Zvido zvehunyanzvi zvemabhodhoro epurasitiki ekushandiswa kwemushonga.Mabhodhoro epurasitiki emishonga anowanzo gadzirwa nePE, PP, PET uye zvimwe zvinhu, izvo zvisiri nyore kukuvara, kuita zvakanaka kuvhara, hunyoro-uchapupu, hutsanana, uye kusangana nezvinodiwa zvekurongedza zvinodhaka.Inogona kushandiswa zvakananga kurongedza zvinodhaka pasina kuchenesa kana kuomesa, uye yakanakisa mishonga yekurongedza midziyo.Inoshandiswa zvakanyanya pamuromo yakasimba mishonga (senge mahwendefa, capsules, granules, nezvimwewo) uye yemuromo zvinodhaka zvinodhaka (senge manyuchi, tincture yemvura, nezvimwewo) kurongedza, zvichienzaniswa nemamwe epurasitiki maburi ekurongedza mabhodhoro emishonga epurasitiki ane akawanda akakosha. nzvimbo.
Medical bhodhoro repurasitiki
1. Kuonekwa kwehutano hwemabhodhoro epurasitiki ezvokurapa: Oral yakasimba mabhodhoro ezvokurapa anowanzova machena.
Mabhodhoro emishonga yemvura yemuromo anowanzo kuve ebrown kana kujeka, uye anogona zvakare kugadzirwa zvinoenderana nezvinodiwa nevatengi kune mamwe mavara ezvigadzirwa, ruvara runofanira kunge rwakafanana, hapana mutsauko weruvara wakajeka, pamusoro panofanirwa kuve wakatsetseka, wakatsetseka, pasina deformation uye kukwenya, hapana trachoma. , mafuta, mabhuru emhepo, muromo webhodhoro unofanirwa kuve wakatsetseka.
2, kuzivikanwa (1) infrared spectrum: iyo infrared spectrum yezvinhu zvinoshandiswa muchigadzirwa inofanira kuenderana nemepu yekudzora.(2) Density: The density yemabhodhoro epurasitiki ekurapa ndeiyi: oral solid and liquid high-density polyethylene mabhodhoro anofanirwa kunge ari 0.935 ~ 0.965 (g/cm³) Oral solid and liquid polypropylene bottles should be 0.900 ~ 0.915 (g/cm³) Oral solid solid and liquid polypropylene bottles uye mabhodhoro epolyester emvura anofanira kunge ari 1.31 ~ 1.38 (g/cm³)
3, kuisa chisimbiso: vacuum kusvika 27KPa, chengetedza kwemaminitsi maviri, pasina mvura kana kuputira mubhodhoro.
4. Kurasikirwa kwehuremu hwemuromo wemishonga yemishonga mabhodhoro epurasitiki haifaniri kudarika 0.2% maererano nemamiriro ekuedzwa;iyo mhute yemvura permeability yemuromo yakasimba mishonga yepurasitiki mabhodhoro haifaniri kudarika 1000mg / 24h · L maererano nemamiriro ekuedzwa.
5. Kuputsika kunowira kunowira kwechisikigo kune horizontal rigid yakatsetseka pasi maererano nemamiriro ekuedzwa, uye haizoputsika.Muedzo uyu unongogumira kumabhodhoro epurasitiki emumuromo mvura yemishonga.
6. Shock test Uyu muedzo unongogumira kumuromo wakasimba mabhodhoro epurasitiki emishonga, ayo anofanirwa kuve akakodzera zvinoenderana nemamiriro ekuedzwa.
7, kupisa zvakasara zvinoenderana neyeyedzo nzira (Pharmacopoeia yePeople's Republic of China, 2000 edition, Appendix ⅷ N, Chikamu II) bvunzo, zvakasara hazvifanire kudarika 0.1% (bhodhoro rine masara ekupisa zuva haringapfuuri 3.0%).
8, acetaldehyde sekutsanangurwa kwegasi chromatography (Pharmacopoeia yePeople's Republic of China, 2000, Appendix VE), acetaldehyde haifanire kudarika zvikamu zviviri pamiriyoni, bvunzo iyi inogumira kumabhodhoro epurasitiki epolyester nekuda kwemishonga.
9. Dissolution test gadziriro ye dissolution test solution zvinoenderana nezvinodiwa zveyakajairwa, oral liquid pharmaceutical mabhodhoro epurasitiki ekujekesa mhinduro, zvinorema simbi, PH shanduko, UV absorption, nyore oxides, hapana inovhuvhuta bvunzo bvunzo, mhedzisiro inofanirwa kuzadzisa zvakajairwa zvinodiwa. ;Oral akasimba emishonga epurasitiki mabhodhoro anofanirwa kungoongororwa kune nyore oxides, inorema simbi uye isina kuvhurika, uye mhedzisiro yacho inofanirawo kusangana nezvinodiwa zveyero.
1O, decolorization test coloring bhodhoro inofanirwa kuyedzwa zvinoenderana neyakajairwa zvinodiwa, ruvara rwekunyudza mhinduro haizopendi pane isina chinhu mhinduro.
11, microbial muganho zvinoenderana neyakajairwa zvinodiwa uye microbial muganho nzira (Pharmacopoeia yePeople's Republic of China 2000 vhezheni ⅺ Appendix J1 kutsunga, yemuromo mvura yemushonga mabhodhoro epurasitiki ebhakitiriya, mold, mbiriso bhodhoro rega rega haringapfuuri zana, Escherichia coli Huwandu hwemabhakitiriya mumabhodhoro epurasitiki emushonga wakasimba wemukanwa haufanire kudarika 1000, nhamba yeforoma nembiriso haifaniri kudarika zana, uye nhamba yeEscherichia coli haizoonekwa.
12, huturu husina kujairika zvinoenderana nechiyero uye zvinoenderana nemutemo (Pharmacopoeia yePeople's Republic of China 2000 vhezheni II Appendix ⅺ C) bvunzo, inofanirwa kuenderana nezvinodiwa.Izvo zvinhu zviri pamusoro zvinoenderana neyakajairwa yemitemo yekuongorora, uye chivharo chebhodhoro chinofananidzira chinogona kusarudzwa zvinoenderana nezvinodiwa zvezvinhu zvakasiyana, zvichienderana nechiyero mukuyedzwa kwekuparara, abnormal chepfu nharaunda purojekiti bvunzo, uye inofanirwa kutevedzera zvakatemwa. pasi pezvakakodzera.Iyo purojekiti ichaedzwa uye ichaenderana nezvinodiwa pasi pechinhu chakakodzera.
Nguva yekutumira: Sep-19-2022