CN108090669A - A kind of Quality Evaluation of Chinese Medicinal evaluation method - Google Patents
A kind of Quality Evaluation of Chinese Medicinal evaluation method Download PDFInfo
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Abstract
The present invention provides the method for evaluating quality of a kind of Quality Evaluation of Chinese Medicinal evaluation method, particularly Chinese patent drug.This method based on raw material in Chinese medicine manufacturing process, extraction, preparation, pack, keep sample and launch after material in research process, technique, mass parameter, consumer feedback and its specific data, it is obtained with present lot data compared with history lot data, by weight distribution, a composite index centered on 1, so as to expressing the quality state of the Chinese medicine.Method provided by the present invention, it would be possible to influence Chinese patent drug safely, effectively, batch stability, batch first-class material, quality, technological parameter evaluated, can comprehensively, delicately evaluate the interior external quality of Chinese medicine.
Description
Technical field：
The invention belongs to the field of Chinese medicines, and in particular to a kind of method for evaluating quality of Chinese medicine.
Background technology：
Chinese medicine is the main tool that the traditional Chinese medical science is prevented and cured diseases, and includes Chinese medicine, medicine materical crude slice, Chinese patent drug on specific application form
(preparation).The corresponding result that it uses the inspections such as sense organ, physical chemistry to obtain of " the true and false quality " of Chinese medicine and its standard figures (model
Enclose) and " quality " of acquisition is qualified or not.The fine or not and qualified or not of Chinese medicine is all to carry out final assessment with quality standard.Due to
The chemical composition ratio very little that Chinese medicine can directly control at present, therefore, traditional Chinese medicine quality (drug) standard employ whole quality
Control, as Quality of Chinese Traditional Proprietary Medicine standard content generally comprise raw material (prescription), process (preparation method), finished product (qualitative, quantitative inspection) this three
A link.Medicinal material (medicine materical crude slice) factor controllability is worst and control is wide, and finished product detection controllability is good but control plane is minimum, preparation method
Controllability is placed in the middle with control plane, is the intermediate link for influencing Quality of Chinese Traditional Proprietary Medicine.
For the preparation method of Chinese patent drug in addition to ensureing preparations shaping and reaching finished product standard, inherently required is that reservation drug may
Need but not yet can qualitative and quantitative detection most materials.These substances are generally present in production process with certain product form
In, such as extracting solution, concentrate, medicinal extract, generally using relative density as distinguishing rule, such as " being concentrated into relative density is
1.10-1.20(50℃±3℃)”.Therefore, production control in this case has very big quality uncertainty.
Since raw medicinal material (medicine materical crude slice) natural products quality fluctuation is big, the uncertain strong double influence of production control, in
The quality fluctuation of patent medicine is very big, and outstanding behaviours fluctuates big, same place for index components content and the rate of transform, solid content (medicinal extract)
The different manufacturers product of side and preparation method difference is huge.Such as Liuwei Dihuang Wan, there is significant difference between the content of different manufacturers,
RSD reaches 11-33% (fresh clean morning, Zhang Ning, Feng Yi Liuwei Dihuang Wans quality difference analysis [J] Chinese patent drugs 2009,31:882-
886)。
The quality of Chinese medicine
The quality of Chinese medicine and quality are distinguishing concepts of being related, the former covering surface is wider, can more embody Chinese medicine
" quality ".Since traditional Chinese medicine ingredients complicated difficult with single component or several ingredients to be evaluated, Chinese patent drug is then by several tastes
Even tens taste Chinese medicines constantly extract, purify and be made, and being evaluated with 1-2 ingredient more seems and be difficult to reflect it
Real inherent quality.With the continuous improvement of analysis level, there is the methods of research institution is controlled using multicomponent at present to system
Agent carries out quality control, but there is certain limitations for implementation and application.Quality is because of design, in the work of a high quality design
The front lower centre having to of skill premise controls and performs operation, just can guarantee that product handles one and stablizes equal water always
It is flat.With the development of electronic system and big data, Manufacturing Executive System MES, distributed computer control system DCS, using pre-
Alert deviation is set, and production process is monitored in real time, using TPCMS data collecting systems, to the data in production process into
Row acquisition, analysis.Quality to control product comprehensively has worked out whole set of system, safe and effective, stable, homogeneous so as to obtain
Product.These contents are it is possible that form more traditional " quality " widely " quality " concept.The quality research of Chinese medicine, by specialty
Document and patented technology retrieval, it is as a result as follows：
2006, martial prowess medicine company proposed " making high-quality Chinese medicine brand ", and " quality is cast ' martial prowess ', in the high-quality modern times
Medicine " is taken the lead at home using industry is integrated and automatic control technology, a variety of leading process combinations apply to traditional Chinese medicine extraction, concentration,
In purification process, carry out to the property made traditional Chinese medicine injection PRODUCTION TRAITS；The fund that new product development is put into over more than 10 years alreadys exceed
1000000000 yuan, domestic first Automatic Control traditional Chinese medicine extraction production line is built up；Carry out tracking control of full process control and quality responsibility
Investigate system；The raw material of each medicine from where, who production, who examine, can be checked within a hour absolutely clear
(Lei Han hair martial prowess medicine companies make high-quality Chinese medicine brand [N] Economic Daily, 2006-09-08 (002), Wang Qinli, Zhang Teli
Quality cast " martial prowess " high-quality modern Chinese herbal medicine [J] capitals medicine, 2007, (07):49-50.).
2008, Wan Deguang defined the connotation and extension of Quality Evaluation of Chinese Medicinal for the first time, it is proposed that Quality Evaluation of Chinese Medicinal is theoretical.From idea
On emphasize that Quality Evaluation of Chinese Medicinal is the characteristics of modern quality produced is seen, embodies national characteristic and cultural (drug in ten thousand moral light
Matter research --- theoretical, method is with putting into practice [M] Shanghai:Shanghai science tech publishing house, 008.).Propose " Quality Evaluation of Chinese Medicinal something lost
(the tight casting cloud Wan Deguang professors review of Quality Evaluation of Chinese Medicinal academic thought [J] is sub- for nine arguments of the Quality Evaluation of Chinese Medicinal such as hero of biography introduction " theory
Too traditional medicine, 2012, (01):1-2.), (ten thousand moral light discuss inheritance and innovation [J] the Chinese medicines of Quality Evaluation of Chinese Medicinal theory with clinical,
2010, (01):3-6.), (ten thousand moral light Quality Evaluation of Chinese Medicinal research [J] Chengdu Medical College journal, 2011, (04):279.).2010
Year, Zhang Wensheng etc. summarize Wang Yong it is scorching " system Chinese medicine --- product, matter, property, effect, with " integral system Research Thinking, it is right respectively
Answer " kind and its research " of Chinese medicine, " quality standard and Study on influencing factors ", " idiomaticity and security ", " pharmacological effect and
(Zhang Wensheng Chinese medicines " quality effectiveness " are integrated for metabolism " and " clinical practice, drug development, Chinese traditional medicinal economy and study on the industrialization "
System research --- the State Administration of Traditional Chinese Medicines of [A] by taking radix scutellariae as an example, China Association of Traditional Chinese Medicine Second combination of Chinese tradiational and Western medicine brains
Sick diagnosis and treatment new development Senior Workshop expert teaching materials and paper compilation [C] State Administration of Traditional Chinese Medicines, China Association of Traditional Chinese Medicine:
2010:7.).The operability of the two concepts is weaker.
2015, the propositions such as Liu Tao were based on the research method of the medicinal quality evaluation of Chinese medicine of " ingredient clinic utilization rate ", solution
The defects of certainly current medical material quanlity is evaluated mainly using effective component amount as main evaluation index (Liu Tao, Gou little Jun, Wan Deguang, Xu
The business that beautiful tinkling of pieces of jade is based on the medicinal quality evaluation model of Chinese medicine of " traditional Chinese medicine ingredients clinic utilization rate " builds [J] Chinese herbal medicines, and 2015,
(13):1863-1866.).The traditional Chinese medicine quality of the concept and Xiao little He " multicomponent comprehensive quantifications comments prosecutor method and application " technology
(Xiao little He, Wang Jiabai, Tan Peng wait a kind of traditional Chinese medicine qualities of multicomponent comprehensive quantification of to comment prosecutor method and application [P] Beijing：
CN201510324220.4,2015-09-09.) intension is consistent.
2017, peak proposed the " base chiller of the multi-method+reasonable Chemical Evaluation based on pharmacopeia+planted based on suitability
Traditional Chinese medicine quality evaluation thinking (the China TCM Academy of Sciences Xiyuan Hospital peak of standardized planting+specification grade of training zoning "
Quality Evaluation of Chinese Medicinal evaluation needs [N] the China traditional Chinese medicine report that sets out again, 2017-05-11 (005)).Peng is adhered into proposition " in system
The characteristic of pharmacy ", the method evaluated with multidimensional study carefully key element, structure and the function of Chinese medicine complication system, the kind of Chinese medicine,
Quality, pharmacy, pharmacological property, effect, using (referred to as " quality effectiveness "), wherein " quality " quality refers to the quality of Chinese medicine, instead
What is reflected is the quality of the intrinsic overall permanence of Chinese medicine germplasm, seedling, cultivation, harvesting, Habitat producing, processing, preparation etc., is included
Exterior quality and interior quality two parts.Exterior quality will refer to the character quality of Chinese medicine, shape based on " distinguish shape discuss matter ",
Color, gas, taste and microscopical characters, the quality evaluation that physical and chemical determination is means；Interior quality mainly includes inhereditary material and drug effect object
Matter.Chinese medicine hereditary quality is mainly to study the biological heredity characteristic and advantage of medicinal material, the germ plasm resource of fine quality, genetic diversity
Property, production, the relation of clinical efficacy of variety diversity, genetic molecule mark and inhereditary material and high-quality medicinal material.Herbal medicine efficacy
Substance is the major way for demarcating Chinese medicine interior quality, and research is mainly applied chemistry and the technology and method of biology, shows base
In the effective ingredient in Chinese, active principle, active ingredient of clinical efficacy, reach useful molecules formula and structural formula represents and has
(Peng discusses " system Chinese pharmacology " its " quality effectiveness " [J] Chinese medicine into facing to the quality mark object of certain physical constant again
Bed, 2017, (01):1-3.).It is Chinese medicine species that the meaning of combination two words of Chinese medicine and quality such as rough bamboo mat boat virtue, which is interpreted as Quality Evaluation of Chinese Medicinal,
Person's character, refer to the good and bad degree of herbal species grade, evaluation method pattern should diversification (in Da Fangfang, Dai Zhonghua, Zhu Hua
Drug matter evaluation study present situation and development trend [J] China traditional Chinese medicine academic periodical, 2017, (06):1485-1488.).These concepts
Operability it is equally not strong.
It is autograph and keyword with " Chinese patent drug quality ", without finding there is substance concept in middle National IP Network (CNKI)
With understanding (the quick near infrared spectroscopies of Wu Li quickly detect application study [D] the Southwest University of some Chinese medicines and Chinese patent drug quality,
2013.), (Liu Chenguang, applies influence [J] Strait Pharmaceutical Journals to Quality of Chinese Traditional Proprietary Medicine from slope Chinese medicines quality, and 1994, (04):62-
64.)。
At present, have with " Quality Evaluation of Chinese Medicinal " for the platform mechanism of goal in research：Shanghai Univ. of Traditional Chinese Medicine's new Resources of Chinese Traditional Drugs and product
Matter evaluation study room is State Administration of Traditional Chinese Medicine's primary study room, is set up in 2009, is responsible for artificial Wang Zheng great waves.It is studied
Direction includes：Safety evaluatio research (Shanghai Univ. of Traditional Chinese Medicine's Chinese medicine of quality standards in Chinese drugs Comprehensive Appraisal Study, toxic herb
New resources and quality evaluation research department --- State Administration of Traditional Chinese Medicine's primary study room brief introduction [J] Shanghai Univ. of Traditional Chinese Medicine is learned
Report, 2009, (06):88.).
New technology in relation to Quality Evaluation of Chinese Medicinal
Digital visual Chinese medicine is proposed for 2003 by Xiao little He etc..Method is using IT technologies, to the company of Chinese medicine tissue
Continuous section is automatically analyzed and handled, to obtain the topology information of Chinese medicine and its histiocytic three-dimensional geometric information, structure
Its solid shape structure is built and characterized, and shows that (Kang Wen Quality Evaluation of Chinese Medicinal realizes " visual " [N] in a manner of dynamic in real time
Chinese Medicine, 2003/10/18.).
DNA fingerprinting technology is proposed for 2003 by Cao Hui etc..This method is more more accurate than four traditional big discrimination methods,
Objective, the scope of application is wider, is very suitable for sibling species, confusion varieties kind, rare kind, animal drug, broken medicinal material, outmoded
Medicinal material, rot medicinal material and the extremely limited species sample of sample size, Chinese medicine are unearthed the precious samples such as sample, ancient collection of fossils
Identification (Cao Hui, research overview [J] the World Sciences of English .DNA molecular marking techniques in terms of Quality Evaluation of Chinese Medicinal and standardization
Technology, 2003, (01):39-47+82.), (Wu children, Zhao Qin, Zhang Xiaoyu, horse jump .DNA fingerprint pattern technologies are applied to middle drug
Progress [J] Chinese veterinarian's medical magazine of matter identification, 2008, (01):24-26.).
Such as, Wu Feng etc. proposes to differentiate that medicinal material is true using differential scanning calorimetry biological tissue's thermodynamics expression technology for 2005
Pseudo- (Wu Feng, the long cutting edge of a knife or a sword of beans, Zhang Huifang Quality Evaluation of Chinese Medicinal evaluation technique progress [J] Zhejiang combination of Chinese tradiational and Western medicine magazines, 2005, (09):
588.).Wu Yanwen is equal to 2005, Zhao Yanling is equal to 2008 etc. to establish the Chinese medicine reached based on thermodynamic table (folium isatidis, big
Yellow, Radix Isatidis) bioactivity and method for evaluating quality research, it is believed that more conventional chemical method is more accurate, reliable (military man of virtue and ability's text
Chinese medicine (the folium isatidis, rheum officinale) bioactivity reached based on thermodynamic table and research [D] the University Of Tianjin of method for evaluating quality,
2005.), (Zhao Yanling, the beautiful plum in mountain, Jin Cheng, Zhou Xu, Radix Isatidis quality evaluations of the Xiao little He based on biological heat activity expression
Research [J] Chinese medicines, 2008).
Sensory evaluation new technology is proposed for 2013 by Zou Huiqin etc., is to imitate people using electronic equipment (electronic nose etc.)
Body-sensing feels to evaluate Quality Evaluation of Chinese Medicinal, concocted quality, and making character objective expression, (Zou Hui qins is based on " gas " bionic olfactory system in
Methodological study [D] Beijing University of Chinese Medicine in the drug matter overall evaluation, 2013.), (Zhao Chongbo, Wu Chunjie Chinese medicines are drunk
Piece quality evaluation and concocting process quality monitoring new technology [J] World Sciences technology-TCM Modernization, 2014, (03):
529-531.)。
Bioelectric detecting technology Xiao Ying etc. is proposed for 2014.It generates and improves around active ingredient, realized using biotechnology
Quality Evaluation of Chinese Medicinal regulate and control, significantly promoted plant cell yield and utilize plant cell plant produced novel active product, energy
It ensures Quality Evaluation of Chinese Medicinal and realizes that (Xiao Ying, Sun Lianna, Zhang Lei, old ten thousand lifes Quality Evaluation of Chinese Medicinal study on regulation will be done step-by-step in quality-improving
Thinking and method [J] World Sciences technology-TCM Modernization, 2014, (03):506-509.).
Infrared fingerprint peak frequency Zou Hua Bin was proposed based on mathematical method and established a kind of based on IR fingerprint peaks in 2016
The intrinsic quality grade mathematical theory of biosystem Chinese medicine of frequency differentiates Chinese medicine, Chinese medicine compound prescription or other biological system quality
(mathematical theory of biosystem Chinese medicine intrinsic quality grades of the refined of Zou Hua based on finger-print differentiates [J] worlds traditional Chinese medicine,
2016, (09):1876-1881.).
Ecological technology Huang woods virtue, Chen Shilin are proposed for 2017, with ecological principle and technique study Quality Evaluation of Chinese Medicinal (Huang Lin
Virtue, Chen Shilin Quality Evaluation of Chinese Medicinal are ecological:One emerging cross discipline [J] Chinese experimental pharmacology of traditional Chinese medical formulae magazine, 2017, (01):1-
11.).The relation of the biology origin cause of formation, medicinal organism distribution, the place of production and the ecological factor that are formed including Quality Evaluation of Chinese Medicinal, Quality Evaluation of Chinese Medicinal,
High-quality medicinal material place of production Ecological Suitability and zoning, ecosystem regulation and control and influence of the protection to Quality Evaluation of Chinese Medicinal, high-quality natural resources of Chinese medicinal materials
Utilization, Quality Evaluation of Chinese Medicinal ecological theory system and technical method.Summarize ecological 6 basic theories of Quality Evaluation of Chinese Medicinal:
Environmental ecology opinion；Variety and quality continues to be discussed with place of production transition；Sustainable use is theoretical；It is environmental theoretical；Adverse circumstance effect theory；Base
Because specialization is theoretical.Describe the ecological Common Methods For Research of Quality Evaluation of Chinese Medicinal:Chemical Evaluation method, physics evaluation method, life
Object evaluation method.
The infrared finger print atlas refined publications of Zou Hua in 2015, according to the red of traditional Chinese medicine ingredients content, species and structural information
Outer finger-print information determines the information threshold standard of the different quality grade Chinese medicines of reflection, establishes the different quality grades of Chinese medicine
A kind of science method for quick identification (method for quick identification [P] the Shandong of Chinese medicine difference quality grades of the refined of Zou Hua：
CN104698144A, 2015-06-10.).It is also possible to differentiation (the refined of Zou Hua are detected to the quality of same quality Chinese medicine
A kind of detection method of discrimination [P] Shandong of same quality Chinese medicine：CN104458632A, 2015-03-25.).
The publications such as automatic detection system for quality of Chinese medicine Wu Chunjie in 2012, including：Kind is selected, determines parameter and power
Weight；Parameter detecting employs electronic visual system, electronic nose, electronic tongues and the appearance shape of Chinese medicine, color, gas, taste parameter is examined
It surveys, while with spectrophotometry or chromatography or common detection methods to chemical composition content parameter, the safety detection of Chinese medicine
Parameter and conventional detection parameter are detected；By the comparison with setup parameter, the tested herbal species true and false and opposite ginseng are drawn
The good and bad value of number；Quality computing module be used for according to the good and bad value of each relative parameter and weight coefficient be calculated quality value (Wu Chunjie,
Huang Qin is drawn, Song Ying, Li Jianghua, Ai Li, Li Min, Sun Ling root automatic detection system for quality of Chinese medicine [P] Sichuan：
CN102435713A, 2012-05-02.).
The Chinese medicine electronic micro image analysis present invention, which is handled and integrated to Chinese medicine micro-image using electronic technology, to be commented
Valency goes out its intrinsic product with reference to chemical composition of Chinese materia medica content parameter, safety detection parameter and conventional detection automatic detection technology of parameter
A kind of matter (Zhou Weihua automatic detection system for quality of Chinese medicine [P] Jiangxi：CN105973858A, 2016-09-28. substantive examination).
Biological indicator evaluation Quality Evaluation of Chinese Medicinal is included from external clearing heat and detoxicating using the method characterization of anti-rabbit red blood cell condensation
The anti-influenza virus activity of class Chinese medicine characterizes the immune anti-inflammatory work of antipyretic and antidotal type Chinese medicine with the method for anti-mouse spleen enlargement
Property (Pan Weisong, Pan Chao U.S. are a kind of for the evaluation of antipyretic and antidotal type Quality Evaluation of Chinese Medicinal and biological detection method [P] of quality control
Guangzhou:201611072033.2 2016-11-29. substantive examinations).
Quality Evaluation of Chinese Medicinal composite index (evaluation method) is the publication technology of 2017 such as Xiao little He.Using gore
Area method handles the data of Chinese medicine experience, chemistry, biological 3 dimensions, utilizes the triangle area divided by maximum of each sample
Triangle area is to get quality composite index.Traditional Chinese medicine Overall View is embodied, has merged traditional cognitive and Contemporary Cognition, is associated
([1] Xiao little He, Wang Jiabai, determine Kun, and a kind of integrated evaluating method of Quality Evaluation of Chinese Medicinal [P] of the bright of ox are northern for effect and security
Capital：CN106353469A, 2017-01-25. substantive examination).Based on this, Chinese traditional Chinese medicine association recommended industry standard is formd
《Quality Evaluation of Chinese Medicinal evaluation method guide》, in May, 2017 issue.The technology is the technology of target most operability, but is evaluated
Scope is still confined to medicinal material, medicine materical crude slice.
In conclusion the concept and its technology of " Quality Evaluation of Chinese Medicinal " are known together not yet, and content is limited to medicinal material, medicine materical crude slice.Due to
The concept of Chinese medicine includes Chinese medicine, medicine materical crude slice, patent medicine, and " Quality Evaluation of Chinese Medicinal " concept needs the concept and range according to Chinese medicine further fixed
Justice.Chinese patent drug is one of Major Clinical application form of Chinese medicine, is from Chinese medicine → medicine materical crude slice, using prescription, extracting and developing essence
System, preparations shaping, packaging, storage transport, could be for consumer use.Each factor of this whole process, it is including material, plus
Work process, each factor for even packing Chinese patent drug product may all be made to generate certain influence or even a part to consumer
Chinese patent drug product quality (security and validity) only consumer passes through using can just embody.Therefore, it is necessary to an energy
Enough in summary whole materials, information flow and process, even consumer feedback's evaluation integrated quality evaluation method.
The content of the invention：
In order to overcome the shortcomings of current traditional Chinese medicine quality and method for evaluating quality, the present invention provides a kind of Quality Evaluation of Chinese Medicinal evaluation side
Method, the material run-of-the-mill information of particularly comprehensive whole Chinese patent drug manufacturing processes, technological parameter etc. by control indication information, with
And the method for evaluating quality of consumer evaluation's information.
The present invention provides a kind of Quality Evaluation of Chinese Medicinal evaluation method, and this method is based on raw material, extraction, system in Chinese medicine manufacturing process
Agent, pack, keep sample, the material after launch in research process, technique, mass parameter, consumer feedback and its specific data
, it is obtained with present lot data compared with history lot data, by weight distribution, one centered on 1 is comprehensive
Hop index, so as to expressing the quality state of the Chinese medicine.
Quality Evaluation of Chinese Medicinal evaluation method of the present invention, includes the following steps：
(1) input parameter selects：
(1.1) be derived from the Chinese medicine material of the same Chinese patent drug of history qualification production batch, medicine materical crude slice, Chinese patent drug intermediate products,
Chinese patent medicine preparation finished product and its standard test that keeps sample as a result, including but not limited to foregoing medicine materical crude slice, intermediate products, preparation according to
《Chinese Pharmacopoeia》Or other standards examine the whole for obtaining testing result quantitative or qualitative numerical value；(1.2) it is qualified raw to be derived from history
Produce the parameters of technique process of extracting and developing in the production process of the same Chinese patent drug of batch, concentration, drying, preparation and packaging, bag
It includes but is not limited to previous process process according to the Chinese medicine registered standard, the fabrication process parameters title and its tool of technological procedure requirement
Body numerical value；
(1.3) it is derived from uniformity testing knot in the batch of the Chinese patent drug product of the same Chinese patent drug of history qualification production batch
Fruit, and represented with " 100%- uniformity of dosage units relative standard deviations RSD "；
(1.4) the history number of consumer's adverse reaction monitoring after being derived from same Chinese patent drug product clinical research and listing
According to the former is represented with " 100%- adverse reaction rates (percentage) ", and the latter is with " 100%- adverse reactions report number of cases/right
Seasonable interior lot number × 100% " represents；
(1.5) the efficiency evaluation result and consumer feedback's history being derived from after same Chinese patent drug clinical research and listing
Data represent with " satisfaction rate " (percentage), the evaluation of Objective and subjective evaluations, sensory experience including curative effect；
(1.6) parameter of corresponding above-mentioned (1.1)-(1.5) of same Chinese patent drug of new production batch is derived from, wherein
(1.4), the data of acquisition are studied after listing of (1.5) data for specified present lot；
(2) input parameter data processing：
(2.1) input data (1.1) and the history average of (1.2) and standard deviation S D；
(2.2) input data (1.6) is in the history mean value ± standard deviation S D of input parameter (1.1) and (1.2)
The percentage of corresponding wide parameter quantity；
(2.3) ratio that counts (percentage) of corresponding input parameter (1.3) data of input data (1.6)； (2.4)
The ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), wherein data take corresponding title
One group of data；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6)； (2.6)
Weight decomposition is carried out in 100% with above-mentioned (1.3), (1.4), (1.5), is added " e numerical value weight and "；
(2.7) above (2.2)-(2.5) are subjected to weight decomposition, addition divided by (2.6) e numerical value weights in 100%
With, obtain one 1 near numerical value (quality composite index Q)；
(3) result judges：
(3.1) during Q=1, show that the quality of the same Chinese patent drug of new production batch maintains an equal level with historical level, at the Chinese medicine
In stable state；
(3.2) during Q ＜ 1, the quality of same Chinese patent drug of new production batch is shown less than historical level, Q is smaller to be shown
Chinese medicine stabilization sexual deviation is bigger, and quality reduces；
(3.3) during Q ＞ 1, the quality of same Chinese patent drug of new production batch is shown higher than historical level, Q shows more greatly
Chinese medicine stabilization sexual deviation is bigger, and Quality advance.
For the technical terms occurred in evaluation method of the present invention, further explanation and explanation are made：
(1.1) Plays inspection result, including but not limited to according to《Chinese Pharmacopoeia》Or other standards are examined and obtain the complete of testing result
Portion quantifies or qualitative numerical value；Wherein, all quantify or qualitative numerical value includes but not limited to：The qualitative examination project of medicine materical crude slice or tablet
Qualified or not, moisture, extract content, leading indicator component content, the inspection of HPLC finger-prints and similarity etc..
(1.2) parameters of technique process in includes but not limited to；Amount of water-temperature and pressure, the extracting solution of each extractor
Amount-proportion-HPLC collection of illustrative plates similarity, thickening temperature-pressure, concentrate total amount-proportion-solid content-HPLC collection of illustrative plates are similar
Property, auxiliary material usage quantity, mix when it is m- mixing motor current value, particle size distribution-content, always mix amounts of particles, tabletting
Pressure-piece redistribution-hardness etc..
(1.3) in batch uniformity testing as a result, include but not limited to；Solid pharmaceutical preparation always mixes powder (particle), finished product sheet
The uniformity of agent content, such as the content standard deviation of parallel 5 samples and the ratio of its average value
(RSD)；Liquid preparation always mixes liquid and carries out leading indicator component content measure after uniform sampling in preparing tank body, takes
Ratio (RSD) between its standard deviation and its average；With a batch finished product with standing time, different time set quota contains
It is fixed to measure, and takes the ratio (RSD) between its standard deviation and its average.
(1.4) historical data of consumer's adverse reaction monitoring in includes but not limited to；The product of manufacture in certain month is through consumption
The adverse reaction number of reports that person generates after taking.
(1.5) efficiency evaluation result and consumer feedback's historical data in include but not limited to；The product of manufacture in certain month
Subjective satisfaction evaluation scoring after consumer takes, to the complaint quantity of product packaging quality problems.(2.1) history is equal
Value and standard deviation S D；Computational methods are as follows：Historical data such as certain products material medicine materical crude slice content is x1, x2, x3 ..., and xn should
The history average of index " certain products material medicine materical crude slice content " is：Flat X=(x1+x2+x3+ ...+xn)/n, standard deviation calculation
Formula is：
Sample X1 used by representative, X2 ..., the average of Xn
(2.2) percentage of the corresponding wide parameter quantity of history mean value ± standard deviation S D；Computational methods are as follows：Point
Other input data (1.6) is in the corresponding scopes of history mean value ± standard deviation S D of input parameter (1.1) and (1.2)
The percentage of number of parameters, i.e., whether the new numerical value of more same parameter is in the corresponding models of its history mean value ± standard deviation S D
In enclosing, then by all number of parameters in the range of divided by total number of parameters, such as parameter sum 100, there are 90 parameters
New value in average and one Standard deviation-Range, then obtain numerical value 90/100=90%.
(2.3) ratio that counts (percentage) of data；Computational methods are as follows：I.e. input parameter (1.6) corresponds to input parameter
(1.3) ratio that counts (percentage) of data, for example, take it is newest " solid pharmaceutical preparation always mix powder (particle) content the uniformity (such as
The content standard deviation of parallel 5 samples and the ratio R SD of its average value) obtain 98% as it such as 2%, 100%-2%
Evenness divided by its history average 98%, the ratio of acquisition is 1 (100%).(2.4) ratio that counts (percentage) of data,
Computational methods are as follows：That is the ratio that counts (percentage) of corresponding input parameter (1.4) data of input parameter (1.6), such as takes newest
The adverse reaction number of reports such as 3 that monthly product generates after consumer takes, this month production 100 batches, with " 100%- adverse reactions
Report number of cases/in correspondence time lot number × 100% " calculate 97% divided by the parameters history average 95%, obtain 1.02
(102%).
(2.5) ratio that counts (percentage) of data；Computational methods are as follows：Input parameter (1.6) corresponds to input parameter
(1.5) efficiency evaluation result and consumer feedback after the ratio that counts (percentage) of data, i.e. clinical research and listing are gone through
History data represent with " satisfaction rate " (percentage), the evaluation of Objective and subjective evaluations, sensory experience including curative effect, the numerical value
Current value 90% divided by history average 90% 1 (100%).(2.6) e numerical value weight and, computational methods are as follows：
(100%- (1.3) numerical value) × 0.3+ (1.4) numerical value × 0.2+ (1.5) numerical value × 0.2+0.3, such as 98% × 0.3+95% ×
0.2+90% × 0.2+0.3=0.96.Such as by input parameter (1.3)-(1.5), all fixed setting is 1, at this time e numerical value weight
With for 1.
(2.7) weight decomposition, addition divided by e numerical value weight are carried out in 100% and obtains the numerical value near one 1
(quality composite index Q)；Computational methods are as follows：Above-mentioned (2.2)-(2.5) numerical value is such as taken, is multiplied by weight coefficient 0.3,0.3 respectively,
0.2,0.2, i.e. 90% × 0.3+100% × 0.3+102% × 0.2+100% ×
0.2=0.97, then divided by (2.6) calculate obtain 0.96, obtain 1.01.When in (2.6) by input parameter
(1.3)-(1.5) all fixed setting is 1, is engaged in 0.97/1 and obtains 0.97.
Preferably, Quality Evaluation of Chinese Medicinal evaluation method of the present invention, includes the following steps：
(1) parameter inputs, including：
(1.1) be derived from the Chinese medicine material of history qualification production batch, medicine materical crude slice, Chinese patent drug intermediate products, Chinese patent medicine preparation into
Product and its standard test that keeps sample as a result, including but not limited to foregoing medicine materical crude slice, intermediate products, preparation according to《Chinese Pharmacopoeia》Or its
The whole of his standard test acquisition testing result quantifies or qualitative numerical value；
(1.2) it is derived from extracting and developing in the production process of history qualification production batch, concentration, drying, preparation and packaging
Parameters of technique process includes but not limited to previous process process according to the Chinese medicine registered standard, the manufacture work of technological procedure requirement
Skill parameter name and its concrete numerical value；
(1.3) be derived from uniformity testing in the batch of the Chinese patent drug product of history qualification production batch as a result, and with
" 100%- uniformity of dosage units relative standard deviations RSD " is represented；
(1.4) historical data of consumer's adverse reaction monitoring, preceding after being derived from the Chinese patent drug product clinical research and listing
Person represents that the latter is with " number of cases/correspondence time is reported in 100%- adverse reactions with " 100%- adverse reaction rates (percentage) "
Interior lot number × 100% " represents, certain adverse reaction of tcm report of manufacture in 201610 months is such as collected by October 31st, 2017
Number is 8, and kind manufacture lot number is 100 batches within 201610 months, then the Chinese medicine " consumer's adverse reaction data after listing " is
100%-8/100 × 100%=92%；
(1.5) the efficiency evaluation result and consumer feedback's history number being derived from after the Chinese patent drug clinical research and listing
According to being represented with " satisfaction rate " (percentage), the evaluation of Objective and subjective evaluations, sensory experience including curative effect；
(1.6) corresponding above-mentioned input parameter (1.1)-(1.5) of present lot, wherein (1.4), (1.5) data are specified
The data that (investigate and visit) obtains are studied after the listing of present lot.
(2) data processing：
(2.1) input data (1.1) and the history average of (1.2) and standard deviation S D；
(2.2) input data (1.6) is in the history mean value ± standard deviation S D of input parameter (1.1) and (1.2)
The percentage of corresponding wide parameter quantity；
(2.3) ratio that counts (percentage) of corresponding input parameter (1.3) data of input data (1.6)； (2.4)
The ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), wherein data take corresponding title
One group of data；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6)； (2.6)
Weight decomposition is carried out in 100% with above-mentioned (1.3), (1.4), (1.5), is added " e numerical value weight and "；
(2.7) above (2.2)-(2.4) are carried out weight decomposition, addition divided by e numerical value weight and is obtained in 100%
Numerical value (quality composite index Q) near one 1.
(3) result judges：
(3.1) during Q=1, the quality and historical level that show this batch of Chinese patent drug maintain an equal level, which is in stable state；
(3.2) during Q ＜ 1, showing that the quality of this batch of Chinese patent drug is less than historical level, Q is smaller to show that Chinese medicine stabilization sexual deviation is bigger, and
Quality reduces；
(3.3) during Q ＞ 1, the quality of this batch of Chinese patent drug is shown higher than historical level, Q shows that more greatly the Chinese medicine stability is inclined
From bigger, and Quality advance.
Wherein, input parameter (1.3)-(1.5) can be all fixedly installed as 1 in the method, at this point, quality synthesis refers to
Number Q is up to 1, using the fixed numbers of ＜ 1 or the numerical value history value as criterion.
Wherein, to further include the medicine materical crude slice, intermediate products, the chemical multi objective of finished product special for input parameter (1.1) in the method
Similarity of the collection of illustrative plates compared with standard diagram is levied, includes but not limited to HPLC-UV collection of illustrative plates.
Wherein, input parameter (1.2) further includes the production schedule response time and (that is, generates first production number in the method
According to when m- production ordering assign the time) whether in standard response time and its Standard deviation-Range, batch manufacturing schedule when
Between whether be in normal pace time and its Standard deviation-Range.Such as, certain Chinese patent drug batch production ordering was assigned one day 12:
00, start obtain first record numerical value after production be the weighing time to feed intake be the 14 of the same day:30, then the batch Chinese patent drug
" production schedule corresponding time " be
14:30-12:When 00=2.5 is small.The history of the same Chinese patent drug normally produce average " production schedule is corresponding
When time " is 2 small, when standard deviation is 0.5 small, then " the standard production plan response time " of the Chinese patent drug is [1.5,2.5]
Hour.Then, in standard response time and its Standard deviation-Range, (" standard is given birth to during the production schedule response of this batch Chinese patent drug
The production plan response time ") in, it is calculated when step (2.1) calculates satisfactory number of parameters.For another example, the Chinese patent drug
History average time under series-produced normal condition is 10 days, and standard deviation is 1 day, then its " normal pace time and its mark
Quasi- deviation range " is [9,10] day.The production of this batch takes 12 days, then, the manufacturing schedule of this batch Chinese patent drug do not have " standard into
Spend time and its Standard deviation-Range " in, it is not calculated when step (2.1) calculates satisfactory number of parameters..
Wherein, the source of input parameter includes but not limited in the method：It manually computes, computer equipment obtains, can
Program PLC device, dcs (DCS), manufacturing execution system (MES), independent terminal.
The present invention for Chinese patent drug safely, effectively, the material of the equal first-class of the stability of batch, batch, quality, technique ginseng
Number is evaluated, and includes the feedback information of consumer, can comprehensively, delicately evaluate the inside and outside in quality, body of Chinese medicine
Show to Chinese medicine Product Safety, validity, manufacture and the synthesis of product stable uniformity and the various dimensions of consumer satisfaction
Function of Evaluation.
Description of the drawings
Fig. 1 is the principle schematic of technical solution of the present invention, the main contents and its related pass that display quality evaluation is related to
System.
Fig. 2 is the Software for Design prototype figure 1 of technical solution of the present invention, shows the flat of the multi-product based on a production unit
Equal product quality evaluation.
Fig. 3 is the Software for Design prototype figure 2 of technical solution of the present invention, shows specific product quality evaluation.Wherein, product
Matter Q=quality state P/ demands E=(state p1 × proportion p1+ states p2 × proportion p2 ...)/(demand e1 × proportion e1+ is needed
Seek e2 × proportion e2 ...)；Demand e1=demand e2=demands e3=1.Wherein, proportion p1+ proportions p2+ ...=1, proportion e1
+ proportion e2+ ...=1；Wherein, proportion e1=proportions e2=30%, proportion e3=40%.
Fig. 4 investigates for female's gold size capsule product stability
Specific embodiment
Technical solution of the present invention is further illustrated with reference to embodiment.But embodiment is not represented to the technology of the present invention side
The limitation of case, this specialty or related personnel can description and embodiments, and being configured with reference to specific Chinese medicine according to the present invention
With development the technical program.
Embodiment 1
Quality Evaluation of Chinese Medicinal evaluation system is completed in technical solution exploitation according to the present invention, such as attached drawing 1, by the consumer of Chinese patent drug S
Demand is arranged to safely, effectively 4 property, product stability and homogeneity aspects, further discriminates between as several parts.Then,
Security validity is merged into satisfaction, e3=e2=e1=1 is expressed as with manufacturing process stability and product homogeneity,
It is 40%, 30%, 30% to set weight respectively, such as attached drawing 3.Correspondingly, Product Status index is dynamic value, greatest measure is
1。
In next step, (1) data preparation, including：
(1.1) it is derived from the Chinese medicine material of S product history qualification production batch, medicine materical crude slice, Chinese patent drug intermediate products, Chinese patent drug system
Agent finished product and its standard test to keep sample obtain testing result as a result, being examined including S prescriptions medicine materical crude slice, extract product, preparation
Total data；
(1.2) be derived from extracting and developing in the production process of S product history qualification production batch, concentration, drying, preparation and
The parameters of technique process of packaging, including previous process process according to registered standard, the fabrication process parameters name of technological procedure requirement
Title and its concrete numerical value；
(1.3) be derived from uniformity testing in the batch of the Chinese patent drug product of S product history qualification production batch as a result, and with
" 100%- uniformity of dosage units relative standard deviations RSD " is represented, such as uniformity RSD=1%, then numerical value is 100%-1% herein
=99%；
(1.4) historical data that consumer's adverse reaction detects after being derived from the Chinese patent drug product clinical research and listing, it is preceding
Person represents that the latter is with " number of cases/correspondence time is reported in 100%- adverse reactions with " 100%- adverse reaction rates (percentage) "
Interior lot number × 100% " represents, certain adverse reaction of tcm report of manufacture in 201610 months is such as collected by October 31st, 2017
Number is 8, and kind manufacture lot number is 100 batches within 201610 months, then the Chinese medicine " consumer's adverse reaction data after listing " is
100%-8/100 × 100%=92%；
(1.5) the efficiency evaluation result and consumer feedback's history number being derived from after the Chinese patent drug clinical research and listing
According to being represented with " satisfaction rate " (percentage), the evaluation of Objective and subjective evaluations, sensory experience including curative effect, between different indexs
It is summed it up with 100% for the weight of summation, finally obtains numerical value such as 90%；
(1.6) corresponding above-mentioned input parameter (1.1)-(1.5) of present lot are obtained, wherein (1.4), (1.5) are not can
During acquisition, history average is taken, specific this example is 92% and 90%.
(1.7) the technological operation book of the technological operation number of production technology completion rate=completed/total is wherein criticized, during production
Between progress=current production and application time/plan used time production cycle, the two parameters are directly displayed on interface.
Then (2) data are carried out by computer software according to following algorithm to judge：
(2.1) input data (1.1) and the history average of (1.2) and standard deviation S D；
(2.2) input data (1.6) is in the history mean value ± standard deviation S D of input parameter (1.1) and (1.2)
The percentage of corresponding wide parameter quantity if this batch obtains 198 all kinds of controlled parameters in critical field, accounts for whole
200 controlled parameter ratios are 198/200=99% as p2；
(2.3) ratio that counts (percentage) of corresponding input parameter (1.3) data of input data (1.6), works as previous existence
Production kind product, takes (1.3) historical values 99% to be used as p1；
(2.4) ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), works as previous existence
Production kind product, takes (1.4) historical values 92%；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6), works as previous existence
Production kind product, takes (1.5) historical values 90%；With (2.4) according to 1:1 weight calculation, acquisition p3=92% × 0.5+90% ×
0.5=91%；
(2.6) e numerical value weight and that is, 1 is calculated；
(2.7) by above (2.2)-(2.5) according to foregoing e1, e2, the addition of e3 weights divided by e numerical value weight and calculating
Current cultivars quality composite index Q=(99% × 0.3+99% × 0.3+91% × 0.4)/(1 × 30%+1 × 30%+1 ×
40%)=(99% × 0.3+99% × 0.3+91% × 0.4)/1=0.958.
Finally, (3) result is carried out to judge：Due to e1 in this example, e2, e3 numerical value is 1, then Q value is up to 1.Therefore by Q
=0.9 is used as criterion, and this example Q=0.958 ＞ 0.9 show the high stability of this batch of product, and stable quality.
The 2 batch Q as hereafter produced are respectively 0.960,0.962, are all higher than 0.958 and constantly rise, illustrate production product
Matter is gradually promoted.Such as certain batch Q of series production is 0.927 ＜ 0.962 thereafter, illustrates that producing quality fluctuates, quality
Decline.
Embodiment 2
With embodiment 1, but step (2.6) calculate e numerical value weight and, do not take theoretical values 1, and this is same with actual
Each data history mean value computation of Chinese patent drug, i.e. step (1.3), (1.4), 99% in (1.5), 92%, 90%；Step
(2.2) history average is such as 98% (every batch of that is averaged has 4/200 parameter drift-out averages and Standard deviation-Range),
At this point, e numerical value weight and=step (1.3) history average × 0.3+[(1.4) history average+(1.5) step history average] ×
The history average of 0.4+ (2.2) × 0.3=99% × 0.3+ (92%+90%) × 0.4/2+98% × 0.3=0.955.At this point,
Calculate current cultivars quality composite index Q=(99% × 0.3+99% × 0.3+91% × 0.4)/0.955=1.003.
Finally, (3) result is carried out to judge：Due to e1 in this example, e2, e3 numerical value takes actual average, then Q value can be more than
1, it is up to 1/0.955=1.047.Can be using Q=1 as criterion, this example Q=1.003 ＞ 1 show this batch of product
High stability, and stable quality.
The 3 batch Q as hereafter produced are respectively 0.999,0.998,1.001, the preceding equal ＜ 1 of two batches Q and continuous decline, explanation
Production quality is gradually reduced.Sequentially the 3rd batch is recovered normal, and the measure taken between 2,3 batches is effective.
Embodiment 3
With embodiment 1, calculate other kinds Q, safely, effectively, stable, homogeneous numerical value, such as 5 kinds are average, acquisition
Average quality state.See attached drawing 2.
Embodiment 4
The calculating of female's gold size capsule quality composite index
Female's gold size capsule system《Chinese Pharmacopoeia》2015 editions Chinese patent medicine preparations recorded, by extracting, concentrating, drying, making
The capsule that grain forms.Technical solution according to the present invention, by the quality composite index of female's gold size capsule composition be arranged to safely, have
Effect, stable and homogeneous 4 aspects, will " safely, effectively " merge by investigating the female's gold size capsule customer satisfaction obtained,
" stabilization " includes the fluctuation status of crucial controlled parameter in female's gold size capsule manufacturing process, " homogeneous " to include in female's gold size capsule batch uniformly
Degree and content fluctuate situation, more than three aspect be expressed as e1, e2, e3.It is 100% to set e1, e2, e3 numerical value, power
Be respectively 30%, 30%, 40% again, then e3+e2+e1=1.Certain batch female's gold size capsule quality composite index is calculated below：
(1) data input and acquisition, including：
(1.1) acquisition of standard test data：Take the medicine materical crude slice that feeds intake, the intermediate products (bag of product history qualification production batch
Include alcohol extracting thick paste, water carries thick paste, fine medicinal material powder, always mixes powder, total mixed particle etc.) and its finished product one-hundred-percent inspection as a result, will always mix
Powder, always mixed particle quantitative or qualitative number list are as follows, and other inspection results are pressed sheet format and inputted, and include but not limited to
1 content of table.
Table 1
(totally 37 parameters, qualitative data is qualified for 1, and unqualified is 0) to arrange as follows, is shown in Table 2 for each batch data above
1-4 is arranged：
Table 2
(1.2) input and acquisition of female's gold size capsule technical process data：In the production process for taking history qualification production batch
Extracting and developing, concentration, drying, the parameters of technique process of preparation and packaging, including previous process process according to registered standard (powder
Broken mesh number, volatile oil distillation time, refluxing ethanol concentration, reflow's cycle, return time, thick paste relative density, decoct number,
Decocting time etc.), technological procedure requirement fabrication process parameters title and its concrete numerical value (return pressure, reflux temperature, thick paste
Amount, drying time, incorporation time etc.), totally 28 parameters are arranged according to table 2, and specific name is shown in Table 3.
(1.3) study on the stability of female's gold capsule product homogeneity data source history qualification production batch, periodically or
Have because investigating, this example takes product quality stable case inspection result in always mixed particle batch, and female is measured as Testing index with content
Gold size capsule always mixes granule content RSD=2.3%；Changes of contents or study on the stability in the term of validity are collected history lot data and are taken
Its average value, using month be abscissa content as ordinate, carry out linear regression, as shown in Figure 4.
According to equation of linear regression, computational stability investigates data=(investigating month * slope)/content average value
=(24*0.01)/2.3=10.43%.
(1.4) clinical research of female's gold size capsule and listing after consumer's adverse reaction detect historical data, with " 100%-
Adverse reaction rate (percentage) " represents and " 100%- adverse reactions report number of cases/in correspondence time lot number × 100% "
It represents, this product adverse reaction number of reports of manufacture in 201610 months is such as collected by October 31st, 2017 as 8,201610
Month kind manufacture lot number is 100 batches, then the Chinese medicine " consumer's adverse reaction data after listing " for 100%-8/100 ×
100%=92%；
(1.5) clinical research of female's gold size capsule and the efficiency evaluation result and consumer feedback's historical data after listing, with
" satisfaction rate " (percentage) represents, including subjectivities, objective, sensory experiences such as good results degree, packaging satisfaction, user satisfactions
Evaluation, be very dissatisfied, dissatisfied, general, satisfied respectively, feel quite pleased 5 options and score value 1-5 is indicated, acquirement is gone through
History average, data include but not limited to following content：
Calculate satisfaction percentage=(4.29+4.25+4.27+4.16)/4/5=84.85%
(1.6) corresponding above-mentioned input parameter (1.1)-(1.5) of present lot (such as 1711100) are taken, wherein (1.1) are detailed
2 the 7th row are shown in Table, (1.2) see the table below 3 the 2nd row.Study on the stability, (1.4), (1.5) be when that can not obtain wherein in (1.3),
Take history average.
Table 3
(1.7) production of 1711100 batches, female's gold size capsule take=used time production cycle of current production and application time/plan=
22 days/20 days=1.1, the standard time is 20 ± 1 days.
(2.1) history of input data (1.1) and (1.2) average/standard ± standard deviation S D, wherein, history
Average/standard+standard deviation S D is early warning upper limit value, and history average/standard-standard deviation S D is early warning lower limiting value；Tool
Body is shown in Table 2 the 5th, 6 row, 4,6 row of table 3.
(2.2) input data (1.6) (1.7) is in input parameter (1.1) and (1.2) corresponding wide parameter number
The percentage of amount, is shown in Table 2, table 3, obtains in table 2 35,28 in table 3, wherein 2 in the range of controlled parameter, then and this batch
Ratio of the controlled parameter in critical field is 1-2/ (35+28)=96.9%；(1.7) as the 66th parameter, its power is set
Weight coefficient is 2, then recalculates technology stability
P2=1- (2+1*2)/(35+28+1)=93.9%.
(2.3) input data (1.6) corresponds to input parameter (1.3) data, wherein having because of investigation value
=100%-2.3%=97.7%, study on the stability data reference history (1.3) historical values 10.43%, according to
1:1 weight calculation, then p1=(100%-10.43%) * 0.5+97.7%*0.5)=93.63%.
(2.4) ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), works as previous existence
Product is produced, takes (1.4) historical values 92%；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6), works as previous existence
Production kind product, takes (1.5) historical values 84.85%；With (2.4) according to 1:1 weight calculation obtains p3=(92%*50%+
84.85%*50%=88.42%
(2.6) by above (2.2), (2.3) (2.5) according to foregoing p1, p2, p3 are multiplied by respective weights (with e1, e2, e3
Unanimously) be added afterwards divided by e numerical value weight and, calculate female's gold size 1711100 batches of quality composite indexes of capsule：Q=(p1*0.3+p2*
0.3+p3*0.4)/(e1+e2+e3)=
93.63% × 0.3+93.9% × 0.3+88.42% × 0.4/ (1 × 30%+1 × 30%+1 × 40%)=
0.916。
(3) result judges：Since the sum of e1 in this example, e2, e3 weights are 1, then Q value is up to 1.Therefore by Q=0.9
As criterion, this example Q=0.916 ＞ 0.9 show the high stability of this batch of product, and stable quality.
Q values average value ± standard deviation such as female's gold size capsule history qualification production batch is 0.911 ± 0.006,0.916
∈ (0.905,0.917), then normally.
1711101,1711102 batch female's gold size capsule Q as hereafter produced successively are respectively 0.918,0.921, are all higher than
0.916 and constantly rise, illustrate produce quality gradually promoted.And exceed the history mean value ± Standard deviation-Range of N-1 batches
Right side scope illustrates that each measure in terms of quality is influenced has marked improvement.
If 1711103 series-produced female's gold size capsule Q are 0.907 ＜ 0.921, illustrate that producing quality fluctuates, then quality
Decline.But the left side scope of the history mean value ± Standard deviation-Range without departing from N-1 batches illustrates each in terms of quality is influenced
A parameter has unstability.
Embodiment 5
The quality composite index of Chinese patent drug kidney treasured piece
Kidney treasured piece system《Chinese Pharmacopoeia》The same square preparation of 2015 editions SHENBAO HEJIs recorded, by extracting, concentrating, making
Grain, tabletting form.Technical solution according to the present invention calculates the quality composite index Q of kidney treasured piece with reference to above-described embodiment.201710
The moon produces each batch Q average out to 0.927 ± 0.005.
Claims (8)
1. a kind of evaluation method of Quality Evaluation of Chinese Medicinal, which is characterized in that comprise the following steps：
(1) input parameter selects：
(1.1) be derived from the Chinese medicine material of the same Chinese patent drug of history qualification production batch, medicine materical crude slice, Chinese patent drug intermediate products, it is middle into
Medicine finished dosage form and its standard test result to keep sample；
(1.2) it is derived from extracting and developing, concentration, drying, preparation in the production process of the same Chinese patent drug of history qualification production batch
And the parameters of technique process of packaging；
(1.3) be derived from uniformity testing in the batch of the Chinese patent drug product of the same Chinese patent drug of history qualification production batch as a result,
And it is represented with " 100%- uniformity of dosage units relative standard deviations RSD "；
(1.4) historical data of consumer's adverse reaction monitoring, preceding after being derived from same Chinese patent drug product clinical research and listing
Person represents that the latter is with " number of cases/correspondence time is reported in 100%- adverse reactions with " 100%- adverse reaction rates (percentage) "
Interior lot number × 100% " represents；
(1.5) the efficiency evaluation result and consumer feedback's history number being derived from after same Chinese patent drug clinical research and listing
According to being represented with " satisfaction rate " (percentage)；
(1.6) parameter of corresponding above-mentioned (1.1)-(1.5) of same Chinese patent drug of new production batch is derived from, wherein (1.4),
(1.5) data of acquisition are studied after listing of the data for specified present lot；
(2) input parameter data processing：
(2.1) input data (1.1) and the history average of (1.2) and standard deviation S D；
(2.2) it is corresponding with the history mean value ± standard deviation S D of (1.2) to be in input parameter (1.1) for input data (1.6)
In the range of number of parameters percentage；
(2.3) ratio that counts (percentage) of corresponding input parameter (1.3) data of input data (1.6)；
(2.4) ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6)；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6)；
(2.6) weight decomposition is carried out in 100% with above-mentioned (1.3), (1.4), (1.5), be added " e numerical value weight and "；
(2.7) above (2.2)-(2.5) are carried out weight decomposition, addition divided by (2.6) e numerical value weight and is obtained in 100%
Obtain the numerical value (quality composite index Q) near one 1；
(3) result judges：
(3.1) during Q=1, show that the quality of the same Chinese patent drug of new production batch maintains an equal level with historical level, which is in steady
Determine state；
(3.2) during Q ＜ 1, the quality of same Chinese patent drug of new production batch is shown less than historical level, Q is smaller to be shown in this
Drug stabilisation sexual deviation is bigger, and quality reduces；
(3.3) during Q ＞ 1, the quality of same Chinese patent drug of new production batch is shown higher than historical level, Q shows in this more greatly
Drug stabilisation sexual deviation is bigger, and Quality advance.
2. evaluation method according to claim 1, which is characterized in that include the following steps：
(1) input parameter selects：
(1.1) be derived from the Chinese medicine material of the same Chinese patent drug of history qualification production batch, medicine materical crude slice, Chinese patent drug intermediate products, it is middle into
Medicine finished dosage form and its standard test that keeps sample as a result, including but not limited to foregoing medicine materical crude slice, intermediate products, preparation according to《China
Pharmacopeia》Or other standards examine the whole for obtaining testing result quantitative or qualitative numerical value；
(1.2) it is derived from extracting and developing, concentration, drying, preparation in the production process of the same Chinese patent drug of history qualification production batch
And the parameters of technique process of packaging, include but not limited to previous process process according to the Chinese medicine registered standard, technological procedure requirement
Fabrication process parameters title and its concrete numerical value；
(1.3) be derived from uniformity testing in the batch of the Chinese patent drug product of the same Chinese patent drug of history qualification production batch as a result,
And it is represented with " 100%- uniformity of dosage units relative standard deviations RSD "；
(1.4) historical data of consumer's adverse reaction monitoring, preceding after being derived from same Chinese patent drug product clinical research and listing
Person represents that the latter is with " number of cases/correspondence time is reported in 100%- adverse reactions with " 100%- adverse reaction rates (percentage) "
Interior lot number × 100% " represents；
(1.5) the efficiency evaluation result and consumer feedback's history number being derived from after same Chinese patent drug clinical research and listing
According to being represented with " satisfaction rate " (percentage), the evaluation of Objective and subjective evaluations, sensory experience including curative effect；
(1.6) parameter of corresponding above-mentioned (1.1)-(1.5) of same Chinese patent drug of new production batch is derived from, wherein (1.4),
(1.5) data of acquisition are studied after listing of the data for specified present lot；
(2) input parameter data processing：
(2.1) input data (1.1) and the history average of (1.2) and standard deviation S D；
(2.2) it is corresponding with the history mean value ± standard deviation S D of (1.2) to be in input parameter (1.1) for input data (1.6)
In the range of number of parameters percentage；
(2.3) ratio that counts (percentage) of corresponding input parameter (1.3) data of input data (1.6)；
(2.4) ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), wherein data take
One group of data of corresponding title；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6)；
(2.6) weight decomposition is carried out in 100% with above-mentioned (1.3), (1.4), (1.5), be added " e numerical value weight and "；
(2.7) above (2.2)-(2.5) are carried out weight decomposition, addition divided by (2.6) e numerical value weight and is obtained in 100%
Obtain the numerical value (quality composite index Q) near one 1；
(3) result judges：
(3.1) during Q=1, show that the quality of the same Chinese patent drug of new production batch maintains an equal level with historical level, which is in steady
Determine state；
(3.2) during Q ＜ 1, the quality of same Chinese patent drug of new production batch is shown less than historical level, Q is smaller to be shown in this
Drug stabilisation sexual deviation is bigger, and quality reduces；
(3.3) during Q ＞ 1, the quality of same Chinese patent drug of new production batch is shown higher than historical level, Q shows in this more greatly
Drug stabilisation sexual deviation is bigger, and Quality advance.
3. evaluation method according to claim 1, which is characterized in that comprise the following steps：
(1) parameter inputs, including：
(1.1) be derived from the Chinese medicine material of history qualification production batch, medicine materical crude slice, Chinese patent drug intermediate products, Chinese patent medicine preparation finished product and
Its standard test to keep sample as a result, including but not limited to foregoing medicine materical crude slice, intermediate products, preparation according to《Chinese Pharmacopoeia》Or other marks
Standard examines the whole for obtaining testing result quantitative or qualitative numerical value；
(1.2) it is derived from the technique of extracting and developing in the production process of history qualification production batch, concentration, drying, preparation and packaging
Procedure parameter includes but not limited to previous process process and joins according to the manufacturing process of the Chinese medicine registered standard, technological procedure requirement
Several titles and its concrete numerical value；
(1.3) uniformity testing in the batch of the Chinese patent drug product of history qualification production batch is derived from as a result, and with " 100%- contains
Uniformity relative standard deviation RSD " is measured to represent；
(1.4) be derived from the Chinese patent drug product clinical research and listing after consumer's adverse reaction monitoring historical data, the former with
" 100%- adverse reaction rates (percentage) " represents, the latter is with " 100%- adverse reactions are criticized in report number of cases/correspondence time
Number × 100% " represents that certain adverse reaction of tcm number of reports that manufacture in 201610 months is such as collected by October 31st, 2017 is
8, kind manufacture lot number is 100 batches within 201610 months, then the Chinese medicine " consumer's adverse reaction data after listing " is 100%-
8/100 × 100%=92%；
(1.5) the efficiency evaluation result and consumer feedback's historical data being derived from after the Chinese patent drug clinical research and listing, with
" satisfaction rate " (percentage) represents, the evaluation of Objective and subjective evaluations, sensory experience including curative effect；
(1.6) corresponding above-mentioned input parameter (1.1)-(1.5) of present lot, wherein (1.4), (1.5) data are specified current
The data that (investigate and visit) obtains are studied after the listing of batch.
(2) data processing：
(2.1) input data (1.1) and the history average of (1.2) and standard deviation S D；
(2.2) it is corresponding with the history mean value ± standard deviation S D of (1.2) to be in input parameter (1.1) for input data (1.6)
In the range of number of parameters percentage；
(2.3) ratio that counts (percentage) of corresponding input parameter (1.3) data of input data (1.6)；
(2.4) ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), wherein data take
One group of data of corresponding title；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6)；
(2.6) weight decomposition is carried out in 100% with above-mentioned (1.3), (1.4), (1.5), be added " e numerical value weight and "；
(2.7) above (2.2)-(2.4) in 100% are subjected to weight decomposition, addition divided by e numerical value weight and obtain one
Numerical value (quality composite index Q) near 1.
(3) result judges：
(3.1) during Q=1, the quality and historical level that show this batch of Chinese patent drug maintain an equal level, which is in stable state；
(3.2) during Q ＜ 1, the quality of this batch of Chinese patent drug is shown less than historical level, Q is smaller to show that the Chinese medicine is stablized sexual deviation and got over
Greatly, and quality reduces；
(3.3) during Q ＞ 1, the quality of this batch of Chinese patent drug is shown higher than historical level, Q shows that more greatly the Chinese medicine stablizes sexual deviation more
Greatly, and Quality advance.
4. evaluation method according to claim 1, which is characterized in that input parameter (1.3)-(1.5) can all be fixed
1 is arranged to, at this point, quality composite index Q is up to 1, using the fixed numbers of ＜ 1 or the numerical value history value as criterion.
5. evaluation method according to claim 1, which is characterized in that input parameter (1.1) further includes the medicine materical crude slice, intermediate production
The similarity of product, the chemical multi objective characteristic spectrum of finished product compared with standard diagram includes but not limited to HPLC-UV collection of illustrative plates.
6. evaluation method according to claim 1, which is characterized in that input parameter (1.2) further includes production schedule response
Whether the time (the when m- production ordering for obtaining first creation data assigns the time) is in standard response time and its standard deviation
In the range of, batch manufacturing schedule time whether be in normal pace time and its Standard deviation-Range.
7. evaluation method according to claim 1, which is characterized in that the source of input parameter includes but not limited to：By hand
Calculating, computer equipment acquisition, programmable PLC equipment, dcs (DCS), manufacturing execution system (MES), independence
Terminal.
8. evaluation method according to claim 1, which is characterized in that comprise the following steps：
(1) data input and acquisition, including：
(1.1) acquisition of standard test data：Take the medicine materical crude slice that feeds intake of product history qualification production batch, intermediate products and its into
The one-hundred-percent inspection of product will be as a result, powder will always be mixed, always mixed particle quantitative or qualitative numerical value following table are as follows, other inspection result accordings to the form below 1
It is inputted,
(totally 37 parameters, qualified qualitative data is 1 to each batch data above, and unqualified is that 0) arrangement is as follows, is shown in Table 2 1-4
Row：
(1.2) input and acquisition of female's gold size capsule technical process data：Take in the production process of history qualification production batch extraction,
Separation, concentration, the parameters of technique process of dry, preparation and packaging, including previous process process according to registered standard, technological procedure
It is required that fabrication process parameters title and its concrete numerical value, totally 28 parameters arranged according to table 2, specific name is shown in Table 3,
(1.3) study on the stability of female's gold capsule product homogeneity data source history qualification production batch, periodicity or have because
It investigates, this example takes product quality stable case inspection result in always mixed particle batch, and female's gold size is measured as Testing index with content
Capsule always mixes granule content RSD=2.3%；Changes of contents or study on the stability in the term of validity collect history lot data and take it flat
Average, using month be abscissa content as ordinate, carry out linear regression, according to equation of linear regression, computational stability is investigated
Data=(investigating month * slope)/content average value=(24*0.01)/2.3=10.43%.
(1.4) historical data that consumer's adverse reaction detects after the clinical research of female's gold size capsule and listing, with " 100%- is bad anti-
Answer incidence (percentage) " it represents and " 100%- adverse reactions report number of cases/in correspondence time lot number × 100% " expression, such as
This product adverse reaction number of reports that manufacture in 201610 months is collected by October 31st, 2017 is 8,201610 months product
Kind manufacture lot number is 100 batches, then the Chinese medicine " consumer's adverse reaction data after listing " is 100%-8/100 × 100%=
92%；
(1.5) clinical research of female's gold size capsule and the efficiency evaluation result and consumer feedback's historical data after listing, with " satisfied
Rate " (percentage) represents, including good results degree, packaging satisfaction, the subjectivities such as user satisfaction, objective, sensory experience comments
Valency is very dissatisfied, dissatisfied, general, satisfied respectively, feel quite pleased 5 options and score value 1-5 is indicated, and it is equal to obtain history
Value,
Calculate satisfaction percentage=(4.29+4.25+4.27+4.16)/4/5=84.85%
(1.6) corresponding above-mentioned input parameter (1.1)-(1.5) of present lot (such as 1711100) are taken, wherein (1.1) refer to table 2
7th row, (1.2) see the table below 3 the 2nd row, wherein study on the stability, (1.4), (1.5) take history when that can not obtain in (1.3)
Average
(1.7) production cycle used time=22 of time-consuming=current production and application time/plan of 1711100 batches of productions of female's gold size capsule
My god/20 days=1.1, the standard time is 20 ± 1 days,
(2.1) history of input data (1.1) and (1.2) average/standard ± standard deviation S D, wherein, history average/
Standard+standard deviation S D is early warning upper limit value, and history average/standard-standard deviation S D is early warning lower limiting value；Specifically it is shown in Table
2 the 5th, 6 row, 4,6 row of table 3,
(2.2) input data (1.6) (1.7) is in input parameter (1.1) and (1.2) corresponding wide parameter quantity
Percentage, is shown in Table 2, table 3, obtains in table 2 35,28 in table 3, wherein 2 in the range of controlled parameter, then this batch it is controlled
Ratio of the parameter in critical field is 1-2/ (35+28)=96.9%；
(1.7) as the 66th parameter, its weight coefficient is set for 2, then recalculate technology stability p2=1- (2+1*2)/
(35+28+1)=93.9%,
(2.3) input data (1.6) corresponds to input parameter (1.3) data, wherein having because of investigation value=100%-2.3%=
97.7%, study on the stability data reference history (1.3) historical values 10.43%, according to 1:1 weight calculation, then p1=
(100%-10.43%) * 0.5+97.7%*0.5)=93.63%,
(2.4) ratio that counts (percentage) of corresponding input parameter (1.4) data of input data (1.6), current production production
Product take (1.4) historical values 92%；
(2.5) ratio that counts (percentage) of corresponding input parameter (1.5) data of input data (1.6), current production kind
Product takes (1.5) historical values 84.85%；With (2.4) according to 1:1 weight calculation obtains p3=(92%*50%+
84.85%*50%=88.42%
(2.6) by above (2.2), (2.3) (2.5) according to foregoing p1, p2, p3 are multiplied by respective weights (consistent with e1, e2, e3)
After be added divided by e numerical value weight and, calculate female's gold size 1711100 batches of quality composite indexes of capsule：Q=(p1*0.3+p2*0.3+
P3*0.4)/(e1+e2+e3)=93.63% × 0.3+93.9% × 0.3+88.42% × 0.4/ (1 × 30%+1 × 30%+1
× 40%)=0.916,
(3) result judges：Since the sum of e1 in this example, e2, e3 weights are 1, then Q value is up to 1, therefore using Q=0.9 as sentencing
Disconnected standard, this example Q=0.916 ＞ 0.9 show the high stability of this batch of product, and stable quality.
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| CN116153462A (en) * | 2023-04-20 | 2023-05-23 | 南京引光医药科技有限公司 | Drug alert system and drug alert feedback data processing method |
| CN117408649A (en) * | 2023-12-15 | 2024-01-16 | 山东一方制药有限公司 | Production and processing consistency control method of traditional Chinese medicine formula particles |
| CN117408649B (en) * | 2023-12-15 | 2024-02-23 | 山东一方制药有限公司 | Production and processing consistency control method of traditional Chinese medicine formula particles |
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