淺談(tan)中(zhong)藥(yao)片(pian)劑硬(ying)度檢測(ce)

  中(zhong)藥(yao)片(pian)劑因其(qi)服用,攜(xie)帶方便(bian),劑量較(jiao)易(yi)控制(zhi)等方面的因(yin)素(su),其(qi)使用越來(lai)越廣泛,生產量日(ri)益擴(kuo)大(da).在中(zhong)藥(yao)片(pian)劑生產中(zhong),硬(ying)度和崩解是(shi)兩(liang)個(ge)重(zhong)要的質(zhi)量(liang)指(zhi)標(biao),但這(zhe)兩項指標不(bu)合(he)格(ge)也(ye)是中(zhong)藥(yao)片(pian)劑生產中(zhong)經(jing)常(chang)遇到(dao)的難題(ti),而且(qie)較(jiao)西(xi)藥(yao)片(pian)劑更為(wei)突(tu)出.

  片劑的硬(ying)度中(zhong)藥(yao)片(pian)劑的硬(ying)度壹(yi)般(ban)是指其(qi)抗擠壓強(qiang)度,目(mu)前多采(cai)用硬(ying)度儀(yi)或(huo)松(song)木(mu)板(ban)法(fa)測(ce)定,由(you)於不(bu)同(tong)片劑在生產過程中(zhong)對(dui)硬(ying)度的要(yao)求(qiu)也(ye)不(bu)盡(jin)相(xiang)同(tong),因此(ci)《藥(yao)典(dian)》對(dui)其(qi)無具體(ti)要(yao)求(qiu),但這(zhe)並不(bu)降低(di)硬(ying)度在中(zhong)藥(yao)片(pian)劑生產中(zhong)的重(zhong)要性(xing),特別是對(dui)包衣(yi)片(pian)等對(dui)硬(ying)度有壹(yi)定(ding)要求(qiu)的片(pian)劑更為(wei)重(zhong)要,若(ruo)包(bao)衣(yi)前(qian)素(su)片(pian)硬(ying)度達(da)不(bu)到(dao)要求(qiu),在包(bao)衣(yi)過程中(zhong)將(jiang)出現(xian)碎(sui)片(pian),麻(ma)面等影(ying)響包衣(yi)片(pian)質(zhi)量(liang)的情況,嚴重(zhong)時可(ke)使(shi)包(bao)衣(yi)無(wu)法進(jin)行.

  壹(yi)般(ban)情況下素(su)片(pian)在包衣(yi)前(qian)硬(ying)度應下小於19.6N/cm~2,不(bu)需(xu)要(yao)包(bao)衣(yi)的素(su)片(pian)為(wei)防止其(qi)在包裝和運(yun)輸過程中(zhong)松(song)裂,硬(ying)度應不(bu)小於29.4N/cm~2.