g㥃џㅵ⧚g

-.R/O¯0g›13

(n ÀJ n À 050031)



   !"# $%&'
(
)*-+*,-./0123345 67
8# 9
:;<,=>
 6?@ AB CDEFG!"#
,H
ABIJ6K!LM
NOPQ#
 :;<,RST R7

R927.1 A 1007-7693(2014)01-0116-04

Applications of Shewhart Control Charts in Drug Testing

ZHOU Jianmin, CAO Fengxi(Shijiazhuang Institute for Food and Drug Control, Shijiazhuang 050031, China)

ABSTRACT: OBJECTIVE Using statistical techniques to control the process of laboratory testing, timely detection and
elimination of abnormal variation factors, ensure the reliable detection result. METHODS This paper introduces a commonly
Mean-Range control charts application instance at atomic absorption spectrophotometric detection. RESULTS Shewhart
control charts could be applied to discover and exclude abnormal factors of detection process. The effective control of testing
process could ensure accurate and reliable of detection data. CONCLUSION The control charts is an indispensable means in
the laboratory quality management.
KEY WORDS: Shewhart control charts; drug testing; application

u$¡p¢PÀFG|™{PŒxo£~ r‰ [2]Z$¡BJÄ ¡òϧD_

5.9.1 ÀFGu[¤rJ¥:¹¤$¡p¢ 2 Èn< qÄØ2 ÜIÅq$¡BJ ¡
PÎ2Zƒ¦§D¨©‰kuª!{X/ ª(}ÄØ ÄØôÆ!$¡»
\X^ôõ Å{ uÉv«¬­Çòϳ ¼oNJKpÇ«yzæ«[,JK’
®%Z5.9.2 u_—[¤r§D -X/ 6¡ª¾ÇÈq~J_ ÅC*_
[¤r§DoA.^¯"°D
uÉ æ6É_æÊË+(Poisson)_Z
*ÌÍ
¬± !{²C./™š 8_€B³´ n<yzÎô°~q°Ïyz(ÁÐqÑ
[1]
µòÏZ ÀFG[ \Ä uv«¬­ yz) Ì°yzBJÒæÍG„ \
Ç$¡BJ³¤r [
X/p6S$¡À «{Ó;Ô:çS \Ž¥ÄØ[¡
/BJÄDh {:Τr$¡BJ ÄDÕC*_’q°q«yz(ÁÐDy
Œ\¢!{4æŠ¶ ËÌ5F$¡ z) Ì°yz®…D„ Ç$¡òÏ«ô
§DP"æ{·Z \¯y{:ÖL8çS \Ž¥ÄØ®ÕC*
1  _Z0×n(Shewhart)Ø?CDÌqn< «
ÀFG{Ä “¸¹ÈBJ no5º ¬¸¯\Ž³[ \Ä a.c¤rÙ\ÚZ
BJu¢!¤*Zj¤®!Jh ¤rÙMµBÇ$¡BJ[n2ª³¡
܌4»¼} ½¡[®÷¦LoS4 権惄 ËÌ$%¿BJÛ¢!¤r
òÏ ¡¦ª£¾„¿ ƒ:h *qøv«¬‰ÜݬÙZµBÙÄ¡
qøÀ•„ZjhÁ®…Â&à  §D_ ËÏyzŽ¥ÄØÄX/D
q«¬~J «¬­CX/~J8¤ yzŽ¥ÄØ [
BÞ :ªÉ²CQ

԰㗙ㅔҟ˖˜LÁ ! $N Tel: (0311)67803302 E-mail: hbszjm@126.com

g116g Chin J Mod Appl Pharm, 2014 January, Vol.31 No.1
 2014 1
 31  1
^_ ! )L$¡BJ¤r
Z 3.1.3 ¤’rg¡ èé[óûôz
[3-4]
2 −( X − R ) OP’ 0.1 mL â 100 mL [ Ä \ 2%¶å
·ß[$¡BJÄ¡§Dt!¬[§ ’
'9K ê r*óOP ’è
D
ËC*_\Ú \¡§DD°ª( X ) é[óOP  1 mL âû¯¬â
(}_ \àâJKDvP¿(R){wì y Ä \¶å 5 mL ê ›B ÇÄv·
°ªpP¿M*Ìq_ 2 ÈnEªZ¬[ 2010 Ò6à‰ÜÃ[5]~v 2%¶å’™9
¤rÙM
vàâJK(áßh)pš [ Ä 8v 2%¶å’
'9K ê Ã
â(BJ¶°)çãBJ§DZy¬[¤rÙ ¤’Z
*Çär8\:_—~\Ä q(5!š èé[óOP [ v 2%¶å’
â¤rÙ q(5!àâJK¤rÙZå
'r*½ 1 mL ‚ó 0~80 ng ÇÈߒ(½v
DÉvqÇ X ¤rÙp R ¤rÙZ X Ùp R dr)ZÇÈߒg¤’ :óø¯

ÙµBMNæ$¡òϧD ÇÈ
ç¥ þÊU ǯþ}N_ððKÜ  357.9 nm Ä
[¢¡ ¬ ܦ¤’Äó‚[Z
<ãäÌ*Z X Ùv!¹¤°ªh •–B
3.1.4 ¤§DÉæ Ç3.1.3 É}‰Üræ
J2’R Ùv!•–_âQèéKh
¡¤’‚[ E1¡ 25 d(þ¨§ m) ½
{¹¤BJq„2Q°ê2Z
"¡ 4 ȧª(þ¨ôÆ n)ZÌáMNæ¦c
¤rÙÄQÍ«¬‰Ü" 2 »¤r
q¨:¤’Äó‚[(X)[nE«¬[
E _oš!Ä1¸(CL)Îj 3σ ëࢠÐ
¤§DZÌͤ§DÇ¡
ç¥6
(¤r¸(UCL)p}¤r¸(LCL)Z3σ ¤r¸wx
¬.°ª X pP¿ R òÏ)w 1Z
ABJ¢!«¬¤r* Œô† 99.7%þ¨
ªì¤ríE£Zîïì -BJ¤  1


Tab 1 Statistics table of Cr content in quality control

ô† 0.3%ð‡ Q½<ä 1 000 Ķ

solution
° 3 ã<÷ì¤rE£¤Z
(X)/ng·mL−1  

3  1 2 3 4  X
 R
1 18.89 19.88 19.36 19.72 19.46 0.99
ǯþ}N_ððKÜ¡xñò1ñîÄ
2 19.75 19.53 19.66 19.62 19.64 0.22
óôz$¡BJ[5]uv¤rÙ³[¤rZ 3 19.50 19.21 19.99 19.06 19.44 0.93
3.1 ¤rÙär 4 18.68 20.26 19.40 19.96 19.58 1.58
5 19.59 19.70 19.66 20.15 19.78 0.56
3.1.1 õU[ö· CPA225D £ þ " ¶ ( ÷ v
6 19.25 20.42 19.80 19.93 19.85 1.17
Sartorius)’AA-7000 ¯ þ} N_ ðð K¬(Ô´ 7 20.43 20.14 20.54 19.67 20.20 0.87
Shimadzu)’MARS5 ÓĬâø(Wv CEM ùú)’ 8 20.55 19.41 19.93 20.02 19.98 1.14

óûôzOP’(vüOPÍ%&Ä1 ý~ 9 18.99 19.70 19.68 19.18 19.39 0.71

10 19.28 20.53 20.45 20.19 20.11 1.25
GBW08614 10081 ¬K~1 000 µg·mL−1)’¶å 11 20.46 20.04 19.76 19.94 20.05 0.70
(MERCK Mþ
)Z 12 19.59 19.70 19.66 19.45 19.60 0.25

3.1.2 ¤ßˆ[‰Ü ¤ßˆv¯Œ~q 13 19.86 19.13 19.60 19.91 19.63 0.78

14 18.97 19.99 20.07 18.78 19.45 1.29
\¨*u[gƒo_—¡áß4 6 15 18.99 19.78 19.36 19.08 19.30 0.79
\¡§u[g¡áß4 Z¤ßˆ 16 18.81 20.39 19.10 19.49 19.45 1.58

MÇ\³ m ¨ n $¡ $¡§D 17 19.76 19.91 20.03 20.53 20.06 0.77

[3] 18 18.89 19.98 19.10 19.02 19.25 1.09
¥är*¤rÙ CD°PŒ ƒ„$¡BJ
19 19.52 19.51 19.23 19.77 19.51 0.54
ې¤Z 20 20.83 20.11 20.03 20.24 20.30 0.80
´#Ĉ¤ßóûôzOP’ 21 18.86 19.80 19.30 19.62 19.40 0.94
22 18.71 20.17 19.48 19.63 19.50 1.46
 ¢\‰ÜÄv· 2010 Ò6àxñò
23 19.46 19.07 19.25 19.86 19.41 0.79
1ñîó$¡É}böߒr‰Ü[5]Z¢\ 24 19.55 18.68 18.52 19.91 19.16 1.39
’Ð䒍Z 25 19.47 19.91 19.68 20.19 19.81 0.72

 2014 1
 31  1 Chin J Mod Appl Pharm, 2014 January, Vol.31 No.1 g117g
3.1.5 är R ¤rÙp X ¤rÙ þ¨¶°ª ( R Ùp X م$%°° ìx$¡B
m
¶°ª X ¬ùk~ X = 1 ∑ X ’þ¨P¿ J1 
{_—vo* ³•¤
m i =1 rv Ü{ R Ùg X Ùv!ÇÔD$¡B
m
¶°ª R ¬ùk~ R = 1 ∑ Ri Z J§D[¹¤ÄZ
m i =1 3.2 ¤rÙuv
3.1.5.1 R ¤rÙ ËD~¬[¤rÙ¤rEù 3.2.1 ¡‰Ü ¡áß 0.5 g ÇÄv·
[3]
k {~Ä1¸ CL= R ’(¤rE UCL=D4 R ’ 2010 Ò6àxñò1ñîÉ}ó$¡‰Ü[5]
}¤rE LCL=D3 R Z r¦böߒ’Ç3.1.3 É}‰Ür¤
\Ä D3 D4 g n 5q§Z´#Äá ’gÇÈߒZböߒæ¤’p
[3] ÇÈߒ :óø¯þÊU Ü¡
´ôÆ n=4 ˬ[¤rÙ¬¤rEq§w
Ä%¦~q§ D3=0 D4=2.282Z%¦q§±• ¬ܦZ
ùk {¦Ä1¸ CL=0.93’(¤rE UCL=2.12’ 3.2.2 ¤§D¬ Ü¡(¤’
}¤rE LCL=0Z ¬ ¦ 4 ¨ó‚[(Xi)_o~20.47 19.32
ã<äÙrà R ¤rÙ ÅÙ 1Z 19.91 20.98 ng·mL−1Z±•P¿æ°ª¬ùk
ܦ´ýáߤª~Ri=1.66 X i =20.17Z
3.2.3 òÏ°#  Ri ªg X i ª_o±• R Ùp
X ÙÄ òÏ 2 <§ª°ì(æ}¤rEK
೒ 1 R ࣅᄥ෍
 wx$¡BJ¢!¤* ¿ýáß$¡
Fig 1 R control diagram òÏP"{·ZRi ªæ X i ª 2 <Ä Loq<

CDuD~¤rÙx[3]°PŒ Ù 1 ŧ ì(æ}¤rE£¤ Üwì$¡BJ1Kç

D<°K¤ ®„DkQôõ w ¤r uÛÜ$%¯y ö:²C 8Id¡
xBJ¢!«¬¤r* gÜBJàâJK ¿$¡Sàáß[3]Z
(¨h¿) Ç R Ù°Z 4 ߚᵤϢ䅼䆎
3.1.5.2 X ¤rÙ ËD~¬[¤rÙ¤rEù ¤rÙ$¡BJ¤ruvÇ!…B 2 È
 Ü_—vp¤rvZ_—v
k [3] {  ~ Ä 1 ¸ CL= X ’ ( ¤ r E UCL=
 ÀFGSo’$¡BJ¸|L* BJ
X +A2 R ’}¤rE LCL= X −A2 R Z
° ¾[¤rÙ¤r¸ ³•¤rv
\Ä A2 g n 5q§Z´#Äá´ô
v!ÇÔD$¡BJ§D°#[6]Z
Æ n=4 ˬ[¤rÙ¬¤rEq§w[3]Ä%
cärP"æ¤rÙ Ç!6Sy
¦~q§ A2=0.729Z¿q§±•¤rEùk
"¡Çh#{¡[òÏ$¿Zy¤
{¦~Ä1¸ CL=19.65’(¤rE UCL=20.33’
ß(ý%OP)Ç!qøæh@ÆÍ
}¤rE LCL=18.97Z
ß µDˆvOPÍ{±w"¡ÇZˆ
ã<äÙrà X ¤rÙ òÏ)Ù 2Zg(æ
¤ß ®o{%=k—&üpý -Œv
}¤rEÇ$% Ù 2 ŧD<°&K¤
d¤ß
u\p¯¤ß
$¡
g®„DkQôõ "BJšâ®

ÌhØ {:BJ¨h¿ ¯¤Ù(•– Ťr* Œ®Ç

 ¢!«¬¤r* Ç X Ù°Z ä¤rْÅôgh u'Ö¯y Å¡

ª…¢C{¦LmxòÏ Œ{ãäv¯
¤Ù(¤ªS¢C) jÇ!ìx¼½8¨©Z
Ë(ÃÙBJ{:Ž. R ¤rÙK¤
*÷«L X ¤rÙ yu¯( R ¤rÙZ
ÅÏ R ¤rÙ®)©°PŒ MoËÖ*æÝ
೒2 X ࣅᄥ෍
Fig 2 X control diagram æ+,æ‰Üæ-.æ¡[/‰8³_—

g118g Chin J Mod Appl Pharm, 2014 January, Vol.31 No.1
 2014 1
 31  1

Ö.«yz
8Ç\³²C
IdÉæ yz
*Z
§D( R ¤rÙ
3L{:°€Z
REFERENCES
v¤rÙÇ$¡BJ¹¤

uCDÔD
[1] Accreditation Criteria for the Competence of Testing and
ÂÃÄ¿É
¡[Llp¡[Ö*Ã01
Calibration Laboratories()
JK
½C-

¤ßrá
$¡ [S]. 2006: 25.
áß
³¡’Çî01Ö*p¡[ [2] China National Accreditation Board for Laboratories(CNAL).
Laboratory Accreditation and Management Basics(
LlXÉ

½¾u
¡[¤ßZ  !) [M]. Beijing: China Metrology Publish
ÔD¹¤

X ¤rÙ(¤<AE
µD House, 2003: 102-113.
wì$¡BJ®æ$¡§DP"K{;ZR ¤ [3] GB/T 4091-2001 Shewhart Control Charts("#$%&) [S].
2001.
rÙ(¤<AE
wì$¡BJq„2Q°ê [4] Department of Quality Management, General Administration
2{|./™š
«L§DèéKZ܌° of Quality Supervision, Inspection and Quarantine of
P.R.C.(AQSIQ). Professional Theory and Practice of Quality
#òÏwx$¡BJ¢!¤r*
{CD4 (Intermediate)['()*+,(
-)] [M]. Beijing:
Ÿ/¡ª_ôõ
Ç¡[[{|Xk
23™š³45°#~µDôÞ2hÊ(Å./
E1§<ßà(óQ}Q¢Ä1¸qj
/)@{|q«µ¿ƒ„’èéKhÊ(ÅE
1§<ÄØ6KBô)yÀF§hÊK¤QÖ
China Personnel Publish House, 2002: 320-332.
[5] Ch.P(2010)Vol .(
/ 2010 0. 12) [S]. 2010:
1205.
[6] GUO Y L, CUI L R, ZHANG C Y. The analysis of nonrandom
behaviors on a control chart [J]. Appl Statis Manage(345
), 2007, 26(3): 468-474.
ᬊ〓᮹ᳳ˖2013-03-25

 2013 


  
    !"#$%&'()*
+,%'-./*0(123%+45678*9:;<=>?*@AB:+CDE%FG HIJ
KLMN9OPQR(1ST1*UVPWXY%Z[\

]^_ `ab cde cfg chi cjk clm c n cEo pqr

pst ufg vwx +ym +zt {m| {}~  € ‚ƒ „…†
‡ˆf ‡‰+ ‡Š‹ Œf Œ 8 Ž ‘ ’ “”• –—t –˜™
– š ›œ žjŸ ž   ¡¢£ ¤ ¥ ¦§¨ ¦©ª « ¬ «ª­
®¯° ±²m ±³´ µ…¶ ·¸¹ ºNr »¼’ ½¾y¿ À˜Á ÂÃÄ
 ’ ÅÆÇ Å^È ÉˆÊ Ë y ËhÌ Ë Í Ë Î ËÏÏ ËÐÑ
ËÒ´ ËÓÔ ËՃ ËÖ× Ë  ËØÙ ËÚÛ ËEÜ ËEÝ Þ Ç
ßàá ߊâ [ãä åæç èáé ê ë ê¯t êì€ íîï ðñr
òóô õ ö õ ÷ õw” õŠ” ø ù úhû üýþ
 
+…   r  

 2014 1
 31  1 Chin J Mod Appl Pharm, 2014 January, Vol.31 No.1 g119g