Masturbation agent of thirteen-ingredient middle-jiao-regulating pill as well as preparation process and quality evaluation method of masturbation agent

Abstract

The invention discloses a thirteen-ingredient Zhongzhong pill placebo as well as a preparation process and a quality evaluation method thereof, and relates to the technical field of placebo preparation. In order to overcome the difficulty in preparation of the conventional placebo, the placebo prepared by adding raw material medicines of an original preparation, an excipient (glutinous rice flour), a flavoring agent (a bitter agent) and a color correcting agent (caramel color, lemon yellow and sunset yellow) according to a certain proportion is basically consistent with the original preparation in the aspects of appearance, smell, taste, texture, particle size and the like; and blind clinical tests are effectively avoided. And the prepared placebo has no physiological activity and is more suitable for clinical test research. According to the invention, a visual sensor, an olfactory sensor and a taste sensor are adopted to respectively simulate three sensory organs of eyes, nose and tongue of a human body, so that objective quantification of character evaluation of the thirteen-ingredient and Zhongzhong pill placebo is realized, thereby avoiding subjective deviation caused by sensory evaluation of human experience, and improving the evaluation accuracy of the thirteen-ingredient and Zhongzhong pill placebo. And the accuracy and the consistency of clinical test results are ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of placebo preparation, and particularly to a placebo of Shisanwei Hezhong Pills and its preparation process and quality evaluation method. Background Art

[0002] With the rise of evidence-based medicine and the modern development of the traditional Chinese medicine industry, the frequency of use of traditional Chinese medicine compound placebos in drug clinical trials has been showing an upward trend. In the process of designing drug clinical trials, the four major principles of randomization, control, replication, and blinding are mostly followed. As a control drug, the traditional Chinese medicine compound placebo must ensure no drug effect and no adverse reactions. At the same time, its appearance, smell, taste, texture, particle size and other key attributes should be similar to those of the original preparation, so that it is difficult for clinical trial patients to distinguish when taking the medicine, avoiding unblinding, and thus effectively ensuring the accuracy of clinical trial results. Therefore, the similarity degree between the traditional Chinese medicine compound placebo and the original preparation is particularly important.

[0003] Shisanwei Hezhong Pills are characteristic hospital preparations of Anhui Acupuncture Hospital, which are composed of Bupleurum chinense, Fructus Aurantii, Corydalis yanhusuo, stir-fried Paeonia lactiflora, Citrus reticulata Blanco, wine-processed Coptis chinensis, wine-processed Scutellaria baicalensis, Melia toosendan, Pinellia ternata, Evodia rutaecarpa, Poria cocos, Amomum villosum, and Glycyrrhiza uralensis Fisch. It has the effects of soothing the liver and regulating qi, and harmonizing the stomach to relieve pain, and is mainly used for treating epigastric distending pain, noisy acid regurgitation, belching and nausea, etc. It has been clinically applied for more than 20 years with remarkable curative effects. In order to ensure that the data obtained in drug clinical trial research is more scientific, it is necessary to prepare a placebo of Shisanwei Hezhong Pills and conduct a double-blind experiment. However, Shisanwei Hezhong Pills are composed of thirteen traditional Chinese medicine decoction pieces in total. This preparation has a large number of medicinal flavors and a complex composition, and has its unique appearance, smell and taste, etc. It is difficult to make a placebo similar to its appearance, smell and taste according to the existing methods.

[0004] In addition, the current evaluation methods for traditional Chinese medicine placebos are mainly manual evaluations, requiring the properties of the placebo to be as similar as possible to those of the original preparation. However, such evaluation methods mainly conduct independent tests on the placebo and the original preparation by the evaluators, evaluate their properties through observation and tasting, and then analyze the comprehensive scoring results. This method is greatly interfered by subjective and objective factors, and many factors such as the external environment, the physical condition and mental state of the evaluators may affect the accuracy and stability of the results. Therefore, it is particularly important to provide a placebo evaluation method that is not affected by human experience and senses. Summary of the Invention

[0005] The object of the present invention is to provide a placebo of Shisanwei Hezhong Pills, its preparation process and quality evaluation method. The prepared placebo of Shisanwei Hezhong Pills is basically consistent with the original preparation in terms of appearance, smell, taste, texture and particle size, etc., effectively avoiding the blinding of clinical trials. At the same time, this quality evaluation method can objectively quantify the evaluation of the placebo's properties, thus avoiding the subjective deviation caused by the empirical sensory evaluation of people.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] First of all, the present invention provides a placebo of Shisanwei Hezhong Pills, which is composed of the following components in parts by weight:

[0008] 1 - 228 parts of the raw materials of Shisanwei Hezhong Pills, 798 - 1254 parts of glutinous rice flour, 8 - 12 parts of caramel color, 0.07 - 0.11 parts of lemon yellow, 0.05 - 0.09 parts of sunset yellow, and 0.8 - 1.2 parts of bitter agent.

[0009] As a preferred technical solution of the present invention, the placebo of Shisanwei Hezhong Pills is composed of the following components in parts by weight:

[0010] 114 parts of the raw materials of Shisanwei Hezhong Pills, 1026 parts of glutinous rice flour, 10 parts of caramel color, 0.09 parts of lemon yellow, 0.07 parts of sunset yellow, and 1 part of bitter agent.

[0011] Secondly, the present invention provides a preparation process of the above - mentioned placebo of Shisanwei Hezhong Pills, including the following steps:

[0012] Step 1: Dry the raw materials of Shisanwei Hezhong Pills, then powder them and sieve them to obtain fine powder and coarse powder;

[0013] Step 2: Mix the obtained fine powder with glutinous rice flour, caramel color, lemon yellow, sunset yellow and bitter agent evenly to obtain a mixed powder;

[0014] Step 3: Add the coarse powder obtained in Step 1 to drinking water and decoct twice, and combine and filter the two decoctions;

[0015] Step 4: Pour the decoction obtained in Step 3 and the mixed powder obtained in Step 2 into a mixer, stir and make a soft material;

[0016] Step 5: Put the soft material obtained in Step 4 into a pill - making machine to make pill grains, dry, polish, dry again, sieve through a 5 - mesh sieve, select pills, and package them to obtain the placebo of Shisanwei Hezhong Pills, and its packaging quality is the same as that of Shisanwei Hezhong Pills.

[0017] As a preferred technical solution of the present invention, in the preparation process:

[0018] In Step 1, the raw materials of Shisanwei Hezhong Pills are powdered and then sieved through a 100 - mesh sieve.

[0019] In the decocting step in Step 3: For the first decoction, add 800 - 1000 mL of drinking water, bring to a boil over high heat, then simmer for 30 minutes until it reduces to 400 - 500 mL, and filter while it is still hot; for the second decoction, add 500 - 700 mL of drinking water, bring to a boil over high heat, then simmer for 30 minutes until it reduces to 250 - 350 mL, and filter while it is still hot; combine the two water decoctions, filter using a gauze to obtain the water decoction.

[0020] In Step 5, the drying temperature is 60 - 80 °C and the drying time is 8 - 12 h. The glazing step is as follows: Put the dried pills into a sugar coating machine, add distilled water in small amounts multiple times, and rotate until the surface is smooth, and finally take out the pills.

[0021] Finally, the present invention also proposes a quality evaluation method for the placebo of the Thirteen - Flavor Harmony Pill, including the following steps:

[0022] Step 1: Take the placebo of the Thirteen - Flavor Harmony Pill and the original preparation, and respectively measure their visual indicators, taste indicators, and olfactory indicators through a visual sensor, a taste sensor, and an olfactory sensor, and calculate their similarities respectively; among them, the similarity score is divided as follows: exactly the same = 100%, very close = 80%, significantly different = 60%, inconsistent = 0.

[0023] Step 2: Conduct a comprehensive score on each index obtained in Step 1. If the comprehensive score is greater than 80%, it is a qualified placebo of the Thirteen - Flavor Harmony Pill.

[0024] Machine vision makes the comparison of colors objectively quantifiable, the electronic nose makes the comparison of odors objectively quantifiable, and the electronic tongue makes the comparison of tastes objectively quantifiable. The comprehensive score of the three can improve the accuracy. As a preferred technical solution of the present invention, the weight coefficients for the comprehensive score in Step 2 of the quality evaluation method are: the visual index accounts for 50%, the taste index accounts for 30%, and the olfactory index accounts for 20%.

[0025] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0026] 1) The placebo of the Thirteen - Flavor Harmony Pill provided by the present invention overcomes the difficulties existing in the preparation of existing placebos. It is prepared by adding a certain proportion of the original preparation's raw materials, excipients, flavoring agents, and color - correcting agents. The preparation process is simple. The prepared placebo is basically consistent with the original preparation in terms of appearance, odor, taste, texture, and particle size, effectively avoiding the unblinding of clinical trials, and also solving the problem that it is difficult to simulate the appearance, odor, and taste of pills prepared from the placebo of the Thirteen - Flavor Harmony Pill; at the same time, the prepared placebo has no physiological activity and is more suitable for clinical trial research.

[0027] 2) The present invention also provides an intelligent sensory quality evaluation method for the placebo of Shisanwei Hezhong Pills. By using three sensors, namely machine vision (vision sensor), electronic nose (olfactory sensor), and electronic tongue (taste sensor), to simulate the three sensory organs of human eyes, nose, and tongue respectively, the objective quantification of the properties of the placebo of Shisanwei Hezhong Pills is achieved, thus avoiding the subjective deviation caused by human empirical sensory evaluation and ensuring the accuracy and consistency of the clinical trial results. Detailed implementation manners

[0028] Example 1:

[0029] The preparation process of the placebo of Shisanwei Hezhong Pills specifically includes the following steps:

[0030] Step 1: Weigh 114 g of the raw materials of Shisanwei Hezhong Pills (one prescription amount): 15 g of Poria cocos, 10 g of Fructus Aurantii Immaturus, 6 g of Toosendan Fruit, 6 g of Amomum villosum, 3 g of Evodia rutaecarpa, 10 g of Pericarpium Citri Reticulatae, 8 g of Bupleurum chinense, 6 g of Rhizoma Coptidis, 6 g of Glycyrrhiza uralensis, 12 g of Scutellaria baicalensis, 10 g of Pinellia ternata, 10 g of Corydalis yanhusuo, and 12 g of Paeonia lactiflora Pall., dry them, powder them, and pass through a 100-mesh sieve to obtain fine powder and coarse powder.

[0031] Step 2: Mix the obtained fine powder evenly with 1026 g of glutinous rice flour, 10 g of caramel color, 0.09 g of lemon yellow, 0.07 g of sunset yellow, and 1 g of bitter agent to obtain a mixed powder for standby.

[0032] Step 3: Add 900 mL of drinking water to the coarse powder obtained in Step 1 for the first decoction, bring to a boil over high heat, and then simmer for 30 min until it is reduced to 450 mL, and filter while it is hot; for the second decoction, add 600 mL of drinking water, bring to a boil over high heat, and then simmer for 30 min until it is reduced to 300 mL, and filter while it is hot; combine the two water decoctions and filter them with a gauze to obtain a water decoction.

[0033] Step 4: Pour the water decoction obtained in Step 3 and the mixed powder obtained in Step 2 into a mixer, stir to make a soft material, put the soft material into a pill-making machine to make pill grains, dry them at 60 °C for 12 h, polish them, dry them again at 60 °C for 12 h, pass through a 5-mesh sieve, select the pills, and package them to obtain the placebo of Shisanwei Hezhong Pills; the packaging quality of the placebo of Shisanwei Hezhong Pills is the same as that of Shisanwei Hezhong Pills.

[0034] Example 2:

[0035] The difference between Example 2 and Example 1 is only that:

[0036] In Step 1, the addition amount of the raw materials of Shisanwei Hezhong Pills is 0.

[0037] Example 3:

[0038] The difference between Example 3 and Example 1 is only that:

[0039] In Step 1, the addition amount of the raw materials of Shisanwei Hezhong Pills is two prescription amounts.

[0040] Example 4:

[0041] The difference between Example 4 and Example 1 is only that:

[0042] In Step 2, the dosage of glutinous rice flour is 798 g.

[0043] Example 5:

[0044] The difference between Example 5 and Example 1 is only that:

[0045] In Step 2, the dosage of glutinous rice flour is 1254 g.

[0046] Example 6:

[0047] The difference between Example 6 and Example 1 is only that:

[0048] In Step 2, the obtained fine powder is mixed evenly with 1026 g of glutinous rice flour, 8 g of caramel color, 0.07 g of lemon yellow, 0.05 g of sunset yellow, and 0.8 g of bitter agent to obtain a mixed powder.

[0049] Example 7:

[0050] The difference between Example 7 and Example 1 is only that:

[0051] In Step 2, the obtained fine powder is mixed evenly with 1026 g of glutinous rice flour, 12 g of caramel color, 0.11 g of lemon yellow, 0.09 g of sunset yellow, and 1.2 g of bitter agent to obtain a mixed powder.

[0052] Example 8:

[0053] The difference between Example 8 and Example 1 is only that:

[0054] In Step 3, for the obtained coarse powder, add 800 mL of drinking water for the first decoction, bring to a boil over high heat, and then simmer for 30 min until it is reduced to 400 mL, and filter while it is hot; add 700 mL of drinking water for the second decoction, bring to a boil over high heat, and then simmer for 30 min until it is reduced to 350 mL, and filter while it is hot; combine the two water decoctions and filter them with a gauze to obtain a water decoction.

[0055] Example 9:

[0056] The difference between Example 9 and Example 1 is only that:

[0057] In Step 3, for the obtained coarse powder, add 1000 mL of drinking water for the first decoction, bring to a boil over high heat, and then simmer for 30 min until it is reduced to 500 mL, and filter while it is hot; add 500 mL of drinking water for the second decoction, bring to a boil over high heat, and then simmer for 30 min until it is reduced to 250 mL, and filter while it is hot; combine the two water decoctions and filter them with a gauze to obtain a water decoction.

[0058] Example 10:

[0059] The difference between Example 10 and Example 1 is only that:

[0060] In step 4, the thermometer and time for both dryings are drying at 70 °C for 10 h.

[0061] Example 11:

[0062] The difference between Example 11 and Example 1 is only that:

[0063] In step 4, the thermometer and time for both dryings are drying at 80 °C for 8 h.

[0064] Example 12

[0065] Preparation of the original preparation of Shisanwei Hezhong Pills:

[0066] Prescription: Bupleurum chinense DC. 80 g, Fructus Aurantii 100 g, Radix Paeoniae Alba (parched) 100 g, Pericarpium Citri Reticulatae 100 g, Fructus Toosendan 100 g, Rhizoma Corydalis 100 g, Scutellaria baicalensis Georgi (processed with wine) 100 g, Coptis chinensis Franch. (processed with wine) 80 g, Evodia rutaecarpa (Juss.) Benth. 40 g, Fructus Amomi 60 g, Poria cocos (Schw.) Wolf 150 g, Pinellia ternata (Thunb.) Breit. (processed with ginger) 100 g, Glycyrrhiza uralensis Fisch. 80 g.

[0067] Preparation method: Pericarpium Citri Reticulatae and Fructus Amomi are moistened with 75% ethanol for 2 h and dried at 50 °C; Bupleurum chinense DC., Fructus Aurantii, Radix Paeoniae Alba (parched), Rhizoma Corydalis, Scutellaria baicalensis Georgi (processed with wine), Coptis chinensis Franch. (processed with wine), Poria cocos (Schw.) Wolf, and Glycyrrhiza uralensis Fisch. are sterilized by moist heat at 115 °C for 30 min and dried at 80 °C. The two groups of medicinal materials are mixed, pulverized into fine powder, screened through a 100-mesh sieve, and mixed evenly. Fructus Toosendan, Evodia rutaecarpa (Juss.) Benth., and Pinellia ternata (Thunb.) Breit. (processed with ginger) are decocted twice with 8 times the amount of water, each time for 1.5 h. The decoction liquids are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.10 - 1.15 (20 °C), mixed with the above-mentioned fine powder and 124 g of starch, made into pills, dried, and polished to obtain 1000 g, thus obtaining the product.

[0068] I. Using single-factor experiments to investigate the optimal dosage of each component

[0069] 1. Screening of excipients

[0070] Investigate the forming effects of different excipients (glutinous rice flour, wheat flour, edible starch).

[0071] Table 1 Screening of excipient types and ratios

[0072]

[0073] Conclusion: When glutinous rice flour was used as the excipient in this experiment, the formability was the best. When the weight ratio of glutinous rice flour to the raw material drug of the original preparation was 7:1, 9:1, and 11:1, the formability was good and closest to the original preparation. Considering the proximity of the placebo odor to the original preparation, the weight ratio of glutinous rice flour: raw material drug of the original preparation = 9:1 was finally selected.

[0074] 2. Investigation on the dosage of the raw material drug of Shisanwei Hezhong Pills

[0075] The original preparation has a special odor and is difficult to flavor with current flavors. Therefore, an appropriate amount of the raw material drug of the original preparation was added to the preparation of its placebo to improve the similarity of the placebo without physiological activity. In the following screening tests, the dosage of the raw material drug of the original preparation was investigated with the excipient (glutinous rice flour) dosage of 1026 g.

[0076] Table 2 Investigation on the dosage of the raw material drug of the original preparation

[0077]

[0078] Conclusion: When 114 g or 228 g of the raw material drug of Shisanwei Hezhong Pills was added in this experiment, the odor of its placebo was closest to that of the original preparation. To reduce the influence of the original preparation on the physiological activity of the placebo, 114 g of the raw material drug of the original preparation was used to prepare the placebo of Shisanwei Hezhong Pills in this experiment.

[0079] 3. Investigation on the dosage of the flavoring agent

[0080] The original preparation of Shisanwei Hezhong Pills is bitter. In this experiment, the bitterness was masked by adding an appropriate amount of bitter agent.

[0081] In the following screening tests, the dosage of the flavoring agent was investigated with the optimized dosages of glutinous rice flour and the raw material drug of the original preparation being 1026 g and 114 g respectively.

[0082] Table 3 Investigation on the dosage of the flavoring agent

[0083]

[0084] Conclusion: When 1.0 g of the bitter agent was added, the taste of its placebo was closest to that of the original preparation. The finally optimized dosage of the bitter agent was 1.0 g.

[0085] 4. Investigation on the dosage of the colorant

[0086] The original preparation of Shisanwei Hezhong Pills is a light yellowish-brown to brownish-black aqueous pill. In this experiment, different colorants were investigated alone or in different proportions to select a suitable colorant.

[0087] In the following screening tests, the type and dosage of the colorant were investigated with the optimized dosages of glutinous rice flour, the raw material drug of the original preparation, and the bitter agent being 1026 g, 114 g, and 1.0 g respectively.

[0088] Investigation on the types and proportions of color correctors

[0089]

[0090] Conclusion: When the weights of caramel color, tartrazine, and sunset yellow added are 10 g, 0.09 g, and 0.07 g respectively, the appearance of the placebo is closest to that of the original preparation. Finally, the optimal weights of the flavoring agents are determined to be 10 g of caramel color, 0.09 g of tartrazine, and 0.07 g of sunset yellow respectively.

[0091] 5. Determination of drying temperature and time

[0092] Investigation on drying temperature and time

[0093] Temperature, Time Character Description 80°C, 8 h (Example 11) Surface cracking of the pill 70°C, 10 h (Example 10) Slight surface cracking of the pill 60°C, 12 h (Example 1) Almost no surface cracking of the pill

[0094] Conclusion: When the drying temperature is 60 °C and the drying time is 12 h, the surface of the prepared placebo is intact and almost no cracking occurs. Therefore, the drying temperature of 60 °C and the drying time of 12 h are selected as the optimal conditions.

[0095] 6. Determination of placebo ratio

[0096] The placebo of Shisanwei Hezhong Pills has the following ratio: 114 g of the raw materials of Shisanwei Hezhong Pills (one prescription amount), 1026 g of glutinous rice flour, 10 g of caramel color, 0.09 g of tartrazine, 0.07 g of sunset yellow, and 1 g of bitter agent. This product is a light yellowish-brown to brownish-black water pill, with a fragrant smell and a bitter taste.

[0097] II. Quality evaluation of the placebo of Shisanwei Hezhong Pills:

[0098] Comprehensive evaluation is carried out by using manual evaluation and intelligent sensory technology.

[0099] 1 Manual evaluation

[0100] Please ask 10 relevant professionals to give similarity scores for the visual index (appearance), olfactory index (odor), taste index (taste), etc. of the placebo of Shisanwei Hezhong Pills obtained in Example 1.

[0101] Table 6 Manual similarity scores

[0102] 1 2 3 4 5 6 7 8 9 10 Mean value Score 80％ 80％ 100％ 80％ 100％ 100％ 80％ 100％ 80％ 100％ 90％

[0103] Conclusion: The similarity of the placebo of Shisanwei Hezhong Pills to the original preparation in the manual evaluation is 90%, which is a qualified placebo of Shisanwei Hezhong Pills.

[0104] 2 Intelligent sensory evaluation

[0105] 2.1 Machine vision technology was used to compare the placebo of Shisanwei Hezhong Pills and its original preparation.

[0106] Table 7 Machine vision measurement results

[0107]

[0108] Conclusion: Based on the machine vision measurement results, the similarity of the visual indicators between the placebo of Shisanwei Hezhong Pills and its original preparation was calculated to be 97%.

[0109] 2.2 Machine olfaction technology was used to compare the placebo of Shisanwei Hezhong Pills and its original preparation.

[0110] Table 8 Machine olfaction measurement results

[0111]

[0112] Conclusion: Based on the machine olfaction measurement results, the similarity of the olfactory indicators between the placebo of Shisanwei Hezhong Pills and its original preparation was calculated to be 90%.

[0113] 2.3 Machine gustation technology was used to compare the placebo of Shisanwei Hezhong Pills and its original preparation.

[0114] Table 9 Machine gustation measurement results

[0115]

[0116] Conclusion: Based on the machine gustation measurement results, the similarity of the gustatory indicators between the placebo of Shisanwei Hezhong Pills and its original preparation was calculated to be 100%.

[0117] 2.4 Similarity and comprehensive score

[0118] Table 10 Similarity comprehensive score

[0119]

[0120] Conclusion: As can be seen from Table 10, the total similarity between the placebo of Shisanwei Hezhong Pills and its original preparation was calculated to be 96.5%.

[0121] As can be seen from Table 6 and Table 10, the intelligent sensory evaluation of the placebo of Shisanwei Hezhong Pills is higher than the similarity of the manual evaluation, and the evaluation is more accurate.

[0122] In summary, the placebo of Shisanwei Hezhong Pills provided by the present invention is prepared by adding a certain proportion of the raw materials of the original preparation, excipients, flavoring agents and colorants. The preparation process is simple. The prepared placebo of Shisanwei Hezhong Pills is basically consistent with the original preparation in terms of appearance, smell, taste, texture and particle size, effectively avoiding the unblinding of clinical trials. Moreover, the placebo has no physiological activity and is more suitable for clinical trial research. At the same time, the present invention also provides an intelligent sensory quality evaluation method for the placebo of Shisanwei Hezhong Pills, which uses three sensors, namely machine vision (visual sensor), electronic nose (olfactory sensor) and electronic tongue (taste sensor), to simulate the three sensory organs of human eyes, nose and tongue respectively, realizing the objective quantification of the character evaluation of the placebo of Shisanwei Hezhong Pills, thus avoiding the subjective deviation caused by human empirical sensory evaluation, and being of great significance to the accuracy and consistency research of the clinical trials of this preparation.

[0123] The above content is only an example and illustration of the concept of the present invention. Those skilled in the art of the present technology can make various modifications or supplements to the described specific embodiments or use similar methods for substitution, as long as they do not deviate from the concept of the invention or exceed the scope defined by this claim book, they should all belong to the protection scope of the present invention.

Claims

1. A placebo of Shisanwei Hezhong Pills, characterized in that, It consists of the following components in parts by weight: 1 - 228 parts of the raw materials of Shisanwei Hezhong Pills, 798 - 1254 parts of glutinous rice flour, 8 - 12 parts of caramel color, 0.07 - 0.11 parts of lemon yellow, 0.05 - 0.09 parts of sunset yellow, and 0.8 - 1.2 parts of bitter agent.

2. The placebo of the Thirteen-Ingredient Harmony Middle Pill according to claim 1, characterized in that, It consists of the following components in parts by weight: 114 parts of the raw materials of Shisanwei Hezhong Pills, 1026 parts of glutinous rice flour, 10 parts of caramel color, 0.09 parts of lemon yellow, 0.07 parts of sunset yellow, and 1 part of bitter agent.

3. The preparation process of the placebo of Shisanwei Hezhong Pills according to claim 1 or 2, characterized in that, It includes the following steps: Step 1: Dry the raw materials of Shisanwei Hezhong Pills, then powder them and sieve them to obtain fine powder and coarse powder; Step 2: Mix the obtained fine powder with glutinous rice flour, caramel color, lemon yellow, sunset yellow, and bitter agent evenly to obtain a mixed powder; Step 3: Add the coarse powder obtained in Step 1 to drinking water and decoct twice, and combine and filter the two decoctions; Step 4: Pour the decoction obtained in Step 3 and the mixed powder obtained in Step 2 into a mixer, stir, and make into a soft material; Step 5: Put the soft material obtained in Step 4 into a pill - making machine to make pill grains, dry, polish, dry again, sieve through a 5 - mesh sieve, select pills, and package them to obtain the placebo of Shisanwei Hezhong Pills, and its packaging quality is the same as that of Shisanwei Hezhong Pills.

4. The preparation process according to claim 3, characterized in that, In Step 1, the raw materials of Shisanwei Hezhong Pills are sieved through a 100 - mesh sieve after powdering.

5. The preparation process according to claim 3, characterized in that, The decocting steps in Step 3 are as follows: For the first decoction, add 800 - 1000 mL of drinking water, bring to a boil over high heat, and decoct over low heat for 30 min until it is reduced to 400 - 500 mL, then filter while it is hot; for the second decoction, add 500 - 700 mL of drinking water, bring to a boil over high heat, and decoct over low heat for 30 min until it is reduced to 250 - 350 mL, then filter while it is hot; combine the two decoctions, filter with a gauze to obtain the decoction.

6. The preparation process according to claim 3, characterized in that, The drying temperature in Step 5 is 60 - 80 °C, and the drying time is 8 - 12 h.

7. The preparation process according to claim 3, characterized in that, The polishing step in Step 5 is as follows: Put the dried pill grains into a sugar - coating machine, add distilled water in small amounts and multiple times, and rotate until the surface is smooth, and finally take out the pill grains.

8. A quality evaluation method for the placebo of Shisanwei Hezhong Pills as described in claim 1 or 2, characterized in that, It includes the following steps: Step 1: Take the placebo of Shisanwei Hezhong Pills and the original preparation, and measure their visual indexes, taste indexes, and olfactory indexes respectively through a visual sensor, a taste sensor, and an olfactory sensor, and calculate their similarities respectively; Step 2: Conduct a comprehensive score on each index obtained in Step 1. If the comprehensive score is greater than 80%, it is a qualified placebo of Shisanwei Hezhong Pills.

9. The quality evaluation method according to claim 8, characterized in that: The weight coefficients for the comprehensive score in Step 2 are as follows: the visual index accounts for 50%, the taste index accounts for 30%, and the olfactory index accounts for 20%.

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