Use of Sanryo-byakutsu in the manufacture of medicines to treat after-effects of COVID-19 infection in patients who have recovered

Abstract

Use of Shenling Baizhuang in the manufacture of a medicine for treating after-effects of a patient infected with the novel coronavirus after recovery, wherein the after-effects are at least one selected from shortness of breath, physical weakness, loss of appetite, and diarrhea, and the raw materials for Shenling Baizhuang consist of the following parts by weight of traditional Chinese medicines: 400 parts of ginseng, 400 parts of Poria cocoon, 400 parts of fried wheat flour atractylodes, 400 parts of Chinese yam, 300 parts of fried white beans, 200 parts of lotus seeds, 200 parts of fried wheat flour job seeds, 200 parts of sand seeds, 200 parts of Platycodon grandiflorum, and 400 parts of licorice.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to a Chinese patent application bearing application number 202211652297.0 and entitled "Use of Shenling Baizhuang in treating residual symptoms and improving the quality of life of patients infected with COVID-19 after recovery," filed with the State Intellectual Property Office of the People's Republic of China on December 21, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to the field of medicine and traditional Chinese medicine, and in particular to the use of Shen Ling Baizhuang in treating sequelae after recovery and improving the quality of life of patients infected with the novel coronavirus, particularly those with pneumonia caused by the novel coronavirus. [Background technology]

[0003] Coronavirus disease 2019 (COVID-19), hereafter referred to as "COVID-19," is one of the most serious public health emergencies of the current century. According to the World Health Organization's latest real-time statistics, as of December 5, 2022, the total number of confirmed cases of COVID-19 worldwide had exceeded 644 million, with a total of 6.652 million deaths. According to literature reports from both China and abroad, COVID-19 not only damages the respiratory system but also the lungs, heart, liver, kidneys, blood system, and reproductive system, causing severe damage to multiple organ systems in patients even after recovery. This can lead to a range of after-effects, including weakness, cough, shortness of breath, drowsiness, low-grade fever, night sweats, constipation or diarrhea, chest distress, palpitations, chronic bleeding, sensory impairment, and motor impairment. In January 2021, The Lancet, a leading medical journal, published a follow-up study of 1,733 discharged COVID-19 patients conducted at multiple centers, including Wuhan Jinyintan Hospital. The results showed that over 70% (76%) of the patients still had at least one symptom six months after acute infection. The most common symptoms were fatigue or muscle weakness (63%) and sleep disturbances (26%) (Huang C, et al. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study [J]. Lancet. 2021;397(10270):220-232). These after-effects significantly impacted the quality of life of COVID-19 pneumonia patients after recovery, delayed their full recovery, and hindered their immune system recovery, increasing the risk of reinfection. Experts predict that the new coronavirus is constantly mutating, becoming less virulent but more infectious and stealthy in its transmission routes. It is likely that the new coronavirus will coexist with humanity for a long time to come, and new cases of pneumonia caused by the new coronavirus will continue to appear. Therefore, there is an ongoing clinical need to provide medicines to treat the aftereffects of COVID-19 pneumonia and improve the quality of life of patients who have been clinically cured.

[0004] The Shenling Baizhuang Atractylodes Macrocephala Granules produced by Beijing Handi Pharmaceutical Co., Ltd. are the only Shenling Baizhuang Atractylodes Macrocephala Granules (National Drug Standard Number Z20040416) approved by the former State Food and Drug Administration, with a specification of 3g per bag, for a daily intake of 27.9g of herbal medicine; this specification of Shenling Baizhuang Atractylodes Macrocephala Granules is a proprietary variety of Handi Pharmaceutical. Other Shenling Baizhuang Atractylodes Macrocephala Granules on the market have the same name but different formulations or substances (specification of 6g per bag, for a daily intake of 13.95g of herbal medicine). Beijing Hantian Pharmaceutical's process is divided into four parts: volatile oil extraction, water extraction, ethanol extraction, and compounding with scutellaria baicalensis powder; other granule manufacturers' processes are divided into two parts: volatile oil extraction and water extraction. Because both Shenlingbaijutsu San and Pills incorporate the drug's bulk powder, the material base is significantly different from that of the Shenlingbaijutsu Granules produced by Beijing Hantian Pharmaceutical. The formulation process is also significantly different. Other Shenlingbaijutsu Granules are manufactured according to the 1998 industry standard, using 1 part plaster, 2 parts sucrose, and 2.5 parts dextrin. Beijing Hantian Pharmaceutical's Shenlingbaijutsu Granules are manufactured according to the 2005 national standard, using 1 part plaster and 0.4 parts lactose, significantly reducing the amount of supplements patients need to take and improving patient compliance.

[0005] The unique manufacturing process of Shenling Baizhuang Atractylodes granules, which is based on the medicinal substance basis and produced by Beijing Han Dian Pharmaceutical Co., Ltd., has also been granted a Chinese national invention patent, patent number ZL200510086669.8. In order to alleviate the after-effects of COVID-19 pneumonia patients after recovery, and to enable them to fully recover as soon as possible and return to normal work and life, the inventors tried to treat the after-effects of COVID-19 pneumonia patients using Shenling Baizhuang Atractylodes granules produced by Beijing Han Dian Pharmaceutical Co., Ltd., and achieved remarkable therapeutic effects. Summary of the Invention [Problem to be solved by the invention]

[0006] In response to the shortcomings of the prior art, the present disclosure provides a new medicinal use of Shenlingbai Atractylodes macrocarpa, particularly Shenlingbai Atractylodes Granules (National Drug Standard Number Z20040416) produced by Beijing Hantian Pharmaceutical Co., Ltd., in treating sequelae of patients with novel coronavirus pneumonia after recovery and improving the quality of life of patients after recovery. [Means for solving the problem]

[0007] To achieve the above technical effects, the present disclosure adopts the following technical solutions.

[0008] 1. Use of Shenling Baizhuang in the manufacture of a medicine for treating residual symptoms and improving the quality of life of patients with novel coronavirus pneumonia after recovery, wherein the residual symptoms are at least one selected from shortness of breath, physical weakness, loss of appetite, and diarrhea, and the raw material of Shenling Baizhuang consists of the following parts by weight of traditional Chinese medicine: 400 parts of carrots, 400 parts of turmeric, 400 parts of fried white soybean, 400 parts of wild herbal medicine, 300 parts of fried white beans, 200 parts of lotus root, 200 parts of fried soybean root, 200 parts of sand bean, 200 parts of bellflower, and 400 parts of licorice.

[0009] Optionally, the after-effects further include at least one selected from nausea and vomiting, chest / subcardiac puffiness, and inability to defecate.

[0010] Optionally, the improvement in the quality of life of patients with novel coronavirus pneumonia after recovery means that when the Radix Shen Ling Baizhuang is administered to patients with novel coronavirus pneumonia, the patients' SF12 Health Survey score is significantly reduced compared to the score before treatment, with a P value of at least less than 0.05.

[0011] Optionally, the pharmaceutical preparations of the present disclosure are clinically acceptable formulations.

[0012] Optionally, the pharmaceutical is selected from a decoction, pills, powder, granules, tablets or capsules.

[0013] In one alternative embodiment, the pharmaceutical product is a granule, Step I: weighing each Chinese herbal medicine according to the weight part; Step II involves grinding the yam into a fine powder and passing it through a 100-mesh sieve to prepare it for use. Step III: extracting the volatile oil from the sand kernels by steam distillation until it is exhausted, and collecting the distilled aqueous solution in a separate container; adding 4-5 times by weight of 95% ethanol to the sand kernel residue, ginseng, and fried Atractylodes macrocarpa, soaking for 24 hours, heating under reflux for 3 hours, filtering, recovering the ethanol from the filtrate, and concentrating until the crust has a relative density of 1.00-1.15 at 65°C (crust refers to the crust that has been concentrated during the crust preparation process and has reached a viscous state, eliminating the need for additional sugar addition); obtaining alcoholic extract A; adding 4-5 times by weight of 50% ethanol to the crust, refluxing for 3 hours; filtering, recovering the ethanol from the filtrate; and concentrating until the crust has a relative density of 1.12-1.13 at 80°C; obtaining alcoholic extract B; and preparing the crust after ethanol extraction for use; Step IV: add 8-10 times the weight of Poria cocos, roasted white beans, lotus seeds, roasted gluten, job's seed, platycodon grandiflorum, and licorice root in water, boil for 2 hours, filter, combine the residue with the residue reserved for use after the ethanol extraction in step III, add 8 times the weight of water, boil for 1.5 hours, filter, combine the two filtrates and the distilled aqueous solution obtained in step III, allow to stand, filter, concentrate the filtrate until the relative density at 80°C is 1.20, add the alcohol extracts A and B, and continue concentrating until the relative density at 80°C is 1.30-1.34; Step V: Mix the yam powder obtained in Step II with the plaster obtained in Step IV, dry it at a low temperature of 60°C to make a dry plaster, and pulverize it to obtain a medicinal powder. Step V is prepared by weighing 1 part by weight of the pharmaceutical powder and 0.4 parts by weight of sugar powder, mixing them uniformly, granulating them with 70% to 75% ethanol, drying them, sizing them, spraying them with the sand kernel volatile oil obtained in Step III, mixing them uniformly, and making them into 1000 g to obtain the pharmaceutical product. Step VI is prepared.

[0014] In one possible embodiment, when the granules are administered to a subject in need thereof, they are administered three times a day, at a dose of 3 g each time, which is equivalent to a crude drug amount of 27.9 g / day.

[0015] Clinical observations have shown that Shenling Byakujutsu Granules can effectively treat the aftereffects of COVID-19 pneumonia patients after recovery and improve their quality of life. [Brief explanation of the drawings]

[0016] The present disclosure will now be further described with reference to the drawings. [Figure 1] This is a sample of the Quality of Life Assessment Form (SF-12). DETAILED DESCRIPTION OF THE INVENTION

[0017] The 2019 novel coronavirus (2019-nCoV) not only severely damages patients' respiratory systems during the infection phase, but also has a profound impact on their entire biological systems, causing persistent and long-term sequelae and significantly affecting their physical health and quality of life. The inventors conducted clinical observational studies to evaluate the effects of Shen Ling Baizhuang (Shen Ling Baizhuang) preparation on the quality of life of patients with COVID-19 pneumonia after recovery at four hospitals in Hubei Province: Tongshan County People's Hospital, Dongfeng General Hospital of the National Institute of Pharmaceutical Sciences, Xianning City Central Hospital, and Yangxin County People's Hospital. After approximately one month of interventional treatment, the patients' symptoms, including shortness of breath, physical fatigue, loss of appetite, and diarrhea, all significantly improved, significantly improving their quality of life.

[0018] The present invention will now be described with reference to specific examples. Those skilled in the art will understand that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention in any way.

[0019] Unless otherwise specified, the experimental methods used in the following examples are all conventional methods. The raw materials of herbal medicines and reagents used in the following examples are all commercially available products unless otherwise specified.

[0020] In the field of traditional Chinese medicine, clinical symptoms are expressed by their own terms, for example, "body fatigue" is called "fatigue," "loss of appetite" is called "no appetite," and "diarrhea" is called "loose stool." In the following examples, the relevant clinical symptoms are generally expressed in terms of traditional Chinese medicine.

[0021] Example 1 Preparation of Sanryo-byakujutsu Granules Prescription: 400g of ginseng, 400g of turmeric, 400g of fried white soybeans, 400g of wild herbs, 300g of fried white beans, 200g of lotus root, 200g of fried soybeans, 200g of sand kernels, 200g of bellflower, and 400g of licorice.

[0022] Production Process I. Weigh out each herbal ingredient according to the prescription.

[0023] II. Grind the yam into a fine powder and sieve it through a 100 mesh sieve to prepare it for use.

[0024] III. Extract the volatile oil from the sand kernels using steam distillation, and collect the distilled aqueous solution in a separate container. Add 4-5 times the weight of 95% ethanol to the sand kernel residue, ginseng, and fried Atractylodes orbiculatus and soak for 24 hours, then heat under reflux for 3 hours, filter, recover the ethanol from the filtrate, and concentrate until a paste with a relative density of 1.00-1.15 at 65°C is obtained. Alcoholic extract A is obtained. Add 4-5 times the weight of 50% ethanol to the residue and reflux for 3 hours. Filter, recover the ethanol from the filtrate, and concentrate until a paste with a relative density of 1.12-1.13 at 80°C is obtained. Alcoholic extract B is obtained. The ethanol-extracted residue is ready for use.

[0025] IV. Add 8 to 10 times the weight of Poria cocos, roasted white peas, lotus seeds, roasted gluten, job's seed, platycodon grandiflorum, and licorice root to 8 to 10 times the weight of water, decoction for 2 hours, filter, combine the residue with the residue reserved for use after the ethanol extraction in step III, add 8 times the weight of water, decoction for 1.5 hours, filter, combine the two filtrates with the distilled aqueous solution obtained in step III, allow to stand, filter, concentrate the filtrate until the relative density at 80°C is 1.20, add the alcohol extracts A and B, and continue concentrating until a crust with a relative density at 80°C of 1.30 to 1.34 is obtained.

[0026] V. The yam powder obtained in step II is mixed with the plaster obtained in step IV, dried at a low temperature of 60°C to form a dry plaster, and then pulverized to obtain a medicinal powder.

[0027] VI. Weigh out 1 part by weight of the pharmaceutical powder obtained in step V and 0.4 parts by weight of sugar powder, mix uniformly, granulate with 70% to 75% ethanol, dry, and then sieve the granules. Spray on the sand kernel volatile oil obtained in step III, mix uniformly, make into 1000 g, and package individually so that each bag contains 3 g.

[0028] Dosage and usage: 1 sachet 3 times a day.

[0029] Example 2 Intervention effect of Sanryo-byakujutsu Granules on quality of life after recovery in patients with coronary pneumonia This study was conducted from September 2021 to July 2022 at Tongshan County People's Hospital, National Institute of Pharmaceutical Sciences Dongfeng General Hospital, Xianning City Central Hospital, and Yangxin County People's Hospital in Hubei Province.

[0030] 1. Distribution of cases A total of 313 subjects were enrolled in the study, and 313 completed the study, accounting for 100% of the enrolled cases. After excluding 8 subjects whose ages were outside the 18-80 year age range, 305 subjects were included in the analysis set.

[0031] 2. General information about the case There were 166 men (54.43%) and 139 women (45.57%), and 303 (99.34%) were Han Chinese. The mean age was 46.34±14.09 years, with the youngest being 2 years old and the oldest being 84 years old. The mean weight was 63.41±7.51 (kg).

[0032] 3. Vital Signs At the time of selection, the physical signs of body temperature, respiration, blood pressure, and heart rate were basically normal, and no obvious abnormalities were found in these physical signs during the study period.

[0033] 4. Dosage regimen During the study period, the mean number of days taking medication was 28.09 ± 0.88 days, with the shortest number of days being 25 and the longest number being 32, and the median number of days being 28. The day before subjects began taking medication was recorded as day 0, and the day subjects began taking medication was recorded as day 1, continuing in this manner until day 28.

[0034] The specific administration schedule was as follows: Shenling Byakujutsu Granules were taken three times a day, one bag (3g / bag) per time, for 28 consecutive days. The Shenling Byakujutsu Granules were produced by Beijing Han Dian Pharmaceutical Co., Ltd., using the same production process as described in Example 1, with batch numbers 211032, 211134, and 211232.

[0035] 5. Evaluation index of treatment effect The primary evaluation index of the treatment effect was the disappearance rate of symptoms of shortness of breath, physical weakness, loss of appetite, and loose stools, and the secondary index was the SF-12 (a form for assessing quality of life, see Figure 1).

[0036] 6. Data Collection All selected subjects visited the clinic on days 0, 14, and 28 to collect symptoms and assign and record scores. Data from day 0 was recorded as "Visit 1," data from day 14 was recorded as "Visit 2," and data from day 28 was recorded as "Visit 3," and the three sets of data were statistically analyzed.

[0037] 7. Statistics and Analysis Statistical analysis was performed using SAS 9.4 (or higher version) statistical analysis software.

[0038] All statistical tests were two-sided, yielding a test statistic and corresponding P value; differences were considered statistically significant if P<0.05.

[0039] Quantitative data included the number of cases, mean, standard deviation, minimum, median, maximum, upper quartile (Q1), lower quartile (Q3), and 95% confidence interval (95% CI). Comparisons between treatment groups were performed using t-tests. Analysis of covariance was used to consider the effects of covariates. Time-series data included median survival times, Kaplan-Meier curves, and the log-rank test was used to compare the differences in median survival times between two groups. Cox regression analysis was used to consider the effects of center and other factors.

[0040] Qualitative data described the number of cases in each category and their percentage. The chi-square test and Fisher's exact probability test were used to compare enumeration data between treatment groups, and the Wilcoxon rank-sum test was used to compare graded data between treatment groups. To consider the influence of centers and other factors, the CMH chi-square test or logistic regression was used.

[0041] 8. Therapeutic effects of the intervention 8.1 Improvement of major symptoms The results are shown in Tables 1, 2, and 3.

[0042] [Table 1]

[0043] [Table 2]

[0044] [Table 3]

[0045] 8.1.1 Shortness of breath symptoms: With the intervention treatment, the score at Visit 2 during the study period decreased by an average of 1.44±1.32 points compared to the baseline score, and the score at Visit 3 decreased by an average of 2.4±1.8 points compared to the baseline score. Using mixed-effects models and Wilcoxon signed-rank tests, all differences were found to be statistically significant (p<0.05), demonstrating that the treatment significantly reduced the score for shortness of breath symptoms. At the end of the study, the disappearance rate of shortness of breath symptoms was 90%.

[0046] 8.1.2 Fatigue symptoms The intervention treatment resulted in a mean reduction of 1.91 ± 1.24 points at Visit 2 compared to baseline, and a mean reduction of 3.16 ± 1.45 points at Visit 3 compared to baseline. Using mixed-effects models and Wilcoxon signed-rank tests, the differences were statistically significant (p < 0.05), demonstrating a significant reduction in fatigue symptom scores with treatment. At the end of the study, the fatigue symptom elimination rate was 89.7%.

[0047] 8.1.3 Loss of appetite The intervention treatment resulted in a mean reduction of 1.94 ± 1.22 points at Visit 2 compared to baseline scores, and a mean reduction of 3.02 ± 1.29 points at Visit 3 compared to baseline scores. Using mixed-effects models and Wilcoxon signed-rank tests, the differences were all statistically significant (p < 0.05), demonstrating a significant reduction in anorexia symptom scores with treatment. At the end of the study, the anorexia symptom elimination rate was 97.94%.

[0048] 8.1.4 Loose stool symptoms The intervention treatment resulted in a mean reduction of 1.05 ± 1.54 points at Visit 2 compared to baseline, and a mean reduction of 1.57 ± 1.65 points at Visit 3 compared to baseline. Using mixed-effects models and Wilcoxon signed-rank tests, the differences were all statistically significant (p < 0.05), demonstrating that treatment significantly reduced loose stool symptom scores. At the end of the study, the disappearance rate of loose stool symptoms was 91.48%.

[0049] 8.2 Treatment of secondary symptoms The results are shown in Tables 4, 5, and 6.

[0050] [Table 4]

[0051] [Table 5]

[0052] [Table 6]

[0053] 8.2.1 Nausea and vomiting The intervention treatment resulted in a mean reduction of 0.76 ± 0.68 points at Visit 2 compared to baseline, and a mean reduction of 1.04 ± 0.76 points at Visit 3 compared to baseline. Using mixed-effects models and Wilcoxon signed-rank tests, the differences were all statistically significant (p < 0.05), demonstrating that treatment significantly reduced nausea and vomiting symptom scores. At the end of the study, the elimination rate of nausea and vomiting symptoms was 98.3%.

[0054] 8.2.2 Pectoral bracts / heart bracts symptoms The intervention treatment resulted in a mean reduction of 0.7 ± 0.66 points at Visit 2 compared to baseline, and a mean reduction of 0.89 ± 0.76 points at Visit 3 compared to baseline. Using mixed-effects models and Wilcoxon signed-rank tests, the differences were all statistically significant (p < 0.05), demonstrating that treatment significantly reduced chest / subcardiac puffiness symptom scores. At the end of the study, the resolution rate of chest / subcardiac puffiness symptoms was 97.18%.

[0055] 8.2.3 Defecation incompetence symptoms The intervention treatment resulted in a mean reduction of 0.47±0.67 points at Visit 2 compared to baseline, and a mean reduction of 0.7±0.73 points at Visit 3 compared to baseline. Using mixed-effects models and Wilcoxon signed-rank tests, the differences were all statistically significant (p<0.05), demonstrating a significant reduction in symptom scores for inability to defecate throughout the treatment period. At the end of the study, the disappearance rate for inability to defecate symptoms was 87.85%.

[0056] 8.3SF12 Health Survey (Quality of Life Assessment Score) Score Results The results are shown in Tables 7 and 8.

[0057] [Table 7]

[0058] [Table 8]

[0059] The intervention treatment resulted in an average increase of 9.16 ± 11.59 points in Visit 2 scores during the study period compared to baseline scores, and an average decrease of 17.06 ± 12.42 points in Visit 3 scores compared to baseline scores. Using mixed-effects models and Wilcoxon signed-rank test analyses, we found that all differences were statistically significant (p<0.05), demonstrating that the treatment significantly increased SF12 Health Survey scores compared to baseline.

[0060] 9. Conclusion Shenling-byakutsu can significantly treat various after-effects of COVID-19 pneumonia patients after recovery, and significantly improve the patients' quality of life scores.

[0061] The above description is merely a selection embodiment of the present disclosure, and does not limit the present disclosure, and those skilled in the art can make various changes and modifications to the present disclosure. Any modifications, equivalent substitutions, improvements, etc. made without departing from the spirit and principle of the present disclosure should be included in the protection scope of the present disclosure. [Industrial Applicability]

[0062] The present disclosure provides the use of Shenling Baizhuang in the manufacture of a medicine for treating residual symptoms after recovery and improving the quality of life of patients with novel coronavirus pneumonia, the residual symptoms being at least one selected from shortness of breath, physical weakness, loss of appetite, and diarrhea. The Shenling Baizhuang provided in the present disclosure can significantly treat various residual symptoms after recovery of patients with novel coronavirus pneumonia and significantly improve the quality of life scores of patients, and has excellent industrial applicability.

Claims

1. Use of Shen Ling Baizhuang in the manufacture of a medicine for treating sequelae of patients with novel coronavirus pneumonia after recovery and improving their quality of life, wherein the sequelae are at least one selected from shortness of breath, physical weakness, loss of appetite, and diarrhea, and the raw material of Shen Ling Baizhuang consists of the following parts by weight of traditional Chinese medicine: 400 parts of carrots, 400 parts of turmeric, 400 parts of fried white soybeans, 400 parts of wild herbs, 300 parts of fried white beans, 200 parts of lotus root, 200 parts of fried soybean seeds, 200 parts of sand kernels, 200 parts of bellflower, and 400 parts of licorice.

2. The use according to claim 1, characterized in that the after-effects further include at least one selected from nausea and vomiting, chest / subcardiac puffiness, and inability to defecate.

3. The use according to claim 1, characterized in that the improvement in the quality of life of patients with novel coronavirus pneumonia after recovery means that when the Radix Shen Ling Baizhuang is administered to patients with novel coronavirus pneumonia, the patients' SF12 health survey score is significantly reduced compared with the score before treatment, with a P value of at least less than 0.

05.

4. The use according to any one of claims 1 to 3, characterized in that the medicament is a clinically acceptable formulation.

5. The use according to claim 4, characterized in that the pharmaceutical product is selected from decoctions, pills, powders, granules, tablets or capsules.

6. The pharmaceutical product is a granule, Step I: weighing each herbal medicine according to the weight part; Step II: grinding the yam into a fine powder and passing it through a 100 mesh sieve to prepare it for use; Step III: extracting volatile oil from sand kernels by steam distillation until exhaustion, collecting the distilled aqueous solution in another container, adding 4-5 times by weight of 95% ethanol to the sand kernel residue, ginseng, and fried Atractylodes macrocarpa, soaking for 24 hours, heating under reflux for 3 hours, filtering, recovering the ethanol from the filtrate, and concentrating it to a paste with a relative density of 1.00-1.15 at 65°C to obtain alcoholic extract A, adding 4-5 times by weight of 50% ethanol to the residue, refluxing for 3 hours, filtering, recovering the ethanol from the filtrate, and concentrating it to a paste with a relative density of 1.12-1.13 at 80°C to obtain alcoholic extract B, and preparing the ethanol-extracted residue for use; Step IV: adding 8-10 times the weight of Poria cocos, roasted white beans, lotus seeds, roasted gluten, job's seed, platycodon grandiflorum, and licorice root with 8-10 times the weight of water, boiling for 2 hours, filtering, combining the residue with the residue reserved for use after the ethanol extraction in step III, adding 8 times the weight of water, boiling for 1.5 hours, filtering, combining the two filtrates and the aqueous solution obtained after distillation in step III, allowing to stand, filtering, concentrating the filtrate until the relative density at 80°C is 1.20, adding the alcohol extracts A and B, and continuing to concentrate until the filtrate becomes a crust with a relative density at 80°C of 1.30-1.34; Step V: Mixing the yam powder obtained in Step II with the plaster obtained in Step IV, drying at a low temperature of 60°C to form a dry plaster, and pulverizing it to obtain a medicinal powder. The use according to claim 5, characterized in that the pharmaceutical is produced by the following steps: 1 part by weight of the pharmaceutical powder obtained in step V and 0.4 parts by weight of sugar powder are weighed, mixed uniformly, granulated with 70% to 75% ethanol, dried, sieved, sprayed with sand kernel volatile oil obtained in step III, mixed uniformly, and made into 1000 g, thereby obtaining the pharmaceutical; and step VI.

7. The use according to claim 6, wherein the granules are administered to a subject in need thereof in a dose of 3 g three times a day, which corresponds to a crude drug amount of 27.9 g / day.

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