p>\n\n\n\n

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    • P\u0159\u00edprava roztoku \u017eelatiny (6,67% w\/w),<\/li>\n\n\n\n
    • Kondicionov\u00e1n\u00ed gelu p\u0159i teplot\u011b 10 \u00b0C \u00b10,1 \u00b0C po dobu 16-18 hodin,<\/li>\n\n\n\n
    • K m\u011b\u0159en\u00ed odporu (v gramech) pou\u017eijte standardn\u00ed p\u00edst (12,7 mm).<\/li>\n<\/ul>\n\n\n\n

      A\u010dkoli se tato zkou\u0161ka zam\u011b\u0159uje na vlastnosti surov\u00e9 \u017eelatiny, m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro hodnocen\u00ed p\u0159edch\u00e1zej\u00edc\u00edho materi\u00e1lu p\u0159i v\u00fdrob\u011b kapsl\u00ed.<\/p>\n\n\n\n

      Zkou\u0161ka tvrdosti \u017eelatinov\u00fdch kapsl\u00ed - hodnocen\u00ed kone\u010dn\u00e9ho produktu<\/h3>\n\n\n\n

      Jakmile se kapsle vytvo\u0159\u00ed, jejich tvrdost<\/strong> a odolnost v\u016f\u010di s\u00edle<\/strong> je t\u0159eba ov\u011b\u0159it pomoc\u00ed zkou\u0161ka tvrdosti \u017eelatinov\u00fdch tobolek<\/strong>. Tato zkou\u0161ka spo\u010d\u00edv\u00e1 v p\u016fsoben\u00ed s\u00edly na obal tobolky, dokud nedojde k jej\u00ed deformaci nebo prasknut\u00ed, co\u017e simuluje nam\u00e1h\u00e1n\u00ed p\u0159i balen\u00ed, skladov\u00e1n\u00ed a po\u017eit\u00ed.<\/p>\n\n\n\n

      Jedn\u00edm z nejefektivn\u011bj\u0161\u00edch n\u00e1stroj\u016f pro tento \u00fa\u010del je CHT-01 Tvrdom\u011br \u017eelatinov\u00fdch kapsl\u00ed<\/strong> z Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong>.<\/p>\n\n\n\n

      Postup zkou\u0161en\u00ed tvrdosti \u017eelatinov\u00fdch tobolek<\/h2>\n\n\n\n

      P\u0159\u00edprava vzorku<\/h3>\n\n\n\n
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      • Vy\u010dist\u011bte kapsle a kondicionujte je p\u0159i 20-25 \u00b0C s relativn\u00ed vlhkost\u00ed 50%.<\/li>\n\n\n\n
      • P\u0159ed testov\u00e1n\u00edm se ujist\u011bte, \u017ee nejsou viditeln\u00e9 \u017e\u00e1dn\u00e9 vady.<\/li>\n<\/ul>\n\n\n\n

        Proveden\u00ed testu<\/h3>\n\n\n\n
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