I roto i te whakamātautau me te whakaputa papatipu o ngā papa nifedipine tuku-pūmau, ngā papa ārai hapūtanga, ngā papa rongoā puku, ngā papa ferrous fumarate, ngā papa buflomedil hydrochloride, me ētahi atu, ka whakamahia e mātouhydroxypropyl methylcellulose (HPMC)Ko te wai, te wai Hydroxypropyl methylcellulose me te wai kapia polyacrylic, ko Opadry (nā Colorcon, UK) i whakarato), me ētahi atu, he wai paninga kiriata, kua angitu te whakamahi i te hangarau paninga kiriata, engari kua pāngia e ngā raruraru i roto i te whakamātautau whakaputa me te whakaputa. Whai muri i ētahi raruraru hangarau, kei te kōrero mātou ki ngā hoa mahi mō ngā raruraru me ngā otinga noa i roto i te tukanga paninga kiriata.
I ngā tau tata nei, kua whānuitia te whakamahinga o te hangarau paninga kiriata i roto i ngā whakaritenga totoka. Ka taea e te paninga kiriata te tiaki i te rongoā mai i te mārama, te makuku me te hau hei whakanui ake i te pumau o te rongoā; te huna i te reka kino o te rongoā me te whakahaere i te tūroro ki te tango; te whakahaere i te wāhi tuku me te tere tuku o te rongoā; te ārai i te huringa hototahi o te rongoā; te whakapai ake i te āhua o te papa. He painga anō hoki ōna, arā, he iti ake ngā tukanga, he poto ake te wā, he iti ake te whakapaunga pūngao, me te iti ake o te pikinga taumaha o te papa. Ko te kounga o ngā papa paninga kiriata e whakawhirinaki ana ki te hanganga me te kounga o te matua papa, te whakaritenga o te wai paninga, ngā tikanga whakahaere paninga, ngā tikanga takai me te rokiroki, me ētahi atu. Ko te hanganga me te kounga o te matua papa e whakaatahia ana i roto i ngā kai hohe o te matua papa, ngā momo excipients me te āhua, te pakeke, ngā wahi pakarukaru, me te āhua o te papa o te matua papa. Ko te hanganga o te wai paninga he maha ngā polymers ngota, ngā plasticizers, ngā tae, ngā whakarewa, me ētahi atu, ā, ko ngā tikanga whakahaere o te paninga ko te taurite hihiri o te rehu me te whakamaroke me ngā taputapu paninga.
1. Te pakaru o te taha kotahi, te pakaru o te taha kiriata me te tihore
Ko te pakeke o te mata o runga o te matua papa te mea iti rawa, ā, ka ngāwari te pāngia e te waku kaha me te ahotea i te wā e pania ana, ā, ka taka te paura, ngā matūriki rānei kotahi-taha, ka puta he tohu, he pore rānei i runga i te mata o te matua papa, he kakahu kotahi-taha, inā koa me te kiriata Tohu whakairo. Ko te wāhanga tino ngoikore o te kiriata i roto i te papa pania-kiriata ko ngā kokonga. Ina kore e ranea te piri, te kaha rānei o te kiriata, tera pea ka pakaru, ka tihore ngā taha o te kiriata. Nā te mea ka mimiti te kiriata nā te mimiti o te whakarewa, ā, ko te whānui nui o te kiriata paninga me te matua ka whakanui ake i te ahotea o roto o te kiriata, ka nui ake i te kaha kume o te kiriata paninga.
1.1 Te tātari i ngā take matua
Mō te matua maramara, ko te take matua he kore pai te kounga o te matua maramara, ā, he iti te pakeke me te pakarukaru. I te wā e pania ana, ka pāngia te matua papa e te waku kaha ina hurihia i roto i te paraharaha paninga, ā, he uaua ki te tu atu i taua kaha me te kore e ranea te pakeke, e pā ana ki te tikanga hanga me te whakarite o te matua papa. I te wā i tākaihia ai e mātou ngā papa nifedipine tuku-roa, nā te iti o te pakeke o te matua papa, ka puta te paura i te taha kotahi, ka puta he pore, ā, kāore i maeneene te kiriata papa pania-kiriata, ā, he āhua kino. Hei tāpiri, e pā ana hoki tēnei hapa paninga ki te momo papa. Mena he kore whakamarie te kiriata, inā koa he tohu kei te karauna o te kiriata, ka ngawari ake te mau o te taha kotahi.
I roto i te mahi paninga, ko te tere o te rehu puhoi rawa me te nui o te hau e tomo mai ana, te pāmahana nui rānei o te hau e tomo mai ana ka tere te maroke, ka puhoi te hanganga kiriata o ngā matua papa, ka roa te wā e noho puku ana ngā matua papa i roto i te paninga paninga, ā, ka roa te wā e mau ai. Tuarua, he nui te pēhanga atomization, he iti te matotoru o te wai paninga, ka kukū ngā pata i roto i te pokapū atomization, ā, ka memeha te whakarewa i muri i te horapa o ngā pata, ka hua ake he ahotea nui i roto; i te wa ano, ko te waku i waenga i ngā mata kotahi-taha ka whakanui ake i te ahotea o roto o te kiriata, ka tere ake te kiriata. Ka pakaru ngā taha.
Hei tāpiri, ki te tere rawa te tere hurihuri o te paninga paninga, ki te kore rānei e tika te whakatakotoranga o te parepare, ka nui te kaha waku i runga i te papa, ā, kāore e horapa pai te wai paninga, ā, ka puhoi te hanganga kiriata, ka puta ai te kakahu taha kotahi.
Mai i te wai paninga, ko te nuinga o te take he whiriwhiri i te polymer i roto i te hanganga me te iti o te matotoru (kukū) o te wai paninga, me te koretake o te piri i waenga i te kiriata paninga me te matua papa.
1.2 Otinga
Ko tētahi ko te whakarerekē i te tukanga whakahaunga, te tukanga whakaputa rānei o te papa hei whakapai ake i te pakeketanga o te matua o te papa. Ko te HPMC he rauemi paninga e whakamahia whānuitia ana. Ko te piri o ngā mea tāpiri papa e pā ana ki ngā rōpū hydroxyl i runga i ngā ngota tāpiri, ā, ka hangaia e ngā rōpū hydroxyl he hononga hauwai ki ngā rōpū e rite ana o te HPMC hei whakaputa i te piri nui ake; Ka ngoikore te piri, ā, ka wehe te taha kotahi me te kiriata paninga. He nui te maha o ngā rōpū hydroxyl i runga i te mekameka ngota o te cellulose microcrystalline, ā, he kaha piri teitei, ā, he kaha piri ngawari ngā papa i hangaia mai i te lactose me ētahi atu huka. Mā te whakamahi i ngā hinu whakahinuhinu, inā koa ngā hinu whakahinuhinu hydrophobic pērā i te waikawa stearic, te konupūmā stearate, me te glyceryl stearate, ka whakaiti i te hononga hauwai i waenga i te matua o te papa me te polymer i roto i te otinga paninga, ka heke te kaha piri, ā, i te pikinga o te hinu whakahinuhinu, ka ngoikore haere te kaha piri. I te nuinga o te wā, ko te nui ake o te hinu whakahinuhinu, ka ngoikore haere te piri. Hei tāpiritanga, i te kōwhiringa o te momo papa, me whakamahi te momo papa porowhita biconvex ki te whānuitanga e taea ana mō te paninga, ka taea ai te whakaiti i te putanga mai o ngā hapa paninga.
Ko te tuarua ko te whakarerekē i te whakaritenga o te wai paninga, te whakanui ake i te ihirangi totoka i roto i te wai paninga, te matotoru rānei o te wai paninga, me te whakapai ake i te kaha me te piri o te kiriata paninga, he tikanga māmā tēnei hei whakaoti rapanga. Ko te tikanga, ko te ihirangi totoka i roto i te pūnaha paninga wai he 12%, ā, ko te ihirangi totoka i roto i te pūnaha whakarewa waro he 5% ki te 8%.
Ka pā te rerekētanga o te matotoru o te wai paninga ki te tere me te nui o te urunga o te wai paninga ki roto i te pūtake papa. Mēnā he iti, he kore rānei he urunga, he tino iti te piri. E pā ana te matotoru o te wai paninga me ngā āhuatanga o te kiriata paninga ki te taumaha ngota toharite o te pūmua i roto i te hanganga. Ko te teitei ake o te taumaha ngota toharite, ko te nui ake o te pakeke o te kiriata paninga, ko te iti ake o te ngāwari me te ātete ki te kakahu. Hei tauira, he rerekē ngā taumata matotoru o te HPMC e wātea ana i te hokohoko hei whiriwhiri nā te rerekētanga o te taumaha ngota toharite. Haunga te awe o te pūmua, ko te tāpiri i ngā mea whakapūmau kirihou, te whakanui ake rānei i te ihirangi o te talc ka taea te whakaiti i te auau o te pakaru o te taha kiriata, engari ko te tāpiri i ngā tae waikura rino me te hauhā titanium ka taea hoki te pā ki te kaha o te kiriata paninga, nō reira me whakamahi i te iti rawa.
Tuatoru, i roto i te mahi paninga, me whakanui ake te tere o te rehu, inā koa i te tīmatanga o te paninga, me tere ake te tere o te rehu, kia poto ai te wā e kapi ai te matua papa ki te paparanga kiriata, e tiaki ana i te matua papa. Mā te whakanui ake i te tere rehu ka taea hoki te whakaiti i te pāmahana o te moenga, te tere mimiti me te pāmahana kiriata, te whakaiti i te ahotea o roto, me te whakaiti hoki i te auau o te pakaru kiriata. I taua wā anō, whakatikatikahia te tere hurihuri o te paninga paninga ki te āhua pai rawa atu, me te whakatakoto i te ārai kia tika hei whakaiti i te waku me te kakahu.
2. Te piri me te pupuhi
I roto i te tukanga paninga, ina nui ake te hononga o te atanga i waenga i ngā poro e rua i te kaha wehenga ngota, ka piri poto ētahi poro (maha ngā matūriki) kātahi ka wehe. Ina kore e pai te taurite i waenga i te rehu me te whakamaroke, he nui rawa te mākū o te kiriata, ka piri te kiriata ki te pakitara o te kohua, ka piri rānei tetahi ki tetahi, engari ka pakaru hoki te kiriata i te wāhi piri; i roto i te rehu, ina kāore anō kia tino maroke ngā pata, ka noho ngā pata kāore i pakaru ki roto i te kiriata paninga ā-rohe, ka puta he mirumiru iti, ka hanga he paparanga paninga mirumiru, kia puta ai he mirumiru ki te pepa paninga.
2.1 Te tātari i ngā take matua
Ko te whānuitanga me te auau o tēnei hapa paninga te take matua o ngā āhuatanga mahi paninga, te kore taurite i waenga i te rehu me te whakamaroke. He tere rawa te tere o te rehu, he nui rawa rānei te rahinga o te hau i whakakōkīhia. He puhoi rawa te tere whakamaroke nā te iti o te rahinga hau e tomo mai ana, te iti rānei o te pāmahana hau e tomo mai ana me te iti o te pāmahana o te moenga rau. Kāore te rau e whakamarokehia paparanga i te paparanga, ā, ka puta he piri, he mirumiru rānei. Hei tāpiri, nā te kore tika o te koki rehu, te tawhiti rānei, he iti te kōne i hangaia e te rehu, ā, ka kukū te wai paninga ki tētahi wāhi, ka hua ake he mākū ā-rohe, ka hua ake he piri. He puhoi te tere o te kohua paninga, he iti rawa te kaha o te nekehanga, ā, ka puta he piri i te kore e pai te takai kiriata.
Ko te matotoru o te wai paninga he nui rawa, ko tētahi o ngā take anō hoki. He nui te matotoru o te wai o ngā kākahu, he ngāwari ki te hanga i ngā pata kohu nui ake, he ngoikore tōna kaha ki te uru ki roto i te uho, he nui ake te whakakotahitanga me te piri taha kotahi, i te wa ano, he ngoikore te matotoru o te kiriata, he nui ake ngā mirumiru. Engari kāore tēnei e tino pā ki ngā piritanga rangitahi.
Hei tāpiritanga, ka puta hoki te āhua piri o te kiriata kāore i te tika. Mēnā kāore te kiriata papatahi i roto i te ipu paninga e pai te hurihuri, ka taupatupatu tetahi ki tetahi, ā, ka ngāwari te hanga kiriata paparua, paparua rānei. I roto i tā mātou whakamātautau whakaputa papa buflomedil hydrochloride, he maha ngā wahi taupatupatu i puta i roto i te ipu paninga nati wai noa nā te mea he papatahi te paninga.
2.2 Ngā Otinga
Ko te tikanga matua he whakarerekē i te tere o te rehu me te whakamaroke kia taurite ai te hihiri. Whakaitihia te tere o te rehu, whakanuia te rahinga o te hau e tomo mai ana me te pāmahana o te hau, whakanuia te pāmahana o te moenga me te tere whakamaroke. Whakanuia te horahanga kapi o te rehu, whakaitihia te rahi toharite o ngā pata rehu, whakarerekētia rānei te tawhiti i waenga i te pū rehu me te moenga rau, kia iti ake ai te auau o te piripono i te whakarerekētanga o te tawhiti i waenga i te pū rehu me te moenga rau.
Whakatikatikahia te whakaritenga o te otinga paninga, whakanuia te ihirangi totoka i roto i te otinga paninga, whakaitihia te nui o te whakarewa, whakanuia rānei te kukū o te etanoru i roto i te whānuitanga matotoru; Ka taea hoki te tāpiri i ngā mea ārai-piripiri, pērā i te paura talcum, te konupūmā stearate, te paura silica gel, te peptide waikura rānei. Ka taea te whakapai ake i te tere o te ipu paninga, te whakanui ake i te kaha centrifugal o te moenga.
Kōwhiria te paninga rau e tika ana. Heoi, mō ngā rau papatahi, pērā i ngā papa buflomedil hydrochloride, i oti pai te paninga i muri mai mā te whakamahi i tētahi paninga paninga whai hua, mā te tāuta rānei i tētahi ārai ki roto i te paninga paninga noa hei whakatairanga i te hurihuri o te rau.
3. Kiri taratara, kiri miro kotahi te taha
I te tukanga paninga, nā te mea kāore i te horapa pai te wai paninga, kāore te pūhui maroke e marara, ka puta he whakatakotoranga koretake, he piri rānei ki te mata o te kiriata, ka hua ake he tae kino, he mata koretake hoki. Ko te kiri miro he momo mata taratara, he nui rawa te taratara o te whakaaturanga tirohanga.
3.1 Te tātari i ngā take matua
Ko te tuatahi e pā ana ki te matua maramara. Ka nui ake te taratara o te mata tuatahi o te matua, ka nui ake te taratara o te mata o te hua kua pania.
Tuarua, he hononga nui tōna ki te whakaritenga o te otinga paninga. E whakaponohia whānuitia ana ko te taumaha ngota, te kukū me ngā tāpiringa o te polymer i roto i te otinga paninga e pā ana ki te taratara o te mata o te paninga kiriata. Ka mahi rātou mā te pā ki te matotoru o te otinga paninga, ā, he tata rite te taratara o te paninga kiriata ki te matotoru o te otinga paninga, ka piki haere me te pikinga o te matotoru. Ki te nui rawa te matū totoka i roto i te otinga paninga, ka ngāwari te whakararu i te taha kotahi.
Hei whakamutunga, e pā ana ki te mahi paninga. He iti rawa, he teitei rawa rānei te tere o te atomization (kāore i te pai te pānga atomization), kāore e ranea hei hora i ngā pata kohu, hei hanga i te kiri miro taha kotahi. Ā, he nui rawa te hau maroke (he nui rawa te hau putanga) he teitei rawa rānei te pāmahana, he tere te mimiti, inā koa he nui rawa te rere o te hau, ka puta he au hurihuri, ā, kāore hoki e pai te horapa o te pata.
3.2 Ngā Otinga
Ko te tuatahi ko te whakapai ake i te kounga o te matua. I runga i te kaupapa o te whakarite i te kounga o te matua, whakatikatikahia te whakaritenga o te otinga paninga me te whakaiti i te matotoru (te kukū) te ihirangi totoka rānei o te otinga paninga. Ka taea te whiriwhiri i te otinga paninga waipiro-rewa, waipiro-2-wai rānei. Kātahi ka whakatikatikahia ngā āhuatanga mahi, whakapai ake i te tere o te ipu paninga, kia ōrite te hurihanga o te kiriata, kia nui ake te waku, kia tere ake te horapa o te wai paninga. Mena he teitei te pāmahana o te moenga, whakaitihia te rahinga hau whakauru me te pāmahana hau whakauru. Mena he take rehu, me whakanui ake te pēhanga atomization hei tere ake i te tere rehu, me whakapai ake te taumata atomization me te rahinga rehu kia horapa kaha ai ngā pata kohu ki runga i te mata o te pepa, kia hanga ai he pata kohu he iti ake te diameter toharite me te aukati i te putanga mai o ngā pata kohu nui, inā koa mō te wai paninga he nui te matotoru. Ka taea hoki te whakarite i te tawhiti i waenga i te pū rehu me te moenga pepa. Ka tīpakohia te pū rehu he iti te diameter o te pū (015 mm ~ 1.2 mm) me te tere rere teitei o te hau atomizing. Ka whakarerekētia te āhua o te rehu ki te whānuitanga o te rere o te kohu o te kōne papatahi, kia marara ai ngā pata ki tētahi wāhi pokapū nui ake.
4. Tāutuhia te piriti
4.1 Te tātari i ngā take matua
Ka puta tēnei ina tohua te mata o te kiriata, ina tohua rānei. Nā te mea he tika ngā tawhā miihini o te kiriuhi kakahu, pērā i te tauwehenga ngāwari teitei, te kaha ngoikore o te kiriata, te piri ngoikore, me ētahi atu, i te wā e whakamaroke ana i te kiriuhi kakahu ka puta he kukume nui, ka puta te tānga o te mata o te kiriuhi kakahu, ka hoki te kiriuhi me te piri, ka ngaro te kohao taha kotahi, ka kore rānei e mārama te tohu, ko te take o tēnei āhuatanga kei roto i te wai paninga.
4.2 Otinga
Whakatikatikahia te whakaritenga o te otinga paninga. Whakamahia ngā polymer taumaha ngota iti, ngā rauemi hanga kiriata piri nui rānei; Whakanuia te nui o te whakarewa, whakaitihia te matotoru o te otinga paninga; Whakanuia te nui o te plasticizer, whakaitihia te ahotea o roto. He rerekē te pānga plasticizer, he pai ake te polyethylene glycol 200 i te propylene glycol, te glycerin. Ka taea hoki te whakaiti i te tere o te rehu. Whakanuia te pāmahana urunga hau, whakanuia te pāmahana o te moenga rau, kia kaha ai te paninga kua hangaia, engari kia kore ai e pakaru te taha. Hei tāpiri, i te hoahoa o te mate kua tohua, me aro tātou ki te whānui o te koki tapahi me ētahi atu pūwāhi angiangi, kia taea ai te ārai i te puta o te āhuatanga piriti.
5. Te tae o te kiriuhi kākahu
5.1 Te tātari i ngā take matua
I roto i te maha o ngā otinga paninga, he tae, he tae rānei e iri ana i roto i te otinga paninga, ā, nā te kore e tika te mahi paninga, kāore te tae e ōrite, ā, ka puta he rerekētanga tae i waenga i ngā poro, i ngā wāhanga rerekē rānei o ngā poro. Ko te take matua he puhoi rawa te tere o te ipu paninga, he ngoikore rānei te pai o te whakaranu, ā, kāore e taea te whakatutuki i te pānga paninga ōrite i waenga i ngā wahi i te wā paninga noa; He nui rawa te kukū o te tae, te tae rānei i roto i te wai paninga tae, he nui rawa rānei te ihirangi totoka, he tere rawa rānei te tere rehu o te wai paninga, he teitei rawa te pāmahana o te moenga, ā, kāore e taea te huri i te wai paninga tae i te wā tika; Tērā pea ka puta te piri o te kiriata; Kāore e tika te āhua o te wahi, pērā i te wahi roa, te wahi āhua kāpū, nā te hurihanga hei wahi porowhita, ka rerekē hoki te tae.
5.2 Otinga
Whakanuia te tere o te paninga paninga, te maha rānei o ngā ārai, whakatikatikahia ki te āhua tika, kia ōrite te hurihuri o te rau i roto i te paninga. Whakaitihia te tere o te rehu wai paninga, whakaitihia te pāmahana o te moenga. I roto i te hoahoa whakaritenga o te otinga paninga tae, me whakaiti te horopeta, te ihirangi totoka rānei o te tae, ā, me whiriwhiri te tae he uhi pakari. Me ngawari te tae, te tae rānei, ā, me iti ngā matūriki. He pai ake ngā tae kore-wai i ngā tae wairewa, kāore ngā tae kore-wai e rere ki te wai me te ngāwari pērā i ngā tae wairewa, ā, i roto i te atarangi, te pumau me te whakaiti i te mamaoa wai, he pai ake te waikura i te urunga o te kiriata i ngā tae wairewa. Kōwhiria hoki te momo wahi tika. I roto i te tukanga paninga kiriata, he maha ngā raruraru, engari ahakoa te momo raruraru, he maha ngā āhuatanga, ka taea te whakatau mā te whakapai ake i te kounga o te matua, te whakarerekē i te whakaritenga me te mahi paninga, kia tutuki ai te tono ngāwari me te mahi whakawhitiwhiti. I te matatau ki te hangarau paninga, te whanaketanga me te whakamahinga o ngā mīhini paninga hou me ngā rauemi paninga kiriata, ka tino pai ake te hangarau paninga, ā, ka tere te whanaketanga o te paninga kiriata i roto i te hanga o ngā whakaritenga totoka.
Wā tuku: Paenga-whāwhā-25-2024