CN108090669B - Traditional Chinese medicine quality evaluation method - Google Patents
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Abstract
The invention provides a method for evaluating the quality of traditional Chinese medicines, in particular to a method for evaluating the quality of Chinese patent medicines. The method is based on materials, processes, quality parameters, consumer feedback and specific data in the research process after raw materials, extraction, preparation, packaging and sample preparation in the traditional Chinese medicine manufacturing process and products are listed, and is obtained by comparing current batch data with historical batch data, and a comprehensive index which is distributed by weight and takes 1 as the center is used for expressing the quality state of the traditional Chinese medicine. The method provided by the invention evaluates the materials, quality and process parameters which may affect the safety, effectiveness, batch stability, batch uniformity and the like of the Chinese patent medicine, and can comprehensively and sensitively evaluate the internal and external quality of the Chinese medicine.
Description
The technical field is as follows:
the invention belongs to the field of traditional Chinese medicines, and particularly relates to a quality evaluation method of a traditional Chinese medicine.
Background art:
the Chinese medicine is a main tool for preventing and treating diseases in the traditional Chinese medicine, and the specific application forms comprise Chinese medicinal materials, decoction pieces and Chinese patent medicines (preparations). The "true or false" of a Chinese medicine corresponds to the qualification or non-qualification of the "quality" obtained by adopting the results obtained by adopting the tests of sense, physical chemistry, and the like and the standard numerical values (ranges) thereof. The quality and qualification of the Chinese medicine are finally evaluated by using quality standards. Because the proportion of chemical components which can be directly controlled by the traditional Chinese medicine is very small at present, the quality standard of the traditional Chinese medicine (medicine) adopts the quality control of the whole process, for example, the content of the quality standard of the Chinese patent medicine generally comprises three links of raw materials (prescription), process (preparation method) and finished products (qualitative and quantitative inspection). The controllability of the factors of the medicinal materials (decoction pieces) is the worst and the control surface is wide, the detection controllability of the finished product is good but the control surface is the minimum, and the controllability and the control surface of the preparation method are intermediate links influencing the quality of the Chinese patent medicine.
The preparation method of the Chinese patent medicine not only ensures the preparation to be formed and reach the standard of finished products, but also has the inherent requirement of retaining most substances which are possibly required by the medicine but can not be qualitatively and quantitatively detected. These substances are generally present in the production process in the form of certain products, such as extract, concentrated solution, extract, etc., which generally adopt the relative density as the basis for discrimination, such as "concentrating to a relative density of 1.10-1.20(50 ℃. + -. 3 ℃). Therefore, the production control in this case has a large quality uncertainty.
Due to the double influences of large quality fluctuation of natural products of raw medicinal materials (decoction pieces) and strong uncertainty of production control, the quality of the Chinese patent medicine has large fluctuation, and is highlighted by large fluctuation of index component content, transfer rate and solid matters (extractum), and the products of different manufacturers with the same prescription and preparation method have huge difference. For example, the contents of different manufacturers of Liuwei Dihuang Wan have significant differences, and the RSD reaches 11-33% (Xianjiehu, Zhang Ning, Von Yi. Liuwei Dihuang Wan quality difference analysis [ J ] Chinese patent medicine 2009,31: 882-.
Quality of Chinese medicine
The quality and quality of Chinese medicine are related with different concepts, the coverage of the quality and quality is wider, and the quality of Chinese medicine can be reflected better. Because the traditional Chinese medicine components are complex and difficult to be evaluated by a single component or a plurality of components, the Chinese patent medicine is prepared by continuously extracting and purifying a plurality of or even dozens of traditional Chinese medicines, and the evaluation by 1-2 components is more difficult to reflect the real internal quality. With the continuous improvement of the analysis level, at present, research institutions adopt methods such as multi-component control and the like to control the quality of preparations, but the implementation and the application have certain limitations. The quality is due to design, and good intermediate control and execution operation are required in advance before a high-quality designed process, so that the product can be guaranteed to be always treated at a stable and uniform level. With the development of electronic systems and big data, manufacturing an execution system MES and a distributed computer control system DCS, adopting early warning deviation setting to monitor the production process in real time, and adopting a TPCMS data acquisition system to acquire and analyze data in the production process. A whole set of system is formulated for comprehensively controlling the quality of the product, thereby obtaining a safe, effective, stable and uniform product. These contents are likely to constitute a broader concept of "quality" than conventional "quality". The quality research of the traditional Chinese medicine is searched by professional documents and patent technologies, and the result is as follows:
in 2006, "creation of high-quality traditional Chinese medicine brands", "quality casting of" Shenwei ", high-quality modern traditional Chinese medicines" were proposed in Shenwei pharmaceutical industry, and industrial integration and automatic control technologies were adopted at home first, and various advanced processes were combined and applied to the traditional Chinese medicine extraction, concentration and purification processes, so that traditional Chinese medicine injection production research was developped constructively; the capital invested in new product development for more than 10 years exceeds 10 billion yuan, and a first full-automatic control traditional Chinese medicine extraction production line in China is built; carrying out whole-process tracking control and a quality responsibility pursuit system; the raw materials of each medicine come from where, who produces and who tests, and can be clearly checked within one hour (Rehanfa, Shenwei pharmacy creates high-quality traditional Chinese medicine brand [ N ]. economic journal, 2006-09-08(002), Wangzhimi, Zhangli, quality casting "Shenwei" high-quality modern traditional Chinese medicine [ J ]. capital medicine, 2007, (07): 49-50.).
In 2008, the content and the extension of the quality of the traditional Chinese medicine are defined for the first time by Wandexing, and the theory of the quality of the traditional Chinese medicine is provided. The emphasis on the quality of Chinese herbs is on the modern quality of production in concept, and the characteristics of ethnic character and culture are reflected (Wandeli. Chinese medicine quality research-theory, method and practice [ M ]. Shanghai: Shanghai science and technology Press, 008.). Nine arguments of the traditional Chinese medicine quality theory such as the 'traditional Chinese medicine quality inheritance leading theory' and the like are provided (strictly casting cloud, professor of traditional Chinese medicine quality theory [ J ] Asia Pacific traditional medicine, 2012, (01):1-2.), (inheritance and innovation of the traditional Chinese medicine quality theory [ J ] traditional Chinese medicine and clinic, 2010, (01):3-6.), (research on the traditional Chinese medicine quality [ J ] institute academic newspaper of Chengdu medical college, 2011, (04): 279.). In 2010, Zhang Wen Sheng, etc. summarize the systematic Chinese medicine of Wang Yongyan-product, quality, property, effect, and use of integrated systematic research thinking, respectively corresponding to the Chinese medicine 'variety and research', 'quality standard and influence factor research', 'genuine and safety', 'pharmacological efficacy and metabolism' and 'clinical application, drug development, Chinese medicine economy and industrialization research' (Zhang Wen Sheng. Chinese medicine 'quality and effectiveness' integrated systematic research-taking radix Scutellariae as example [ A ]. national institute of traditional Chinese medicine, Chinese medicine society, second diagnosis, new development of Chinese and western medicine combined encephalopathy, advanced seminar expert lectures and compilation of treatises [ C ] national institute of traditional Chinese medicine, Chinese medicine society: 2010: 7.). The operability of these two concepts is weak.
In 2015, Liutao and the like propose a research method for evaluating the medicinal quality of traditional Chinese medicines based on the component clinical utilization rate, and the method solves the defect that the existing medicinal material quality evaluation mainly takes the amount of medicinal ingredients as a main evaluation index (Liutao, Gou Xiaojun, Wangdui, Xuyulingui. the traditional Chinese medicinal material quality evaluation mode based on the component clinical utilization rate of traditional Chinese medicines is commercially established [ J ] Chinese herbal medicines, 2015, (13):1863 + 1866.). The concept is consistent with the connotation of ' a multi-component comprehensive quantitative Chinese medicine quality evaluation and control method and application ' technology (Xiaoxiahe, Wangbai, Tanpeng, and the like) ' of a multi-component comprehensive quantitative Chinese medicine quality evaluation and control method and application [ P ]. Beijing: CN201510324220.4, 2015-09-09.).
In 2017, a Chinese medicinal material quality evaluation thought of 'multi-method basis source identification + reasonable chemical evaluation based on pharmacopoeia + standardized planting based on suitability cultivation region + specification grade' is provided at a peak (peak in western garden hospital of Chinese academy of sciences, Chinese medicinal material quality evaluation needs to be started again [ N ]. Chinese medicinal newspaper, 2017-05-11 (005)). The characteristic of ' Chinese medicine science in system ' is developed, the key elements, structures and functions of a Chinese medicine complex system, the variety, quality, pharmacy, drug property, efficacy and application (called ' quality control effect ' for short) of the Chinese medicine are researched by a multidimensional evaluation method, wherein the ' quality refers to the quality of the Chinese medicine and reflects the quality of inherent overall characteristics of the Chinese medicine in the aspects of germplasm, seedlings, cultivation, harvesting, production place processing, preparation and the like, and comprises two parts of external quality and internal quality. External quality refers to the property and quality of Chinese medicinal materials, and quality evaluation by means of shape, color, smell, taste, microscopic identification and physicochemical measurement based on "syndrome differentiation"; the intrinsic quality mainly includes genetic material and pharmacodynamic material. The genetic quality of the traditional Chinese medicine is mainly used for researching the biological genetic characteristics and advantages of the medicinal materials, germplasm resources, genetic diversity, variety diversity and genetic molecular markers of high-quality varieties, and the relationship between genetic materials and the production and clinical curative effects of the high-quality medicinal materials. The Chinese medicine effective substance is a main mode for calibrating the internal quality of the Chinese medicine, and the research mainly applies chemical and biological technology and method to show that the Chinese medicine effective part, effective components and effective components based on clinical curative effect reach a quality marker which can be expressed by molecular formula and structural formula and has a certain physical constant (Peng. reiterate the quality control effect of the systematic Chinese pharmacology) [ J ] Chinese medicine and clinic, 2017, (01): 1-3.). The mat boat and the like are combined with the meanings of the Chinese medicines and the quality words, the Chinese medicine quality is the nature of the Chinese medicine variety, and means the quality degree of the Chinese medicine variety grade, and the evaluation method mode is diversified (the mat boat, faithful to wear, Zhuhua, the research status and the development trend of the Chinese medicine quality evaluation [ J ] Chinese materia medica, 2017, (06):1485 and 1488.). These concepts are also not very operable.
The quality of Chinese patent medicine is taken as subject name and key word, no substantive concept and understanding are found on the Chinese knowledge network (CNKI) (Wulixin. application research for rapidly detecting certain Chinese medicines and the quality of Chinese patent medicine by near infrared spectroscopy [ D ]. southwest university, 2013.), (morning willow morning light, applied from Banban. influence of the quality of Chinese medicinal materials on the quality of Chinese patent medicine [ J ]. Haixia pharmacy, 1994, (04): 62-64.).
At present, platform mechanisms taking the 'quality of traditional Chinese medicine' as a research target are as follows: the research room for evaluating new traditional Chinese medicine resources and quality of Shanghai Chinese medicine university is a key research room of the State administration of traditional Chinese medicine, and is established in 2009 and responsible for artificial towns. The research directions comprise: the comprehensive evaluation research of the quality standard of traditional Chinese medicines and the safety evaluation research of toxic traditional Chinese medicines (research room for evaluating new resources and quality of traditional Chinese medicines of Shanghai medical university-national institute of traditional Chinese medicine Key research laboratory introduction [ J ]. proceedings of Shanghai medical university, 2009 (06): 88.).
New technology related to quality of traditional Chinese medicine
Digital visualization traditional Chinese medicine was proposed by Xiaoxianhe et al in 2003. The method utilizes IT technology to automatically analyze and process the continuous slices of the tissues of the traditional Chinese medicine so as to obtain the topological information of the three-dimensional geometric information of the traditional Chinese medicine and the histiocyte thereof, construct and represent the three-dimensional morphological structure of the traditional Chinese medicine, and display the three-dimensional geometric information in a real-time dynamic mode (Kangwen, the quality of the traditional Chinese medicine realizes 'visible' [ N ]. Chinese medicine report, 2003/10/18.).
The DNA fingerprinting technique was proposed by Caohui et al in 2003. Compared with the traditional four identification methods, the method is more accurate and objective, has wider application range, and is very suitable for identifying precious samples such as kindred species, easily-confused varieties, rare varieties, animal medicinal materials, broken medicinal materials, old medicinal materials, rotten medicinal materials and plant mode specimens with extremely limited sample amount, traditional Chinese medicine soil specimens, ancient fossil specimens and the like (research overview of the DNA molecular marking technology in the aspects of traditional Chinese medicine quality and standardization [ J ]. world science and technology 2003, (01):39-47+82.), (Wu Young, Zhao Qin, Zhang yog, Ma. DNA fingerprint technology is applied to research progress of traditional Chinese medicine quality identification [ J ]. Chinese veterinary medicine journal, 2008, (01):24-26 ]).
The thermodynamic expression technology of biological tissues, such as Wufeng, etc., proposes to identify true and false medicinal materials by differential scanning calorimetry in 2005 (Wufeng, Doujifeng, Zhang Huiyiwang. New technology development of Chinese and Western medicine quality evaluation in Zhejiang J. (09): 588.). The wuyanling equals 2005, zhao yanling equals 2008, etc. established the research of the method for evaluating the bioactivity and quality of the traditional Chinese medicine (isatis leaf, rhubarb, isatis root) based on thermodynamic expression, which is considered more accurate and reliable than the conventional chemical method (wuyanling. the research of the method for evaluating the bioactivity and quality of the traditional Chinese medicine (isatis leaf, rhubarb) (D. Tianjin university, 2005.), (zhao yanling, shan li mei, jin cheng, zhou xu, xiao he. the research of evaluating the quality of the isatis root based on the biological heat activity [ J ]. traditional Chinese medicine, 2008').
A new sensory evaluation technology is proposed in 2013 by Zhouhuijing and the like, and the quality and the processing quality of the traditional Chinese medicine are evaluated by simulating human body feeling by using electronic instrument equipment (an electronic nose and the like) so as to objectively express characters (Zhouhuijing, a methodology research based on a 'qi' bionic olfaction system in the integral evaluation of the quality of the traditional Chinese medicine [ D ]. Beijing university of traditional Chinese medicine, 2013.), (Zhao Chong Bo, Wu Chu pure, a new technology for evaluating the quality of traditional Chinese medicine decoction pieces and monitoring the quality of the processing process [ J ]. world science technology-traditional Chinese medicine modernization, 2014, (03):529 and 531.).
The biological regulation and control technology was proposed in 2014. The quality of the traditional Chinese medicine can be guaranteed and the quality improvement can be realized gradually by surrounding the generation and the improvement of effective components, utilizing the biotechnology to realize the quality control of the traditional Chinese medicine, greatly improving the yield of plant cells and utilizing plant cell factories to produce novel active products (Xiaoyingying, Sunjianna, Zhangiun, Chenwangsheng. the idea and the method for the quality control research of the traditional Chinese medicine [ J ]. world science and technology-traditional Chinese medicine modernization, 2014, (03):506 + 509.).
In 2016, an IR fingerprint peak frequency Zhouxian proposes and establishes a mathematical theory of intrinsic quality grade of traditional Chinese medicine in biological system based on IR fingerprint peak frequency based on mathematical method to judge the quality of traditional Chinese medicine, traditional Chinese medicine compound or other biological systems (Zhouxian. mathematical theory of intrinsic quality grade of traditional Chinese medicine in biological system based on fingerprint spectrum judge [ J ] world traditional Chinese medicine, 2016, (09): 1876-.
The ecological technology of Huanglinfang and Chenthrene was proposed in 2017, and the quality of Chinese medicine was studied by using the ecological principle and method (Huanglinfang, Chenthrene. ecology of quality of Chinese medicine: a new cross discipline [ J ]. J. China journal of laboratory and prescriptions, 2017, (01): 1-11.). Comprises the quality of the traditional Chinese medicine, the biological cause formed by the quality of the traditional Chinese medicine, the medicinal biological distribution, the relationship between the producing area and ecological factors, the ecological suitability and the partition of the producing area of high-quality medicinal materials, the influence of the regulation and the protection of an ecological system on the quality of the traditional Chinese medicine, the development and the utilization of high-quality traditional Chinese medicine resources, and the ecological theoretical system and the technical method of the quality of the traditional Chinese medicine. Summarizes 6 basic theories of the ecology of the quality of the traditional Chinese medicine, namely the environmental ecology theory; the continuation of variety quality and the transition theory of producing area; a sustainable utilization theory; the ecotype theory; theory of adverse effects; theory of gene specialization. Introduces the common research methods of traditional Chinese medicine quality ecology, namely a chemical evaluation method, a physical evaluation method and a biological evaluation method.
In the published patent of Zhouyanhua Zhou, infrared fingerprint spectra 2015, Chinese flowering trees determine threshold value standards reflecting traditional Chinese medicines with different quality grades according to infrared fingerprint spectra information of content, types and structure information of traditional Chinese medicines, and establish a scientific rapid identification method for the traditional Chinese medicines with different quality grades (Zhouyanhua, a rapid identification method for the traditional Chinese medicines with different quality grades [ P ]. Shandong: CN104698144A, 2015-06-10.). Meanwhile, the quality of Chinese traditional medicine with the same quality can be detected and judged (Zhouxian. detection and judgment method for Chinese traditional medicine with the same quality [ P ]. Shandong: CN104458632A, 2015-03-25.).
Traditional chinese medicine quality automated inspection system 2012 discloses patents such as wuchunjie, include: selecting varieties, and determining parameters and weights; the parameter detection adopts an electronic vision system, an electronic nose and an electronic tongue to detect the appearance, color, smell and taste parameters of the traditional Chinese medicine, and simultaneously adopts a spectrophotometry method or a chromatography method or a conventional detection method to detect the chemical component content parameters, the safety detection parameters and the conventional detection parameters of the traditional Chinese medicine; comparing with the set parameters to obtain the truth of the tested Chinese medicinal variety and the relative parameter value; the quality calculation module is used for calculating to obtain a quality value (Wu Chun, Huang Qin Wang, Song English, Li Jianghua, ai Li, Li Min, Sun Ling Gen. Chinese medicine quality automatic detection system [ P ]. Sichuan: CN102435713A, 2012-05-02.) according to the relative parameter quality value and the weight coefficient.
The invention utilizes the electronic technology to process and comprehensively evaluate traditional Chinese medicine microscopic images, and combines the content parameters of the chemical components of the traditional Chinese medicine, the safety detection parameters and the conventional detection parameters to automatically detect the inherent quality (Zhouweihua automatic detection system for the quality of the traditional Chinese medicine [ P ]. Jiangxi: CN105973858A, 2016-09-28. practical examination).
Biological index evaluation of traditional Chinese medicine quality comprises representing anti-influenza virus activity of heat-clearing and detoxifying traditional Chinese medicines by adopting a rabbit erythrocyte agglutination resisting method in vitro, and representing immune anti-inflammatory activity of the heat-clearing and detoxifying traditional Chinese medicines by using a mouse spleen swelling resisting method (pandasone, pandumei. a biological detection method for evaluating and controlling quality of heat-clearing and detoxifying traditional Chinese medicines [ P ]. Guangzhou: 201611072033.2, 2016-11-29. examination).
The comprehensive index (evaluation method) of Chinese medicine quality is the published patent technology of 2017 of Xiaoxiahe et al. And (3) processing the data of 3 dimensions of traditional Chinese medicine experience, chemistry and biology by adopting a triangular area method, and dividing the triangular area of each sample by the maximum triangular area to obtain the comprehensive quality index. Embodies the overall view of the traditional Chinese medicine, integrates the traditional cognition and the modern cognition, and associates the efficacy and the safety (1) Xiao He, Wang Kabo, Zhang Ding \22531, Niaoming. a comprehensive evaluation method of the quality of the traditional Chinese medicine [ P ]. Beijing: CN106353469A, 2017-01-25. practical examination). Based on the above, the recommended standard of the industry of the Chinese medicine Association, namely the Chinese medicine quality evaluation method guideline, is formed, and is released in 2017 in the 5 th month. The technology is the most operable technology, but the evaluation range is still limited to medicinal materials and decoction pieces.
In summary, the concept and technology of "quality of Chinese herbs" are not well known and the content is limited to herbs and decoction pieces. Because the concept of traditional Chinese medicine comprises traditional Chinese medicinal materials, decoction pieces and patent drugs, the concept of "quality of traditional Chinese medicine" needs to be further defined according to the concept scope of traditional Chinese medicine. The Chinese patent medicine is one of the main clinical application forms of the Chinese traditional medicine, and can be used by consumers only through the processes of prescription, extraction, separation and refining, preparation forming, packaging, storage and transportation. All factors of the whole process, including material, processing process and even packaging, can cause the Chinese patent medicine product to have certain influence on consumers, and even part of the quality (safety and effectiveness) of the Chinese patent medicine product can be reflected only after the consumer uses the Chinese patent medicine product. Therefore, there is a need for a comprehensive quality evaluation method that can integrate all of the above materials, information streams, and processes, even for consumer feedback evaluation.
The invention content is as follows:
in order to overcome the defects of the traditional Chinese medicine quality and quality evaluation method at present, the invention provides a traditional Chinese medicine quality evaluation method, in particular to a quality evaluation method which integrates the general material quality information, process parameters and other controlled index information of all Chinese patent medicine manufacturing processes and the evaluation information of consumers.
The invention provides a method for evaluating the quality of traditional Chinese medicine, which is based on the materials, extraction, preparation, packaging, sample retention, materials, process, quality parameters, consumer feedback and specific data in the research process after the product is marketed in the traditional Chinese medicine manufacturing process, is obtained by comparing the current batch data with the historical batch data, and is subjected to weight distribution to express the quality state of the traditional Chinese medicine by using a comprehensive index with 1 as the center.
The method for evaluating the quality of the traditional Chinese medicine comprises the following steps:
(1) input parameter selection:
(1.1) taking the standard test results of the traditional Chinese medicine raw materials, the decoction pieces, the intermediate products and the finished products of the Chinese patent medicine preparations of the same Chinese patent medicine in the historical qualified production batches and the sample reservation thereof, wherein the standard test results comprise but are not limited to all quantitative or qualitative values of the test results obtained by the decoction pieces, the intermediate products and the preparations according to Chinese pharmacopoeia or other standard tests; (1.2) technological process parameters of extraction, separation, concentration, drying, preparation and packaging in the production process of the same Chinese patent medicine from a historical qualified production batch, including but not limited to the name and specific numerical values of the technological process parameters of the traditional Chinese medicine according to the registration standard and the technological specification requirement of the traditional Chinese medicine;
(1.3) taking the uniformity inspection result in the batch of the Chinese patent medicine products of the same Chinese patent medicine in the historically qualified production batch, and expressing the uniformity as 100 percent and relative standard deviation RSD;
(1.4) taking historical data of clinical research and consumer adverse reaction monitoring after marketing of the same Chinese patent medicine product, wherein the former is expressed by 100% -adverse reaction incidence (percentage), and the latter is expressed by 100% -adverse reaction report example number/batch number in corresponding time multiplied by 100% ";
(1.5) effectiveness evaluation results and consumer feedback historical data obtained from clinical research and marketing of the same Chinese patent medicine are expressed as satisfaction rate (percentage), and the satisfaction rate comprises subjective and objective evaluation of curative effect and evaluation of sensory experience;
(1.6) the parameters (1.1) - (1.5) corresponding to the same Chinese patent medicine from the new production batch, wherein the data (1.4) and (1.5) are obtained by specifying the post-marketing study of the current batch;
(2) processing input parameter data:
(2.1) calculating historical mean values and standard deviations SD of the input parameters (1.1) and (1.2);
(2.2) calculating the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value +/-standard deviation SD of the input parameters (1.1) and (1.2);
(2.3) calculating the arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.3) data; (2.4) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.4) data, wherein the data is a set of data corresponding to the name;
(2.5) calculating the arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.5) data; (2.6) carrying out weight decomposition on the components (1.3), (1.4) and (1.5) within 100%, and adding to obtain 'e numerical value weight sum';
(2.7) performing weight decomposition on the above (2.2) - (2.5) within 100%, adding, and dividing by the sum of the (2.6) e numerical weights to obtain a numerical value (quality comprehensive index Q) around 1;
(3) and (5) judging a result:
(3.1) when Q is 1, the quality of the same Chinese patent medicine in the new production batch is equal to the historical level, and the Chinese patent medicine is in a stable state;
(3.2) when Q is less than 1, the quality of the same Chinese patent medicine in a new production batch is lower than the historical level, and the smaller Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is reduced;
(3.3) when Q is more than 1, the quality of the same Chinese patent medicine in a new production batch is higher than the historical level, and the larger Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is improved.
For the technical terms appearing in the evaluation method according to the invention, further explanations and explanations are made: (1.1) obtaining all quantitative or qualitative values of the detection results according to the standard test in Chinese pharmacopoeia or other standard tests; wherein all quantitative or qualitative values include, but are not limited to: qualitative inspection of decoction pieces or tablets for qualification, water content, extract content, main index component content, HPLC fingerprint inspection and similarity.
(1.2) process parameters including, but not limited to; the water adding amount-temperature-pressure, the extract liquid amount-specific gravity-HPLC map similarity, the concentration temperature-pressure, the total amount-specific gravity-solid content-HPLC map similarity of the concentrated liquid, the using amount of auxiliary materials, the mixing time-current value of a mixing motor, the particle size distribution-content, the total mixed particle amount, the tabletting pressure-tablet weight distribution-hardness and the like of each extraction tank.
(1.3) the within-batch homogeneity test results including, but not limited to; content uniformity of total mixed powder (granule) and finished tablet of solid preparation, such as ratio of content standard deviation of parallel five-point sample to average value thereof
(RSD); uniformly sampling the total mixed liquid of the liquid preparation in a preparation tank, then carrying out content determination on main index components, and taking the Ratio (RSD) between the standard deviation and the mean value of the standard deviation; the same batch of finished products is subjected to standard content measurement according to different time specification along with the standing time, and the Ratio (RSD) between the standard deviation and the mean value of the standard deviation is taken.
(1.4) historical data of consumer adverse reaction monitoring, including but not limited to; the number of adverse reaction reports generated after the product manufactured in a certain month is taken by the consumers.
(1.5) effectiveness evaluation results and consumer feedback historical data, including but not limited to; the subjective satisfaction evaluation score of the product manufactured in a certain month after being taken by a consumer, and the complaint number of the product packaging quality problem. (2.1) historical mean and standard deviation SD; the calculation method is as follows: if the historical data of the content of the raw material decoction pieces of a certain product is x1, x2, x3, … and xn, the historical mean value of the index of the content of the raw material decoction pieces of a certain product is as follows: the standard deviation of the average X ═ X1+ X2+ X3+ … + xn)/n is calculated as:
(2.2) percentage of the number of parameters in a range corresponding to the historical mean value plus or minus the standard deviation SD; the calculation method is as follows: the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value ± standard deviation SD of the input parameters (1.1) and (1.2) is respectively calculated, that is, whether the new value of the same parameter is in the range corresponding to the historical mean value ± standard deviation SD is compared, and then the number of all the parameters in the range is divided by the total number of the parameters, for example, if the total number of the parameters is 100, and the new value of 90 parameters is in the range of the mean value and one standard deviation thereof, the value 90/100 is 90%.
(2.3) arithmetic ratio (percentage) of data; the calculation method is as follows: namely, the input parameter (1.6) corresponds to the arithmetic ratio (percentage) of the data of the input parameter (1.3), for example, the latest' uniformity of the total mixed powder (particle) content of the solid preparation (for example, the ratio RSD of the content standard deviation of the parallel five-point sample to the average value thereof) is 2%, 98% is obtained by 100% -2% as the uniformity thereof, and the ratio is 1 (100%) by dividing the historical average value thereof by 98%. (2.4) arithmetic ratio (percentage) of data, calculated as follows: the arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.4) data is calculated, for example, the number of adverse reaction reports generated after the latest monthly product is taken by a consumer is 3, 100 batches are produced in the same month, 97 percent is calculated by '100 percent to adverse reaction report example number/batch number in corresponding time multiplied by 100 percent', and the calculation is divided by the historical average value of the parameter to 95 percent to obtain 1.02(102 percent).
(2.5) arithmetic ratio (percentage) of data; the calculation method is as follows: the arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.5) data, i.e. the results of the evaluation of effectiveness after clinical research and marketing and the historical data of consumer feedback, is expressed as "satisfaction" (percentage), including subjective and objective evaluation of efficacy, evaluation of sensory experience, and the current value of 90% divided by the historical mean value of 90% to yield 1 (100%). (2.6) e numerical weight sum, the calculation method is as follows: (100% - (1.3) value) × 0.3+ (1.4) value × 0.2+ (1.5) value × 0.2+0.3, such as 98% × 0.3+ 95% × 0.2+ 90% × 0.2+0.3 ═ 0.96. If all the input parameters (1.3) - (1.5) are fixedly set to 1, the sum of the e-value weights is 1.
(2.7) performing weight decomposition within 100%, adding, and dividing by the sum of the e-value weights to obtain a value (quality comprehensive index Q) around 1; the calculation method is as follows: for example, the above values (2.2) - (2.5) are multiplied by the weighting factors 0.3, 0.3, 0.2, 0.2, i.e. 90% × 0.3+ 100% × 0.3+ 102% × 0.2+ 100%, (the values are expressed as symbols)
0.2 to 0.97, and then divided by 0.96 obtained by (2.6) calculation to obtain 1.01. When all the input parameters (1.3) - (1.5) are fixedly set to 1 in (2.6), 0.97 is obtained from 0.97/1.
Preferably, the method for evaluating the quality of the traditional Chinese medicine comprises the following steps:
(1) parameter input, including:
(1.1) taking the standard test results of the traditional Chinese medicine raw materials, the decoction pieces, the Chinese patent medicine intermediate products, the Chinese patent medicine preparation finished products and the reserved samples thereof from the historical qualified production batches, wherein the standard test results include but are not limited to all quantitative or qualitative values of the test results obtained by testing the decoction pieces, the intermediate products and the preparations according to Chinese pharmacopoeia or other standards;
(1.2) extracting, separating, concentrating, drying, preparing and packaging technological process parameters in the production process of a historical qualified production batch, wherein the technological process parameters comprise but are not limited to the names and specific numerical values of the technological process parameters required by the registration standard and the technological procedures of the traditional Chinese medicine in the prior technological process;
(1.3) the in-batch uniformity test results of the Chinese patent medicine products from the historically qualified production batches are obtained
"100% -content uniformity versus standard deviation, RSD";
(1.4) historical data of consumer adverse reaction monitoring after clinical research and marketing of the Chinese patent medicine product are obtained, wherein the former is expressed by 100% -adverse reaction incidence (percentage), and the latter is expressed by 100% -adverse reaction report example number/batch number multiplied by 100% in corresponding time, if the number of adverse reaction reports of a certain traditional Chinese medicine manufactured by 201610 months collected up to 31 days 10 months of 2017 is 8, and the number of batches manufactured by the variety in 201610 months is 100, the traditional Chinese medicine 'consumer adverse reaction data after marketing' is 100% -8/100 multiplied by 100% which is 92%;
(1.5) effectiveness evaluation results and consumer feedback historical data obtained from clinical research and marketing of the Chinese patent medicine are expressed as satisfaction rate (percentage), and the satisfaction rate comprises subjective and objective evaluation of curative effect and evaluation of sensory experience;
(1.6) the input parameters (1.1) - (1.5) corresponding to the current batch, wherein the data (1.4) and (1.5) are obtained by specifying the post-market research (investigation and visit) of the current batch.
(2) Data processing:
(2.1) calculating historical mean values and standard deviations SD of the input parameters (1.1) and (1.2);
(2.2) calculating the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value +/-standard deviation SD of the input parameters (1.1) and (1.2);
(2.3) calculating the arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.3) data; (2.4) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.4) data, wherein the data is a set of data corresponding to the name;
(2.5) calculating the arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.5) data; (2.6) carrying out weight decomposition on the components (1.3), (1.4) and (1.5) within 100%, and adding to obtain 'e numerical value weight sum';
(2.7) the above (2.2) to (2.4) are subjected to weight decomposition within 100%, added, and divided by the sum of the e-value weights to obtain a value (quality integration index Q) around 1.
(3) And (5) judging a result:
(3.1) when Q is 1, the quality of the Chinese patent medicine is equal to the historical level, and the Chinese patent medicine is in a stable state; (3.2) when Q is less than 1, the quality of the Chinese patent medicine is lower than the historical level, and the smaller Q is, the greater the deviation of the stability of the Chinese patent medicine is, and the quality is reduced;
(3.3) when Q is more than 1, the quality of the Chinese patent medicine of the batch is higher than the historical level, and the larger Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is improved.
In the method, all input parameters (1.3) - (1.5) can be fixedly set to be 1, at the moment, the quality comprehensive index Q is maximum to be 1, and a fixed numerical value less than 1 or a historical value of the numerical value is used as a judgment standard.
Wherein, the input parameter (1.1) in the method also comprises the similarity of the chemical multi-index characteristic maps of the decoction pieces, the intermediate products and the finished products compared with a standard map, including but not limited to an HPLC-UV map.
The input parameters (1.2) of the method also comprise whether the production plan response time (namely, the time for generating the first production data-the production instruction issuing time) is within the standard response time and the standard deviation range thereof, and whether the batch production progress time is within the standard progress time and the standard deviation range thereof. If a batch of Chinese patent medicines is produced at 12:00 of a day, the first recorded numerical value obtained after production is started is that the weighing time of the material feeding is 14:30 of the day, and the 'corresponding time of the production plan' of the batch of Chinese patent medicines is
14:30-12:00 ═ 2.5 hours. The average 'corresponding time of production plan' of the historical normal production of the same Chinese patent medicine is 2 hours, the standard deviation is 0.5 hour, and then the 'response time of standard production plan' of the Chinese patent medicine is 1.5, 2.5 hours. Then, the production plan of the batch of Chinese patent medicines is within the standard response time and the standard deviation range thereof (the 'standard production plan response time'), and the number of parameters meeting the requirements is calculated in the step (2.1). For another example, if the average historical time under normal conditions of batch production of the Chinese patent medicine is 10 days and the standard deviation is 1 day, the "standard schedule time and standard deviation range" thereof is [9, 10] days. The production of the batch takes 12 days, the production progress of the batch of Chinese patent medicines does not have the standard progress time and the standard deviation range thereof, and the calculation is not carried out when the number of the parameters meeting the requirements is calculated in the step (2.1). .
Wherein, the sources of the input parameters in the method include but are not limited to: manual calculation, computer equipment acquisition, programmable PLC equipment, a Distributed Control System (DCS), a Manufacturing Execution System (MES) and an independent computer terminal.
The invention evaluates the safety, effectiveness, batch stability, batch uniform materials, quality and process parameters of the Chinese patent medicine, brings feedback information of consumers into the evaluation, can comprehensively and sensitively evaluate the internal and external quality of the Chinese medicine, and embodies the comprehensive evaluation functions of safety, effectiveness, manufacturing and product stability and uniformity of the Chinese medicine product and the satisfaction of the consumers in multiple dimensions.
Drawings
Fig. 1 is a schematic diagram of the technical solution of the present invention, which shows the main contents related to quality evaluation and the correlation thereof.
FIG. 2 is a software design prototype of the present invention FIG. 1 showing the average product quality evaluation of multiple products based on one production unit.
Fig. 3 is a software design prototype of the technical solution of the present invention fig. 2, showing a specific product quality evaluation. Wherein quality Q ═ quality state P/demand E ═ (state P1 × specific gravity P1+ state P2 × specific gravity P2 … …)/(demand E1 × specific gravity E1+ demand E2 × specific gravity E2 … …); demand e 1-demand e 2-demand e 3-1. Wherein the specific gravity p1+ the specific gravity p2+ … … is 1, and the specific gravity e1+ the specific gravity e2+ … … is 1; wherein, the specific gravity e1 is 30 percent of the specific gravity e2, and the specific gravity e3 is 40 percent.
FIG. 4 shows the stability of the Nymphaea tetragona capsule product
Detailed Description
The technical solution of the present invention is further illustrated by the following examples. However, the embodiments do not represent the limitation of the technical solution of the present invention, and the professional or the related person can set and develop the technical solution according to the description and the embodiments of the present invention and by combining the specific traditional Chinese medicine.
Example 1
The traditional Chinese medicine quality evaluation system developed and completed according to the technical scheme of the invention is shown in figure 1, and the consumer demand of the Chinese patent medicine S is set to 4 aspects of safety, effectiveness, product stability and uniformity, and further divided into a plurality of parts. The safety effectiveness is then combined to satisfaction, with the manufacturing process stability and product homogeneity respectively denoted as e 3-e 2-e 1-1, with weights of 40%, 30%, 30% respectively, as shown in fig. 3. Correspondingly, the product condition index is a dynamic value, and the maximum value is 1.
Next, (1) data collation comprising:
(1.1) taking the standard inspection results of the traditional Chinese medicine raw materials, decoction pieces, Chinese patent medicine intermediate products, Chinese patent medicine preparation finished products and sample reservation thereof from the historical qualified production batches of the S product, wherein the standard inspection results comprise all data of the detection results obtained by inspection of the decoction pieces, the extract products and the preparation in the S prescription;
(1.2) extracting, separating, concentrating, drying, preparing and packaging technological process parameters in the production process of the historical qualified production batch of the S product, wherein the technological process parameters comprise the name and specific numerical values of the technological process parameters required by the technological process according to the registration standard and the technological procedure;
(1.3) taking the in-batch uniformity test result of the Chinese patent medicine products from the S product historical qualified production batch, and expressing the in-batch uniformity test result by 100 percent relative standard deviation RSD, wherein if the uniformity RSD is 1 percent, the numerical value is 100 percent to 1 percent to 99 percent;
(1.4) historical data of consumer adverse reaction detection after clinical research and marketing of the Chinese patent medicine product are obtained, wherein the former is expressed by 100% -adverse reaction incidence (percentage), and the latter is expressed by 100% -adverse reaction report example number/batch number multiplied by 100% in corresponding time, if the number of adverse reaction reports of a certain traditional Chinese medicine which is manufactured by 201610 months is 8 after 10 months and 31 days of 2017, and the number of manufacturing batches of the variety is 100 in 201610 months, the traditional Chinese medicine 'consumer adverse reaction data after marketing' is 100% -8/100 multiplied by 100% which is 92%;
(1.5) effectiveness evaluation results and consumer feedback historical data obtained after clinical research and marketing of the Chinese patent medicine are taken, and the satisfaction rate (percentage) is expressed, wherein the satisfaction rate comprises subjective and objective evaluation of curative effect and evaluation of sensory experience, the weights of different indexes which are 100 percent of the total sum are added, and finally, the numerical value is 90 percent;
(1.6) acquiring the input parameters (1.1) - (1.5) corresponding to the current batch, wherein the historical average values of (1.4) and (1.5) are taken when the input parameters cannot be acquired, and the specific examples are 92% and 90%.
(1.7) wherein the completion rate of the batch production process is the completed process operation number/total process operation book, and the production time schedule is the current production use time/planned production period time, and the two parameters are directly displayed on the interface.
Then, the data judgment is carried out by the computer software according to the following algorithm (2):
(2.1) calculating historical mean values and standard deviations SD of the input parameters (1.1) and (1.2);
(2.2) calculating the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value +/-standard deviation SD of the input parameters (1.1) and (1.2), if 198 various types of controlled parameters obtained in the batch are in the standard range, the proportion of 198/200-99% of all 200 controlled parameters is taken as p 2;
(2.3) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.3) data, and taking 99% of a historical value of (1.3) of a currently produced product as p 1;
(2.4) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.4) data, and taking a historical value of (1.4) of the currently produced product as 92%;
(2.5) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.5) data, and taking a historical value of (1.5) of a currently produced product as 90%; and (2.4) by 1:1 weight, yielding p3 ═ 92% x 0.5+ 90% x 0.5 ═ 91%;
(2.6) calculating the e numerical weight sum, namely 1;
(2.7) adding the above (2.2) to (2.5) by weight according to the aforementioned e1, e2, e3, dividing the sum by the e numerical weight, and calculating the current variety quality comprehensive index Q ═ 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.
And finally, judging the result (3): since the values of e1, e2 and e3 are all 1 in this example, the value of Q is at most 1. Therefore, Q is 0.9 as the judgment standard, and Q is 0.958 > 0.9 in this example, which shows that the product of this batch has high stability and stable quality.
The Q of 2 batches produced thereafter was 0.960, 0.962, respectively, and was greater than 0.958 and increased, indicating a gradual increase in production quality. A batch Q of 0.927 < 0.962 produced sequentially thereafter indicates that the production quality fluctuates and is degraded.
Example 2
The same as example 1, but the e value weight sum calculated in step (2.6) is not taken as theoretical value 1, but calculated as the actual historical average of the data of the same Chinese patent medicine, namely 99%, 92% and 90% in steps (1.3), (1.4) and (1.5); the historical mean of step (2.2) is for example 98% (i.e. on average there are 4/200 parameters per batch that deviate from the mean and standard deviation range), at which point the e-value weight sum is 99% x 0.3+ [ (1.4) historical mean + (1.5) step historical mean ] × 0.4+ (2.2) historical mean × 0.3 ═ 99% × 0.3+ (92% + 90%) x 0.4/2+ 98% × 0.3 ═ 0.955. At this time, the current variety quality comprehensive index Q is calculated to be (99% × 0.3+ 99% × 0.3+ 91% × 0.4)/0.955 ═ 1.003.
And finally, judging the result (3): since the values of e1, e2 and e3 are actually averaged in this example, the Q value may exceed 1 and be 1.047 at the maximum of 1/0.955. The product of the batch has high stability and stable quality as shown by the fact that Q is 1, and Q is 1.003 to be more than 1 in the example.
If the Q of 3 batches produced later is 0.999, 0.998 and 1.001 respectively, the Q of the former two batches is less than 1 and continuously decreases, which indicates that the production quality gradually decreases. The 3 rd batch of the sequence is recovered to be normal, and the measures taken between 2 and 3 batches are effective.
Example 3
The average quality status obtained by calculating the average of the other varieties Q, such as 5 varieties, safely, effectively, stably and uniformly, is the same as the example 1. See figure 2.
Example 4
Calculation of comprehensive index of quality of woman gold capsules
The 'Nujin' capsule is a capsule prepared by extracting, concentrating, drying and granulating Chinese patent medicine preparations collected in the first part of the 'Chinese pharmacopoeia' 2015 edition. According to the technical scheme of the invention, the quality comprehensive index composition of the gynura japonica capsules is set to be 4 aspects of safety, effectiveness, stability and uniformity, the safety and effectiveness are combined into the customer satisfaction degree of the gynura japonica capsules obtained through research, the stability comprises the fluctuation state of key controlled parameters in the manufacturing process of the gynura japonica capsules, the uniformity comprises the uniformity and content fluctuation conditions in the gynura japonica capsules, and the three aspects are respectively represented as e1, e2 and e 3. Setting the values of e1, e2 and e3 to 100% respectively, and the weights thereof to 30%, 30% and 40%, respectively, results in 1 being e3+ e2+ e 1. The quality comprehensive index of a certain batch of the gynura japonica capsules is calculated as follows:
(1) data input and collection, including:
(1.1) acquisition of standard test data: taking all inspection results of the fed decoction pieces, the intermediate products (including alcohol extract thick paste, water extract thick paste, medicinal material fine powder, total mixed particles and the like) and the finished products of the production batches with historical qualified products, listing the quantitative or qualitative numerical values of the total mixed powder and the total mixed particles as follows, and inputting other inspection results according to a table format, including but not limited to the contents in the table 1.
TABLE 1
The data for each batch (37 parameters total, qualitative data of 1, and unqualified data of 0) are collated as follows, see columns 1-4 of Table 2:
TABLE 2
(1.2) inputting and collecting the technical process data of the gynura japonica capsule: the technological process parameters of extraction, separation, concentration, drying, preparation and packaging in the production process of a historical qualified production batch are taken, and the technological process comprises the steps of sorting 28 parameters according to the registered standards (the number of crushing meshes, the distillation time of volatile oil, the concentration of reflux ethanol, the reflux frequency, the reflux time, the relative density of thick paste, the decoction frequency, the decoction time and the like), the names of the manufacturing process parameters required by the technological procedures and the specific numerical values (the reflux pressure, the reflux temperature, the amount of the thick paste, the drying time, the mixing time and the like) of the manufacturing process parameters, wherein the specific names are shown in a table 3.
(1.3) the uniformity data of the capsule product comes from stability investigation, periodicity or cause investigation of historically qualified production batches, the example takes the product quality stability inspection result in the total mixed particle batch, and the content of the capsule total mixed particle RSD is measured to be 2.3% by taking the content as the detection index; and (3) investigating content change or stability in the period of validity, collecting historical batch data, taking the average value of the historical batch data, taking the month as an abscissa and taking the content as an ordinate, and performing linear regression, wherein the linear regression is shown in figure 4.
Calculating stability data (observation month slope)/content average value according to linear regression equation
＝(24*0.01)/2.3＝10.43％。
(1.4) the historical data of the clinical research of the gynecopathy and the adverse reaction detection of the consumers after marketing are expressed by 100% -adverse reaction incidence (percentage) and 100% -adverse reaction report cases/batch times multiplied by 100% in the corresponding time, if the adverse reaction report number of the product manufactured by 201610 month collected by 31 days 10 months of 2017 is 8, and the batch number of the product manufactured by 201610 months is 100 batches, the adverse reaction data of the consumers after marketing of the traditional Chinese medicine is 100% -8/100 multiplied by 100% which is 92%;
(1.5) evaluation results of effectiveness of the female golden capsule clinical research and after marketing and historical data of consumer feedback, which are expressed as 'satisfaction' (percentage), including evaluation of subjective, objective and sensory experiences such as effect satisfaction, packaging satisfaction and use satisfaction, which are respectively expressed as 5 options and scores of 1-5, are expressed as very unsatisfactory, general, satisfactory and very satisfactory, and historical mean values are obtained, wherein the data include but are not limited to the following contents:
the calculated percent satisfaction was (4.29+4.25+4.27+4.16)/4/5 ═ 84.85%
(1.6) the above input parameters (1.1) - (1.5) are taken for the current batch (e.g. 1711100), wherein (1.1) is detailed in table 2, column 7, (1.2) is shown in table 3, column 2. Wherein, in (1.3), stability examination, (1.4) and (1.5) are taken as historical averages when the stability examination cannot be obtained.
TABLE 3
(1.7) time required for batch production of the capsules 1711100 is 22 days/20 days is 1.1 days, and the standard time is 20 ± 1 day.
(2.1) calculating a historical mean value/guide value plus standard deviation SD of the input parameters (1.1) and (1.2), wherein the historical mean value/guide value plus the standard deviation SD is an early warning upper limit value, and the historical mean value/guide value plus the standard deviation SD is an early warning lower limit value; see, in particular, columns 5 and 6 of Table 2, and columns 4 and 6 of Table 3.
(2.2) calculating the percentage of the number of the input parameters (1.6) (1.7) in the corresponding ranges of the input parameters (1.1) and (1.2), see table 2 and table 3, and obtaining 35 in table 2 and 28 in table 3, wherein 2 are not in the range of the controlled parameters, so that the proportion of the batch of controlled parameters in the standard range is 1-2/(35+28) which is 96.9%; (1.7) as the 66 th parameter, setting the weight coefficient to 2, then recalculating the process stability
p2＝1-(2+1*2)/(35+28+1)＝93.9％。
(2.3) calculating the input parameter (1.6) corresponding to the input parameter (1.3) data, wherein the causal consideration values
When the weight is 100% -2.3% ═ 97.7%, the historical value of the stability survey data reference history (1.3) is 10.43%, and when calculated by a 1:1 weight, p1 ═ (100% -10.43%) 0.5+ 97.7% × 0.5) ═ 93.63%.
(2.4) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.4) data, and taking a historical numerical value of (1.4) for the currently produced product as 92%;
(2.5) calculating an arithmetic ratio (percentage) of the input parameter (1.6) to the input parameter (1.5) data, and taking a historical value (1.5) of a currently produced product as 84.85%; and (2.4) by 1:1 weight calculation, obtained p3 ═ 92% + 50% + 84.85% + 50% — 88.42%
(2.6) the above (2.2), (2.3), (2.5) are added after multiplying the above p1, p2, p3 by the corresponding weights (consistent with e1, e2, e3), and divided by the sum of the e numerical weights to calculate the batch quality index of Fujinglas 1711100: q ═ Q (p1 × 0.3+ p2 × 0.3+ p3 × 0.4)/(e1+ e2+ e3) ═ Q
93.63％×0.3+93.9％×0.3+88.42％×0.4/(1×30％+1×30％+1×40％)＝0.916。
(3) And (5) judging a result: since the sum of the weights e1, e2 and e3 is 1 in this example, the Q value is at most 1. Therefore, Q is 0.9 as the judgment standard, and Q is 0.916 > 0.9 in the example, which shows that the batch product has high stability and stable quality.
If the mean value of the Q values of the historical qualified production batches of the gynecox capsules +/-the standard deviation is 0.911 +/-0.006, and 0.916 epsilon (0.905 and 0.917), the process is normal.
For example, 1711101 batches and 1711102 batches of the lady's golden capsules Q which are sequentially produced from the beginning are respectively 0.918 and 0.921, which are both greater than 0.916 and are continuously increased, which indicates that the production quality is gradually improved. And beyond the range on the right side of the historical mean ± standard deviation range of the N-1 batch, there is a significant improvement in the various measures affecting quality.
If the Q of the woman golden capsules produced by 1711103 batches is 0.907 < 0.921, the production quality is fluctuated, and the quality is reduced. But not outside the left-hand range of the historical mean ± standard deviation range of the N-1 batch, indicates that there is instability in the individual parameters affecting quality.
Example 5
Quality comprehensive index of Chinese patent medicine Shenbao tablets
Shenbao tablets are the same prescription preparation of Shenbao mixture collected in the first part of the 'Chinese pharmacopoeia' 2015 edition and are prepared by extraction, concentration, granulation and tabletting. According to the technical scheme of the invention, the quality comprehensive index Q of the Shenbao tablet is calculated by referring to the above embodiment. Batches Q produced at 201710 averaged 0.927 ± 0.005.
Claims (7)
1. The method for evaluating the quality of the traditional Chinese medicine is characterized by comprising the following steps of:
(1) input parameter selection:
(1.1) taking the traditional Chinese medicine raw materials, decoction pieces, intermediate products and finished products of the Chinese patent medicine preparation of the same Chinese patent medicine from historically qualified production batches and standard test results of samples thereof;
(1.2) extracting, separating, concentrating, drying, preparing and packaging technological process parameters in the production process of the same Chinese patent medicine from the historical qualified production batch;
(1.3) taking the uniformity inspection result in the batch of the Chinese patent medicine products of the same Chinese patent medicine in the historically qualified production batch, and expressing the uniformity as 100 percent and relative standard deviation RSD;
(1.4) taking historical data of clinical research and consumer adverse reaction monitoring after marketing of the same Chinese patent medicine product, wherein the former is expressed by 100% -adverse reaction incidence rate, and the latter is expressed by 100% -adverse reaction report cases/batches within corresponding time multiplied by 100% ";
(1.5) effectiveness evaluation results and consumer feedback historical data obtained from clinical research and marketing of the same Chinese patent medicine are expressed as satisfaction rate;
(1.6) the parameters (1.1) - (1.5) corresponding to the same Chinese patent medicine from the new production batch, wherein the data (1.4) and (1.5) are obtained by specifying the post-marketing study of the current batch;
(2) processing input parameter data:
(2.1) calculating historical mean values and standard deviations SD of the input parameters (1.1) and (1.2);
(2.2) calculating the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value +/-standard deviation SD of the input parameters (1.1) and (1.2);
(2.3) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.3) data;
(2.4) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.4) data;
(2.5) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.5) data;
(2.6) carrying out weight decomposition on the components (1.3), (1.4) and (1.5) within 100%, and adding to obtain 'e numerical value weight sum';
(2.7) performing weight decomposition on the above (2.2) - (2.5) within 100%, adding, and dividing by the sum of the (2.6) e numerical weight to obtain a quality comprehensive index Q;
(3) and (5) judging a result:
(3.1) when Q is 1, the quality of the same Chinese patent medicine in the new production batch is equal to the historical level, and the Chinese patent medicine is in a stable state;
(3.2) when Q is less than 1, the quality of the same Chinese patent medicine in a new production batch is lower than the historical level, and the smaller Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is reduced;
(3.3) when Q is more than 1, the quality of the same Chinese patent medicine in a new production batch is higher than the historical level, and the larger Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is improved.
2. The evaluation method according to claim 1, characterized by comprising the steps of:
(1) input parameter selection:
(1.1) taking the standard test results of the traditional Chinese medicine raw materials, the decoction pieces, the intermediate products and the finished products of the Chinese patent medicine preparations of the same Chinese patent medicine in the historical qualified production batches and the sample reservation thereof, wherein the standard test results comprise but are not limited to all quantitative or qualitative values of the test results obtained by the decoction pieces, the intermediate products and the preparations according to Chinese pharmacopoeia or other standard tests;
(1.2) technological process parameters of extraction, separation, concentration, drying, preparation and packaging in the production process of the same Chinese patent medicine from a historical qualified production batch, including but not limited to the name and specific numerical values of the technological process parameter set according to the registration standard and the technological specification requirement of the Chinese patent medicine in the technological process;
(1.3) taking the uniformity inspection result in the batch of the Chinese patent medicine products of the same Chinese patent medicine in the historically qualified production batch, and expressing the uniformity as 100 percent and relative standard deviation RSD;
(1.4) taking historical data of clinical research and consumer adverse reaction monitoring after marketing of the same Chinese patent medicine product, wherein the former is expressed by 100% -adverse reaction incidence rate, and the latter is expressed by 100% -adverse reaction report cases/batches within corresponding time multiplied by 100% ";
(1.5) effectiveness evaluation results and consumer feedback historical data obtained from clinical research and marketing of the same Chinese patent medicine are expressed as satisfaction rates, and the satisfaction rates comprise subjective and objective evaluation of curative effect and evaluation of sensory experience;
(1.6) the parameters (1.1) - (1.5) corresponding to the same Chinese patent medicine from the new production batch, wherein the data (1.4) and (1.5) are obtained by specifying the post-marketing study of the current batch;
(2) processing input parameter data:
(2.1) calculating historical mean values and standard deviations SD of the input parameters (1.1) and (1.2);
(2.2) calculating the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value +/-standard deviation SD of the input parameters (1.1) and (1.2);
(2.3) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.3) data;
(2.4) calculating an arithmetic ratio of the input parameter (1.6) to the input parameter (1.4) data, wherein when the arithmetic ratio is calculated, the name of the parameter selected from the input parameter (1.6) is the same as that of the parameter selected from the input parameter (1.4);
(2.5) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.5) data;
(2.6) carrying out weight decomposition on the components (1.3), (1.4) and (1.5) within 100%, and adding to obtain 'e numerical value weight sum';
(2.7) performing weight decomposition on the above (2.2) - (2.5) within 100%, adding, and dividing by the sum of the (2.6) e numerical weight to obtain a quality comprehensive index Q;
(3) and (5) judging a result:
(3.1) when Q is 1, the quality of the same Chinese patent medicine in the new production batch is equal to the historical level, and the Chinese patent medicine is in a stable state;
(3.2) when Q is less than 1, the quality of the same Chinese patent medicine in a new production batch is lower than the historical level, and the smaller Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is reduced;
(3.3) when Q is more than 1, the quality of the same Chinese patent medicine in a new production batch is higher than the historical level, and the larger Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is improved.
3. The evaluation method according to claim 1, characterized by comprising the steps of:
(1) parameter input, including:
(1.1) taking the standard test results of the traditional Chinese medicine raw materials, the decoction pieces, the Chinese patent medicine intermediate products, the Chinese patent medicine preparation finished products and the reserved samples thereof from the historical qualified production batches, wherein the standard test results include but are not limited to all quantitative or qualitative values of the test results obtained by testing the decoction pieces, the intermediate products and the preparations according to Chinese pharmacopoeia or other standards;
(1.2) extracting, separating, concentrating, drying, preparing and packaging technological process parameters in the production process of a historical qualified production batch, wherein the technological process parameters comprise but are not limited to the names and specific numerical values of the technological process parameters set according to the registration standard and the technological procedure requirement of the traditional Chinese medicine;
(1.3) taking the intra-batch uniformity test result of the Chinese patent medicine products of the historically qualified production batches, and expressing the intra-batch uniformity test result as 100 percent content uniformity Relative Standard Deviation (RSD);
(1.4) historical data of adverse reaction monitoring of consumers after clinical research and marketing of the Chinese patent medicine product are taken, wherein the former is expressed by 100% -adverse reaction incidence rate, and the latter is expressed by 100% -adverse reaction report example number/batch number in corresponding time multiplied by 100% ";
(1.5) effectiveness evaluation results and consumer feedback historical data obtained after clinical research and marketing of the Chinese patent medicine are taken, and the satisfaction rate is expressed and comprises subjective and objective evaluation of curative effect and evaluation of sensory experience;
(1.6) the input parameters (1.1) - (1.5) corresponding to the current batch, wherein the data (1.4) and (1.5) are data obtained by specifying the after-market research of the current batch;
(2) data processing:
(2.1) calculating historical mean values and standard deviations SD of the input parameters (1.1) and (1.2);
(2.2) calculating the percentage of the number of the input parameters (1.6) in the range corresponding to the historical mean value +/-standard deviation SD of the input parameters (1.1) and (1.2);
(2.3) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.3) data;
(2.4) calculating an arithmetic ratio of the input parameter (1.6) to the input parameter (1.4) data, wherein when the arithmetic ratio is calculated, the name of the parameter selected from the input parameter (1.6) is the same as that of the parameter selected from the input parameter (1.4);
(2.5) calculating the arithmetic ratio of the input parameter (1.6) to the input parameter (1.5) data;
(2.6) carrying out weight decomposition on the components (1.3), (1.4) and (1.5) within 100%, and adding to obtain 'e numerical value weight sum';
(2.7) performing weight decomposition on the components (2.2) - (2.5) within 100%, adding, and dividing by the sum of the e numerical weight to obtain a quality comprehensive index Q;
(3) and (5) judging a result:
(3.1) when Q is 1, the quality of the Chinese patent medicine is equal to the historical level, and the Chinese patent medicine is in a stable state;
(3.2) when Q is less than 1, the quality of the Chinese patent medicine is lower than the historical level, and the smaller Q is, the greater the deviation of the stability of the Chinese patent medicine is, and the quality is reduced;
(3.3) when Q is more than 1, the quality of the Chinese patent medicine of the batch is higher than the historical level, and the larger Q is, the larger the deviation of the stability of the Chinese patent medicine is, and the quality is improved.
4. The evaluation method according to claim 1, wherein all of the input parameters (1.3) - (1.5) are fixedly set to 1, and the quality index Q is a fixed value at a maximum of 1, and a fixed value < 1 derived from the data history value is used as a judgment criterion.
5. The method of claim 1, wherein the input parameters (1.1) further comprise similarity of chemical multi-index profiles of the decoction pieces, intermediate products, and finished products to standard profiles, including but not limited to HPLC-UV profiles.
6. The evaluation method according to claim 1, wherein the input parameters (1.2) further include a production plan response time, which is a time at which the first production data is obtained-a time at which the production order is issued, and a batch production progress time; and judging whether the production plan response time is in a range of standard response time plus or minus the standard deviation of the response time or not, and judging whether the batch production progress time is in a range of standard progress time plus or minus the standard deviation of the progress time or not.
7. The evaluation method according to claim 1, wherein the sources of the input parameters include but are not limited to: manual calculation, computer equipment acquisition, programmable PLC equipment, a distributed control system, a manufacturing execution system and an independent computer terminal.
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