Kev Npaj Technology Rau Wenyang Tongbian Granules 2
Sep 20, 2024
Tab 3 Variance analysis of the orthogonal test
| Qhov chaw ntawm Variation | SS | f | S | F | P |
|---|---|---|---|---|---|
| A | 55.86 | 2 | 27.93 | 1.29 | > 0.05 |
| B | 193.94 | 2 | 96.97 | 4.49 | > 0.05 |
| C | 43.18 | 2 | 21.59 | 1.00 | > 0.05 |
| D | 1361.61 | 2 | 680.80 | 31.53 | < 0.05 |
| yuam kev | 21.59 |
Nco tseg:F0.05(2,2)=19.00,F0.01(2,2)=99.00.
2.2.2 Kev sim ua pov thawj
Ntsuas 3 feem ntawm cov khoom siv tshuaj kho mob thiab muab rho tawm raws li cov txheej txheem zoo. Cov txiaj ntsig tau pom tias cov ntsiab lus echinacoside yog 3.0397, 2.6835, thiab 3.7308 mg·g-1 feem; 46.56%, 48.53%, thiab 47.39% feem. Cov txiaj ntsig tau pom tias cov txheej txheem dej rho tawm tau xaiv los ntawm txoj kev sim no yog qhov ruaj khov thiab muaj qhov rov ua tau zoo.
HERBAL CISTANCHE RAU
2.3 Kev npaj molding txheej txheem tshawb fawb
2.3.1 Kev tshuaj xyuas ntawm cov khoom siv ntxiv
Dextrin, pob kws hmoov txhuv nplej siab, microcrystalline cellulose, sucrose thiab lactose raug xaiv los ua cov khoom ntxiv rau kev sim ua ntej. Lawv tau tov nrog cov hmoov qhuav qhuav ntawm qhov sib piv ntawm 1: 1, thiab tom qab ntawd 80% ethanol tau ntxiv los npaj cov khoom muag. Cov ntaub ntawv raug nyem los ntawm No. 2 sieve, qhuav ntawm 60 degree, thiab granulated los ntawm No. 1 thiab No. 5 sieves. Cov granules qhuav tau muab tso rau hauv qab ntawm lub raj mis uas muaj qhov hnyav tas li, raug hnyav, thiab muab tso rau hauv lub tshuab ziab khaub ncaws nrog cov tshuaj supersaturated NaCl. Cov granules tau muab tso rau ntawm qhov kub tsis tu ncua ntawm 25 degree thiab hnyav ntawm 6, 12, 24, 36, 48 thiab 60 h, feem. Tus nqi nqus noo noo tau xam [moisture absorption feem pua (%)=(qhov hnyav ntawm granules tom qab nqus dej noo - qhov hnyav ntawm granules ua ntej nqus dej) / hnyav ntawm granules ua ntej noo noo nqus × 100%), thiab kev hloov ntawm cov dej noo. Kev nqus feem pua tau pom. Cov txiaj ntsig tau qhia hauv Table 4.. Xav txog tus nqi, txheej txheem thiab lwm yam ua tiav, dextrin tau raug xaiv thaum kawg ua tus excipient rau kev npaj molding.
Tab 4 Cov nyhuv ntawm cov khoom sib txawv ntawm qhov nqus dej noo ntawm graules (%)
| Ntxiv | 6 | 12 | 24 | 36 | 48 | 60 |
|---|---|---|---|---|---|---|
| Agar | 2.29 | 3.81 | 5.60 | 6.93 | 7.94 | 8.83 |
| Pob kws Starch | 3.42 | 5.25 | 7.28 | 8.25 | 9.59 | 10.03 |
| Microcrystalline Cellulose | 2.39 | 4.11 | 6.03 | 7.22 | 8.46 | 9.08 |
| Glucose | 2.04 | 3.00 | 4.50 | 5.32 | 6.07 | 6.79 |
| Lactose | 1.75 | 2.81 | 4.18 | 5.07 | 5.77 | 6.30 |
2.3.2 Kev tshuaj xyuas ntawm tus neeg sawv cev ntub dej
Cov hmoov qhuav qhuav tau tov nrog qee qhov nyiaj ntawm dextrin (1: 1), thiab sib txawv ntawm ethanol (70%, 75%, 80%, 85%, 90%) tau siv los npaj cov khoom muag, uas tau nyem los ntawm No. 2 sieve, qhuav ntawm 60 degree, thiab granulated los ntawm ib tug No. 1 sieve thiab ib tug No. 5 sieve. Qhov nyuaj granulation, granule zog thiab granule yield tau siv raws li kev ntsuas ntsuas los xaiv qhov tsim nyog ethanol concentration [11]. Cov txiaj ntsig tau qhia hauv Table 5. Thaum 85% ethanol tau siv rau granulation, granule yield yog qhov siab tshaj plaws thiab granulation yog qhov yooj yim tshaj plaws, yog li 85% ethanol thaum kawg xaiv los ua tus neeg sawv cev ntub dej.
Tab 5 Cov nyhuv ntawm cov nplaum nrog sib txawv ethanol ntawm granules
| Ethanol concentration /% | Granulation nyuaj | Granule yam ntxwv | Granule Yield /% |
|---|---|---|---|
| 70 | Loj viscosity, nyuaj rau sieve | Tsis sib xws granules, clumping | 92.39 |
| 75 | Viscous, tsis yooj yim rau sieve | Granules daim ntawv, me ntsis clumped | 90.01 |
| 80 | Nruab nrab viscosity, yooj yim rau sieve | Granules tsim, me ntsis clumped | 93.87 |
| 85 | Nruab nrab viscosity, me ntsis nyuaj rau sieve | Txawm granules, me ntsis xoob | 95.63 |
| 90 | Qhov sib txawv me ntsis viscosity, yooj yim rau sieve | Granules tawg yooj yim, hmoov zoo dua | 90.96 |
Tab 6 Cov nyhuv ntawm qhov sib txawv ntawm dextrin ntawm granules
| Binder ratio: Agar | Granulation nyuaj | Granule yam ntxwv | Granule Yield /% |
|---|---|---|---|
| 1:0.7 | Loj viscosity, nyuaj rau sieve | Loj granules, yooj yim tawg | 67.98 |
| 1:0.8 | Loj viscosity, nyuaj rau sieve | Loj granules, me ntsis clumped | 90.59 |
| 1:0.9 | Nruab nrab viscosity, me ntsis nyuaj rau sieve | Txawm granules, me ntsis xoob | 93.38 |
| 1:1.0 | Nruab nrab viscosity, yooj yim rau sieve | Txawm granules, me ntsis xoob | 91.06 |
| 1:1.1 | Qhov sib txawv me ntsis viscosity, yooj yim rau sieve | Cov granules xoob, tsis zoo tsim | 86.22 |
| 1:1.2 | Qhov sib txawv me ntsis viscosity, yooj yim rau sieve | Cov granules xoob, tsis zoo tsim | 82.15 |
2.3.3 Qhov sib piv ntawm qhuav muab tshuaj txhuam thiab excipients
Cov kev faib ua feem sib txawv ntawm excipients raug xaiv rau kev soj ntsuam. Cov hmoov qhuav qhuav tau tov nrog ib qho nyiaj ntawm dextrin, granulated nrog 85%
ethanol, thiab qhuav ntawm 6 0 degree . Qhov nyuaj ntawm granulation thiab cov txiaj ntsig ntawm granules tau siv los ua qhov ntsuas ntsuas. Ib txoj hauv kev tau siv los ua kom zoo dua qhov tsim nyog ntawm dextrin. Cov txiaj ntsig tau pom nyob rau hauv Table 6. Thaum qhov piv ntawm qhuav muab tshuaj txhuam rau excipients yog 1:0.9, granulation yog qhov yooj yim tshaj plaws thiab granule tawm los yog siab tshaj.
2.3.4 Granule Verification Test
Peb cov khoom ntawm Wenyang Tongbian granules tau npaj raws li cov txheej txheem zoo. Raws li cov kev cai ntawm cov txheej txheem kev npaj nyob rau hauv cov khoom muaj feem ntawm 2020 tsab ntawm "Suav Pharmacopoeia", qhov tsos, noo noo, solubility, thiab echinacoside cov ntsiab lus ntawm cov granules raug soj ntsuam thiab ntsuas. Cov txiaj ntsig tau pom tias qhov loj me thiab qhov loj me ntawm peb pawg ntawm Wenyang Tongbian granules tau zoo ib yam, cov tsos yog xim daj-xim av, tsis hnov tsw tsw me ntsis, thiab cov dej noo thiab solubility yog nyob rau hauv txoj kab nrog cov kev cai ntawm cov tshuaj pharmacopoeia. Cov txiaj ntsig tau pom nyob rau hauv Table 7. Nws qhia tau hais tias cov txheej txheem kev npaj ntawm Wenyang Tongbian Granules ruaj khov, tswj tau, tsim nyog thiab ua tau.
3 Kev sib tham
3.1 Xaiv cov khoom ntsuas ntsuas
Cov ntsiab lus qhia txog kev txiav txim siab ntawm Cistanche deserticola hauv 2020 tsab ntawm Suav Pharmacopoeia yog tag nrho cov ntsiab lus ntawm echinacoside thiab verbascoside. Txawm li cas los xij, hauv qhov kev sim tshwj xeeb ntawm kev txiav txim siab cov ntsiab lus hauv qhov kev sim no, nws tau pom tias chromatographic ncov ntawm verbascoside hauv Wenyang Tongbian Granules tsawg heev thiab muaj kev cuam tshuam tsis zoo. Cov ntsiab lus ntawm echinacoside thiab verbascoside hauv ntau tshaj kaum pawg ntawm Cistanche deserticola hlais tau txiav txim siab. Cov txiaj ntsig tau pom tias cov ntsiab lus ntawm verbascoside nyob rau hauv txhua pawg ntawm Cistanche deserticola slices yog qis dua li ntawm echinacoside, tab sis tag nrho cov ntsiab lus ntawm ob qho tib si nyob rau hauv txoj kab nrog cov tshuaj pharmacopoeia yuav tsum tau ntau tshaj 0.3%. Echinacoside yog lub ntsiab active ingredient ntawm Cistanche deserticola, uas muaj antioxidant, anti-inflammatory, mucosal kho thiab immunomodulatory kev ua ub no [3]. Muaj cov ntaub ntawv tshaj tawm: Kev tswj hwm intragastric ncaj qha ntawm echinacoside rau cem quav qauv nas muaj cov nyhuv laxative, thiab nws cov txheej txheem yuav cuam tshuam txog kev txo cov plab hnyuv oxidative kev nyuaj siab thiab inflammatory teb, txhim kho plab hnyuv neurotransmitter abnormalities thiab nce AQP3 qhia nyob rau hauv cov hnyuv [{{6} }]. Yog li ntawd, tom qab kev txiav txim siab dav dav, qhov kev sim no thaum kawg xaiv tsuas yog echinacoside ua qhov taw qhia rau kev txiav txim siab cov ntsiab lus.
3.2 Xaiv cov excipients
Dextrin, pob kws starch, lactose, sucrose, thiab lwm yam yog feem ntau siv excipients rau granules. Vim tias lactose kim heev thiab rau cov neeg mob lactose-tsis tolerant, noj cov granules npaj nrog cov tshuaj no yuav ua rau raws plab, ntuav, mob thiab mob thiab lwm yam kev phiv tshwm sim. Sucrose yog hygroscopic thiab muaj noo noo nqus thaum lub sij hawm granulation txheej txheem, uas ua rau granulation nyuaj. Nws kuj yog ib qho yooj yim kom nqus dej noo thiab muag muag thaum lub sijhawm khaws tshuaj, cuam tshuam rau cov tshuaj stability. Tsis tas li ntawd, kev noj sucrose ntau dhau tuaj yeem ua rau lossis ua rau muaj kab mob xws li ntshav qab zib, rog rog, thiab cov hniav caries.
Microcrystalline cellulose yog kim thiab muaj hygroscopicity ntau dua li dextrin. Pob kws hmoov txhuv nplej siab muaj qhov siab tshaj plaws hygroscopicity, yog li cov txheej txheem no thaum kawg xaiv dextrin ua tus excipient rau granulation. Cov kev tshawb fawb tau pom tias granulation yog qhov yooj yim tshaj thaum cov tshuaj-excipient piv yog 1:0.9, cov granules yog ntau uniform, lub operability yog muaj zog, thiab cov granule yield yog siab tshaj.
Cov ntaub ntawv
[1] Xiao Wenjie, Lin Aizhen. Lin Aizhen qhov kev paub txog kev kho mob cem quav hauv cov neeg laus nrog txoj kev ua kom sov Yang [J]. Phau ntawv Journal of Integrated Traditional Chinese and Western Medicine, 2019, 11 (1): 43-44.
[2] Guo Yuanheng. Kev siv cov suab puam Cistanche deserticola cov peev txheej [D]. Beijing: University of Chinese Academy of Sciences (Institute of Process Engineering, Suav Academy of Sciences), 2017: 3.
[3] Liu Xinhong, Zheng Anmin. Kev tshawb fawb soj ntsuam ntawm 31 tus neeg mob cem quav kho nrog Cistanche deserticola decoction [J]. Tus Kws Kho Mob Hauv Zej Zog Suav, 2020, 36 (4): 126-127.
[4] Chen Xu, Liu Xu, Ma Ninghui, et al. Kev tshawb fawb tau nce qib ntawm cov tshuaj muaj pes tsawg leeg, cov tshuaj pharmacological thiab kev siv cinnamon [J]. Suav Pharmacy, 2018, 29 (18): 2581-2584.
[5] Zhang Xu, Liu H., Li X., et al. Chemical Chemical Chemical Chemical Effects of Astragalus thiab Q-marker prediction analysis [J]. Suav Journal of New Drugs, 2023, 32 (4): 410-419.
[6] Han KH, Park JM, Jeong M, et al. Heme oxygenase -1 induction thiab anti-inflammatory kev ua ntawm atractylodes macrocephala thiab taraxacum herba extracts tiv thaiv colitis thiab ua tau zoo dua sulfasalazine hauv kev tiv thaiv relapse [J]. Lub plab thiab lub siab, 2017, 11 (5): 655-666.
[7] Pei Xiangping, Liang Huizhen, Jin Beibei, et al. Optimization ntawm extraction thiab molding txheej txheem ntawm txiv neej Yangrong Granules los ntawm orthogonal sim txoj kev [J]. Northwest Journal of Pharmacy, 2020, 35 (2): 183-186.
[8] Li Guoyu, Liang Haodu, Guan Tong, et al. Kawm txog kev npaj ntawm Gushen Zhiyi Shuangzi Granules [J]. Zhongnan Pharmacy, 2023, 21(3): 700-705.
[9] Suav Pharmocopoeia 2020 Tsab. Volume 1 [S]. Xyoo 2020: 257.
[10] Wang Jingxia, Chen Lin. Kawm txog cov txheej txheem rho tawm ntawm cov menyuam yaus Qingre suppository optimized los ntawm ntau qhov ntsuas kev ntsuas kev sib tw [J]. Suav Journal of Traditional Chinese Medicine, 2014, 32(10): 2396-2399.
