N g h i e n
CLPU- Ky t h u a t
Qui trinh san xuat, dac diem cua tra tan nhan kim trong dieu tri ho tro* benh soi mat
o • • • •
Dat van de
Tra tan nhin kim do Viin Y hpc Cd truyen quin dpi nghien ciru trin ea sd 8 vj thude hay gap trong cic bii thude cd phuang chua cic benh gan mat '^' ^' ^' ^'' nhim muc dich hd trp trong viec chira benh sdi mat. Diy l i mpt cich gdp phin hien dai hoa thude Y hpc ed truyin, vira tien sir dung vira d i bao quan, m i van giir ban sie din tdc.
Be dam bao chit lupng thude, dat hieu qua cao, lai an toin trong qui trinh sir dung, chimg tdi nghien eiru quy trinh sin xuit v i cie die diem eua ehi phim chi nhin kim.
Chat lieu doi tu'p'ng va Phu'O'ng phap Chit lieu nghien cii'u:
Bai thude nghiin ciru: Nhin Kim l i 2 vj quan.
Nhin: Nhin trin, Kim: Kim tiin thao.
- Cdng thirc dieu che 5g thanh pham:
(Cdng thirc thude sdng)
Nhan trin: 8,00g; kim tien thao: 8,00g; dai hoing: 1,30g; hoing cim: 4,70g; nghe; 4,70g;
chi xic: 4,70g; mpc huang: 1,20g; cam thao:
3,20g; lactose; 0,80g
- Nguyen lieu: Cie nguyen lieu nhin trin (Herba Adenosmatis caerulei), kim tiin thao (Herba Desmodii styraclfolli), dai hoing (Rhizoma Rhei), hoing cam (Radix Scutellariae), nghe (Rhizoma Curcumae longae), chi xic (Fructus Aurantii), mdc huang (Radix Saussureae lappae), cam thao (Radix Glycyntiizae): dat DDVNIII; riing lactose: Oat BP 98.
Phirang phap nghien cii'u
Quy trinh san xuat: Khoa dupe Vien Y hpc cd truyin Quin dpi: L i phuang phip san xuit niu chiet dupe lieu bing dung mdi nu'de, thu dich ehiit, ed die, tich nude, xu ly tao hat, ddng gdi.
- Quy trinh ehi biin: Cae dupe lieu dupe che biin dat tieu chuin thude chin (hit tap chit, dp i m dudi 13%, miu sic, miii vj dung quy djnh) '''•'.
- Quy trinh san xuit cao khd: Niu dupe lieu da ehi biin vdi nude 3 lan, thdi gian sdi lan lupt
TAP CHi DUQC HQC - 7/2009 (SO 399 NAM 49)
Vu Thi Khanh Van Vien Y hgc Co truyen Qudn dgi l i 3 gid, 2 gid, 1,5 gid. Lupng nude niu mdi lin gip 10 din 8 lin lupng dupe lieu. T i p trung dich chiit, Ipc qua vai gac, ed djch ehiit thinh cao die. Siy cao tir 50 - 60°C trong 20 gid den khd.
Xay cao thinh bdt min, trdn vdi lactose, dting cdn 90° xit hat, siy khd. Chia liiu, ddng gdi:
Diing may ddng tiii tu dpng, mdi till nhdm 5g.
Ddng gdi hop x 30 tui nhdm.
Tieu chuan co so: Trung tim kiem nghiem v i nghien eiru Dupe - Bp Y t i (BYT).
. - Tinh chit (bing cam quan).
-Dp hoi tan (thir theo DDVN III, phu luc 1.7 (thude cdm)'''''.
- Dp khdng ddng d i u khdi lupng (thir theo DDVN III, phu luc 8.3 phep thir dp ddng diu khdi lupng, phuang phip 4).
- Dp i m (thir theo DDVN III, phu iiic 5.16 lupng miu thir 1 gam, siy d i p suit thudng, nhiet dp 85 °C trong 5 gid).
- Gidi han nhiim khuin, tdng sd nim mdc, nim men (Tiin hinh thu theo DDVN III - phu luc 10.7 (thir gidi han nhiem khuan).
Djnh tinh nhan tran, kim tien thao:
Nhan trin;
+ Dung djch miu thir: Liy lupng c h i phim tuang duang vdi 5 gam nhin trin, them 30ml ethanol tuyet ddi, dun sdi nhe tren cich thuy trong 20 phiit, lie trong 15 phut; Ipc liy djch chiit ethanol, ed tren cich thuy den can. Hoi tan cin trong 1ml ethanol tuyet ddi, dupe dung djch miu thir.
+ Dung dich miu ddi chiiu: Liy 50 gam bdt nhin trin, them 50ml nude, dun sdi trong 30 phiit (bd sung nude trong qua trinh dun), Ipc liy djch chiet nude. Lim thim mdt lin nira nhu tren vdi b i cdn lai. Gop eie djch ehiit nude, cd can.
Them vio c i n 20ml ethanol tuyet ddi, dun sdi nhe trin each thuy 15 phiit, Ipc. Cd dich Ipe trin cich thuy din can. Hoi tan cin trong 1ml ethanol tuyet ddi dupe dung dich miu ddi chieu.
+ Cich thir: Trin ban mdng silicagel 6OF254 d i hoat h o i 110°C trong Igid, chim 10^1 dung
11
Nghien
CLPU- Ky thuat
djch miu thu- v i lOjii dung djch m i u ddi chieu tai hai diem riing re. Khai trien s i c ky vdi h i dung mdi: benzen- ethyl acetat (9.1). Sau khi trien khai dupe khoang 15-17cm, liy ban mdng ra, de khd nhiet dp phdng, soi dudi d i n UV d budc sdng 254nm.
+ Kit qua; Mau thii' phai eho eie vet ed mau s i c v i Rf tuang duang vdi eic vet eua dung djch miu ddi chieu.
Kim tiin thdo:
+ Dung djch m i u thCr; lay lupng e h i phim tuang duang vdi 8 gam kim tien thao, thim 50ml ethanol 70% v i 1ml acid hydrocloric 10%, lie ky trong 10 phiit, Ipe tren cich thuy d i n can.
Cin dupe ehiit bing ethyl acetat 2 lin, mdi lin 15ml. Gdp c i c djch chiet ethyl acetat, ed den can tren cich thuy. H o i tan ein trong 1ml eloroform dupe dung djch m i u thu.
+ Dung djch mau ddi chiiu; Liy 8g bdt kim tiin thao, thim 50ml nude, dun sdi trong 30 phiit (bd sung nude trong q u i trinh dun) Ipe liy djch chiit nude. Lim them mpt lin nua nhu tren vdi b i cdn lai. Gdp c i c djch ehiit nude, cd can. Hoi c i n trong 50ml ethanol 70% v i 1ml acid hydrocloric 10%, lie ky trong 10 phut, Ipe.
Cd dich Ipe trin cich thuy d i n can. Cin dupe ehiit bing ethyl acetat 2 lan, mdi lan 15ml. Gdp cie djch ehiit ethyl acetat, cd tren each thuy d i n can. Hoi tan c i n trong 1ml chloroform dupe dung dich miu ddi chiiu.
+ Cich thir: Tren ban mdng silicagel 6OF254 d i hoat hoa 110°C trong Igid, chim 30|il dung dich m i u thir v i 30|xl dung dich m i u ddi chiiu tai hai diim riing re. Khai triin s i c ky vdi he dung mdi: Chloroform - acid acetie(9:1). Sau khi trien khai dupe khoang 15-17em, lay ban mdng ra, de khd d nhiet dp phdng, soi dudi d i n UV d birac sdng 254nm.
+ K i t qua: M i u thir phai eho c i e vet ed mau sie v i Rf tuang duang vdi dung djch m i u ddi chiiu.
Theo doi dp on djnh:
- Thinh pham 3 m i u t r i tan Nhin kim sd 1 (san xuit ngiy 16/01/2000), sd 2 (san xuit ngiy 12/ 02/2000), sd 3 (san xuit ngiy 01/03/2000).
- Kiem tra thude sau 6, 12, 18, 21, 24 v i 30 thing, theo tiiu chuan ca sd, trong nhiet dp phdng tir 15 - 30 °C, khd rio, dp i m dudi 90%.
Ket qua
Qui trinh san xuit:
Thanh phim la bpt cim v&i lactose, tdng dp ching dinh, tao hat nho diu, gap nu&c hoa tan nhanh, dbng tui theo liiu mpt lin uing, chinh xdc,di si> dung. Dang dong goi tui nhPm hien dai, kdo ddi han sir dung ciia thanh phdm, d§
bdo quan, thanh phdm dbng gdi trong hpp in nhdn dep, dung quy chi.
Dac diim thanh phim:
Dang thuoc:
- Cao khd t i n thinh b i t m i u n i u den, miii tham dupe lieu, ddng trong tui nhdm ed din nhin, 5 gam/gdi, 30 gdi/ hop eari:on in nhin r6 ring dimg quy c h i , bao quan nai khd mit, tranh i n h sing.
- Cdng dung: Lpi mat, chdng viim. Dieu tri viim gan mat man, sol biin mat.
- Cich diing: Ngiy udng 3 l i n , mdi lin 1 gdi, hoi tan vdi 100ml nude ndng.
- Chdng chT djnh: Khong diing cho phu nir c6 thai, BN dang bj tieu chay.
Tieu chuin ca sd cua thude:
Chit luang thanh phim:
- Tinh chit: Dang hat cdm m i u n i u den, mill tham hie, vi ngpt ding.
- Dp h o i tan: Tan hoin t o i n trong nude, khdng de lai tap chat ca hpe.
- Dp khdng ddng deu khdi luang; 5 g ± 5 % - Dp am; Khdng q u i 5%
- Gidi han nhiem khuan: Tdng sd vi khuan hiiu khi: Khdng q u i 10.000/g
Tdng sd n i m mdc, n i m men: Khdng quei 100/g. Khdng dupe cd: Staphylococcus aureus, Pseudomonas aeruginosa. Salmonella vd Escherichia coli.
Quy trinh san xuat thude dat dupe y i u ciu de ra eua d i t i i l i dn dinh edng nghe bio che.
Thinh pham l i dang bpt cdm khd tao hat vdi lactose, tang dp chdng dinh khd chay nhio, dl bao quan, tao dieu kien cho cai tien dang ddng gdi till nhdm hien dai han, theo lieu mdt lan udng, chinh xic, hat nho gap nude hoi tan nhanh, d i sir dung, keo d i i ban sir dung. Thuoc cd chit lupng cao, tien dung, dung quy ehi, nhung v i n giii' dupe ban s i c cua thude YHCT, cd tinh dn djnh khi san xuit.
12 TAP CHI DUQC HQC - 7/2009 (SO 399 NAM 49)
N g h i e n
CLFU- Ky t h u a t
S<y dd cdc giai doan sdn xuit:
DlTQCli^U
Ki^msoat Chebiai
Nau cao
'
Ba dinK l i ^
' ^ Mnii
''
Twining dich chiet
Cao dgc
Lpc, CO d$c
Saykho50°C-
Xay Botcao
Tipn Lactose, con 90°, xat hat, say kho
D6ngg6i
Nhjp kho
Kiem nghiein b&ithMiphim
Kiem nghiem thanh phjm
Quy trinh san xuat thuoc dat dupe yiu ciu de ra eiia d i tii l i dn dinh edng nghi bio chi.
Thanh phim l i dang bdt cdm khd tao hat vdi lactose, ting dp ehdng dinh khd chay nhio, d i bao quan, tao diiu kien eho cai tien dang ddng gdi till nhdm hiin dai han, theo lieu mpt lin udng, chinh xic, hat nhd gap nude hoi tan nhanh, de sir dung, kio d i i han sir dung. Thude ed chit lupng cao, tiin dung, dimg quy che, nhung van giir dupe ban sie cua thude YHCT, ed tfnh dn djnh khi san xuit.
Ban luan
Trong Y hpe cd truyin khdng cd binh danh sdi mit, m i binh nim trong chirng hiip thing, hdn nhipt vdng lal, hodng dan, cd nhiiu t h i lim sing. Trin ea sd bien chirng, vdi nhirng kinh nghiim thuc tien, binh sdi mat dupe ehu'a bing eic bii thude Cd phuang nhu dai sdi hi thang, nhdn trin cao thang .v.v. song viic nghien ciru de dinh g i i tie dung dich thuc eua cie bii thude gdp phan hiin dai hoi YHCT thi chua nhiiu. Mdt sd benh viin nhu; Viet Dire, Vien 103, Vien Dupe liiu, Quan Y vipn 108 v.v. d i nghiin ciru tie diing eua tirng ciy thude dan le nhu aetiso,
TAP CHi DUQC HQC - 7/2009 (SO 399 NAM 49)
kim tien thao, nhin tran... Nhu'ng nghiin ciru dd d i cd kit luin v i san xuit thinh cic thinh pham luu hinh tren thi trudng v i cie vj thude niy.
YHCT quan niem con ngudi l i mpt chinh thi, binh t i t l i su mit c i n bang Am Duang, tiin hinh he thdng, tdng hpp, phin tich v i biin chirng luan tri, trin nguyen tie lay lai su ein bing trong sir dung thude, cd su phdi ngu cac vi thude thinh bii thude, it sir dung dpc vi. Vdi nhCrng ly do trin chiing tdi de xuit bii thude hhdn kim" gdm 8 vi. Vdi nhCrng thiet bi siy cao chuyin dung dam bao siy cao khd diu, may ddng till tu dpng cd tai Khoa Dupe Vien YHCTQD ... chiing tdi xiy dung dupe quy trinh ky thuit san xuit dang thude t r i tin, sir dung thuin tipn, cd chit lupng dn dinh; ds nghiin ciru die diem eiia thinh phim. Chi thude ed tie dyng Ipi mat, khing khuan tren thuc nghiem;
trin lim sang dat kit qua tdt, gdp phin lim phong phd thim cie dang thude cd ngudn gdc tir dupe thao d i sCT dung trong dieu tri hd trp benh sdi mat.
Ket luan
- Da nghien eiru hoin thien quy trinh sin xuit t r i tan nhan kim; Thude sin xuit dudi dang cao khd tin thinh bpt, ddng trong tui giiy thiic cd din nhin, 5 gam/gdi, 30 gdi/ hop carton in nhin rd ring diing quy chi, ban diing 24 thing.
- Thude dat tieu chuin ea sd qui djnh ciia cao hoi tan, d i bao quan v i tien sir dung, dn djnh khi sin xuit quy md nhd cho nghien ciru v i theo quy md Idn cho san xuat dai t r i , van giCr dupe tinh chit ciia thude YHCT.
Summary
By applying the selection principle of herbal Items In gallstone treatment based on the differential diagnosis theory of the traditional medicines, a compound herbal remedy named
"Nhan Kim" f'NK" In short) was introduced, which composes of (1) Nhan tran (Herba Adenosmatis caerulei) - 20g, (2) Kim tien thao (Herba Desmodii styracifolii) - 20g, (3) Dai hoang (Rhizoma Reith) - 3g, (4) Hoang cam (Radix Scutelllae) - 12g, (5) Uat kim (Rhizoma Curcumae longae) - 12g, (6) Chi xac (Fructus Aurantii) - 12g, (7) Moc huong (Radix Saussureae) - 3g, (8) cam thao (Radix Glycyrrhlzae) - 8g. The product was in form of instant tea pack (In aluminium foil) of 5g/pack, 30 packs/carton, with label shelf-life of 24 months.
The product satisfied its home specifications In 13
Nghien
CLPU- Ky thuat
extract solubility, storage and use convenience.
The production process was standardized and practically applicable for smaller or larger production from laboratory, pilot to industrial scales.
Tai lieu tham khao
1. Bp Y te: Quy che danh gia tinh an toan va hieu lyc cua thuoc Co truyen. Phu luc 3: Hudng dan vi khao sat dpc tinh ciia thu6c Co truyen. Phy lyc 4:
Hu-ang din ve nghien ciru lam sang thuoc Co truyen.
Tap chi Dugc hoc so 6 (1996) fr. 3 - 8
2. Le Tiing Chau- Nghien cieu cay thu6c chi Adenosma mang ten "Nhan trin" chCTa benh gan trong
Y hpc Co truyen Viit Nam. - Thbng bdo Dugc li^u tJp 23 so 3, 4-1991 (51 -54).
3. Vo Van Chi- Tir dien cay thuoc Viet Nam- Nhi xuat ban Y hgc C1997) tr. 72, 174 - 175, 440 - 441, 560, 762, 838, 863 - 864, 1322.
4. Du'pc dien Vipt Nam tap II, III. Nha xuat ban Y hgc (1983).
5. Vu Van Diin, Nguyen Thj Nga. Tim hieu cau tao chung cua nhung bai thuoc chua benh gan - mat. Tap chi Dugc hoc so 5tr ^2 - 14 (1997)
6. D5 TSt Lpi. Nhu'ng cay thude va vi thuoc Vi?t Nam. Nha xuat ban Khoa hgc va Ky thuat Ha Ngi 1995 (296,348,404,471, 582,511, 784, 1071).
Nghien ciru tac dung dieu trj cua kem VMl tai cho vet bong tren lam sang
Oat van de
Nghien eiru hien dai hda cio bii thude ed ngudn gdc tir y hpe ed truyin l i mdt hudng di eua nhiiu nude ed nen y t i phit trien hien nay.
Ddi vdi nude ta thi diy l i y i u c i u c i p thiit, gdp phin ning cao chit lupng diiu tri v i ddng thdi bao dam nhu ciu chim sdc y te eho mpi ngudi din. Thude VMl l i 1 bai thude k i thira kinh nghiem din gian, dupe bio che tir la c i y thude bdng (Bryophyllum calyclnum Salisb, hp Crassulaceae), thin r i ciy nghe [Curcuma longa L., hp Zingiberaceae) v i diu virng [Sesamum indicum DC, hp Pedaliaeeae). D i y la nhirng thue pham thdng dung, ddng thdi cung l i nhirng du'pc thao sin cd, v i n dugc diing trong nhin dan de dieu tri v i t thuang, v i t bdng cd hieu qua '^•'''. Trin ea sd k i thira, nhim hiin dai hda cae bii thude y hpc cd truyin, Vien Bdng qudc gia da tien hinh nghiin ciru ban diu kem VMl diing trong dieu tri bdng, hoin thien quy trinh bio che kem VMl, dat tieu chuin ca sd. C h i phim da dupe xic dinh dpc tinh bin cap, kha ning dung nap trin da linh, dieu trj tren v i t bdng thuc nghiem ed hiiu qua. O i t i i niy tien hinh nghiin eiru tic dung eiia thude trin lim sing, nhim ddnh gid tdc dung kich thich qud trinh tdi tao vd biiu mo hoa cua kem VMl tai vit bong va ddnh gid tdc dung uc chi vi khudn cua kem VM1 tal vit bong.
14
Nguyen Ngoc Tuan Vien Bbng quoc gia D6i tirang, phu'ang phap Benh nhan nghien cii'u
Tien hinh tren 60 benh nhin (BN) bdng dieu trj ndi trii tir 10/2003 d i n thing 10/2005 tai vien Bdng Qudc gia. Tudi BN tCr 6 thing d i n 16 tudi, gdm 25 nCr, v i 35 nam.
77eo chuan lira chgn BN: BN v i o viin trong 3 ngiy diu sau bdng, bdng do nhiet, tu nguyen diiu tri theo phie dd nghiin ciru. Tieu chuin loai trir: BN bdng do dien, h o i chit v i birc xa, gia dinh khdng ddng y hpp t i e nghien eiru.
Thiit k i miu nghien cii'u:
BN dupe chia l i m 2 nhdm:
Nhbm 1: 30 BN. Dinh g i i t i c dung eua kem VMl tai v i t thuang bdng ndng dp II, dd III.
Nhbm 2: 30 BN bdng s i u dp IV. Tdn thuang bdng siu dp IV dupe c i t hoai tir theo phuang phip tiip tuyin, sau dd dieu trj bing kem VM1 tdi khi ed md hat ghip da. Viing dieu trj vdi thuoc ddi chiiu a 2 nhdm; dupe diiu trj bing SSD 1%.
Chit lieu nghien ciru
- Thude nghien cuu (NC); kem VMl ndng dfi 40%, dung trong hop 250 g, dupe kiem nghiim tai Trung t i m Kiim nghiem Nghiin eiru Dupe - Cue Quin Y dat TCCS. Kem VMl cd miu ving nhat, diem chay; 40 - 45°C,' dat dp ddng nhat, dO mjn, khdng ed vi khuan, n i m mde. pH: 5,5 - 7,0.
TAP CHi DUQC HQC - 7/2009 (SO 399 NAM 49)
