Y HOC VIET NAM THANG 4 - s 6 1/2013 IV. KET LUAN
Hlnh anh canxi vi the tren phim X quang chup tuyen vu lien quan den cac tdn thu'dng te bao try.
Tat ca cac benh nhan cd tdn thu'dng te bao try dien hlnh hoac khdng dien hinh it hdn 02 ddn vj thuy/dng cd ket qua tu'dng tu" tren benh pham sinh thiet ldi va phau thuat rdng sau d d .
- Cac benh nhan cd tdn thu'dng te bao try kem theo qua san dng khdng dien hinh d ft hdn 02 ddn vj thuy/dng khdng phat hien thay tdn thu'dng miTc dd cao hdn d benh pham p h l u thuat rdng sau sinh thiet Idi.
Phau thuat rdng sau sinh thiet Idi d cac benh nhan cd tdn thu'dng te bao try dien hinh, khdng dien hinh va/hoac kem qua san dng khdng dien hinh ft hdn 02 ddn vi thuy/dng cd the la khdng can thiet.
TAI LIEU T H A M K H A O
1. Brogi E and L. Tan. Findings at excisional biopsy performed after identification of columnar cell change of ductal epithelium in breast core biopsy.
Mod Pathot 2002. 15 p29-30.
Fraser.J.L.et al. Columnaralteraion with pnaminent apical snouts and secretions: a spectum of changes frequently present in brea*
biopsy performed for microcandfication. Am ] Surg Pathol 1998, 22(12) pl521-7.
Goldstein. N.S and O'malley. B.A.
Cancerization of small ectatic ducts of the breast by ductal carcinoma in situ. Cells with apcrine snouts: a lesion associated with tubular carcinoma. Am J Clin Pathol 1997, 107(5) p561-6.
Rossen.P.P. Columnar cell hyperplasia is associated w^ith lobular carcinoma in situ. /Vn J Surg Pathol 1999, 23 (12) pl561.
Guerra-Wallace M.M, Christensen W.N, White R.L. A retrospective study of columnar alteration with prominent atipical snouts and secretion and the association with cancer. Am J Surg 2004. 188 (4) p395-8.
Bijker N, et all Risk factors for recurrence and metastasis after breast conserving therapy for ductal carcinoma in situ: Analysis of Eurapean organization for reseach and treatment of Cancer tnal 10853. 3 Clm Oncol 2001, 19 (8) p2263-71.
Euseb L.V, et a l . Long-term follow-up of in situ carcinoma of the breast. Semin Diagn Pathol.
1994 11(3) P223-35.
KHAO SAT PHirONG PHAP DjNH LimNG HOAT CHAT CEFACLOR
Tran Xuan Tri", N g u y e n Minh C h i n h " , Bui Tiing Hiep*"
TOM TAT
Cefaclor can bao che dang PTKD, thdi gian ban hiiy CLia cefaclor la rat ngan.Tren thi trUdng cac che p h a m j x tac dung keo dai chira hoat chat Cefaclor, hau het la nhiJng san pham ngoai nhap gia thanh cao.
Cac phu'dng phap djnh IUdng cefaclor bSng HPLC va quang pho UV-Vis trong thanh pham cho do diing va do lap lai nSm trong gidi han quy dmh; cd do tuyen tfnh, gidi han phat hien lan Iu'dt la R^ = 0,99623 va 0,17-0,40 mg/ml; R^ = 0,9987 va 8,75-45 pg/ml, cho phep sir dung trong nghien ciru tiep theo ve dang bao che PTKD hoat chat cefaclor.
SUMMARY
THIS STUDY WAS DESIGNED TO INVESTIGATE QUALITATIVE, QUANTITATIVE DETERMINATION OF
CEFACLOR
Sustained release formulation is desirable for
* Trung cip kinh teky thuat Quan Trung
** ligc Vien Quan y; ^** Benh vien cap cCtu Trdng Vddnq Phan bien khoa hoc: PGS.TS. Tr^n Thanh Nhan 26
Cefaclor, as its half-life ts very short. The current Vietnam pharmaceutical market has circulated no home-mad preparations of cefaclor in sustened release form, but foreign ones at high pances. This study was designed to invesbgate qualitative, quantitative detemiinabon of cefedor in such dosage form by HPLC and UV-Vis spectnaphotometry. The lineanty, detectkxi limit of H a c methol and UV-Vis spectrophotometry were R^ = 0,99623 and 0,17-0,40 mg/ml; R^ = 0,9987 and 8,75-45 IJg/ml, respectivly. The fiDrmulatran of sustained release cefactor tablet is being examined.
I.
OAT VAN OEHien nay tren the gidi cung nhu' tai Viet Nam da xuat hien nhieu dang bao che cd tac dung keo dai de dieu tri cac benh man ti'nh nhu" tim mach, huyet ap, tieu du'dng, hen suyen vdi nhieu Itu diem trong tri lieu nhu': giam so lan dung
y HQC V l g T NAM THANG 4 - SO 1/2013
thudc, duy tri nong dp thudc trong mau hang djnh tir dd nang cao du'dc hieu qua dieu tri, giam hieu irng phy, dpc tfnh, nang cao du'dc sinh kha dung ciia dudc chat, gdp phan mang lai hieu qua kinh te trong dieu trj. Qua khao sat tren thj trudng cac che pham cd tac dung keo dai chu& hoat chat Ce^ctor, hau het la nhuhg san pham ngoai nhap gia thanh cao, khdng phii hdp vdi nhu cau dieu tri cua da sd ngudi dan trong nu'dc.
Mat khac, thdi gian ban hiiy ciia cefaclor
trong huyet thanh la 0,6-0,9 gid, lieu trung binh 250mg x 3 lan/ngay (udng nhieu lan), nen khdng thuan tien cho dieu tri nhii'ng benh nhiem triing keo dai nhU viem xoang man tfnh, viem tai giu'a...nen cefaclor can bao che du'di dang phdng thi'ch keo dai (PTKD), san xuat trong nu'dc.'^^ Do vay, myc tieu ciia de tai budc dau can khao sat phu'dng phap djnh lu'png hoat chat cefaclor phyc vu cho nghien ciTu dang bao che PTKD hoat chat cefaclor se du'dc tien hanh tiep theo.
I. Odi TU0NG VA PHUONG PHAP NGHIEN COU 2.1. Ddi tu'dng nghien cu'u
Bangl: Nguyen lieu chinh
T e n n g u y e n l i e u Cefaclor Cefaclor c h u a n
Con 9 6 ° NUdc cat Acid h y d r o d o n c
T i e u c h u 3 ' n BP C h a t chua'n
DDVN DDVN DDVN
N g u o n g o c
I N D I A Vien KN TPHCM
Viet Nam Viet Nam T r u n g q u o c
ifng d u n g Hoat chat chfnh
Chat chuan Pha ta dUdc dfnh Pha cac dunq dich, ru^ dunq cu
Pha dung dich dem Bang 2: Thiet bi sir dunq
Ten thiet bi May x a t h a t LTdt v a sira h a t May t r o n sieu t o e T u say Can p h a n t i c h May t r o n k h o May t r u n u'cli May d a p vien x o a y t r o n May (Jo thcfi qian v a t o e d o c h a y h a t May d o t h e t i c h c o m
Can c h i n h xac d o a m b a n q h o n q n q o a i May d o d o c i m g
May d o d o m a i m o n May thu' d o hoa t a n May q u a n g p h o May HPLC May d o oH
May say t a n q soi
H i e u ERWEKA CY-OG-A KBC-ST-20 JERMARKS A N D - H K 2 0 0 EWEKA TYPE KB 20S EWEKA TYPE LK5 a B - 3 B - 2 7 EWEKA TYPE GT-L EWEKA SVM 102 SHIMADZU LIBROREB-340 EWEKA TBA 30 EWEKA TYPE TAP P T W S I I I / S I 2 / D 6 - P T S 3 C U V - 1 6 0 1 - S H I M A D 2 U WATER 2 6 9 5 M E L T R O H M - I T 4 4 0 0 1 0 KBC-02.C.01
Nu'dc S a n x u a t DL/C
DLfC DLTC DlJC
ocrc
AN D O O L T C DLTC NHAT DLfC D l f C THUY D I E N
NHAT MY MY
2.2. Phu'dng phap nghien cu'u.
Phu'dng phap phan tich kiem nghiem:
Quy trinh dinh lu'dng cefador trong thanh pham bang phu'dng phap HPLC
Tt'nh tuyen tfnh: Pha 6 dd cefaclor chuan vao nong dp tir 0,17 -0,40 mg/ml, tien hanh sac kl cac dd nay theo dieu kien USP 29 thu du'dc cac dien tich dfnh tu'dng u'ng. Tfnh he sd tu'dng quan R giii^ dien tfch va ndng dp.
Bp dung: Pha dd thu' cd nong do khoang 0,3mg/ml. Tien hanh them cefaclor chuan 80%,
100%,120% lu'dng cefaclor trong mau thir. Tfnh tl le phyc hdi. Phu'dng phap djnh lu'dng dat dp dung khi tl le phyc hoi dat tir 98%- 102%
Dp lap lai: Pha 6 dd thiy tir mpt mau da 6ddc dong nhat cd ndng dp cefaclor khoang 0,3 mg /ml vdi 6 lan can khac nhau. Tir dien tich dinh thu du'dc tren sac ki do tim du'dc ham lu'dng mau thu'. Tinh RSD. Phu'dng phap dinh lu'dng dat dp lap lai khi RSD khdng qua 2%.
Dinh lu'dng:
Phu'dng phap HPLC: vien nen PTKD chijra
Y Hpc Vl|T NAM THANO 4 - s6 1/2013
cefaclor 375mg phai chuS til 90 - 110% (337,5 -
412,5mg) iiTc^ng hoat chat ghi tren nhan.
Pha dpng: hoa tan lg Na 1-pentanesufonat trong 780 ml H2O va 10 ml triethylamine, dieu chinh bSng H3PO, den pH tir 2,5 ±0,1, them 220ml MeOH.^
A / ctiuan: dd co nong do l<hoang 0,3g/ml (cefaclor USP RS).
l^ thit: can va nghien thanh bpt 20 vien nen. Can chinh xac mpt lu'png bpt chira khoang 75mg cefaclor, cho vao binh djnh mu'c 250ml, pha loang vcfi pha dpng den dii the tich. Lpc de thu du'pc dd trong.
Orf ptian giai: dd chira khoang 0,3mg cefaclor va 0,3 mg cefaclor delta-3 isomer USP RS trong 1ml.
He tliong va dieu ttien sac la':
DetectonUV, bi/dc song 265nm.
The tich bPm mau; 20pl.
Got RP18, d=4,6mm, l=0,25m, c8 hat Spm.
Toe dp d6ng:l,5ml/phut.
Thittinh tu'dng thi'cti he thdng.
Tien hanh sac ki dd phan giai de danh gia tuang thich he thong. Qui dinh IR tUdng doi cua cefaclor va cefaclor delta -isomer khoang 0,8 va 1,0. Dp phan giai ciia cefaclcr delta-isomer >
2,5, he so bat doi <1,5 va RSD <2%
Tien hanh sac kf dd thir va dd chuan . Bo dien tich dinh thu dUdc tren sac ki do. Ham lu'png cefaclor(mg) du'dc tinh theo cong thirc:
5W,(P/1000)(r,yr,j
W,: khoi lupng (mg) cefaclor chuan.
P: ham lUPng (pg/mg) ciia cefaclor chuan.
^rs, Tu: dien tich peak thu 6\i(ic tif dung djch chuan va dung djch thu'
2.3. Quy trinh djnh lu'ong cefaclor trong djch thuf kha nang phong thich hoat chat bang phifong phap quang pho UV-Vis
Tinh tuyen tinh: Pha 6 dd cefaclor chuan CO nong dp tif 7,5 - 45pg/ml. Oo do hap thu ciia
cac dd nay 6 bu'Sc song khoang 265nm. 1;nh he so tuong quan R gius dp hap thu A va nong do dd.
Bp Mng: Ptia dd co nong dp khoang 25Mg/ml. Tien hanh them cefaclor chuan 80%, 100%m,120% lu'dng cefaclor trong mau thif. Bo dp hap thu d bu'dc song khoang 265nm. Tfnh ty le phuc hoi. Phu'dng phap djnh lu'dng dat do dung Ichi ty le phuc h5l dat tir 98% -102%
Dp l$p lai: Pha 6 dd thif tif mpt mau da dong nhat co nong dp cefaclor khoang 25Mg/ml vdi 6 lan can khac nhau. Tif dp hap thu A thu dU(;fc tim dUdc ham lu'dng mau thu'.'Tfnh RSD, PhUOng phap djnh lu'dng dat dp lap lai khi RSD khong qua 2%.
2.4. Djnh lu'ang:
a. Dieu Icien thu":
Thiet bi: gio quay.
Toe dp canh khuay: 100 vpng/phiit.
Nhiet dp: 37 ± 0,5°C
Moi trudng thif: 900 ml HCI 0,1N (± 0,1%) Thdi gian: 30 phiit, 60 phiit, va 240 phut.
b. Tien hanh:
Sau 30 phut, 60 phiit, va 240 phut thiJ, rut lay 10ml dung dich thir d mol coc, sau do bii lai 10 ml moi trudng 6 37°C.
Lpc dich thiJ qua giay Ipc tro 0,45pm, sau do dUdc pha long vdi HCI 0,1N de duOc dung djch thif CO nong dp trong khoang tuyen tinh 7,5^5 pg/ml. Do dp hap thu cua cac dung djch nay cl budc song ctfc dai khoang 265 nm.
Dung dich mau chuan: Can chfnh xac khoang 250mg cefaclor cho vao binh dlnh mu'c 100ml, them dung djch HCI 0,1N viia dii, lac deu va Ipc qua giay Ipc. Hiit chinh xac 1ml djch loc nay cho vao binh dlnh mirc 100ml, them dung djch HCI 0,1N vift dil, I3c deu, thu du'i?c dung djch cd nong do Q tu'dng du'dng 25Mg/mi. Bo dp hap thu ciia cac dung djch nay d bu'dc sdng cut dai khoang 265 nm, thu dUdc gia tri At
c, Cong thii'c tinh toan:
+ So lieu khong luy tien:
Dp hoa tan (%X) ciia cefaclor so vdi ham luBng ghi tren nhan, cd the du'dc tinh theo 2 cong thut:
* Cong thwc 1: ^ A, X C. X I X 900 I; (Jo pha loang
/oX X 100 A,: dp hap thu cua dung dich thu- At X 375 X 1000 At: dp hap thu ciia dung djch chuan
Q: nong dp dung djch m§u chuan
Y HQC VlgT NAM THANG 4 - s 6 1/2013
**• Cong thtk: 2: Ndng dp dung djch thir Q (Mg/ml) du'dc tfnh tdn du'a tren du'dng chuan y = ax + b thu du'dc bang each pha cac dung dich chuan cd nong dd biet tru'dc va do dd hap thu:
At - b
Q =a Q X I X 900 o/ox = X 100
375 X1000 + Sd lieu luy tien :%X, (LT) = %X, + i X, . i /IOO
Yeu cau:
Lan dtty thi/' nhat: ThiT tren 6 vien, khdng du'dc cd vien nao nam ngoi mdi gidi han quy djnh va d thdi diem cudi ciing khdng cd vien nao cho gia tri nhd hdn quy djnh. Neu khdng dat thy'c hien thir lan thiy hai.
Lan thty thd hai: ThiT tren 6 vien, gia trj trung binh ciia 12 vien da thir (Lan 1 + Lan 2) phai nam trong gidi han cho phep va khdng du'dc nhd hdn gla tn cho phep d thdi diem cudi cimg.
Khdng dudc cd vien nao lech qua gidi han ±10%
va khdng cd vien nao hda tan It hdn 10% d thdi
diem cudi (240 phut). Neu khdng dat, thu'c hien thil" nghiem lan ba.
Lan thty thii' tja: Thir tren 12 vien, gia tri trung binh cua 24 vien da thir (Lan 1 + Lan 2 + Lan 3) phai nam trong gidi han quy djnh va khdng du'dc nhd hdn gfa tn qui djnh d thdi diem cudi. Khdng du'dc qua 2 vien lech qua gidi han ± 10%; khdng qua 2 vien thap hdn qua 10% gia tn quy dinh d thdi diem cudi (240 phut); khdng du'dc cd vien nao lech qiia gidi han ± 20% va khdng cd vien nao hda tan ft hdn 20% d thdi diem cudi (240 phut).
III. KET QUA NGHIEN CQU
Ket qiia tham djnh quy trinh dinh lu'dng Cefaclor trong thanh pham:
Tmh tuy^n tinh: Pha 6 dd cefador chuan cd ndng dp td 0,17-0,40 mg/ml, tien hanh do cac mlu nay bang sac ky long hieu nang cao theo dieu kien USP 29 thu du'dc cac dien tfch dfnh tu'dng irhg.
Bang 3: S\/tifdng quan giu'a nong do va dien tfch peak
Mau chuanNong do Dien tich peak (pAu.s)
1 0,1801 3205962
2 0,2341 4281243
3 0,2880 5259171
4 0,3060 5684885
5 0,3419 6228352
6 0,3959 7573397
Hinh 1. Do thj hdi quy tuyen ti'nh
Dien tfch peak
= 19814388x-393864
0.35 0.4 0.45 Nong do (mg/ ml) Bang 4: Bang tinh thonq ke hoi qui
R '
Hoi qui
0 , 9 9 6 2 2 6
Bac tWdo 1
Tong binh phu'dnq 1,15x10"
Binh phu'dng trung binh 1 , 1 5 x 1 0 "
Fo.„s=7,709 Gfa tn thdng
t<e(F) 1056,016
Y HQC VI$T NAM THANG 4 - S6 1/2013
Tung do qoc Tham so
4 5
- 393864 6=19814388
4,37 xlO'°
1,16x10"
182490,1 609741,1
1,09 xlO'°
tons = 2,776 f 2,15827 32,4964 Sanh gla phUdng trinh y = 19814388x -
393864 ( y = Bx + Bo )
Phu'dng trinh hoi quy co y nghia (F=1056,016 >Fo,o5=7,709; a=0,05)
He so B„ = -393864 khong y nghia (t„=2,15827< to,05= 2,776; 0=0,05)
He so B cd y nghta (t = 32,4964 < to,os 2,776; 0=0,05)
Vay phudng phap djnh IUdng vien nen cefaclor PTKD tuyen tinh trong khoang nong dp 0,17-0,40 mg/ml
Op dung; Dd thU: nghien 20 vien doi chieu {ceclor® SR, Lilly Suzhou Pharmaceutical Co.,
Ltd). Can chinh xac IUdng bpt chii'a khoang 75mg cefaclor, cho vao binh dinh mii'c 2 ^ m l , them pha dpng, sieu am trpng 20 phiit, bo sung den dli the tich va Ipc qua giay Ipc dUdc dd thir.
Mau thtr them chuan: them mpt lUOng cefador chuan (diing dung djch chuan 0,279mg/ml) chinh xac bang khoang 80%, 100%, 120% ham IUdng hoat chat co trong dd ttiir.
Khoi IUdng trung binh 1 vien la 550mg, dien tich dinh = 7661485. Dien tich dinh trung binh ciia 3 dd chuan co n5ng dp 0,279mg/ml la 7579980. Vay nong dp dd thir la 0,282mg/ml.
Bang 5: Ket que Ham lu'dng mau
thu' (mq) 2,330 2,765 3,434
khao sat do dunq cita phUdnq phap dinh tu'ffng chuan cho
vao (mg) 2,79 2,79 2,79
•Vo chuan cho vao 119,74 102,90 81,25
Udnq banq HPLC Lu'dng tim dtfOcCmg)
2,74 2,75 2,77
Ti i f h3i phuc(%) 98,10%
98,70%
99,30%
Vay tl le phuc hdi nam trong gidl han 98%-102% nen phu'dng phap dinh lu'dng dat dp diing.
Bg lap lai: Mau thiT; can lu'dng bdt vien ddi chieu da du'dc lam ddng nhat chu^ khoang 75 mg cefaclor, tien hanh vcfi 6 mau. Cach pha dd thir nhu' d do dimg.
Chay sac ki va tfnh ham lu'dng tii' mau nay.
Bang 6: Ket q Khoi iLTpng can
(mq) Dien tich dinh(uA.s)
RSD(<Ki)
ua khao sat do lap lai cua phUdnq phap dinh lUdnq banq HPLC 108,3
5448680 108,1 5346767
108.4 5434177
0,85
108,4 5482111
108,0 5385508
108,5 5388719
Ket luan: phu'dng phap djnh lu'dng cefaclor trong thanh pham cho dd diing va dd lap lai nam trong gicfi han quy djnh
Ket qiia tham dmh quy trinh dmh lu'dng cefaclor trong dich thOr kha nang phong thich hoat chat:
Tinh tuyen tinh: Pha dd chuan goc A cd nong do cefaclor 250 pg/ml trong HCI 0,1 N. Tii dd nay pha long tiep thanh 6 dd chuan.
Bang 7: Ket qua khao sat tinh tuyen tlnh ciia phu'dnq phao dinh lUdnq banqquanq pho UV-Vis Dd
Nong do 06 hap thu A
1 8,75 0,194
2 12,5 0,269
3 18.75 0,420
25 0,520
5 40 0,817
45 0.920
Y HOC Viet NAM THANG 4 - SO 1/2013 Bang 8: Banc
R*
Hoi qui Sai so Tonq conq Tunq do qoc
Tham so
tinh thonq ke hoi 0,998732
Bac t u do 6 4 10 0,0273 0,0198
qui:
Tonq binh phu'dnq 0,426877 0,000542 0,427419 0,010033 0,000353
Binh phu'dng trunq binh
0,071146 0,000135
t 2,722 56,134 t„n,= 2,776
F „ „ , . 7,709 Gia tri thonq kefF)
3151
Oanh gia phu'dng trinh Y= 0,0273x + 0,0198 ( y = Bo + Bx)
Phu'dng trinh hoi quy cd y nghTa (F = 3151
>Fo,os=7,709; a=0,05)
' He sd Bo = 0,0198 khdng y nghTa (t^ - 2,722 < to.os = 2,776; a=0,05)
He sd B cd y nghTa (t = 56,134 > toos 2,776; 0=0,05)
Vay phu'dng phap dinh lu'dng vien nen Cefaclor PTKD tuyen tinh trong khoang nong do til" 8,75-45 pg/ml.
Oo d u n g : Mau thiT: can chfnh xac mdt
lu'dng bdt du'dc nghien tir 20 vien ceclor®SR chira khoang 250mg cefaclor, cho vao binh dinh mirc 100ml, them 50ml HCI 0,1 N vao sieu am trong 20 phiit. Bo sung den dii the tfch va loc qua giay lpc, bd it djch loc dau. Hiit chfnh xac 1ml dich Ipc nay pha long vdi HCI 0,1N thanh 100ml, tfiu du'dc dd cd ndng dp cefaclor 25pg/ml. Oo dp hap thu ciia dd nay d bu'dc sdng 265nm.
Mau them chuan: them mpt lu'dng chfnh xac cefaclor chuan (sir dung dd chuan ndng dp 50 pg/ml) vao mau thir bang khoang 80%, 100%, 120% lu'dng cefaclor cd trong mau thir.
Bang 9:Y.^Q,\s.
Ham lu'ang mau thLr(pg)
250 250 250
khao sat do diinq Lu'dng chuan cho vao([jg}
200 250 300
ciia phUOnq phap dmh lUdnq banq quanq pho UV-Vis Lirdng chuan
cho vao(<yo) 80 100 120
Lu'dng chuan l i m au'dc(%)
199,08 247,99 298,95
Ty le hioi phuc(%) 99,54 99,20 99,65 Vay ti le phuc hdi nam trong gidi han 98%-102% nen phUdng phap dmh lu'dng dat dd dung.
€)o lap l a i : Mau thir can IUdng chfnh xac mdt lu'dng bdt vien ceclor® SR da dUdc lam ddng nhat chu^ khoang 250mg cefaclor tien hanh vdi 6 mau. Cach pha dd thir va do dp hap thu nhu" d dp dung.
Ti'nh ham lu'dng vien tir 6 mau nay.
Bang 10: Ket qua khao sat do lap lai ciia phUdng phap dinh ludnq bang quang pho UV-Vis K.iu'dnq can(mq)
0,255 0,256 0,254 0,253 0,251 0,252
Do hap thu (A) 0,536 0,539 0,533 0,531 0,523 0,527
Ham lu'dng (mq) 371,5 373,2 363,83 368,3 370,9 368,3
RSD(°/o)
0,90%
Ketlu$n: phu'dng phap djnh lu'dng cho dp dung va dp lap lai nam trong gidi han quy dinh.
V. KET LU§N
Cac phu'dng phap djnh lu'dng cefaclor bang HPLC va quang phd UV-Vis trong thanh pham cd dp tuyen ti'nh, dp dung va dp lap lai nam trong
gidi han quy dinh, cho phep sir dung trong nghien ciTu tiep theo ve dang bao che PTKD hoat chat cefaclor.
Y HQC VlgT NAM THANG 4 - 561/2013
TAI UEU THAM K H A O
1. Bhamare et al (2006), "Extended release formulation of beta-lactam antibiotics". US, Pat. 0233878
2. British Pharmacopoeia (2005), pp.369-370 3. Handbook of Pharmaceutical excipients
(1994)- Second edition, pp. 362-366 Remington the science and Practice of Pharmacy, 9 * edition 2000, pp. 1660-1675 United States Pharmacopoeia 29 (2006), H , 402-403
Vidal Vi$t Nam ( 2 0 0 0 ) , u. 138.
SO SANH GIA TRj CUA PCR DA MOI VOTI CAY MAU TRONG CHAN DOAN MAM BENH GAY N H I I M KHUAN HUYET
Le Hu'u SongS D a o Thanh Q u y e n \ Ngo T a t T r u n g S P h a n Q u o c H o a n ^ Nguyen Kim Phu'dng^ Pham Minh L o n g ^ N g h i e m X u a n H o a n ^ N g u y e n X u i n Chinh*
TOM
TATDe so sanh dp nhay va dp dSc hieu ciia PCR da moi v6i cay mau trong chan doan NKH chiing toi thu thap 50 mau mau tir benh nhan (BN) nghi ngd NKH.
PCR da moi va cay mau du'dc tien hanh song song, doc lap tai Khoa sinh hpc phan tir va Khoa vi sinh vat.
Ket qua duUc cac Bac sy lam sang tong hop so sanh.
Trong sd 22 BN NKH dUOc chan doan cuoi ciing thi c6 7/22 tru-iing hop cd PCR da moi (+), 22/22 cd PCR universal (+) va 12/22 cay mau (+). 5/12 trUcJng hop cay mau (+) la nhO'ng mam benh khong nam trong danh sach vi anh vat dich ciia PCR da moi. Do nhay oia cay mau a o hdn POl da moi (54,5% so vdi 31,8%); tuy nhien dp dac hieu ciia cay mau lai thap hdn PCR da moi (67,8% so vi5i 85,7%). Nhu" vay, PCR da moi co do nhay thap hdn va dp dac hieu cao hdn so vdi cay mau.
SUMMARY
COMPARISON THE VALUE OF MULTIPLEX-PCR WITH BLOOD CULTURE IN IDENTIFYING PATHOGENS
CAUSED SEPSIS
To compare the sensitivity and specificity of multiplex-PCR with blood culture we collected 50 samples from suspected to be sepsis patients.
MuItiplex-PCR and blood culture were parallel- independent performed at the Dept of Molecular Biology and Dept of Microbiology. The results were analysed by physician. 7/22 sepsis patients were positive with muWplex-PCR, 22/22 positive with PCR universal and 12/22 positve with blood culture. 5/12 pathogens identified by blood culture were not in the target pathogens which were designed fbr mulbplex-PCR. The sensitivity of blood culture was higher than muitiplex-PCR (54.5% vs 31.8%); however, the specificity of blood culture was lower than multiplex-PCR (67.8% vs 85.7%). Thus, multiplex-PCR has sensitivity lower but specificity higher than blood culture.
^Khoa Sinh hgc phan by, ''Khoa Vt sinh vat, ^Khoa Truyen nhi&n, Khoa Hoi sdc, - Benh vien Trung uhg Quan dgi 108
Phan bi$n khoa bgc: PGS.TS. Nguyen LTnh Toan
I.
DAT VAN OECay mau hien dang du'dc cho la tieu chuan vang de chan doan mam benh trong NKH [1].
Tuy nhien, viec lay mpt lu'dng mau Icfn d cac benh nhi sd sinh la mot viec rat khd khSn, quy trinh thUc hien thu'dng keo dai t i f 48-72 gid mdi cd ket qua sd bp. Ket qua nghien ciitJ cho thay chi 2 5 % benh nhan du'dc xac dinh nguyen nhan gay NKH bang cay mau [ 2 ] . Vi vay, viec chan doan NKH hien nay chii yeu la d i f t vao cac trieu chirng lam sang. Va nhu* vay thu'dng benh khong dddc phat hien sdm va do do rat nguy hiem cho ti'nh mang t)enh nhan, dac biet la ddi vdi tre nho va ngu'di cao tudi.
Viec phat hien DNA ciia vi khuan trong mau mau cua benh nhan dUdc cho la mdt phu'dng phap cd dp nhay cao, thi/c hien nhanh cd gia tn ho t r d cho cay mau de chan doan NKH. Tuy nhien, cho den hien nay van chu^a cd phuWig phap phat hien DNA cua vi khuan nao dddc die la chuan de phat hien DNA trong chan doan NKH. Vi vay, nghien ciru xay du'ng mpt phu'dng phap chan doan nhanh, co dp nhay, dp dSc hieu cao dang la nhu rau birc thiet hien nay. Bdi vi, khi CO phu'dng phap chan doan chfnh xac, nhanh, cd dp nhay, dp dac hieu cao thi se giup cac Thay thudc cd su" \da chpn khang sinh cd hieu qua, CUXJ sdng dUdc benh nhan, ngan chan du'dc si xuat hien vi khuan khang thudc.
Tu'khoa: NKH, cay mau, PCR da mdi
