Method, system and equipment for generating placebo formula of traditional Chinese medicine compound decoction, medium and program product

Abstract

The invention provides a method, a system and equipment for generating a placebo formula of a traditional Chinese medicine compound decoction, a medium and a program product. The generation method comprises the following steps: main control equipment determines a primary formula of the traditional Chinese medicine compound decoction placebo according to physical property parameters of to-be-selected components and appearance parameters of the traditional Chinese medicine compound decoction; the main control equipment instructs the test terminals to obtain reaction data of the test object for the primary selection formula to the test terminals, and based on the reaction data, a similarity result, an applicability result, a safety result and a controllability result of the primary selection formula are obtained; under the condition that the similarity result, the applicability result, the safety result and the controllability result of the primarily selected formula all meet the standard conditions of the medicament formula, the main control equipment determines that the primarily selected formula is the placebo formula of the traditional Chinese medicine compound decoction. According to the method for generating the placebo formula of the traditional Chinese medicine compound decoction, the production efficiency is improved, the quality of the placebo is guaranteed, and the placebo has good similarity, applicability, controllability and safety.

Description

Technical Field

[0001] The present invention generally relates to the technical field of Chinese medicine preparation, and specifically relates to a method, system, equipment, medium and program product for generating a placebo formula of a Chinese medicine compound decoction. Background Art

[0002] Placebo refers to a simulated drug that contains no or a small amount of pharmacologically active ingredients, but has no therapeutic effect on the observed physiological and pathological phenomena, and is the same or similar to the test drug in appearance, color, taste, etc. The test personnel cannot distinguish between drugs and placebos, which can eliminate the interference of additional psychological factors such as the inner expectations of the subjects and the doctor's suggestions caused by the intervention itself on the test results, and improve the authenticity and reliability of the test results. However, there are many kinds of Chinese herbal compound decoctions, and the composition and content of Chinese medicine are complex and varied. The sensory characteristics of the prescriptions composed of different Chinese medicines are even more difficult to predict. There are hundreds of kinds of Chinese herbal medicines, and the types of Chinese medicine prescriptions composed of combinations are even more difficult to count. For Chinese medicines with different sensory characteristics, how to make Chinese medicine simulators that meet clinical needs is still lacking in-depth exploration. Chinese herbal compound contains many kinds of herbs and the composition is flexible and varied, and most Chinese herbal medicines have unique sensory characteristics, which brings great difficulties to the production of Chinese medicine placebos. Some researchers have proposed the property requirements of "applicability, safety, similarity, and controllability" for placebos. Applicability means that it must be guaranteed not to have therapeutic effects or contain active ingredients related to therapeutic effects, or not to produce therapeutic effects related to the purpose of the study, and not to interfere with the observation of the safety and effectiveness of the test drug. Controllability refers to the consistency of raw materials, preparation processes, and finished product quality to ensure the quality of the placebo.

[0003] The existing methods for preparing placebos mainly include the simple excipient method and the low-ratio drug combined excipient method. Among them, the simple excipient method refers to the use of only excipients, pigments and flavors to make placebos. However, since the sensory properties of Chinese herbal decoctions are not stable, no researchers have yet summarized how to measure the sensory properties of decoctions and screen appropriate excipients to simulate the properties of Chinese medicine. The low-ratio drug combined excipient method refers to diluting the drug to a certain ratio and using it as a raw material and combined with excipients to make placebos. However, if the dilution ratio of Chinese medicine is too high, the original sensory properties will be retained to a lesser extent, and the simulation effect of the placebo produced cannot be fully guaranteed. It is also unclear to what extent it should be diluted to be used as a placebo. Summary of the invention

[0004] In view of the above-mentioned defects or deficiencies in the prior art, it is desired to provide a method, system, device, medium and program product for generating a placebo formula of a Chinese herbal compound decoction, which can reliably generate a placebo formula, and the placebo formula meets the requirements of applicability, similarity, safety and controllability.

[0005] In a first aspect, the present invention provides a method for generating a placebo formula of a Chinese herbal compound decoction, which is applied to a placebo generation system. The system includes a main control device and multiple test terminals. The generation method includes:

[0006] The main control device determines the preliminary formula of the Chinese herbal compound decoction placebo according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese herbal compound decoction; wherein the physical property parameters include the dosage, efficacy information, processing information, decoction information and formula information of the components to be selected;

[0007] The master control device sends the preliminary formula to each test terminal, and instructs the test terminal to obtain the reaction data of the test object to the preliminary formula, and obtains the similarity result, applicability result, safety result and controllability result of the preliminary formula based on the reaction data reported by each test terminal;

[0008] When the similarity results, applicability results, safety results and controllability results of the preliminary formula all meet the standard conditions of the pharmaceutical formula, the main control device determines that the preliminary formula is a placebo formula of the Chinese herbal compound decoction.

[0009] As an optional solution, if the reaction data includes visual data, taste data, olfactory data and tactile data, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary formula, and the similarity result of the preliminary formula is obtained, including:

[0010] The main control device obtains the sensory profile characteristics of the preliminary selected formula according to the visual data, taste data, olfactory data and tactile data; wherein the sensory profile characteristics refer to the visual characteristics, taste characteristics, olfactory characteristics and tactile characteristics of the preliminary selected formula;

[0011] The main control device instructs the test terminal to obtain the visual data, taste data, olfactory data and tactile data of the test subject for the Chinese herbal compound decoction;

[0012] The main control device obtains a similarity result of the preliminary formula based on the sensory profile characteristics of the preliminary formula and the visual data, taste data, olfactory data and tactile data of the Chinese herbal compound decoction; wherein the similarity result refers to the degree of similarity between the sensory profile characteristics of the preliminary formula and the visual data, taste data, olfactory data and tactile data of the Chinese herbal compound decoction.

[0013] As an optional solution, the main control device obtains the sensory profile characteristics of the preliminary selected recipe based on the visual data, taste data, olfactory data and tactile data, including:

[0014] The main control device sends test requirements and test standards to each test terminal, and instructs each test terminal to obtain visual data, taste data, olfactory data and tactile data; wherein the test requirements are used to instruct the test subject to be familiar with the appearance parameters of the corresponding Chinese herbal compound decoction, the method of use of the preliminary formula and the use environment; the appearance parameters include the color, taste and smell of the Chinese herbal compound decoction; the test standards are obtained based on professional vocabulary in the field of traditional Chinese medicine, and are used to provide the test subject with an optional expression vocabulary for the visual data, taste data, olfactory data and tactile data of the preliminary formula;

[0015] The main control device receives the visual data, taste data, olfactory data and tactile data of the preliminary formula fed back by each test terminal, and counts, screens and defines the visual data, taste data, olfactory data and tactile data of the preliminary formula in turn to obtain the sensory profile characteristics of the preliminary formula; wherein the definition process refers to accurately defining the visual data, taste data, olfactory data and tactile data of the preliminary formula according to dictionaries, textbooks and authoritative guidelines.

[0016] As an optional solution, if the reaction data includes the results of animal test efficacy and / or instrument analysis efficacy, and the efficacy information of each component in the preliminary formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary formula, and the applicability results of the preliminary formula include:

[0017] The main control device instructs at least one test terminal to feedback efficacy information of each component of the preliminary selected formula;

[0018] Alternatively, the main control device instructs at least one test terminal to obtain the animal test efficacy results and / or instrument analysis efficacy results of the preliminary selected formula;

[0019] The main control device determines whether the preliminary selected formula has efficacy based on the efficacy results of animal tests and / or the efficacy results of instrument analysis, as well as the efficacy information of the preliminary selected formula;

[0020] When the master control device determines that the primary selected formula is not effective, the master control device determines that the primary selected formula is suitable for use;

[0021] When the main control device determines that the preliminary selected formula has a therapeutic effect, the main control device determines that the preliminary selected formula has poor applicability.

[0022] As an optional solution, if the reaction data includes toxicological test data of the preliminary selected formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary selected formula, and the safety result of the preliminary selected formula includes:

[0023] The main control device instructs at least one test terminal to obtain toxicological test data of the preliminary selected formula, and determines whether the preliminary selected formula has obvious adverse reactions according to the toxicological test data;

[0024] When the toxicology test data indicates that the preliminary selected formula has no obvious adverse reactions, the main control device determines that the safety of the preliminary selected formula is good;

[0025] When the toxicology test data indicates that the preliminary selected formula has obvious adverse reactions, the main control device determines that the safety of the preliminary selected formula is poor.

[0026] As an optional solution, if the reaction data includes the quality evaluation result of the preliminary selected formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary selected formula, and the controllability result of the preliminary selected formula is obtained, including:

[0027] The main control device instructs each test terminal to obtain a quality evaluation result of the preliminary formula; the quality evaluation result of the preliminary formula includes a result indicating the quality of the raw materials of the preliminary formula, and a result indicating whether the preliminary formula prepared multiple times according to the predetermined preparation process is the same;

[0028] When the quality evaluation result of the initial selected formula indicates that the quality of the raw materials of the initial selected formula is qualified and indicates that the initial selected formulas prepared multiple times are the same, the main control device determines that the controllability of the initial selected formula is good;

[0029] If the quality evaluation result of the initially selected formula indicates that the quality of the raw materials of the initially selected formula is unqualified, and / or indicates that the initially selected formulas prepared multiple times are different, the main control device determines that the controllability of the initially selected formula is poor.

[0030] In a second aspect, the present invention provides a system for generating a placebo of a Chinese medicine compound decoction, the system comprising: a main control device and a plurality of test terminals;

[0031] The main control device determines the preliminary formula of the Chinese herbal compound decoction placebo according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese herbal compound decoction; wherein the physical property parameters include the dosage, efficacy information, processing information, decoction information and formula information of the components to be selected;

[0032] The master control device sends the preliminary formula to each test terminal, and the test terminal receives the preliminary formula;

[0033] The main control device instructs the test terminal to obtain the response data of the test object to the preliminary selected formula;

[0034] The test terminal reports the response data;

[0035] The main control device obtains the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary selected formula based on the reaction data reported by each test terminal;

[0036] When the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary formula all meet the standard conditions of the pharmaceutical formula, the main control equipment determines that the preliminary formula is a placebo formula of the Chinese herbal compound decoction.

[0037] In a third aspect, the present invention provides a computer device, comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor is configured to implement the steps of the method of the first aspect when executing the program.

[0038] In a fourth aspect, the present invention provides a computer-readable storage medium having a computer program stored thereon, wherein the computer program is used to implement the steps of the method of the first aspect.

[0039] In a fifth aspect, the present invention provides a computer program product, comprising a computer program, characterized in that when the computer program is executed by a processor, the steps of the method of the first aspect are implemented.

[0040] The method for generating a placebo formula of a Chinese medicine compound decoction of the present invention, the main control device determines the preliminary formula of the placebo of the Chinese medicine compound decoction according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese medicine compound decoction; the main control device sends the preliminary formula to each test terminal, and instructs the test terminal to obtain the reaction data of the test object for the preliminary formula, and obtains the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary formula based on the reaction data reported by each test terminal; when the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary formula all meet the standard conditions of the pharmaceutical formula, the main control device determines that the preliminary formula is the placebo formula of the Chinese medicine compound decoction. The method for generating a placebo formula of a Chinese medicine compound decoction of the present invention is executed by the main control system, which is conducive to improving production efficiency, and ensuring the quality of the placebo, so that the placebo has good similarity, applicability, controllability and safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Other features, objects and advantages of the present application will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0042] Figure 1 A schematic flow chart of a method for generating a placebo formula of a Chinese medicine compound decoction provided in an embodiment of the present application;

[0043] Figure 2 A schematic diagram of a system for generating a placebo formula of a Chinese medicine compound decoction provided in an embodiment of the present application;

[0044] Figure 3 A structural block diagram of an electronic device provided in an embodiment of the present application. DETAILED DESCRIPTION

[0045] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the relevant invention, rather than to limit the invention. It is also necessary to explain that, for ease of description, only the parts related to the invention are shown in the accompanying drawings.

[0046] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0047] Based on the above problems, the embodiment of the present application provides a method for generating a placebo formula of a Chinese medicine compound decoction, which is applied to a placebo generation system. The system includes a main control device and multiple test terminals, such as Figure 1 As shown, the generation method includes:

[0048] S10, the main control device determines the preliminary formula of the Chinese herbal compound decoction placebo according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese herbal compound decoction; wherein the physical property parameters include the dosage, efficacy information, processing information, decoction information and formula information of the components to be selected;

[0049] Among them, the main control device is preset with various physical parameters of the components for preparing placebos, that is, the physical parameters of the components to be selected; the physical parameters include but are not limited to the dosage, efficacy information, processing information, decoction information and formula information; the appearance parameters include but are not limited to color, smell and taste, etc.; the sensory characteristics of each component under different dosages, different sources, different processing methods, and different decoction methods may show certain differences, and the therapeutic effects may also be different. Therefore, determining the preliminary formula based on these factors is conducive to improving accuracy.

[0050] The main control device and the test terminal in the embodiments of the present application may be, but are not limited to, computers, tablet computers, mobile phones, personal digital assistants and other devices.

[0051] It is understandable that the composition of the Chinese herbal compound decoction can be determined in advance according to the "Standards for Reporting Clinical Randomized Controlled Trials of Chinese Herbal Compounds". If additions or subtractions are required, the addition or subtraction rules and the drugs involved must be clearly defined. The dosage, origin and preparation method of each herbal medicine used must be controlled to be a fixed source from a specific hospital or pharmaceutical company. The specific decoction method is based on the "Technical Specifications for Decoction of Chinese Herbal Decoctions" to obtain the Chinese herbal compound decoction. At this time, the appearance parameters of the Chinese herbal compound decoction can be obtained, and the appearance parameters of the Chinese herbal compound decoction are pre-stored in the main control device. The main control device screens the components to be selected according to the physical properties of the components to be selected and the appearance parameters of the Chinese herbal compound decoction to obtain a preliminary formula.

[0052] It can also be understood that the number of test terminals is determined according to the number of tests actually required, such as but not limited to 10, 20, etc., and each test terminal is operated by one user.

[0053] S20, the master control device sends the preliminary formula to each test terminal, and instructs the test terminal to obtain the reaction data of the test object to the preliminary formula, and obtains the similarity result, applicability result, safety result and controllability result of the preliminary formula based on the reaction data reported by each test terminal;

[0054] It can be understood that the preliminary formula sent by the main control device to each test terminal includes the components of the preliminary formula, trial dosage and usage method, etc.; this is conducive to ensuring that the preliminary formula obtained by each test terminal is completely consistent, and ensuring that the test object feeds back the reaction data of the same preliminary formula.

[0055] It should be noted that the reaction data is the data fed back by the test subject through the test terminal after the test terminal receives the preliminary formula and the test subject tries the preliminary formula. The reaction data may include, but is not limited to, the test subject's visual data, taste data, olfactory data, tactile data, toxicological test data, clinical experimental data, etc. Among them, the test subject may be a human and / or an animal, and of course the test subject should meet certain specific test conditions, such as good health and normal senses.

[0056] It can also be understood that the similarity result refers to the similarity between the sensory profile characteristics of the preliminary formula and the sensory profile characteristics of the Chinese herbal compound decoction; the sensory profile characteristics refer to the description of the sensory characteristics of the sample, which can make the sensory characteristic indicators of the product more intuitively displayed. The sensory profile characteristics include visual characteristics (such as but not limited to shape, texture, color, gloss), taste characteristics (such as but not limited to taste), olfactory characteristics (such as but not limited to smell), and touch (such as but not limited to mouthfeel); the applicability result refers to whether the efficacy is exerted, such as affecting blood sugar fluctuations; the safety result refers to the judgment of adverse reactions after receiving control therapy through testing. Adverse reactions can be observed by observing the reaction after taking the test, or by changes in liver and kidney function indicators; the controllability result refers to judging whether the quality of the placebo is controllable and stable according to the process of the raw materials, production methods, and setting methods used in the production, that is, whether the quality of the raw materials is qualified and whether the preparation method is repeatable.

[0057] S30. When the similarity results, applicability results, safety results and controllability results of the preliminary selected formula all meet the standard conditions of the pharmaceutical formula, the main control device determines that the preliminary selected formula is a placebo formula of the Chinese herbal compound decoction.

[0058] Among them, the standard conditions for pharmaceutical formulations are the standards for qualified placebos formulated according to authoritative documents, textbooks, and experts in the field of placebo formulations, and are determined specifically according to actual applications; in the embodiments of the present application, the standard conditions for pharmaceutical formulations include a high similarity between the sensory profile characteristics of the placebo and the Chinese herbal compound decoction, good applicability results, good safety results, and good controllability results.

[0059] The method for generating a placebo formula of a Chinese medicine compound decoction in an embodiment of the present application solves the problem that the similarity, controllability, safety and applicability of a placebo cannot be simultaneously guaranteed in the prior art. The embodiment of the present application determines the preliminary formula of the placebo of the Chinese medicine compound decoction according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese medicine compound decoction by the main control device; the main control device sends the preliminary formula to each test terminal, and instructs the test terminal to obtain the reaction data of the test object for the preliminary formula, and obtains the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary formula based on the reaction data reported by each test terminal; when the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary formula all meet the standard conditions of the pharmaceutical formula, the main control device determines that the preliminary formula is the placebo formula of the Chinese medicine compound decoction. The method for generating a placebo formula of a Chinese medicine compound decoction of the present invention is executed by the main control system, which is conducive to improving production efficiency and ensuring the quality of the placebo, so that the placebo has good similarity, applicability, controllability and safety.

[0060] As an achievable manner, if the reaction data includes visual data, taste data, olfactory data and tactile data, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary formula, and the similarity result of the preliminary formula is obtained, including:

[0061] The main control device obtains the sensory profile characteristics of the preliminary selected formula according to the visual data, taste data, olfactory data and tactile data; wherein the sensory profile characteristics refer to the visual characteristics, taste characteristics, olfactory characteristics and tactile characteristics of the preliminary selected formula;

[0062] The main control device instructs the test terminal to obtain the visual data, taste data, olfactory data and tactile data of the test subject for the Chinese herbal compound decoction;

[0063] The main control device obtains a similarity result of the preliminary formula based on the sensory profile characteristics of the preliminary formula and the visual data, taste data, olfactory data and tactile data of the Chinese herbal compound decoction; wherein the similarity result refers to the degree of similarity between the sensory profile characteristics of the preliminary formula and the visual data, taste data, olfactory data and tactile data of the Chinese herbal compound decoction.

[0064] Furthermore, in some embodiments, the main control device obtains the sensory profile characteristics of the preliminary selected recipe according to the visual data, taste data, olfactory data and tactile data, including:

[0065] The main control device sends test requirements and test standards to each test terminal, and instructs each test terminal to obtain visual data, taste data, olfactory data and tactile data; wherein the test requirements are used to instruct the test subject to be familiar with the appearance parameters of the corresponding Chinese herbal compound decoction, the method of use of the preliminary formula and the use environment; the appearance parameters include the color, taste and smell of the Chinese herbal compound decoction; the test standards are obtained based on professional vocabulary in the field of traditional Chinese medicine, and are used to provide the test subject with an optional expression vocabulary for the visual data, taste data, olfactory data and tactile data of the preliminary formula;

[0066] The main control device receives the visual data, taste data, olfactory data and tactile data of the preliminary formula fed back by each test terminal, and counts, screens and defines the visual data, taste data, olfactory data and tactile data of the preliminary formula in turn to obtain the sensory profile characteristics of the preliminary formula; wherein the definition process refers to accurately defining the visual data, taste data, olfactory data and tactile data of the preliminary formula according to dictionaries, textbooks and authoritative guidelines.

[0067] The method for acquiring the sensory profile characteristics is as follows: after the test terminal receives an instruction from the main control device to acquire the test subject's reaction data to the preliminary selected formula, the test subject receives the instruction through the test terminal, and performs the test and gives feedback according to the test requirements and test standards. The test subject inputs the visual data, taste data, olfactory data and tactile data of the preliminary selected formula through the human-computer interaction interface of the test terminal;

[0068] Example:

[0069] 1) Recruit a corresponding sensory description team, and set the test subjects to 10 people, that is, the main control device sends instructions to 10 test terminals. The test subjects are all familiar with the corresponding Chinese herbal decoctions according to the test requirements, and their sensory functions are normal.

[0070] 2) The test requirements also specify the test location: refer to the "General Guidelines for Establishing Sensory Analysis Laboratories for Sensory Analysis" (GBT13868-2009), set up an evaluation laboratory that meets the requirements, set up compartments so that the test objects can be identified separately and descriptive words can be selected. The evaluations should be independent of each other to avoid mutual interference between test objects and the influence of other environmental factors.

[0071] 3) The test subjects try the pre-selected formula decoction. Since the test subjects' senses are easily affected by the external environment, factors such as different temperatures, different containers, and different light will affect the sensory impression they leave on people. Therefore, the temperature and packaging of the medicine need to be set in advance to ensure that the characteristics of the medicine are fully and stably exposed to the test subjects. The container for the liquid medicine must be colorless and transparent; Chinese herbal medicine pieces must be decocted in accordance with the "Technical Specifications for Decoction of Chinese Herbal Medicines"; the temperature of the Chinese herbal medicine presented to the evaluator is set between 30°-40°.

[0072] 4) The main control device sends the test standard, which includes a vocabulary list of optional expressions for providing the test subjects with visual data, taste data, olfactory data and tactile data of the preliminary formula: with reference to professional terms in the field of traditional Chinese medicine, each test subject selects appropriate words to fully describe the characteristics perceived by him or her, and if necessary, according to the actual situation and needs of the clinical trial, some inappropriate expressions or meanings of words can be adjusted accordingly.

[0073] 5) The main control device counts and selects words: unclear words can be further modified; words with similar meanings are merged, and some words that are not related to sensory attributes are deleted;

[0074] 6) Master control equipment defines vocabulary: The master control equipment gives clear definitions to professional descriptors based on reference to relevant dictionaries, textbooks, official standards, authoritative guidelines, etc. to obtain the sensory profile characteristics of the preliminary formula.

[0075] The similarity evaluation method is as follows:

[0076] The main control device can choose to use the score evaluation method, two-three point inspection method, three-point inspection method, and independent evaluation method as the main methods. In actual application, it is recommended to carry out the independent evaluation method (in which the test subject only receives one intervention) combined with any of the other three methods (the test subject receives two interventions) (the three-point inspection method is recommended), see Table 1.

[0077] Statistical analysis method: See the eligibility criteria in Table 1. When the final results meet the eligibility criteria, they meet the requirements and can be considered to be sufficiently similar to the placebo.

[0078] During the evaluation process, the test subjects should ensure that the evaluation site is brightly lit, relatively quiet, and relatively constant in temperature. Evaluators should avoid communicating with each other during the evaluation. When evaluating the taste of the drug, they should rinse their mouths with clean water before the evaluation and between two evaluations. The containers used during the evaluation should be colorless and transparent and should not interfere with the appearance of the drug itself.

[0079] Table 1 Evaluation methods

[0080]

[0081]

[0082] Note: RR = (number of cases where placebo was judged as "Chinese herbal compound decoction" / total number of cases where placebo was distributed) / (number of cases where test drug was judged as "Chinese herbal compound decoction" / number of cases where placebo was judged as "Chinese herbal compound decoction") × 100%.

[0083] As an achievable method, if the reaction data includes the results of animal test efficacy and / or instrument analysis efficacy, and the efficacy information of each component in the preliminary formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary formula, and the applicability results of the preliminary formula are obtained, including:

[0084] The main control device instructs at least one test terminal to feedback efficacy information of each component of the preliminary selected formula;

[0085] Alternatively, the main control device instructs at least one test terminal to obtain the animal test efficacy results and / or instrument analysis efficacy results of the preliminary selected formula;

[0086] The main control device determines whether the preliminary selected formula has efficacy based on the efficacy results of animal tests and / or the efficacy results of instrument analysis, as well as the efficacy information of the preliminary selected formula;

[0087] When the master control device determines that the primary selected formula is not effective, the master control device determines that the primary selected formula is suitable for use;

[0088] When the main control device determines that the preliminary selected formula has a therapeutic effect, the main control device determines that the preliminary selected formula has poor applicability.

[0089] It can be understood that the applicability is mainly to judge whether the preliminary formula has therapeutic effects; the embodiments of the present application can be judged from the components to clarify whether the efficacy of each component used plays a therapeutic role. Of course, for placebos with unclear ingredients, the main control device can instruct the test terminal to obtain instrument measurement data, such as selecting appropriate instruments to measure the content of placebo ingredients, such as mass spectrometers, liquid chromatographs, spectrometers, etc., and compare them with the content of the drug to clarify whether the placebo contains pharmacological ingredients in the drug. In addition, for some special diseases, such as diabetes, it is necessary to additionally clarify whether the ingredients contain ingredients that affect blood sugar. The main control device can instruct the test terminal to obtain animal test results and / or clinical trial results. The animal test results are obtained through animal experiments, and the clinical trial results are verified by the outcome indicators set in the clinical trials.

[0090] As an achievable manner, if the reaction data includes toxicological test data of the preliminary selected formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary selected formula, and the safety result of the preliminary selected formula is obtained, including:

[0091] The main control device instructs at least one test terminal to obtain toxicological test data of the preliminary selected formula, and determines whether the preliminary selected formula has obvious adverse reactions according to the toxicological test data;

[0092] When the toxicology test data indicates that the preliminary selected formula has no obvious adverse reactions, the main control device determines that the safety of the preliminary selected formula is good;

[0093] When the toxicology test data indicates that the preliminary selected formula has obvious adverse reactions, the main control device determines that the safety of the preliminary selected formula is poor.

[0094] It is understood that safety is judged by observing the adverse reactions of the subjects after receiving the control therapy. Adverse reactions can be observed by observing the patient's reaction after taking the drug or by changes in liver and kidney function indicators.

[0095] In some embodiments, the main control device can judge the safety of the preliminary formula from the ingredients of each component of the preliminary formula, that is, whether each ingredient has toxic side effects and whether its dosage is within the safety range of relevant standards. Of course, the main control device can also instruct the test terminal to obtain the results of animal tests. After receiving the instructions from the main control device, the user observes the appearance, behavior, mental state and liver and kidney function indicators of the mice after the intervention of the preliminary formula to verify the safety of the placebo.

[0096] As an achievable manner, if the reaction data includes the quality evaluation result of the preliminary selected formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary selected formula, and the controllability result of the preliminary selected formula is obtained, including:

[0097] The main control device instructs each test terminal to obtain a quality evaluation result of the preliminary formula; the quality evaluation result of the preliminary formula includes a result indicating the quality of the raw materials of the preliminary formula, and a result indicating whether the preliminary formula prepared multiple times according to the predetermined preparation process is the same;

[0098] When the quality evaluation result of the initial selected formula indicates that the quality of the raw materials of the initial selected formula is qualified and indicates that the initial selected formulas prepared multiple times are the same, the main control device determines that the controllability of the initial selected formula is good;

[0099] If the quality evaluation result of the initially selected formula indicates that the quality of the raw materials of the initially selected formula is unqualified, and / or indicates that the initially selected formulas prepared multiple times are different, the main control device determines that the controllability of the initially selected formula is poor.

[0100] It is understandable that the placebo should not contain the active ingredients of the target disease in the clinical trial, so it is necessary to select other materials of the above active ingredients to make the placebo. The optional raw materials of the placebo are shown in Table 2-8 below. The placebo raw materials can be pre-stored in the main control device. The main control device executes the steps of the above method according to the actual Chinese herbal compound decoction to obtain the placebo formula corresponding to the Chinese herbal compound decoction;

[0101] For example, the base material can be selected from the food thickeners in Table 6, the food emulsifiers in Table 7, and the base of the food materials in Table 9.

[0102] The color raw materials can be selected from the raw materials in Table 8 and the food raw materials in Table 9.

[0103] You can choose the ingredients in Table 2-5 to adjust the flavor.

[0104] For odor blending, the food raw materials listed in Table 9 and the Chinese herbal essences in the corresponding compound can be selected.

[0105] During the preparation process, a 0-10 point visual analogue scale can be used to compare the similarities between various aspects of the placebo and the Chinese medicine solution. If 8 points are achieved in each aspect, it will be considered qualified and a preliminary evaluation will be conducted.

[0106] Table 2 Summary of sweetness modifiers and their taste characteristics

[0107]

[0108]

[0109] Table 3 Summary of commonly used acidity regulators and their taste characteristics

[0110]

[0111]

[0112] Table 4 Summary of salty taste modifiers and their taste characteristics

[0113]

[0114] Table 5 Summary of bitter taste modifiers and their taste characteristics

[0115]

[0116]

[0117]

[0118] Table 6 Summary of common food thickeners and their characteristics

[0119]

[0120]

[0121]

[0122] Table 7 Summary of common food emulsifiers and their characteristics

[0123]

[0124]

[0125] Note: The combined affinity of the hydrophilic and lipophilic groups in surfactant molecules to oil and water is called the hydrophilic-lipophilic balance (HLB). The higher the HLB value of a surfactant, the stronger its hydrophilicity; the lower the HLB value, the stronger its lipophilicity.

[0126] Table 8 Colorants and their corresponding colors in the "Food Additives Usage Standards"

[0127]

[0128]

[0129] Note: The color coding refers to the national standard GSB05-1426-2001 paint film color standard sample card

[0130] Table 9 Summary of food ingredients available for placebo preparation

[0131]

[0132]

[0133] In a second aspect, the embodiments of the present application provide a system for generating a placebo of a Chinese medicine compound decoction, such as Figure 2 As shown, the system includes: a main control device 100 and a plurality of test terminals 200;

[0134] The main control device 100 determines the preliminary formula of the Chinese herbal compound decoction placebo according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese herbal compound decoction; wherein the physical property parameters include the dosage, efficacy information, processing information, decoction information and formula information of the components to be selected;

[0135] The main control device 100 sends the preliminary selection formula to each test terminal 200, and the test terminal 200 receives the preliminary selection formula;

[0136] The main control device 100 instructs the test terminal 200 to obtain the response data of the test object to the preliminary selected formula;

[0137] The test terminal 200 reports the response data;

[0138] The main control device 100 obtains the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary selected formula based on the reaction data reported by each test terminal 200;

[0139] When the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary selected formula all meet the standard conditions of the pharmaceutical formula, the main control device 100 determines that the preliminary selected formula is a placebo formula of the Chinese herbal compound decoction.

[0140] Regarding the system in the above embodiment, the specific manner in which each module performs operations has been described in detail in the embodiment of the method, and will not be elaborated here.

[0141] Reference below Figure 3 , which shows a schematic diagram of the structure of a computer device 400 suitable for implementing a terminal device or a server in an embodiment of the present application.

[0142] like Figure 3 As shown, the computer device 400 includes a central processing unit (CPU) 401, which can perform various appropriate actions and processes according to a program stored in a read-only memory (ROM) 402 or a program loaded from a storage part 408 into a random access memory (RAM) 403. In the RAM 403, various programs and data required for the operation of the system 400 are also stored. The CPU 401, the ROM 402, and the RAM 403 are connected to each other via a bus 404. An input / output (I / O) interface 405 is also connected to the bus 404.

[0143] The following components are connected to the I / O interface 405: an input section 406 including a keyboard, a mouse, etc.; an output section 407 including a cathode ray tube (CRT), a liquid crystal display (LCD), etc., and a speaker, etc.; a storage section 408 including a hard disk, etc.; and a communication section 409 including a network interface card such as a LAN card, a modem, etc. The communication section 409 performs communication processing via a network such as the Internet. A drive 410 is also connected to the I / O interface 405 as needed. A removable medium 411, such as a magnetic disk, an optical disk, a magneto-optical disk, a semiconductor memory, etc., is installed on the drive 410 as needed, so that a computer program read therefrom is installed into the storage section 408 as needed.

[0144] In particular, according to the embodiments of the present application, the above reference Figure 1 The described processes may be implemented as computer software programs. For example, embodiments of the present application include a computer program product comprising a computer program tangibly embodied on a machine-readable medium, the computer program comprising a computer program for executing Figure 1 In such an embodiment, the computer program may be downloaded and installed from a network via the communication section 409 and / or installed from the removable medium 411.

[0145] It should be noted that the computer-readable medium shown in the present application may be a computer-readable signal medium or a computer-readable storage medium or any combination of the above two. The computer-readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, device or device, or any combination of the above. More specific examples of computer-readable storage media may include, but are not limited to: an electrical connection with one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above. In the present application, a computer-readable storage medium may be any tangible medium containing or storing a program that can be used by or in combination with an instruction execution system, device or device. In the present application, a computer-readable signal medium may include a data signal propagated in a baseband or as part of a carrier wave, which carries a computer-readable program code. This propagated data signal may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. Computer-readable signal media may also be any computer-readable medium other than computer-readable storage media, which may send, propagate or transmit a program for use by or in conjunction with an instruction execution system, apparatus or device. The program code contained on the computer-readable medium may be transmitted using any appropriate medium, including but not limited to: wireless, wire, optical cable, RF, etc., or any suitable combination of the above.

[0146] The flow chart and block diagram in the accompanying drawings illustrate the possible architecture, function and operation of the system, method and computer program product according to various embodiments of the present invention. In this regard, each box in the flow chart or block diagram can represent a module, a program segment, or a part of the code, and the aforementioned module, program segment, or a part of the code contains one or more executable instructions for realizing the specified logical function. It should also be noted that in some alternative implementations, the functions marked in the box can also occur in a different order from the order marked in the accompanying drawings. For example, two boxes represented in succession can actually be executed substantially in parallel, and they can sometimes be executed in the opposite order, depending on the functions involved. It should also be noted that each box in the block diagram and / or flow chart, and the combination of the boxes in the block diagram and / or flow chart can be implemented with a dedicated hardware-based system that performs the specified function or operation, or can be implemented with a combination of dedicated hardware and computer instructions.

[0147] The units or modules involved in the embodiments described in the present application may be implemented by software or by hardware. The described units or modules may also be arranged in a processor, for example, may be described as: a processor includes a first determination unit, a sending unit, and a second determination unit. Among them, the names of these units or modules do not constitute a limitation on the unit or module itself under certain circumstances. For example, the second determination unit may also be described as "a unit for the main control device to determine that the preliminary formula is a placebo formula of a Chinese medicine compound decoction when the similarity results, applicability results, safety results, and controllability results of the preliminary formula all meet the standard conditions of the pharmaceutical formula."

[0148] As another aspect, the present application further provides a computer-readable storage medium, which may be the computer-readable storage medium included in the aforementioned device in the above embodiment; or may be a computer-readable storage medium that exists independently and is not assembled into the device. The computer-readable storage medium stores one or more programs, and the aforementioned programs are used by one or more processors to execute the method for generating a placebo formula of a traditional Chinese medicine compound decoction provided in the present application.

[0149] It should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like used above to indicate orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the panel or component referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0150] The above description is only a preferred embodiment of the present application and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present application is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the present application.

Claims

1. A method for generating a placebo formula of a Chinese herbal compound decoction, applied to a placebo generation system, the system comprising a main control device and a plurality of test terminals, characterized in that: The generation method comprises: The main control device determines the preliminary formula of the Chinese herbal compound decoction placebo according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese herbal compound decoction; wherein the physical property parameters include the dosage, efficacy information, processing information, decoction information and formula information of the components to be selected; The master control device sends the preliminary formula to each of the test terminals, and instructs the test terminal to obtain reaction data of the test object to the preliminary formula, and obtains similarity results, applicability results, safety results, and controllability results of the preliminary formula based on the reaction data reported by each of the test terminals; When the similarity results, applicability results, safety results and controllability results of the preliminary selected formula all meet the standard conditions of the pharmaceutical formula, the main control device determines that the preliminary selected formula is a placebo formula of the Chinese herbal compound decoction.

2. The generation method according to claim 1, characterized in that: If the reaction data includes visual data, taste data, olfactory data and tactile data, the main control device instructs the test terminal to obtain the reaction data of the test object to the preliminary formula, and the similarity result of the preliminary formula is obtained, including: The main control device obtains the sensory profile characteristics of the preliminary selected formula according to the visual data, taste data, olfactory data and tactile data; wherein the sensory profile characteristics refer to the visual characteristics, taste characteristics, olfactory characteristics and tactile characteristics of the preliminary selected formula; The main control device instructs the test terminal to obtain visual data, taste data, olfactory data and tactile data of the test subject for the Chinese herbal compound decoction; The main control device obtains a similarity result of the preliminary formula based on the sensory profile characteristics of the preliminary formula and the visual data, taste data, olfactory data and tactile data of the Chinese herbal compound decoction; wherein the similarity result refers to the degree of similarity between the sensory profile characteristics of the preliminary formula and the visual data, taste data, olfactory data and tactile data of the Chinese herbal compound decoction.

3. The generation method according to claim 2, characterized in that: The main control device obtains the sensory profile characteristics of the preliminary selected recipe according to the visual data, taste data, olfactory data and tactile data, including: The main control device sends the test requirements and test standards to each of the test terminals, and instructs each of the test terminals to obtain the visual data, the taste data, the olfactory data and the tactile data; wherein the test requirements are used to indicate that the test subject is familiar with the appearance parameters of the corresponding Chinese herbal compound decoction, the method of using the preliminary formula and the use environment; the appearance parameters include the color, taste and smell of the Chinese herbal compound decoction; the test standards are obtained based on professional vocabulary in the field of traditional Chinese medicine, and are used to provide the test subject with an optional expression vocabulary for the visual data, taste data, olfactory data and tactile data of the preliminary formula; The main control device receives the visual data, taste data, olfactory data and tactile data of the preliminary formula fed back by each of the test terminals, and counts, screens and defines the visual data, taste data, olfactory data and tactile data of the preliminary formula in turn to obtain the sensory profile characteristics of the preliminary formula; wherein the definition process refers to accurately defining the visual data, taste data, olfactory data and tactile data of the preliminary formula according to dictionaries, textbooks and authoritative guidelines.

4. The generation method according to claim 1, characterized in that: If the reaction data includes the results of animal test efficacy and / or instrument analysis efficacy, and the efficacy information of each component in the preliminary formula, the main control device instructs the test terminal to obtain the reaction data of the test subject for the preliminary formula, and the applicability result of the preliminary formula is obtained, including: The main control device instructs at least one of the test terminals to feedback efficacy information of each component of the primary selected formula; Alternatively, the main control device instructs at least one of the test terminals to obtain the animal test efficacy results and / or instrument analysis efficacy results of the primary selected formula; The main control device determines whether the preliminary selected formula has therapeutic effect according to the animal test efficacy result and / or instrument analysis efficacy result and the efficacy information of the preliminary selected formula; When the main control device determines that the initially selected formula does not have a therapeutic effect, the main control device determines that the initially selected formula has good applicability; When the main control device determines that the preliminary selected formula has a therapeutic effect, the main control device determines that the preliminary selected formula has poor applicability.

5. The generation method according to claim 1, characterized in that: If the reaction data includes toxicological test data of the preliminary selected formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary selected formula, and obtains the safety result of the preliminary selected formula including: The main control device instructs at least one test terminal to obtain toxicological test data of the preliminary selected formula, and determines whether the preliminary selected formula has obvious adverse reactions according to the toxicological test data; When the toxicology test data indicates that the primary selected formula has no obvious adverse reactions, the main control device determines that the safety of the primary selected formula is good; When the toxicology test data indicates that the primary selected formula has obvious adverse reactions, the main control device determines that the safety of the primary selected formula is poor.

6. The generation method according to claim 1, characterized in that: If the reaction data includes the quality evaluation result of the preliminary selected formula, the main control device instructs the test terminal to obtain the reaction data of the test object for the preliminary selected formula, and the controllability result of the preliminary selected formula is obtained, including: The main control device instructs each of the test terminals to obtain a quality evaluation result of the preliminary formula; the quality evaluation result of the preliminary formula includes a result indicating the quality of the raw materials of the preliminary formula, and a result indicating whether the preliminary formula prepared multiple times according to a predetermined preparation process is the same; When the quality evaluation result of the preliminary formula indicates that the quality of the raw materials of the preliminary formula is qualified and indicates that the preliminary formula prepared multiple times is the same, the main control device determines that the controllability of the preliminary formula is good; When the quality evaluation result of the preliminary formula indicates that the quality of the raw materials of the preliminary formula is unqualified and / or indicates that the preliminary formula prepared multiple times is different, the main control device determines that the controllability of the preliminary formula is poor.

7. A system for generating a placebo of a Chinese medicine compound decoction, characterized in that: The system comprises: a main control device and a plurality of test terminals; The main control device determines the preliminary formula of the Chinese herbal compound decoction placebo according to the physical property parameters of the components to be selected and the appearance parameters of the Chinese herbal compound decoction; wherein the physical property parameters include the dosage, efficacy information, processing information, decoction information and formula information of the components to be selected; The main control device sends the preliminary selected formula to each of the test terminals, and the test terminal receives the preliminary selected formula; The main control device instructs the test terminal to obtain the reaction data of the test object to the preliminary selected formula; The test terminal reports the reaction data; The main control device obtains the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary selected formula based on the reaction data reported by each of the test terminals; When the sensory profile characteristics, applicability results, safety results and controllability results of the preliminary selected formula all meet the standard conditions of the pharmaceutical formula, the main control device determines that the preliminary selected formula is a placebo formula of the Chinese herbal compound decoction.

8. A computer device, characterized in that: The computer device comprises a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor is configured to implement the steps of the method according to any one of claims 1 to 6 when executing the program.

9. A computer-readable storage medium having a computer program stored thereon, wherein the computer program is used to implement the steps of the method according to any one of claims 1 to 6.

10. A computer program product, comprising a computer program, characterized in that When the computer program is executed by a processor, the steps of the method according to any one of claims 1 to 6 are implemented.

Images