{"id":5445,"date":"2026-10-19T16:19:18","date_gmt":"2026-10-19T08:19:18","guid":{"rendered":"https:\/\/www.jianpaitech.com\/?post_type=blog&#038;p=5445"},"modified":"2026-10-19T17:01:42","modified_gmt":"2026-10-19T09:01:42","slug":"tablet-content-uniformity-failures","status":"publish","type":"blog","link":"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/","title":{"rendered":"Tablet Content Uniformity Failures"},"content":{"rendered":"<section class=\"codex-docx-preview\">\n<article>\u7247\u5242\u542b\u91cf\u5747\u5300\u6027\u63cf\u8ff0\u4e86\u5355\u4e2a\u7247\u5242\u4e4b\u95f4\u6d3b\u6027\u836f\u7269\u6210\u5206\u6216API\u542b\u91cf\u7684\u4e00\u81f4\u6027\u3002\u6545\u969c\u53ef\u80fd\u8d77\u6e90\u4e8e\u521d\u59cb\u539f\u6599\u836f\u5206\u914d\u3001\u6df7\u5408\u540e\u7684\u5206\u79bb\u6216\u6e7f\u6cd5\u5236\u7c92\u548c\u5e72\u71e5\u8fc7\u7a0b\u4e2d\u7684\u6210\u5206\u91cd\u65b0\u5206\u914d\u3002\u5728\u9009\u62e9\u7ea0\u6b63\u63aa\u65bd\u4e4b\u524d\uff0c\u8c03\u67e5\u5e94\u786e\u5b9a\u6210\u5206\u7684\u53d8\u5316\u3002\u5bf9\u4e8e\u751f\u4ea7\u548c\u5de5\u827a\u5de5\u7a0b\u56e2\u961f\uff0c\u6700\u6709\u7528\u7684\u95ee\u9898 \u662f\u4ee5\u524d\u53ef\u63a5\u53d7\u7684\u6750\u6599\u53d8\u5f97\u4e0d\u5747\u5300\u3002\u672c\u6307\u5357\u9075\u5faa\u4ece\u9884\u6df7\u5408\u5230\u5e72\u71e5\u3001\u8f6c\u79fb\u548c\u538b\u7f29\u7684\u6750\u6599\uff0c\u5e76\u5bf9\u6bcf\u4e2a\u9636\u6bb5\u8fdb\u884c\u5b9e\u9645\u68c0\u67e5\u3002<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u5f55<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"\u5207\u6362\u76ee\u5f55\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">\u5207\u6362<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Why_Consistent_Tablet_Weight_Does_Not_Prove_Uniform_API_Content\" >\u4e3a\u4ec0\u4e48\u4e00\u81f4\u7684\u836f\u7247\u91cd\u91cf\u4e0d\u80fd\u8bc1\u660e\u5747\u5300\u7684API\u542b\u91cf<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Identify_the_Pattern_Before_Changing_the_Process\" >\u5728\u66f4\u6539\u6d41\u7a0b\u4e4b\u524d\u8bc6\u522b\u6a21\u5f0f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Inadequate_API_Distribution_During_Premixing\" >\u9884\u6df7\u8fc7\u7a0b\u4e2dAPI\u5206\u914d\u4e0d\u8db3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Segregation_After_an_Acceptable_Blend\" >\u5728\u53ef\u63a5\u53d7\u7684\u6df7\u5408\u7269\u540e\u8fdb\u884c\u9694\u79bb<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Ingredient_Redistribution_During_Granulation_and_Drying\" >\u5236\u7c92\u548c\u5e72\u71e5\u8fc7\u7a0b\u4e2d\u7684\u6210\u5206\u518d\u5206\u914d<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Verify_Sampling_and_Analytical_Reliability\" >\u9a8c\u8bc1\u91c7\u6837\u548c\u5206\u6790\u53ef\u9760\u6027<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Confirm_the_Root_Cause_Through_Process_Evidence\" >\u901a\u8fc7\u6d41\u7a0b\u8bc1\u636e\u786e\u8ba4\u6839\u672c\u539f\u56e0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Frequently_Asked_Questions\" >\u5e38\u89c1\u95ee\u9898<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/tablet-content-uniformity-failures\/#Discuss_Your_Process_Requirements_With_Jianpai\" >\u4e0eJianpai\u8ba8\u8bba\u60a8\u7684\u6d41\u7a0b\u8981\u6c42<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Why_Consistent_Tablet_Weight_Does_Not_Prove_Uniform_API_Content\"><\/span>\u4e3a\u4ec0\u4e48\u4e00\u81f4\u7684\u836f\u7247\u91cd\u91cf\u4e0d\u80fd\u8bc1\u660e\u5747\u5300\u7684API\u542b\u91cf<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7247\u5242\u8d28\u91cf\u548cAPI\u6d53\u5ea6\u90fd\u4f1a\u5f71\u54cd\u5355\u4e2a\u7247\u5242\u4e2d\u7684API\u91cf\u3002\u5982\u679c\u6d53\u5ea6\u56e0\u6df7\u5408\u7269\u800c\u5f02\uff0c\u91cd\u91cf\u76f8\u4f3c\u7684\u7247\u5242\u53ef\u80fd\u542b\u6709\u4e0d\u540c\u7684\u5242\u91cf\u3002\u590d\u5408\u6279\u91cf\u5206\u6790\u8fd8\u53ef\u4ee5\u9690\u85cf\u5404\u4e2a\u5355\u4f4d\u4e4b\u95f4\u7684\u5dee\u5f02\uff0c\u56e0\u4e3a\u5b83\u5728\u6d4b\u91cf\u524d\u7ec4\u5408\u6750\u6599\u3002<\/p>\n<p>\u4e3e\u4f8b\u6765\u8bf4\uff0c\u4e24\u7247\u53ef\u80fd\u5404\u91cd200 mg\u3002\u57284%\u548c6%\u7684API\u6d53\u5ea6\u4e0b\uff0c\u5b83\u4eec\u5206\u522b\u542b\u67098 mg\u548c12 mg\u7684API\u3002\u8fd9\u4e2a\u7b97\u672f\u793a\u4f8b\u89e3\u91ca\u4e86\u4e3a\u4ec0\u4e48\u4ec5\u91cd\u91cf\u68c0\u67e5\u4e0d\u80fd\u8bca\u65ad\u6d53\u5ea6\u5dee\u5f02\uff1b\u5b83\u5e76\u4e0d\u4ee3\u8868\u4ea7\u54c1\u89c4\u683c\u6216\u9a8c\u6536\u9650\u5236\u3002<\/p>\n<p>\u4f7f\u7528\u9002\u7528\u7684\u836f\u5178\u7a0b\u5e8f\u548c\u6279\u51c6\u7684\u4ea7\u54c1\u89c4\u683c\u6765\u8bc4\u4f30\u5242\u91cf\u5747\u5300\u6027\u3002\u53ea\u6709\u5728\u76f8\u5173\u6761\u4ef6\u4e0b\uff0c\u4f53\u91cd\u53d8\u5316\u624d\u662f\u4e00\u79cd\u5141\u8bb8\u7684\u5242\u91cf\u5747\u5300\u6027\u65b9\u6cd5\uff1b\u5e38\u89c4\u7247\u5242\u4f53\u91cd\u68c0\u67e5\u4e0d\u5e94\u88ab\u89c6\u4e3a\u542b\u91cf\u5747\u5300\u6027\u6d4b\u8bd5\u7684\u901a\u7528\u66ff\u4ee3\u54c1\u3002[1]<\/p>\n<p>\u6709\u5173\u66f4\u5e7f\u6cdb\u7684\u538b\u7f29\u548c\u5916\u89c2\u95ee\u9898\uff0c\u8bf7\u53c2\u9605\u5065\u6d3e\u7684\u6982\u8ff0 <strong><a href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/the-common-problems-for-manufacturing-tablet\/\">\u5e38\u89c1\u7684\u5e73\u677f\u7535\u8111\u5236\u9020\u7f3a\u9677<\/a><\/strong>.<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Identify_the_Pattern_Before_Changing_the_Process\"><\/span>\u5728\u66f4\u6539\u6d41\u7a0b\u4e4b\u524d\u8bc6\u522b\u6a21\u5f0f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5c06\u5355\u4e2a\u7ed3\u679c\u4e0e\u751f\u4ea7\u65f6\u95f4\u3001\u7269\u6599\u8f6c\u79fb\u3001\u6599\u6597\u8865\u5145\u548c\u8fc7\u7a0b\u4e2d\u65ad\u8fdb\u884c\u6bd4\u8f83\u3002\u6a21\u5f0f\u53ef\u4ee5\u6307\u5bfc\u8c03\u67e5\uff0c\u5c3d\u7ba1\u6ca1\u6709\u4e00\u4e2a\u6a21\u5f0f\u53ef\u4ee5\u8bc1\u660e\u5176\u672c\u8eab\u5c31\u662f\u6839\u672c\u539f\u56e0\u3002<\/p>\n<table class=\"first-row first-col no-vband\">\n<colgroup>\n<col \/>\n<col \/>\n<col \/><\/colgroup>\n<tbody>\n<tr>\n<td>\u89c2\u5bdf\u5230\u7684\u6a21\u5f0f<\/td>\n<td>\u53ef\u80fd\u7684\u8c03\u67e5\u89e3\u91ca<\/td>\n<td>\u6709\u7528\u7684\u8bc1\u636e<\/td>\n<\/tr>\n<tr>\n<td>\u5177\u6709\u53ef\u53d8API\u7ed3\u679c\u7684\u7c7b\u4f3c\u5e73\u677f\u7535\u8111\u6743\u91cd<\/td>\n<td>\u6d53\u5ea6\u5dee\u5f02\u800c\u975e\u8d28\u91cf\u53d8\u5316<\/td>\n<td>\u5355\u4e2a\u836f\u7247\u7ed3\u679c\u3001\u5bf9\u5e94\u6743\u91cd\u3001\u6df7\u5408\u6570\u636e<\/td>\n<\/tr>\n<tr>\n<td>\u53ef\u63a5\u53d7\u7684\u6df7\u5408\u6837\u54c1\uff0c\u7136\u540e\u662f\u53ef\u53d8\u7247\u5242<\/td>\n<td>\u53d6\u6837\u540e\u7684\u5206\u79bb\u6216\u4e0d\u5177\u4ee3\u8868\u6027\u7684\u6df7\u5408\u6837\u54c1<\/td>\n<td>\u4f20\u8f93\u8bb0\u5f55\u3001\u91c7\u6837\u65b9\u6cd5\u3001\u8fd0\u884c\u4e2d\u7684\u836f\u7247<\/td>\n<\/tr>\n<tr>\n<td>\u968f\u7740\u538b\u7f29\u7684\u8fdb\u884c\uff0c API\u7ed3\u679c\u4f1a\u968f\u4e4b\u6f02\u79fb<\/td>\n<td>\u6539\u53d8\u8fdb\u6599\u5668\u5904\u7684\u7269\u6599\u6210\u5206<\/td>\n<td>\u5f00\u59cb\u3001\u4e2d\u95f4\u548c\u7ed3\u675f\u6837\u54c1\uff1b\u6599\u6597\u8865\u5145\u65f6\u95f4<\/td>\n<\/tr>\n<tr>\n<td>\u9897\u7c92\u5927\u5c0f\u7ec4\u5206\u7684\u4e0d\u540c\u6d4b\u5b9a<\/td>\n<td>\u8fc1\u79fb\u3001\u9020\u7c92\u4e0d\u5747\u5300\u6216\u9009\u62e9\u6027\u7834\u635f<\/td>\n<td>\u5206\u6570\u6d4b\u5b9a\u3001\u5927\u5c0f\u5206\u5e03\u3001\u6536\u96c6\u7684\u7f5a\u6b3e<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft wp-image-3366 size-full\" src=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JHZ-D-Series-High-efficient-Wet-process-Granulator.jpg?quality=85&strip=all\" alt=\"\" width=\"750\" height=\"750\" srcset=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JHZ-D-Series-High-efficient-Wet-process-Granulator.jpg?quality=85&strip=all 750w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JHZ-D-Series-High-efficient-Wet-process-Granulator-300x300.jpg?quality=85&strip=all 300w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JHZ-D-Series-High-efficient-Wet-process-Granulator-150x150.jpg?quality=85&strip=all 150w\" sizes=\"(max-width: 750px) 100vw, 750px\" \/><\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Inadequate_API_Distribution_During_Premixing\"><\/span>\u9884\u6df7\u8fc7\u7a0b\u4e2dAPI\u5206\u914d\u4e0d\u8db3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"codex-docx-preview_heading2\"><strong>\u8c03\u67e5\u4f4e\u5242\u91cf\u6210\u5206\u548c\u9644\u805a\u7269<\/strong><\/p>\n<p>API\u8d1f\u8f7d\u4f4e\u4f7f\u5f97\u672c\u5730\u5206\u53d1\u7279\u522b\u91cd\u8981\u3002\u5982\u679c\u539f\u6599\u836f\u4fdd\u6301\u5728\u9644\u805a\u4f53\u4e2d\uff0c\u5219\u660e\u663e\u6df7\u5408\u826f\u597d\u7684\u6563\u88c5\u7c89\u672b\u4ecd\u53ef\u80fd\u542b\u6709\u4e0d\u540c\u6d53\u5ea6\u7684\u5c0f\u533a\u57df\u3002\u5c11\u91cf\u76f8\u5bf9\u8f83\u5927\u7684API\u9897\u7c92\u4e5f\u53ef\u4ee5\u9650\u5236\u5355\u4e2a\u5242\u91cf\u5c3a\u5ea6\u4e0a\u5206\u5e03\u7684\u4e00\u81f4\u6027\u3002<\/p>\n<p>\u5ba1\u6838\u4f20\u5165\u7684API\u7c92\u5f84\u3001\u56e2\u805a\u3001\u5206\u914d\u3001\u5145\u7535\u987a\u5e8f\u548c\u9884\u6df7\u5408\u5236\u5907\u3002\u8bc4\u4f30\u89e3\u805a\u3001\u5408\u9002\u7684\u8f7d\u4f53\u3001\u9884\u6df7\u5408\u6216\u51e0\u4f55\u7a00\u91ca\u662f\u5426\u9002\u5408\u914d\u65b9\u3002\u5728\u67d0\u4e9b\u7cfb\u7edf\u4e2d\uff0c\u66f4\u7ec6\u7684\u9897\u7c92\u53ef\u4ee5\u6539\u5584\u5206\u6563\u6027\uff0c\u4f46\u8fc7\u5ea6\u51cf\u5c0f\u5c3a\u5bf8\u4f1a\u589e\u52a0\u5185\u805a\u529b\u548c\u5904\u7406\u96be\u5ea6\u3002<\/p>\n<p class=\"codex-docx-preview_heading2\"><strong>\u5efa\u7acb\u652f\u6301\u7684\u6df7\u5408\u7aef\u70b9<\/strong><\/p>\n<p>\u6df7\u5408\u6027\u80fd\u53d6\u51b3\u4e8e\u8bbe\u5907\u51e0\u4f55\u5f62\u72b6\u3001\u586b\u5145\u6c34\u5e73\u3001\u901f\u5ea6\u3001\u6750\u6599\u6027\u80fd\u548c\u5145\u7535\u987a\u5e8f\u3002\u5728\u6ca1\u6709\u8bc1\u636e\u7684\u60c5\u51b5\u4e0b\u5ef6\u957f\u6df7\u5408\u65f6\u95f4\u53ef\u80fd\u65e0\u6cd5\u6253\u7834\u6301\u4e45\u7684\u9644\u805a\u7269\u6216\u89e3\u51b3\u51fa\u9662\u671f\u95f4\u7684\u9694\u79bb\u95ee\u9898\u3002<\/p>\n<p>\u4f7f\u7528\u5f00\u53d1\u7814\u7a76\u6765\u5efa\u7acb\u9002\u5408\u914d\u65b9\u7684\u64cd\u4f5c\u8303\u56f4\u548c\u53d6\u6837\u7b56\u7565\u3002\u4e00\u8d77\u5ba1\u67e5\u6837\u54c1\u4f4d\u7f6e\u3001\u6837\u54c1\u8d28\u91cf\u548c\u5206\u6790\u80fd\u529b\u3002\u5927\u6837\u672c\u53ef\u80fd\u4f1a\u5e73\u5747\u51fa\u5728\u7247\u5242\u5c3a\u5ea6\u4e0a\u91cd\u8981\u7684\u6d53\u5ea6\u5dee\u5f02\u3002<\/p>\n<p>\u4e00\u4e2a <strong><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/pharma-blender\/\">\u836f\u7c89\u6405\u62cc\u673a<\/a><\/strong> \u5e94\u4f7f\u7528\u4ee3\u8868\u6027\u6750\u6599\u53ca\u5176\u9884\u671f\u88c5\u8f7d\u8303\u56f4\u8fdb\u884c\u8bc4\u4f30\u3002\u8bd5\u9a8c\u5e94\u6f14\u793aAPI\u5206\u5e03\uff0c\u800c\u4e0d\u662f\u4ec5\u4ec5\u4f9d\u9760\u6df7\u5408\u65f6\u95f4\u6216\u76ee\u89c6\u68c0\u67e5\u3002<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Segregation_After_an_Acceptable_Blend\"><\/span>\u5728\u53ef\u63a5\u53d7\u7684\u6df7\u5408\u7269\u540e\u8fdb\u884c\u9694\u79bb<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"codex-docx-preview_heading2\"><strong>\u901a\u8fc7\u51fa\u6599\u548c\u8f6c\u79fb\u8ddf\u968f\u7269\u6599<\/strong><\/p>\n<p>\u9897\u7c92\u5927\u5c0f\u3001\u5bc6\u5ea6\u548c\u5f62\u72b6\u7684\u5dee\u5f02\u4f1a\u4fc3\u8fdb\u5378\u6599\u3001\u81ea\u7531\u843d\u4f53\u3001\u632f\u52a8\u3001\u8f93\u9001\u6216\u6599\u6597\u6d41\u52a8\u8fc7\u7a0b\u4e2d\u7684\u5206\u79bb\u3002\u5728\u6405\u62cc\u673a\u5185\u6536\u96c6\u7684\u4ee4\u4eba\u6ee1\u610f\u7684\u6837\u54c1\u5e76\u4e0d\u80fd\u8bc1\u660e\u5230\u8fbe\u538b\u7247\u673a\u7684\u6750\u6599\u4fdd\u6301\u5747\u5300\u3002<\/p>\n<p>\u7ed8\u5236\u5b9e\u9645\u8f6c\u8fd0\u8def\u7ebf\u56fe\uff0c\u5305\u62ec\u4e2d\u95f4\u96c6\u88c5\u7bb1\u548c\u4fdd\u6301\u6b65\u9aa4\u3002\u68c0\u67e5\u8dcc\u843d\u9ad8\u5ea6\u3001\u6392\u653e\u9650\u5236\u3001\u632f\u52a8\u3001\u6599\u6597\u51e0\u4f55\u5f62\u72b6\u548c\u6c14\u52a8\u8f93\u9001\u6761\u4ef6\uff08\u5982\u9002\u7528\uff09\u3002\u4f7f\u7528\u9002\u5f53\u7684\u91c7\u6837\u65b9\u6848\u6bd4\u8f83\u53ef\u7591\u8f6c\u79fb\u6b65\u9aa4\u4e4b\u524d\u548c\u4e4b\u540e\u7684\u6837\u54c1\u3002<\/p>\n<p>\u5f53\u7ed3\u679c\u5728\u6599\u6597\u8865\u5145\u540e\u6216\u63a5\u8fd1\u8fd0\u884c\u7ed3\u675f\u65f6\u53d1\u751f\u53d8\u5316\u65f6\uff0c\u8bf7\u8c03\u67e5\u538b\u69a8\u64cd\u4f5c\u65f6\u8fdb\u6599\u6210\u5206\u7684\u53d8\u5316\u3002\u964d\u4f4e\u538b\u5236\u901f\u5ea6\u53ef\u4ee5\u6539\u5584\u6a21\u5177\u586b\u5145\uff0c\u4f46\u5b83\u4e0d\u4e00\u5b9a\u4f1a\u7ea0\u6b63API\u6d53\u5ea6\u5df2\u7ecf\u53d8\u5f97\u4e0d\u5747\u5300\u7684\u6df7\u5408\u7269\u3002<\/p>\n<p class=\"codex-docx-preview_heading2\"><strong>\u5728\u5220\u9664\u7f5a\u6b3e\u4e4b\u524d\u68c0\u67e5\u5c3a\u5bf8\u5206\u6570<\/strong><\/p>\n<p>\u4e0d\u540c\u9897\u7c92\u7ea7\u5206\u53ef\u80fd\u542b\u6709\u4e0d\u540c\u7684API\u6d53\u5ea6\u3002\u56e0\u6b64\uff0c\u53bb\u9664\u7ec6\u7c92\u6216\u8d85\u5927\u9897\u7c92\u53ef\u4ee5\u6539\u53d8\u5269\u4f59\u7684\u6279\u6b21\u7ec4\u6210\uff0c\u800c\u4e0d\u662f\u7b80\u5355\u5730\u6539\u5584\u6d41\u7a0b\u3002<\/p>\n<p>\u5728\u63d0\u51fa\u7b5b\u9009\u53d8\u66f4\u4e4b\u524d\uff0c\u5ba1\u67e5\u76f8\u5173\u998f\u5206\u7684\u914d\u65b9\u3001\u7c92\u5f84\u5206\u5e03\u548c\u6d4b\u5b9a\u3002\u5982\u679c\u6d89\u53ca\u94e3\u524a\uff0c\u8bf7\u4f7f\u7528\u5408\u9002\u7684\u65b9\u6cd5\u8bc4\u4f30\u7b5b\u7f51\u5c3a\u5bf8\u3001\u64cd\u4f5c\u901f\u5ea6\u3001\u8fdb\u6599\u6761\u4ef6\u548c\u9897\u7c92\u7834\u788e <strong><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/pharma-mill\/\">\u5236\u836f\u7814\u78e8\u8bbe\u5907<\/a><\/strong>.<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Ingredient_Redistribution_During_Granulation_and_Drying\"><\/span>\u5236\u7c92\u548c\u5e72\u71e5\u8fc7\u7a0b\u4e2d\u7684\u6210\u5206\u518d\u5206\u914d<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"codex-docx-preview_heading2\"><strong>\u68c0\u67e5\u7c98\u5408\u5242\u5206\u5e03\u548c\u9020\u7c92\u4e00\u81f4\u6027<\/strong><\/p>\n<p>\u5728\u6e7f\u6cd5\u9020\u7c92\u4e2d\uff0c\u6e7f\u6da6\u548c\u7c98\u5408\u5242\u5206\u5e03\u7684\u5dee\u5f02\u4f1a\u4ea7\u751f\u5177\u6709\u4e0d\u540c\u7ed3\u6784\u6216\u7ec4\u6210\u7684\u9897\u7c92\u3002\u5982\u679c\u90e8\u5206\u539f\u6599\u836f\u6eb6\u89e3\u5728\u9020\u7c92\u6db2\u4e2d\uff0c\u968f\u540e\u7684\u6db2\u4f53\u79fb\u52a8\u53ef\u80fd\u4f1a\u5f71\u54cd\u539f\u6599\u836f\u5728\u5e72\u71e5\u8fc7\u7a0b\u4e2d\u7684\u6c89\u79ef\u4f4d\u7f6e\u3002<\/p>\n<p>\u5c06\u7c98\u5408\u5242\u6dfb\u52a0\u8bb0\u5f55\u3001\u6df7\u5408\u6761\u4ef6\u3001\u6e7f\u8d28\u91cf\u7ec8\u70b9\u548c\u9897\u7c92\u7279\u6027\u4e0e\u53ef\u63a5\u53d7\u7684\u6279\u6b21\u8fdb\u884c\u6bd4\u8f83\u3002\u8c03\u67e5\u6db2\u4f53\u91cf\u3001\u6dfb\u52a0\u901f\u7387\u548c\u6279\u91cf\u88c5\u8f7d\u7684\u53d8\u5316\u3002\u907f\u514d\u5728\u4e0d\u8bc4\u4f30\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\u7684\u60c5\u51b5\u4e0b\u6539\u53d8\u9020\u7c92\u6db2\u6216\u7c98\u5408\u5242\u6d53\u5ea6\u3002<\/p>\n<p>\u5bf9\u4e8e\u5df2\u5efa\u7acb\u7684\u6e7f\u6cd5\u9020\u7c92\u8def\u7ebf\uff0c\u8bf7\u8bc4\u4f30<strong> <a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/high-shear-mixer\/\">\u9ad8\u526a\u5207\u6df7\u5408\u9020\u7c92\u673a<\/a><\/strong> \u652f\u6301\u6240\u9700\u7684\u7c98\u5408\u5242\u8f93\u9001\u548c\u6df7\u5408\u6761\u4ef6\u3002\u5e94\u901a\u8fc7\u8bd5\u9a8c\u5bf9\u7167\u914d\u65b9\u9a8c\u8bc1\u8bbe\u5907\u80fd\u529b\u3002<\/p>\n<p class=\"codex-docx-preview_heading2\"><strong>\u533a\u5206\u8fc1\u79fb\u548c\u4e0d\u5747\u5300\u7684\u6c34\u5206\u53bb\u9664<\/strong><\/p>\n<p>\u5728\u5e72\u71e5\u8fc7\u7a0b\u4e2d\uff0c\u6eb6\u89e3\u7684\u6210\u5206\u53ef\u80fd\u4f1a\u968f\u6db2\u4f53\u5411\u84b8\u53d1\u8868\u9762\u79fb\u52a8\u3002\u8fc1\u79fb\u53ef\u4ee5\u53d1\u751f\u5728\u5355\u4e2a\u9897\u7c92\u5185\u6216\u56fa\u5b9a\u9897\u7c92\u5e8a\u7684\u533a\u57df\u4e4b\u95f4\u3002\u6bd4\u8f83\u5e72\u71e5\u65b9\u6cd5\u7684\u7814\u7a76\u8868\u660e\uff0c\u8fc1\u79fb\u884c\u4e3a\u53d6\u51b3\u4e8e\u7269\u6599\u7cfb\u7edf\u548c\u5e72\u71e5\u6761\u4ef6\u3002[2]<\/p>\n<p>\u4e0d\u5747\u5300\u7684\u6c34\u5206\u5256\u9762\u662f\u4e00\u4e2a\u6709\u7528\u7684\u8c03\u67e5\u4fe1\u53f7\uff0c\u4f46\u6c34\u5206\u6d4b\u91cf\u672c\u8eab\u5e76\u4e0d\u80fd\u8bc1\u660eAPI\u662f\u5426\u5df2\u7ecf\u91cd\u65b0\u5206\u5e03\u3002\u5982\u679c\u6000\u7591\u8fc1\u79fb\uff0c\u5c06\u6c34\u5206\u548c\u6e29\u5ea6\u8bb0\u5f55\u4e0e\u6765\u81ea\u76f8\u5173\u4f4d\u7f6e\u6216\u9897\u7c92\u7ea7\u5206\u7684\u68c0\u6d4b\u6570\u636e\u76f8\u7ed3\u5408\u3002<\/p>\n<p>\u68c0\u67e5\u5e8a\u8d1f\u8377\u3001\u4ea7\u54c1\u6e29\u5ea6\u3001\u6c14\u6d41\u3001\u5e72\u71e5\u65f6\u95f4\u548c\u65e2\u5b9a\u7ec8\u70b9\u3002\u6d41\u5316\u4f1a\u6539\u53d8\u9897\u7c92\u7684\u8fd0\u52a8\u548c\u4f20\u70ed\u4f20\u8d28\uff0c\u4f46\u4e0d\u80fd\u4fdd\u8bc1\u6d88\u9664\u8fc1\u79fb\u3002<\/p>\n<p class=\"codex-docx-preview_heading2\"><strong>\u6d88\u8017\u548c\u9009\u62e9\u6027\u6750\u6599\u635f\u5931\u8d26\u6237<\/strong><\/p>\n<p>\u9897\u7c92\u78b0\u649e\u548c\u642c\u8fd0\u8fc7\u7a0b\u4e2d\u4f1a\u4ea7\u751f\u7ec6\u7c89\u3002\u5982\u679c\u7ec6\u7c89\u4e2d\u7684\u6d3b\u6027\u836f\u7269\u6210\u5206\uff08API\uff09\u6d53\u5ea6\u4e0e\u6563\u88c5\u7269\u6599\u4e0d\u540c\uff0c\u5219\u901a\u8fc7\u8fc7\u6ee4\u5668\u6355\u83b7\u6216\u8403\u53d6\u53bb\u9664\u7ec6\u7c89\u53ef\u80fd\u4f1a\u5f71\u54cd\u56de\u6536\u4ea7\u54c1\u7684\u7ec4\u6210\u3002<\/p>\n<p>\u5728\u53ef\u80fd\u53d1\u751f\u9009\u62e9\u6027\u635f\u5931\u65f6\uff0c\u5728\u8c03\u67e5\u4e2d\u5305\u62ec\u6750\u6599\u56de\u6536\u548c\u7f5a\u6b3e\u6210\u5206\u3002\u5df2\u53d1\u8868\u7684\u6d41\u5316\u5e8a\u5e72\u71e5\u5de5\u4f5c\u5c06\u6c14\u4f53\u901f\u5ea6\u4e0e\u7ec6\u9897\u7c92\u5939\u5e26\u548c\u4ea7\u54c1\u635f\u5931\u8054\u7cfb\u8d77\u6765\uff0c\u4ece\u800c\u652f\u6301\u4e86\u8003\u8651\u5e72\u71e5\u7ec8\u70b9\u65c1\u8fb9\u7684\u6c14\u6d41\u7684\u9700\u8981\u3002[3]<\/p>\n<p>\u8bc4\u4f30\u65f6 <strong><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/fluid-bed-dryer\/\">\u6d41\u5316\u5e8a\u5e72\u71e5\u673a<\/a><\/strong>\uff0c\u4f7f\u7528\u4ee3\u8868\u6027\u9897\u7c92\u8bc4\u4f30\u6c34\u5206\u63a7\u5236\u3001\u78e8\u8017\u3001\u8fc7\u6ee4\u548c\u56de\u6536\u3002\u5747\u5300\u7684\u6700\u7ec8\u6c34\u5206\u53ea\u662f\u6240\u9700\u8bc1\u636e\u7684\u4e00\u90e8\u5206\u3002<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Verify_Sampling_and_Analytical_Reliability\"><\/span>\u9a8c\u8bc1\u91c7\u6837\u548c\u5206\u6790\u53ef\u9760\u6027<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u53ef\u53d8\u7ed3\u679c\u53ef\u4ee5\u53cd\u6620\u5b9e\u9645\u7684\u4ea7\u54c1\u53d8\u5316\u3001\u62bd\u6837\u504f\u5dee\u3001\u6837\u54c1\u5236\u5907\u95ee\u9898\u6216\u5206\u6790\u95ee\u9898\u3002\u4e0e\u5236\u9020\u8c03\u67e5\u4e00\u8d77\u5ba1\u67e5\u65b9\u6cd5\u548c\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u3002<\/p>\n<p>\u68c0\u67e5\u91c7\u6837\u5668\u662f\u5426\u5e72\u6270\u6216\u4f18\u5148\u6536\u96c6\u7279\u5b9a\u90e8\u5206\u3002\u6839\u636e\u9700\u8981\u5ba1\u67e5\u6837\u672c\u5927\u5c0f\u548c\u4f4d\u7f6e\u3001\u63d0\u53d6\u5b8c\u6574\u6027\u3001\u5236\u5907\u6b65\u9aa4\u3001\u8ba1\u7b97\u548c\u4eea\u5668\u6027\u80fd\u3002\u4fdd\u7559\u539f\u59cb\u7ed3\u679c\u5e76\u9075\u5faa\u7814\u7a76\u4e2d\u5fc3\u7684\u8d85\u51fa\u89c4\u8303\u7a0b\u5e8f\uff1b\u989d\u5916\u7684\u6d4b\u8bd5\u5e94\u8c03\u67e5\u5408\u7406\u7684\u5047\u8bbe\uff0c\u800c\u4e0d\u662f\u7ee7\u7eed\u8fdb\u884c\uff0c\u76f4\u5230\u83b7\u5f97\u5408\u683c\u7684\u7ed3\u679c\u3002[4]<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Confirm_the_Root_Cause_Through_Process_Evidence\"><\/span>\u901a\u8fc7\u6d41\u7a0b\u8bc1\u636e\u786e\u8ba4\u6839\u672c\u539f\u56e0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u4f7f\u7528\u8bb0\u5f55\u7684\u8c03\u67e5\u5c06\u53ef\u7591\u673a\u5236\u4e0e\u89c2\u5bdf\u5230\u7684\u7ed3\u679c\u8054\u7cfb\u8d77\u6765\u3002\u4f8b\u5982\uff0c\u5982\u679c\u6000\u7591\u8f6c\u79fb\u9694\u79bb\uff0c\u8bf7\u5728\u8f6c\u79fb\u524d\u5c06\u9002\u5f53\u6536\u96c6\u7684\u6750\u6599\u4e0e\u5230\u8fbe\u8fdb\u6599\u5668\u548c\u6574\u4e2a\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u751f\u4ea7\u7684\u836f\u7247\u8fdb\u884c\u6bd4\u8f83\u3002\u4ec5\u9650\u4e8e\u6405\u62cc\u5668\u6837\u54c1\u7684\u6539\u8fdb\u5e76\u4e0d\u80fd\u8bc1\u660e\u4e0b\u6e38\u95ee\u9898\u5df2\u7ecf\u89e3\u51b3\u3002<\/p>\n<p>\u6839\u636e\u5176\u4ed6\u76f8\u5173\u5c5e\u6027\uff08\u5305\u62ec\u5316\u9a8c\u3001\u6eb6\u51fa\u5ea6\u3001\u7247\u5242\u5f3a\u5ea6\u548c\u6750\u6599\u56de\u6536\uff09\u8bc4\u4f30\u4efb\u4f55\u62df\u8bae\u7684\u5de5\u827a\u53d8\u66f4\u3002\u91cd\u65b0\u6df7\u5408\u6216\u91cd\u65b0\u5236\u7c92\u5931\u8d25\u7684\u6279\u6b21\u9700\u8981\u8fdb\u884c\u8bb0\u5f55\u7684\u8d28\u91cf\u8bc4\u4f30\uff0c\u4e0d\u5e94\u5047\u5b9a\u5176\u6062\u590d\u53ef\u63a5\u53d7\u7684\u4ea7\u54c1\u3002<\/p>\n<p>\u5bf9\u4e8e\u8bbe\u5907\u8bd5\u9a8c\uff0c\u63d0\u4f9bAPI\u52a0\u8f7d\u8303\u56f4\u3001\u6750\u6599\u5c5e\u6027\u3001\u6279\u91cf\u5927\u5c0f\u3001\u8f6c\u79fb\u5b89\u6392\u3001\u5de5\u827a\u8bb0\u5f55\u548c\u6545\u969c\u6a21\u5f0f\u3002\u8981\u6c42\u63d0\u4f9b\u8bd5\u7528\u8ba1\u5212\uff0c\u4ee5\u8861\u91cf\u88ab\u8c03\u67e5\u7684\u5c5e\u6027\u3002\u5e94\u9009\u62e9\u6405\u62cc\u673a\u3001\u5236\u7c92\u673a\u6216\u5e72\u71e5\u673a\uff0c\u4ee5\u8bc1\u660e\u5176\u5728\u76f8\u5173\u5de5\u827a\u9636\u6bb5\u7684\u9002\u7528\u6027\u3002<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions\"><\/span>\u5e38\u89c1\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"codex-docx-preview_heading2\">Can a batch pass assay and fail content uniformity<\/p>\n<p>Yes. A composite assay describes the combined sample, while content uniformity evaluates individual dosage units. An acceptable average can coexist with excessive variation between tablets.<\/p>\n<p class=\"codex-docx-preview_heading2\">Why can blend samples pass while tablets fail<\/p>\n<p>The blend samples may not represent the variation at the dosage unit scale. Alternatively, material may segregate after sampling during discharge, transfer, hopper storage, or feeding. Review both possibilities before extending the blending time.<\/p>\n<p class=\"codex-docx-preview_heading2\">Does a high shear granulator solve every uniformity problem<\/p>\n<p>No. It may support an appropriate wet granulation process, but it cannot by itself resolve downstream segregation, an unsuitable sampling method, or selective material loss. Identify the mechanism and verify the proposed remedy with process data.<\/p>\n<p class=\"codex-docx-preview_heading2\">What information helps an equipment supplier assess the problem<\/p>\n<p>Provide formulation characteristics, API loading, batch size, particle size and moisture data, process flow, sampling locations, and the timing of variable results. Include containment, cleaning, and utility requirements for any proposed equipment trial.<\/p>\n<h2 class=\"codex-docx-preview_heading1\"><span class=\"ez-toc-section\" id=\"Discuss_Your_Process_Requirements_With_Jianpai\"><\/span>\u4e0eJianpai\u8ba8\u8bba\u60a8\u7684\u6d41\u7a0b\u8981\u6c42<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5efa\u724c\u63d0\u4f9b\u6405\u62cc\u3001\u6e7f\u6cd5\u5236\u7c92\u3001\u94e3\u524a\u548c\u6d41\u5316\u5e8a\u5e72\u71e5\u8bbe\u5907\u3002\u5206\u4eab\u60a8\u7684\u6750\u6599\u7279\u6027\u3001\u751f\u4ea7\u8981\u6c42\u548c\u8c03\u67e5\u7ed3\u679c\uff0c\u4ee5\u8ba8\u8bba\u76f8\u5173\u8bbe\u5907\u9009\u9879\u4ee5\u53ca\u8bc4\u4f30\u9002\u7528\u6027\u6240\u9700\u7684\u8bd5\u9a8c\u3002<\/p>\n<p>\u9020\u8a2a <strong><a href=\"https:\/\/www.jianpaitech.com\/zh\">\u5251\u6d3e\u79d1\u6280<\/a><\/strong> \u63d0\u4ea4\u60a8\u7684\u6d41\u7a0b\u8981\u6c42\u3002<\/p>\n<p>&nbsp;<\/p>\n<\/article>\n<\/section>\n<section class=\"codex-docx-preview\">\n<article>\n<p class=\"codex-docx-preview_heading1\"><strong>\u7f16\u8f91\u53c2\u8003\u6587\u732e<\/strong><\/p>\n<p>[1] FDA \uff0c Q4B\u9644\u5f556\u5242\u91cf\u5355\u4f4d\u7684\u5747\u5300\u6027\u4e00\u822c\u7ae0\u8282\uff1a https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q4b-annex-6-uniformity-dosage-units-general-chapter<\/p>\n<p>[2]\u901a\u8fc7\u6d41\u6001\u5316\u548c\u5176\u4ed6\u65b9\u6cd5\u5e72\u71e5\u7684\u6d4b\u8bd5\u5236\u7c92\u4e2d\u7684\u6eb6\u8d28\u8fc1\u79fb\u7684\u6bd4\u8f83\uff0c PMID 239157 \uff1a https:\/\/pubmed.ncbi.nlm.nih.gov\/239157\/<\/p>\n<p>[3] Briens\u548cBojarra \uff0c\u76d1\u6d4b\u836f\u7269\u9897\u7c92\u7684\u6d41\u5316\u5e8a\u5e72\u71e5\uff0c 2010\u5e74\uff0c DOI 10.1208\/s12249-010-9538-1 \uff1a https:\/\/pubmed.ncbi.nlm.nih.gov\/21061102\/<\/p>\n<p>[4] FDA \uff0c\u836f\u54c1\u751f\u4ea7\u8d85\u6807\u68c0\u6d4b\u7ed3\u679c\u8c03\u67e5\uff0c 2022\u5e745\u6708\uff1a https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision<\/p>\n<\/article>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>Tablet content uniformity describes the consistency of active pharmaceutical ingredient, or API, content between individual tablets. Failures can originate during initial API distribution, segregation after blending, or ingredient redistribution during wet granulation and drying. The investigation should identify where composition changes before selecting a corrective action.For production and process engineering teams, the most useful question [\u2026]<\/p>","protected":false},"featured_media":5446,"template":"","meta":{"_acf_changed":false,"footnotes":""},"blog_category":[16],"class_list":["post-5445","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog_category-industry-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog\/5445","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog"}],"about":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/types\/blog"}],"version-history":[{"count":2,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog\/5445\/revisions"}],"predecessor-version":[{"id":5448,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog\/5445\/revisions\/5448"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/media\/5446"}],"wp:attachment":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/media?parent=5445"}],"wp:term":[{"taxonomy":"blog_category","embeddable":true,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog_category?post=5445"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}