DOI:0.3422/j.cnki.syfjx.202..02 8 202 6 Vol. 8 No. Jun. 202 3 2 2* 2*. 0002 2. 0002 3. 0300 Shewhart EWMA SPE Shewhart EWMA R283. 6 A 005-9903 202-006-05 Application of Statistical Process Control in Pretreatment Production Process of Gardenia jasminoides 20202 009 200ZX09502-002 JYB22-XS034 E-mail zhouhaiyan89@ sohu. com * Tel 00-84738620 E-mail yjqiao@ 263. com * Tel 00-8473862 E-mail shixinyuan0@ 63. com 檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶檶 90% liquid chromatographyj. Chin Pharm J99429 38. 7 Tomoda MKato SOnuma M. Water-soluble constituents of Rehmanniae Radix I carbohydrates and acids of Rehmannia Glutinosafhueioh ingensis J.. Chem Pharm Bull979 7 455. J. 2007 22 7 02. 2. 9. J. J. 2007 42 7 486. 2006 2 7 34. 3. 0. J. J. 997 22 7 408. 2000 4 30. 4. α- β-. J. 2006 29 J. 20084 2 37. 5 LI G S LIU C H WANG H Set al. Assaying of content of catalpol in Rehmannia glutinosa from different origins J. Chin Tradit Herb Drugs200233 2 26. 6 LUO Y YZHANG S QSUO J Zet al. Determination of catalpol in Radix Rehmanniae by high performance 6 8. J. 2007 5 6 40. 5 38. 2. J. 20 7 8 38.
ZHOU Hai-yan 3 XU Bing 2 SHI Xin-yuan 2* QIAO Yan-jiang 2*. School of Chinese MedicineBeijing University of Chinese MedicineBeijing 0002China 2. Key Laboratory of Traditional Chinese Medicine Information EngineeringState Administration of Traditional Chinese MedicineBeijing 0002China 3. Yabao Beizhongda Beijing Pharmaceutical Co. LtdBeijing 0300China Abstract Objective To study on application of statistical process control in pretreatment production process of Chinese medicine with pretreatment production process of Gardenia jasminoides from Qingkailing injection as carrier. Method Univariate statistical process control for extraction ratio of geniposide was researched by Shewhart control chart and EWMA control chart Based on principal component analysis modelmultivariate and SPE control charts for pretreatment process of G. jasminoides were built Technology process was diagnosed by contribution chart. Result Shewhart and EWMA control charts could be achieved monitoring quality parameters in pretreatment technology of G. jasminoides Multivariate statistical process control chart could be successfully applied in monitoring multiple process parameters process analysis and fault diagnosis could be achieved by combining with contribution chart. Conclusion Combination of univariate and multivariate statistical process control could be well monitored and understood of production process for traditional Chinese medicine. Key words statistical process control control chart Gardenia jasminoides production process principal component analysis process diagnosis 2008 ~ 200 7 8 A ~ H 32 SPC SQC TQM SPC B C 2 D 3 F F F 2 F 3 F 4 F 5 F 6 G G G 2 G 3 G 4 G 5 G 6 4 H H H 2 H 3 SPC MathWorks univariate SPC USPC multivariate SPC MSPC 7 32 X 2 Y Kennard-Stone 3 /4 X train Y train 87 /4. X pre Y pre 30 A E A B B 2 C C 2 C 3 C 4 D D 2 D 3 E E 2 E 3 E 4 E 5 E 6. 2 Matlab 7. 2. 3 7 E 7 7
8 202 6 Vol. 8 No. Jun. 202 XS = X - X mean S X mean X S X 2 USPC USPC y i y i 2. Shewhart UCL = μ + kσ LCL = μ - kσ 2 3 μ Y train σ Y train k 2 3 k 3 30 0 ± 3 Y pre Shewhart Shewhart 2. 2 EWMA EWMA 6 5 3. EWMA t = λy t + - λ EWMA t - t = 2 n 4 EWMA 0 0 Y t t 3 n = 30 λ 0. 2 ~ X train 87. 8% 0. 3 λ 0. 3 EWMA MSPC 3. 2 MSPC MSPC λ UCL = EWMA 0 + ks 槡 2 - λ 5 λ LCL = EWMA 0 - ks 槡 2 - λ 6 k Shewhart k s EWMA ±. 2603 EWMA 2 SPE 7 8 2 EWMA ~ 2 30 32 USPC 32 3 MSPC PCA PLS CPV > 85% MSPC SPE
3 D D-statistic T 2 lim K N - = N - K F K N - K α 7 N K K α F F SPE Q Q-statistic [ ] c SPE α = θ α 2θ 槡 2 + + θ 2-2 θ θ θ i = m j = K + λ i j = - 2θ θ 3 3θ 2 2 8 8 λ X train C α 4 α K Q 7 m X train Q α = 0. 95 87 23. 86 7 SPE 7. 584 α = 0. 99 i j 30. 998 7SPE SPE 9. 822 3 3. 3 MSPC Hotelling T 2 k 5 SPE Q 5 8 30 5 5 Q SPE MSPC H 2 F D 4 Shewhart 0 30 0 Q 6 SPE 5 4 A. B. SPE 30 MSPC 9 j i Q Q ij = e 2 = X ij - ^X ij 2 9 X ij i j 6 0 SPE H 2 A G 5 PCA F 9 ^X ij
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