A traditional Chinese medicine composition for treating postprandial malaise syndrome with sleep disorders in the elderly

Abstract

The application discloses a traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorder, which comprises the following components in parts by weight: 15-20 parts of Radix Bupleuri, 15-20 parts of Rhizoma Atractylodis Macrocephalae, 20-25 parts of Radix Codonopsis, 10-15 parts of Fructus Aurantii Immaturus, 15-20 parts of Radix Paeoniae Alba, 10-15 parts of Pericarpium Citri Reticulatae, 10-15 parts of Rhizoma Pinelliae Praeparatum, 10-15 parts of Radix Salviae Miltiorrhizae, 10-15 parts of Fructus Amomi Rotundus, and 10-15 parts of Radix Glycyrrhizae Praeparata Cum Melle. The traditional Chinese medicine composition has the effects of soothing liver and invigorating spleen, regulating qi and adjusting center, and has good effects on improving symptoms such as upper abdominal pain and postprandial fullness, and has good safety. Meanwhile, the traditional Chinese medicine composition can effectively relieve symptoms such as anxiety and depression caused by gastrointestinal discomfort, and has remarkable curative effects on postprandial discomfort syndrome with sleep disorder.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating postprandial discomfort syndrome in the elderly accompanied by sleep disorders. Background Technology

[0002] Postprandial distress syndrome (PDS) is a subtype of functional dyspepsia (FD). Rome IV classifies FD into epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). PDS is a group of functional digestive disorders characterized by early satiety, postprandial fullness, loss of appetite, and belching, often falling under the category of "epigastric fullness" in Traditional Chinese Medicine. Studies indicate that on average, 4 out of 5 FD patients have PDS, with a positive correlation between its incidence and FD. Furthermore, this disease is chronic and difficult to cure, significantly impacting patients' lives and work. However, the pathogenesis of PDS is not yet fully understood; current research suggests it may be related to a single factor or a combination of factors. Current treatments primarily focus on restoring gastrointestinal motility and protecting the gastric mucosa.

[0003] Traditional Chinese medicine believes that external pathogens, internal injuries, diet, and emotions can all cause epigastric fullness (pi). As early as the *Huangdi Neijing* (Yellow Emperor's Inner Classic), various terms such as "pi," "pi ge," "pi," "xin xia pou," and "pi man" appeared. For example, the *Suwen* (Plain Questions) states, "In the cycle of transformation, the qi harmonizes with the heavens, virtue flows through the four policies, the five transformations are cultivated in unison, the qi is balanced, the nature is smooth… the disease is pi." The *Suwen* also states, "Where the Taiyin (Great Yin) arrives, it causes stagnant fluid accumulation and epigastric fullness." Zhang Zhongjing of the Han Dynasty discussed the pathogenesis of epigastric fullness in his *Shanghan Lun* (Treatise on Cold Damage). In the *Shanghan Lun*, he states, "The disease originates in the Yin stage but is treated with purgatives, thus causing epigastric fullness," suggesting that epigastric fullness in cold damage is a Taiyang stage caused by the physician's misuse of purgatives. The key pathogenesis of PDS (Polydigestive Disorder) is the dysfunction of the spleen and stomach. The main syndrome types in PDS patients are spleen deficiency and qi stagnation, liver-stomach disharmony, spleen-stomach damp-heat, spleen-stomach deficiency-cold, and mixed cold-heat syndrome. In recent years, traditional Chinese medicine has shown unique advantages and achieved good results in the treatment of postprandial discomfort syndrome. Based on clinical symptoms such as early satiety and postprandial fullness, it often adopts the methods of strengthening the spleen and stomach, regulating qi and relieving depression, and combining it with other treatment methods to address the etiology and pathogenesis.

[0004] Chinese patent document CN202180030284.7 discloses a novel compound, [2-(dimethylamino)-2-phenylbutyl]-3,4,5-trimethoxybenzoate 4-methyl-2H-chromene-2-one-7-yl sulfate, relating to the use of the compound [2-(dimethylamino)-2-phenylbutyl]-3,4,5-trimethoxybenzoate 4-methyl-2H-chromene-2-one-7-yl sulfate for the treatment and prevention of functional gastrointestinal disorders.

[0005] For patients with functional dyspepsia, Western medicine often uses adjunctive medications, but these have drawbacks such as short-term efficacy and high relapse rates, failing to achieve satisfactory results. Therefore, there is an urgent need to propose new solutions from the field of traditional Chinese medicine. Summary of the Invention

[0006] In order to overcome the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorders in the elderly. It has good effects on improving symptoms such as upper abdominal pain and postprandial fullness, has good safety, and can effectively relieve symptoms such as anxiety and depression caused by gastrointestinal discomfort.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] A traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorders in the elderly, comprising the following components by weight: Bupleurum chinense 15-20 parts, Atractylodes macrocephala 15-20 parts, Codonopsis pilosula 20-25 parts, Citrus aurantium 10-15 parts, Paeonia lactiflora 15-20 parts, Citrus reticulata 10-15 parts, Pinellia ternata 10-15 parts, Salvia miltiorrhiza 10-15 parts, Amomum villosum 10-15 parts, and Glycyrrhiza uralensis 10-15 parts.

[0009] Preferably, by weight, it includes the following components: 18 parts Bupleurum, 18 parts Atractylodes macrocephala, 22 parts Codonopsis pilosula, 12 parts Citrus aurantium, 17 parts Paeonia lactiflora, 12 parts Citrus reticulata peel, 12 parts Pinellia ternata, 12 parts Salvia miltiorrhiza, 12 parts Amomum villosum, and 12 parts Glycyrrhiza uralensis.

[0010] Preferably, by weight, it includes the following components: 20 parts Bupleurum, 20 parts Atractylodes macrocephala, 25 parts Codonopsis pilosula, 15 parts Citrus aurantium, 20 parts Paeonia lactiflora, 15 parts Citrus reticulata peel, 15 parts Pinellia ternata, 15 parts Salvia miltiorrhiza, 15 parts Amomum villosum, and 15 parts Glycyrrhiza uralensis.

[0011] Preferably, by weight, it includes the following components: 15 parts Bupleurum, 15 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 10 parts Citrus aurantium, 15 parts Paeonia lactiflora, 10 parts Citrus reticulata peel, 10 parts Pinellia ternata, 10 parts Salvia miltiorrhiza, 10 parts Amomum villosum, and 10 parts Glycyrrhiza uralensis.

[0012] Preferably, medically acceptable excipients are added to prepare one or more of the following formulations: decoction, granules, tablets, capsules, mixture, pills, powder, and granules.

[0013] Preferably, the preparation method of the granules, tablets or capsules includes the following steps: weighing the raw materials for oral administration, adding 6 to 10 times the amount of boiling water and decocting 2 to 3 times, 1 to 2 hours each time; combining the decoctions, concentrating under reduced pressure to obtain a thick paste with a relative density of 1.15 to 1.3, vacuum drying, pulverizing through an 80 to 120 mesh sieve, adding an appropriate amount of pharmaceutical excipients according to specifications, and then granulating, tableting or filling capsules by dry method to prepare granules, tablets or capsules respectively.

[0014] Preferably, the preparation method of the compound includes the following steps: adding 6 to 10 times the amount of boiling water and decocting 2 to 3 times, 1 to 2 hours each time; combining the decoctions, adding an appropriate amount of pharmaceutical excipients according to the specifications, adding honey or sugar powder for flavoring, and then preparing a liquid compound.

[0015] Preferably, the preparation method of the pills includes the following steps: adding 6 to 8 times the amount of boiling water and decocting 2 to 3 times, 1 to 2 hours each time; combining the decoctions, concentrating under reduced pressure to obtain a thick paste with a relative density of 1.15 to 1.3, vacuum drying, pulverizing through an 80 to 120 mesh sieve, adding an appropriate amount of pharmaceutical excipients according to specifications, and making pills by soaking in water or 15 to 30 wt% ethanol.

[0016] Preferred dosage: 2-3 times daily for 2-4 weeks.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] 1) This invention provides a traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorders in the elderly. It has the effects of soothing the liver and strengthening the spleen, regulating qi and harmonizing the middle jiao. It has good effects on improving symptoms such as upper abdominal pain and postprandial fullness, and has good safety. At the same time, it can effectively relieve symptoms such as anxiety and depression caused by gastrointestinal discomfort. The TCM syndrome efficacy evaluation scores of both the treatment group and the control group were lower than before treatment, and the treatment group was lower than the control group (P<0.05). The NDI scores of both the treatment group and the control group were improved compared with before treatment, and the treatment group was better than the control group (P<0.05). The PSQI total scores of both the treatment group and the control group were lower than before treatment, and the treatment group was lower than the control group (P<0.05). The total effective rate of clinical symptoms in the treatment group and the control group were 86.84% and 69.23%, respectively, and the treatment group was better than the control group (P<0.05).

[0019] 2) This invention provides a traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorders in the elderly. It is composed of Chaihu Shugan San, Xiaojianzhong Tang, and Xiangsha Liujunzi Tang, with modifications. Chaihu is the principal herb, which can soothe the liver and relieve depression; Dangshen is sweet and neutral in nature, tonifying the middle energizer and replenishing qi, nourishing blood and generating fluids, making it a dual tonic for qi and blood; Baizhu enters the spleen and stomach meridians, strengthening the spleen and replenishing qi, and when qi is abundant, yin and blood are naturally generated; Baishao harmonizes the interior, relieves spasms, softens the liver, and stops pain; Zhishi is bitter and cold, effectively breaking up qi stagnation and eliminating accumulations to relieve fullness and dissipate stagnation, and promoting qi circulation to clear blockages; Chenpi is added to regulate qi and promote circulation; Banxia dries dampness, resolves phlegm, eliminates stagnation and dissipates nodules; Danshen enters the blood level, invigorating blood, removing blood stasis, and relieving pain; Sharen is pungent and warm, dispersing and warming, resolving dampness, invigorating the spleen, promoting qi circulation, and warming the middle energizer; Gancao harmonizes all the herbs. The combined use of these herbs achieves both tonification and elimination, working together to soothe the liver, strengthen the spleen, regulate qi, and harmonize the middle energizer.

[0020] Modern pharmacological studies indicate that saikosaponins are the main components of Bupleurum chinense, with saikosaponin A and saikosaponin D being the most abundant. White peony root mainly consists of volatile oils, monoterpenes, triterpenes, and flavonoids. Both can achieve antidepressant effects by inhibiting the action of inflammatory factors on the target sites of the monoamine neurotransmitter system, thus improving patients' insomnia and anxiety. Furthermore, peony root can improve gastric mucosal blood circulation, prevent gastric smooth muscle spasms, and maintain stable gastrointestinal function. Atractylodes macrocephala contains volatile oils, atractylodes lactones, and atractylodes macrocephala polysaccharides, which can regulate gastrointestinal function and the immune system. Experiments on regulating intestinal flora in mice with colitis show that Codonopsis pilosula polysaccharides, through decomposition into smaller molecules, further act on the gastrointestinal tract, restoring intestinal flora and improving gastrointestinal function. Tangerine peel volatile oil has a mild stimulating effect on the gastrointestinal tract, promoting the expulsion of gas and relieving bloating. Glycyrrhizic acid in roasted licorice root can have anti-inflammatory, anti-liver-damage, cellular immunity-enhancing, and humoral immunity-inhibiting effects. The active ingredients in Citrus aurantium can promote intestinal peristalsis in zebrafish, with neohesperidin showing the best effect, thereby improving the symptoms of functional dyspepsia. After being processed with ginger, Pinellia ternata forms 6-gingerol, increasing the content of organic acids in its chemical composition and significantly enhancing its warming effect. Modern pharmacological experiments have shown that ginger-processed Pinellia ternata has strong antitussive, antiemetic, and anti-gastric ulcer effects, effectively relieving discomfort in PDS patients. The water-soluble components of Salvia miltiorrhiza can promote gastric mucus secretion and DNA synthesis in gastric mucosal cells at the ulcer edge, inhibit gastric motility, and improve clinical symptoms of PDS. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. Of course, the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0022] Unless otherwise specified, all chemical reagents and materials in this invention are purchased from the market or synthesized from raw materials purchased from the market.

[0023] All medicines were provided by the Western Medicine Pharmacy and Traditional Chinese Medicine Pharmacy of the Nangang Campus of Heilongjiang Academy of Traditional Chinese Medicine. The Traditional Chinese Medicine Pharmacy of the Nangang Campus of Heilongjiang Academy of Traditional Chinese Medicine prepared the decoctions.

[0024] The present invention will be further described below through specific embodiments.

[0025] Example 1

[0026] A method for preparing a traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorders in the elderly includes the following steps:

[0027] Weigh out 15g of Bupleurum chinense, 15g of Atractylodes macrocephala, 20g of Codonopsis pilosula, 10g of Citrus aurantium, 15g of Paeonia lactiflora, 10g of Citrus reticulata peel, 10g of Pinellia ternata, 10g of Salvia miltiorrhiza, 10g of Amomum villosum, and 10g of Glycyrrhiza uralensis (processed with ginger). Add 10 times the amount of boiling water and decoct three times, 1.5 hours each time. Combine the decoctions and concentrate under reduced pressure to obtain a thick paste with a relative density of 1.2. Vacuum dry, pulverize and pass through a 100-mesh sieve. After adding an appropriate amount of pharmaceutical excipients according to the specifications, granulate by dry method to prepare a traditional Chinese medicine composition for treating postprandial discomfort syndrome with sleep disorders in the elderly.

[0028] Take 3 times daily for 4 consecutive weeks.

[0029] Comparative Example 1

[0030] Take domperidone tablets 3 times daily (10mg / time, orally 30 minutes before meals) for 4 consecutive weeks.

[0031] 1. Clinical Data

[0032] 1.1 Diagnostic criteria

[0033] The Western medicine diagnosis meets the Rome IV criteria. The traditional Chinese medicine diagnosis meets the syndrome differentiation criteria of spleen deficiency and qi stagnation in the "Expert Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Traditional Chinese Medicine (2017)".

[0034] 1.2 Inclusion Criteria

[0035] ① Meets the above diagnostic criteria in both traditional Chinese and Western medicine; ② PDS symptoms last for more than 12 weeks; ③ Sleep disturbance is secondary to PDS; ④ Age is 60-80 years old, and clinical data is complete; ⑤ The patient and their family are informed and give their consent, and sign the informed consent form.

[0036] 1.3 Exclusion Criteria

[0037] ① Those with organic lesions of the digestive system, such as peptic ulcers, gastritis, gastric tumors, etc.; ② Those with insufficiency of vital organs such as the liver, heart, and kidneys; ③ Those with mental illness, such as severe depression, self-harm, or suicidal tendencies; ④ Those with a history of major surgery or trauma; ⑤ Those with primary sleep disorders who have been taking sleep-improving medications for a long time; ⑥ Those with poor adherence to treatment and who cannot follow the prescribed treatment plan.

[0038] 1.4 Rejection Criteria

[0039] ① Patients who use other medications (including sleep aids) during their medical visit; ② Patients who do not take medication as prescribed or who change their medication regimen on their own during the observation period.

[0040] 1.5 General Information

[0041] Eighty elderly patients with spleen deficiency and qi stagnation type PDS accompanied by sleep disorders who visited the geriatric outpatient clinic of the Nangang Campus of Heilongjiang Academy of Traditional Chinese Medicine from September 2020 to September 2022 were selected and randomly divided into a control group and a treatment group using a random number table. The study protocol was approved by the Medical Ethics Committee of our hospital.

[0042] 2. Observation Indicators

[0043] 2.1 Evaluation of the therapeutic effect of TCM syndrome differentiation

[0044] The evaluation of TCM syndrome efficacy should be based on the characteristics of the main and secondary symptoms of each syndrome, as well as the changing patterns of each syndrome, to formulate a more scientific syndrome evaluation standard. The main symptoms of postprandial discomfort syndrome of spleen deficiency and qi stagnation type are epigastric fullness, distension and pain, and poor appetite; secondary symptoms include belching, fatigue, and loose stools. Each symptom is calculated according to a 4-level grading standard. See Tables 1 and 2.

[0045] Table 1. PDS Main Syndrome Scores for Spleen Deficiency and Qi Stagnation

[0046]

[0047] Table 2. PDS sub-syndrome scores for spleen deficiency and qi stagnation.

[0048]

[0049] 2.2 Quality of Life Nipin Digestive Index (NDI)

[0050] The NDI is a dedicated scale for dyspepsia assessment. The score includes four aspects: sleep disturbance, cognitive control, diet, and disturbance. It also assesses the impact of PDS on quality of life. The higher the score, the better the quality of life.

[0051] 2.3 Pittsburgh Sleep Quality Index (PSQI)

[0052] The PSQI comprises seven scoring factors: sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disturbances, hypnotics, and daytime dysfunction. Each factor is scored from 0 to 3, for a total score of 0 to 21. Higher scores indicate poorer sleep quality; a total score >7 indicates insomnia, 8–12 indicates mild insomnia, 13–17 indicates moderate insomnia, and 18–21 indicates severe insomnia. Since none of the patients included in the clinical observation took hypnotics, the hypnotics score was not included in the total score. Therefore, for a total score of 0–18, the insomnia score was reduced by 3 points accordingly; a score >4 indicates insomnia, and so on.

[0053] 3. Efficacy evaluation criteria and statistical methods

[0054] 3.1 Efficacy Evaluation Criteria

[0055] The nimodipine method was used for calculation. The efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. The efficacy assessment criteria are shown in Table 3.

[0056] Table 3. Criteria for Evaluating Therapeutic Effect

[0057] Efficacy assessment Main symptoms and signs Therapeutic effect index invalid No significant improvement, or even at home <30％ efficient Significant improvement ≥30% and <70% Effective Significant improvement ≥70% and <95% get well Disappeared or basically disappeared ≥95％

[0058] Overall effective rate = (Number of clinically cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%.

[0059] 3.2 Statistical Methods

[0060] SPSS 20.0 statistical software was used for data statistical analysis. Quantitative data were analyzed using [method / method / etc.]. This indicates that the independent samples t-test was used for comparisons between groups; the paired samples t-test was used for comparisons within groups; and count data were expressed as percentages (%), using the chi-square test (x̄ ± s). 2 Test. P < 0.05 is considered statistically significant.

[0061] 4 Results

[0062] During the treatment, one patient dropped out of the control group and two patients dropped out of the treatment group, resulting in a final count of 77 patients included in the efficacy observation and statistics, with 39 patients in the control group and 38 patients in the treatment group. There were no statistically significant differences in baseline data between the two groups (P > 0.05), indicating comparability (see Table 4).

[0063] Table 4 Comparison of baseline data between the two groups of patients

[0064]

[0065] 4.1 Comparison of clinical efficacy

[0066] The total effective rate in the treatment group was 86.84% (33 / 38), while the total effective rate in the control group was 69.23% (27 / 39), respectively. The treatment group was superior to the control group (P<0.05). See Table 5.

[0067] Table 5. Comparison of clinical efficacy between two groups of elderly patients with spleen deficiency and qi stagnation-induced PDS accompanied by sleep disorders [n(%)]

[0068] Group Number of examples Effective efficient invalid Total effective Treatment group 38 22 11 5 <![CDATA[33(86.84%) ▲ ]]> control group 39 18 9 12 27(69.23％)

[0069] Note: ▲ P < 0.05, compared with the control group.

[0070] 4.2 Comparison of TCM syndrome efficacy evaluation scores

[0071] Before treatment, there were no statistically significant differences in the scores of the TCM syndrome efficacy evaluation between the two groups (P > 0.05). After treatment, the scores of all TCM syndrome efficacy evaluations in both groups decreased compared with before treatment (P < 0.05), and the decrease in the treatment group was greater than that in the control group, with statistically significant differences (P < 0.05). See Tables 6 and 7.

[0072] Table 6. Comparison of TCM syndrome scores of main symptoms before and after treatment in two groups of elderly patients with spleen deficiency and qi stagnation PDS and sleep disorders (points). )

[0073]

[0074] Note: ▲ P < 0.05, compared with the pre-treatment values ​​in this group; ◆ P < 0.05, compared with the control group at the same time point.

[0075] Table 7. Comparison of TCM syndrome scores of secondary symptoms before and after treatment in two groups of elderly patients with spleen deficiency and qi stagnation PDS and sleep disorders (points). )

[0076]

[0077] Note: ▲P<0.05, compared with the group before treatment; ◆P<0.05, compared with the control group at the same time.

[0078] 4.3 Comparison of Nipin Indigestion Index (NDI) scores

[0079] Before treatment, there was no statistically significant difference in NDI scores between the two groups (P > 0.05). After treatment, the NDI scores of both groups increased compared to before treatment (P < 0.05), and the change in NDI scores in the treatment group was significantly better than that in the control group, with statistically significant differences (P < 0.05). See Table 8.

[0080] Table 8. Comparison of NDI scores before and after treatment in two groups of elderly patients with spleen deficiency and qi stagnation PDS and sleep disorders (points). )

[0081]

[0082] Note: ▲ P < 0.05, compared with the pre-treatment values ​​in this group; ◆ P < 0.05, compared with the control group at the same time point.

[0083] 4.4 Comparison of the Pittsburgh Sleep Quality Index (PSQI)

[0084] Before treatment, there was no statistically significant difference in PSQI scores between the two groups (P > 0.05). After treatment, PSQI scores in both groups decreased compared to before treatment (P < 0.05), and the total PSQI score in the treatment group was lower than that in the control group (P < 0.05). See Table 9.

[0085] Table 9. Comparison of Pittsburgh Sleep Quality Index scores before and after treatment in two groups of elderly patients with spleen deficiency and qi stagnation PDS and sleep disorders (points). )

[0086]

[0087] Note: ▲ P < 0.05, compared with the pre-treatment values ​​in this group; ◆ P < 0.05, compared with the control group at the same time point.

[0088] 4.5 Safety Evaluation

[0089] No significant adverse reactions occurred in either group of patients during the treatment, indicating a high level of safety.

[0090] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating postprandial distress syndrome with sleep disorders in the elderly, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum 15-20 parts, Atractylodes macrocephala 15-20 parts, Codonopsis pilosula 20-25 parts, Citrus aurantium 10-15 parts, Paeonia lactiflora 15-20 parts, Citrus reticulata 10-15 parts, Pinellia ternata 10-15 parts, Salvia miltiorrhiza 10-15 parts, Amomum villosum 10-15 parts, Glycyrrhiza uralensis 10-15 parts; With the addition of medically acceptable excipients, it can be prepared into any one of the following formulations: decoction, granules, tablets, capsules, mixture, pills, powder, or granule.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum 18 parts, Atractylodes macrocephala 18 parts, Codonopsis pilosula 22 parts, Citrus aurantium 12 parts, Paeonia lactiflora 17 parts, Citrus reticulata 12 parts, Pinellia ternata 12 parts, Salvia miltiorrhiza 12 parts, Amomum villosum 12 parts, Glycyrrhiza uralensis 12 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum 20 parts, Atractylodes macrocephala 20 parts, Codonopsis pilosula 25 parts, Citrus aurantium 15 parts, Paeonia lactiflora 20 parts, Citrus reticulata 15 parts, Pinellia ternata 15 parts, Salvia miltiorrhiza 15 parts, Amomum villosum 15 parts, Glycyrrhiza uralensis 15 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum 15 parts, Atractylodes macrocephala 15 parts, Codonopsis pilosula 20 parts, Citrus aurantium 10 parts, Paeonia lactiflora 15 parts, Citrus reticulata 10 parts, Pinellia ternata 10 parts, Salvia miltiorrhiza 10 parts, Amomum villosum 10 parts, Glycyrrhiza uralensis 10 parts.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the granules, tablets or capsules includes the following steps: weigh the raw materials for oral administration, add 6 to 10 times the amount of boiling water and decoct 2 to 3 times, 1 to 2 hours each time; combine the decoctions, concentrate under reduced pressure to obtain a thick paste with a relative density of 1.15 to 1.3, vacuum dry, pulverize through an 80 to 120 mesh sieve, add an appropriate amount of pharmaceutical excipients according to the specifications, and then granulate, compress or fill capsules by dry method to make granules, tablets or capsules respectively.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the compound includes the following steps: add 6-10 times the amount of boiling water and decoct 2-3 times, 1-2 hours each time; combine the decoctions, add appropriate amount of medicinal excipients according to the specifications, add honey or sugar powder for flavoring, and then make a liquid compound.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the pills includes the following steps: add 6-8 times the amount of boiling water and decoct 2-3 times, 1-2 hours each time; combine the decoctions, concentrate under reduced pressure to obtain a thick paste with a relative density of 1.15-1.3, vacuum dry, pulverize and pass through an 80-120 mesh sieve, add an appropriate amount of pharmaceutical excipients according to the specifications, and make pills by soaking in water or 15-30wt% ethanol.

8. The traditional Chinese medicine composition according to claim 1, characterized in that, Take 2-3 times daily for 2-4 weeks.

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