Medicine for improving or treating mixed anxiety and depressive disorder and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicine for improving or treating mixed anxiety and depressive disorder and application thereof. The medicine is prepared from the following raw materials in parts by weight: 10-30 parts of codonopsis pilosula, 10-30 parts of moutan bark, 10-30 parts of liquorice, 10-30 parts of radix angelicae pubescentis, 10-30 parts of radix bupleuri, 10-30 parts of honey-fried licorice root, 10-30 parts of radix paeoniae alba, 10-30 parts of radix puerariae, 10-20 parts of radix saposhnikoviae, 3-20 parts of rhizoma cimicifugae, 10-20 parts of notopterygium root, 10-30 parts of radix rehmanniae recen, 10-30 parts of poria cocos, 10-30 parts of rhizoma acori graminei and 10-30 parts of polygala tenuifolia. The medicine for improving or treating mixed anxiety and depressive disorder, provided by the invention, treats anxiety and depression after stress by a treatment method mainly comprising invigorating spleen and supplementing qi, and dispersing and clearing fire, not only can improve anxiety and depressive mental symptoms of patients, but also can improve somatochemical symptoms of digestive systems and skeletal muscle systems, and can improve the curative effect of the patients. By reducing blood sugar and serum cortisol rise caused by stress, the anti-anxiety effect can be continuously achieved for 14 days after drug withdrawal, the treatment effect is good, and safety and reliability are achieved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to drugs and their applications for improving or treating mixed anxiety and depression disorders. Background Technology

[0002] Mixed anxiety and depressive disorder (MADD) refers to a condition in which patients experience both anxiety and depression symptoms simultaneously; it is also known as subthreshold anxiety and depression. Compared to simple anxiety or depression disorders, MADD manifests as more severe impairment in social functioning, with prominent symptoms including decreased work capacity and strained interpersonal relationships, seriously harming the patient's physical and mental health and normal social life.

[0003] The existing technology (Lai Yunjie. Clinical efficacy study of Shengyang Sanhuo Decoction in treating mixed anxiety and depression in adolescents with spleen and stomach latent heat type [D]. Guangzhou University of Chinese Medicine, 2023.) discloses that Shengyang Sanhuo Decoction is suitable for MADD adolescents with digestive discomfort as the main symptom. In traditional Chinese medicine, it belongs to the spleen and stomach latent heat type. It can improve anxiety and suppress emotions in adolescent patients, help improve sleep quality, and relieve physical symptoms such as stomach pain, constipation, indigestion, dry mouth and bitter taste. Among them, Shengyang Sanhuo Decoction is composed of 10 herbs: Pueraria lobata, Cimicifuga foetida, Notopterygium incisum, Angelica pubescens, Ginseng (now replaced by Codonopsis pilosula), Paeonia lactiflora, Bupleurum chinense, Glycyrrhiza uralensis, Glycyrrhiza uralensis, and Saposhnikovia divaricata.

[0004] However, current technology only studies adolescents, not adults. Furthermore, while Sheng Yang San Huo Tang (a traditional Chinese medicine formula) can strengthen the spleen and clear heat, it neglects nourishing Yin and clearing heat, thus treating the symptoms but not the root cause. The anti-anxiety effect is difficult to stabilize and maintain, and relapse is common once medication is discontinued. Current technology does not address the root cause of the disease, resulting in incomplete treatment and reduced overall therapeutic effectiveness.

[0005] Therefore, for stress-induced anxiety and depression symptoms, especially somatic symptoms such as fever and sweating, bloating and stomach pain, bitter taste and dry mouth, further research is needed on the formulation to make the medicine more effective and reliable, so as to achieve both symptomatic and root cause treatment and prevent relapse after discontinuation of the medicine. Summary of the Invention

[0006] The purpose of this invention is to provide a medicine for improving or treating mixed anxiety and depression disorders and its application, in order to solve the aforementioned problems.

[0007] According to a first aspect of the present invention, a medicament for improving or treating mixed anxiety and depression is provided, which is prepared from the following raw materials in parts by weight: Codonopsis pilosula 10-30 parts, Paeonia suffruticosa 10-30 parts, Glycyrrhiza uralensis 10-30 parts, Angelica pubescens 10-30 parts, Bupleurum chinense 10-30 parts, Glycyrrhiza uralensis (processed) 10-30 parts, Paeonia lactiflora 10-30 parts, Pueraria lobata 10-30 parts, Saposhnikovia divaricata 10-20 parts, Cimicifuga foetida 3-20 parts, Notopterygium incisum 10-20 parts, Rehmannia glutinosa 10-30 parts, Poria cocos 10-30 parts, Acorus tatarinowii 10-30 parts, and Polygala tenuifolia 10-30 parts.

[0008] Stress often causes anxiety and depression symptoms, and 20%-30% can develop into chronic post-traumatic stress disorder, significantly affecting social function and quality of life. Spleen deficiency and internal heat are the fundamental pathological characteristics of stress-induced anxiety and depression. Therefore, this invention starts from the root cause of the disease, "spleen deficiency and internal heat," and provides a medicine to strengthen the spleen and clear heat. In the formula: Codonopsis pilosula and prepared licorice root are the principal herbs to strengthen the spleen and replenish qi; Pueraria lobata strengthens the spleen and raises yang, reducing oxidative stress response; Bupleurum chinense relieves exterior symptoms and has anti-inflammatory effects; Cimicifuga foetida and Saposhnikovia divaricata are aromatic, invigorate the spleen, raise yang, disperse heat, and regulate immune response; Notopterygium incisum and Angelica pubescens dispel wind and dampness, and have good therapeutic effects on anti-inflammation and pain relief, and are the assistant herbs; Paeonia suffruticosa clears heat and reduces fire; Rehmannia glutinosa clears heat and nourishes yin, disperses fire and reduces fire; Paeonia lactiflora nourishes blood, astringes yin, clears heat, and has anti-inflammatory effects, and are the guiding herbs; Poria cocos strengthens the spleen, promotes diuresis, calms the mind and soothes the nerves; Polygala tenuifolia and Acorus tatarinowii invigorate the mind and improve intelligence, and have good effects on anti-anxiety and anti-depression, and are the adjuvant herbs. The entire formula is meticulously prepared, replenishing deficiencies and eliminating excesses, strengthening the spleen and replenishing qi, dispersing heat and clearing fire, and exerting a synergistic effect of anti-stress, anti-inflammatory, anti-anxiety and anti-depressant.

[0009] All raw materials are prepared in accordance with the "Pharmacopoeia of the People's Republic of China" and the "National Processing Standards". Specific sources: Codonopsis pilosula: a plant of the Campanulaceae family. Codonopsis pilosula (Franch.) Nannf. Codonopsis pilosula (Western Codonopsis) Codonopsis pilosula Nannf. var. modesta (Nannf.) L. T. Shen or Sichuan Codonopsis Codonopsis tangshen Oliv. The dried root.

[0010] Peony bark: Peony, a plant of the Ranunculaceae family. Paeonia suffruticosa Andr. The dried root bark.

[0011] Licorice: Licorice, a plant in the legume family. Glycyrrhiza uralensis Fisch. licorice root Glycyrrhiza inflata Bat. Or licorice root Glycyrrhiza glabra L. The dried root.

[0012] Angelica pubescens: Angelica pubescens, a plant of the Apiaceae family. Angelica pubescens Maxim. f. biserrata Shan et Yuan The dried root.

[0013] Bupleurum: Bupleurum chinense, a plant in the Apiaceae family. Bupleurum chinense DC. or narrow-leaved Bupleurum Bupleurum scorzonerifolium Willd. The dried root.

[0014] Prepared licorice root: A processed product of licorice root.

[0015] White peony: Paeonia lactiflora, a plant in the Ranunculaceae family. Paeonia lactiflora Pall. The dried root.

[0016] Kudzu root: Wild kudzu, a legume. Pueraria lobata (Willd.)Ohwi or kudzu vine Pueraria thomsonii Benth. The dried root.

[0017] Wind protection: Apiaceae plants, specifically windbreaks. Saposhnikovia divaricata (Turcz.) Schischk. The dried root.

[0018] Cimicifuga: A plant of the Ranunculaceae family, Cimicifuga macrocarpa. Cimicifuga heracleifolia Kom. Xingan Cimicifuga Cimicifuga dahurica (Turcz.)Maxim. or Cimicifuga Cimicifuga foetida L. The dried rhizome.

[0019] Notopterygium incisum: Notopterygium incisum (also known as winged celery), a plant belonging to the Apiaceae family. Notopterygium incisum Ting ex H. T. Chang Or broadleaf Notopterygium Notopterygium forbesii Boiss. The dried rhizomes and roots.

[0020] Rehmannia glutinosa: a plant of the Scrophulariaceae family called Rehmannia glutinosa Rehmannia glutinosa Libosch. Fresh or dried tubers.

[0021] Poria cocos: a fungus belonging to the Polyporaceae family. Poria cocos (Schw.) Wolf The dried sclerotia.

[0022] Sweet flag (Acorus calamus): A plant of the Araceae family. Acorus tatarinowii Schott The dried rhizome.

[0023] Polygala tenuifolia: a plant of the Polygalaceae family. Polygala tenuifolia Willd. or Polygala tenuifolia Polygala sibirica L. The dried root.

[0024] In some embodiments, the drug for improving or treating mixed anxiety and depression is prepared from the following raw materials in parts by weight: Codonopsis pilosula 15-25 parts, Paeonia suffruticosa 15-25 parts, Glycyrrhiza uralensis 15-25 parts, Angelica pubescens 15-25 parts, Bupleurum chinense 15-25 parts, Glycyrrhiza uralensis (processed) 15-25 parts, Paeonia lactiflora 15-25 parts, Pueraria lobata 15-25 parts, Saposhnikovia divaricata 12-18 parts, Cimicifuga foetida 10-15 parts, Notopterygium incisum 12-18 parts, Rehmannia glutinosa 15-25 parts, Poria cocos 15-25 parts, Acorus tatarinowii 15-25 parts, and Polygala tenuifolia 15-25 parts.

[0025] In some embodiments, the drug for improving or treating mixed anxiety and depression is prepared from the following raw materials in parts by weight: Codonopsis pilosula 30 parts, Paeonia suffruticosa 30 parts, Glycyrrhiza uralensis 30 parts, Angelica pubescens 10 parts, Bupleurum chinense 15 parts, processed Glycyrrhiza uralensis 30 parts, Paeonia lactiflora 30 parts, Pueraria lobata 30 parts, Saposhnikovia divaricata 10 parts, Cimicifuga foetida 5 parts, Notopterygium incisum 10 parts, Rehmannia glutinosa 20 parts, Poria cocos 30 parts, Acorus tatarinowii 10 parts, and Polygala tenuifolia 15 parts.

[0026] In some implementations, the drug is in the form of existing common dosage forms such as decoctions, granules, ointments, pills, and powders. Granules are manufactured in accordance with the "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules" issued by the National Medical Products Administration.

[0027] In some embodiments, the drug may also contain pharmaceutically acceptable excipients, which may include at least one of sustained-release agents, excipients, fillers, binders, wetting agents, disintegrants, absorption enhancers, adsorbents, surfactants, and lubricants.

[0028] Based on the understanding that post-stress anxiety and depression are fundamentally due to spleen deficiency and superficially due to stagnation of deficiency fire, the spleen-tonifying and fire-clearing medicine provided in this invention treats post-stress anxiety and depression by focusing on tonifying the spleen and replenishing qi, dispersing fire and clearing heat. It can not only improve patients' anxiety and depression symptoms, but also improve somatic symptoms of the digestive and musculoskeletal systems. By reducing the increase in blood sugar and serum cortisol caused by stress, it continues to exert an anti-anxiety effect for 14 days after discontinuation of the drug. The treatment effect is good and the safety is reliable.

[0029] According to a second aspect of the invention, the use of the above-described medicament for improving or treating mixed anxiety and depression in the preparation of medicaments for improving or preventing mixed anxiety and depression is provided.

[0030] In some embodiments, the use of drugs for improving or treating mixed anxiety and depression disorders in the preparation of drugs for improving or preventing mixed anxiety and depression disorders caused by latent heat in the spleen and stomach. Symptoms of mixed anxiety and depression disorders caused by latent heat in the spleen and stomach include burning pain in the stomach, fatigue and irritability, body aches, thirst with a preference for cold drinks, red and painful gums, dry or cracked lips, dry mouth, bitter taste, halitosis, excessive hunger, facial acne, scanty and yellow urine with occasional burning sensation, constipation, red tongue with yellow coating, and rapid pulse.

[0031] In some implementations, medications that improve or prevent mixed anxiety and depression disorders refer to medications that exert anti-anxiety and antidepressant effects through anti-stress. Attached Figure Description

[0032] Figure 1This figure shows the changes in various clinical symptoms during the pharmacological treatment and follow-up of patients with mixed anxiety and depression as described in this application. In the figure, A represents the changes in SAS scores after treatment and follow-up in both groups; B represents the changes in SDS scores after treatment and follow-up in both groups; C represents the changes in PSQI scores after treatment and follow-up in both groups; D represents the changes in CMI scores after treatment and follow-up in both groups; E represents the changes in CMI MR scores after treatment and follow-up in both groups; and F represents the changes in CMI somatization scores after treatment and follow-up in both groups. A indicates a comparison with pre-treatment values, P < 0.05; B indicates a comparison with post-treatment values, P < 0.05; C indicates a comparison with the experimental group, P < 0.05; all pairwise comparisons were Bonferroni corrected. Detailed Implementation

[0033] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available.

[0034] Example 1 A drug for improving or treating mixed anxiety and depression is prepared from the following raw materials in parts by weight: Codonopsis pilosula 30g, Paeonia suffruticosa 30g, Glycyrrhiza uralensis 30g, Angelica pubescens 10g, Bupleurum chinense 15g, Glycyrrhiza uralensis (processed) 30g, Paeonia lactiflora 30g, Pueraria lobata 30g, Saposhnikovia divaricata 10g, Cimicifuga foetida 5g, Notopterygium incisum 10g, Rehmannia glutinosa 20g, Poria cocos 30g, Acorus tatarinowii 10g, and Polygala tenuifolia 15g.

[0035] The drug for improving or treating mixed anxiety and depression is prepared as a traditional Chinese medicine decoction. The preparation method is as follows: (1) Soak the prepared raw materials in water for 30 minutes; (2) The above raw materials are decocted twice with water: First, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, keep simmering for 1.5 hours, and separate to obtain the first decoction and the dregs; Second, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, keep simmering for 1.5 hours, and separate to obtain the second decoction and the dregs; Combine the first decoction and the second decoction, filter to obtain the soup.

[0036] Example 2 A drug for improving or treating mixed anxiety and depression is prepared from the following raw materials in parts by weight: Codonopsis pilosula 20g, Paeonia suffruticosa 20g, Glycyrrhiza uralensis 20g, Angelica pubescens 15g, Bupleurum chinense 10g, Glycyrrhiza uralensis (processed) 20g, Paeonia lactiflora 15g, Pueraria lobata 15g, Saposhnikovia divaricata 15g, Cimicifuga foetida 10g, Notopterygium incisum 15g, Rehmannia glutinosa 30g, Poria cocos 20g, Acorus tatarinowii 20g, and Polygala tenuifolia 10g.

[0037] The medication for improving or treating mixed anxiety and depressive disorders is formulated into granules, and the preparation method is as follows: (1) Soak the prepared raw materials in water for 30 minutes; (2) The above raw materials are decocted twice with water: First, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, maintain a gentle boil for 1.5 hours, and separate to obtain the first decoction and the dregs; Second, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, maintain a gentle boil for 1.5 hours, and separate to obtain the second decoction and the dregs; Combine the first decoction and the second decoction, and filter to obtain the filtrate; (3) Concentrate the filtrate obtained in step (2) under reduced pressure (vacuum degree -0.08Mpa, temperature 70℃) to a clear paste with a relative density of 1.15 (60℃); (4) Add 10% of the total mass of the raw material maltodextrin to the clear paste obtained in step (3) and then spray dry to obtain dry paste powder. The spray drying process parameters are: air inlet temperature 170℃ and air outlet temperature 100℃. (5) Add an appropriate amount of maltodextrin to the dry powder obtained in step (4) according to experience, and mix it with a mixer for 30 minutes to make it uniform, so as to obtain a mixed powder; (6) Add 90% ethanol-water solution to the mixed powder obtained in step (5) to make soft material, and granulate the soft material through a 12-mesh sieve to obtain wet granules. (7) The wet granules obtained in step (6) are dried at 65°C to obtain the final product.

[0038] Seal and store the obtained granules in 6g packets. Take three times a day. Example 3 A drug for improving or treating mixed anxiety and depression is prepared from the following raw materials in parts by weight: Codonopsis pilosula 10g, Paeonia suffruticosa 10g, Glycyrrhiza uralensis 10g, Angelica pubescens 10g, Bupleurum chinense 10g, Glycyrrhiza uralensis (processed) 15g, Paeonia lactiflora 10g, Pueraria lobata 15g, Saposhnikovia divaricata 10g, Cimicifuga foetida 3g, Notopterygium incisum 15g, Rehmannia glutinosa 10g, Poria cocos 10g, Acorus tatarinowii 10g, and Polygala tenuifolia 10g.

[0039] Example 4 A drug for improving or treating mixed anxiety and depression is prepared from the following ingredients in parts by weight: Codonopsis pilosula 30g, Paeonia suffruticosa 25g, Glycyrrhiza uralensis 25g, Angelica pubescens 30g, Bupleurum chinense 20g, Glycyrrhiza uralensis (processed) 10g, Paeonia lactiflora 10g, Pueraria lobata 10g, Saposhnikovia divaricata 10g, Cimicifuga foetida 15g, Notopterygium incisum 20g, Rehmannia glutinosa 20g, Poria cocos 30g, Acorus tatarinowii 30g, and Polygala tenuifolia 20g.

[0040] Experiment 1: Study on the evaluation of drug efficacy and safety 1. Test subjects (1) Inclusion criteria: 1) Patients aged 12-65 years, male / female; 2) Patients who meet the Western medical diagnostic criteria for mixed anxiety and depressive disorders; 3) Persistent or recurrent irritability for at least one month; 4) The patient must have at least 4 of the following 10 symptoms at the same time: poor concentration, irritability, fatigue, poor sleep, somatization symptoms, loss of interest, decreased motivation, tearfulness, feelings of hopelessness, and feelings of worthlessness; 5) According to traditional Chinese medicine diagnosis, it belongs to the syndrome of latent heat in the spleen and stomach; 6) The patient is of sound mind, of a reasonable age and appearance, with coordinated emotions, coherent thinking, good orientation, and intact self-awareness. No hallucinations, delusions, or other psychotic symptoms have been reported, and the patient has not complained of memory loss, intellectual decline, or other symptoms.

[0041] (2) Exclusion criteria: 1) Individuals with other primary underlying diseases of the cardiovascular, respiratory, digestive, urinary, or nervous systems; 2) Having severe mental illnesses such as schizophrenia, schizoaffective disorder, paranoid disorder, bipolar disorder, organic psychosis, mental disorders caused by epilepsy, or mental retardation with mental disorders; 3) Individuals at risk of suicide or self-harm, or those with a confirmed diagnosis of severe depression; 4) Those who have been clearly diagnosed with substance use disorder, substance-induced disorder, or long-term use of alcohol, central nervous system agonists or depressants; 5) A history of known allergies to any of the ingredients in Qingluan Decoction; 6) Pregnant or breastfeeding women.

[0042] A prospective, randomized, double-blind controlled trial was conducted. In accordance with the above criteria, 53 eligible subjects were selected, including 35 subjects in the traditional Chinese medicine experimental group and 18 subjects in the placebo control group.

[0043] 2. Test methods (1) Traditional Chinese Medicine Treatment Group: The Chinese herbal decoction prepared according to the formula in Example 1 was taken once a day, divided into 2 bags, each bag containing 200ml. Patients took 1 bag 2 hours after breakfast and dinner, heated it to about 40℃ and then took it orally. The treatment lasted for 14 days.

[0044] (2) Control group: A placebo was given to cope with stress and relieve anxiety and depression. The placebo had the same appearance, color, packaging and administration method as the traditional Chinese medicine decoction. One dose was given daily, divided into two 200ml packets. Patients took one packet two hours after breakfast and dinner, heated to about 40°C and then took it orally. The treatment lasted for 14 days.

[0045] 3. Results of efficacy evaluation (1) Comparison of treatment efficacy for anxiety symptoms The full analysis set (FAS) was analyzed using the two independent samples rank-sum test. The reduction in the anxiety symptom self-rating scale scores of patients in the traditional Chinese medicine treatment group was statistically significant compared with that in the placebo group (P<0.05), as shown in Table 1.

[0046] Table 1. Comparison of the full analysis set (FAS) of the reduction values ​​of the Self-Rating Anxiety Scale (SAS) between the two groups after treatment.

[0047]

[0048] Note: £ represents the rank-sum test for two independent samples.

[0049] Repeated measures ANOVA was used. After treatment and 14 days of follow-up, there was a statistically significant difference in the self-rating anxiety score of the TCM treatment group compared with that before treatment (P<0.05). At 14 days of follow-up, there was a statistically significant difference in the SAS score of the TCM treatment group compared with that of the placebo group (P<0.05), as shown in Table 2.

[0050] Table 2. Comparison of Self-Rating Anxiety Scale (SAS) scores between the two groups after treatment and during follow-up.

[0051]

[0052] Note: A indicates comparison with pre-treatment, P < 0.05; B indicates comparison with post-treatment, P < 0.05; C indicates comparison with the experimental group, P < 0.05; all pairwise comparisons were Bonferroni corrected.

[0053] (2) Comparison of treatment efficacy for depressive symptoms The full analysis set (FAS) was analyzed using a two-independent-samples t-test. The reduction in the depressive symptoms self-rating scale scores of patients in the traditional Chinese medicine treatment group was statistically significant compared with that in the placebo group (P<0.05), as shown in Table 3.

[0054] Table 3. Comparison of the full analysis set (FAS) of the deduction values ​​of the Self-Rating Depression Scale (SDS) between the two groups after treatment.

[0055]

[0056] (3) Comparison of treatment efficacy for somatic symptoms The two independent samples rank-sum test of the full analysis set (FAS) showed statistically significant differences in the reduction scores of the CMI somatization factor, digestive, musculoskeletal factor, and reproductive and urinary factors between the two groups (P < 0.05), as shown in Table 4. Table 4's comparison of the efficacy of treatment for somatic symptoms represents the manifestation of TCM symptom efficacy. Somatization includes scores for fatigue and irritability; musculoskeletal factors include scores for general aches and pains; digestive factors include scores for burning pain in the stomach, thirst with a preference for cold drinks, red and painful gums, dry or cracked lips, dry mouth, bitter taste, halitosis, excessive hunger, and constipation; and reproductive and urinary factors include scores for scanty, yellow urine and occasional burning sensation.

[0057] Table 4. CMI scale of MADD patients with latent heat syndrome in the spleen and stomach in the two groups after treatment. Comparison of deduction values ​​[M (P)] 25 P 75 )]

[0058] (4) Comparison of treatment efficacy for anxiety and depression-related risk factors FAS analysis showed a statistically significant difference in the reduction of fasting blood glucose (GLU) between the two groups after treatment (P < 0.05), while there was no statistically significant difference in serum cortisol (COR) and interleukin-6 (IL-6) at 8:00 am (P > 0.05), as shown in Table 5. The improvement in blood glucose and cortisol levels reflects an increase in the body's stress level, and the drug of this invention can exert its anti-anxiety and antidepressant effects through stress reduction.

[0059] Table 5 Serological indicators of MADD patients with latent heat syndrome in the spleen and stomach in the two groups after treatment. Comparison of decrease values ​​[ M (P 25 P 75 )]

[0060] Note: & indicates a two-independent-samples t-test, and ￡ indicates a two-independent-samples rank-sum test.

[0061] 4. Safety evaluation results During the study, two adverse events occurred in the experimental group, both manifesting as diarrhea, which resolved after discontinuation of the medication. No adverse events occurred in the control group. There was no statistically significant difference in the incidence of adverse events between the two groups. All patients showed no significant abnormalities in vital signs such as blood pressure, respiration, heart rate, and body temperature, as well as in laboratory tests including complete blood count, urinalysis, stool analysis, and liver and kidney function tests.

[0062] The above research results show that the traditional Chinese medicine anti-stress anxiety formula in this study has significant clinical efficacy and good safety.

[0063] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A medicine for improving or treating mixed anxiety and depressive disorders, characterized in that, It is prepared from the following raw materials in parts by weight: Codonopsis pilosula 10-30 parts, Paeonia suffruticosa 10-30 parts, Glycyrrhiza uralensis 10-30 parts, Angelica pubescens 10-30 parts, Bupleurum chinense 10-30 parts, Glycyrrhiza uralensis (processed) 10-30 parts, Paeonia lactiflora 10-30 parts, Pueraria lobata 10-30 parts, Saposhnikovia divaricata 10-20 parts, Cimicifuga foetida 3-20 parts, Notopterygium incisum 10-20 parts, Rehmannia glutinosa 10-30 parts, Poria cocos 10-30 parts, Acorus tatarinowii 10-30 parts, and Polygala tenuifolia 10-30 parts.

2. The medicament for improving or treating mixed anxiety and depression according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: Codonopsis pilosula 15-25 parts, Paeonia suffruticosa 15-25 parts, Glycyrrhiza uralensis 15-25 parts, Angelica pubescens 15-25 parts, Bupleurum chinense 15-25 parts, Glycyrrhiza uralensis (processed) 15-25 parts, Paeonia lactiflora 15-25 parts, Pueraria lobata 15-25 parts, Saposhnikovia divaricata 12-18 parts, Cimicifuga foetida 10-15 parts, Notopterygium incisum 12-18 parts, Rehmannia glutinosa 15-25 parts, Poria cocos 15-25 parts, Acorus tatarinowii 15-25 parts, and Polygala tenuifolia 15-25 parts.

3. The medicament for improving or treating mixed anxiety and depression according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: Codonopsis pilosula 30 parts, Paeonia suffruticosa 30 parts, Glycyrrhiza uralensis 30 parts, Angelica pubescens 10 parts, Bupleurum chinense 15 parts, Glycyrrhiza uralensis (processed) 30 parts, Paeonia lactiflora 30 parts, Pueraria lobata 30 parts, Saposhnikovia divaricata 10 parts, Cimicifuga foetida 5 parts, Notopterygium incisum 10 parts, Rehmannia glutinosa 20 parts, Poria cocos 30 parts, Acorus tatarinowii 10 parts, and Polygala tenuifolia 15 parts.

4. The medicament for improving or treating mixed anxiety and depression according to any one of claims 1-3, characterized in that, The dosage forms of the drug include decoctions, granules, ointments, pills, or powders.

5. The medicament for improving or treating mixed anxiety and depression according to claim 4, characterized in that, The drug also includes pharmaceutically acceptable excipients.

6. The use of the medicament for improving or treating mixed anxiety and depression as described in any one of claims 1-5 in the preparation of a medicament for improving or preventing mixed anxiety and depression.

7. The application according to claim 6, characterized in that, The application of the drug for improving or treating mixed anxiety and depression in the preparation of drugs for improving or preventing mixed anxiety and depression due to spleen and stomach heat syndrome.

8. The application according to claim 6, characterized in that, The drugs mentioned above for improving or preventing mixed anxiety and depression are those that exert anti-anxiety and antidepressant effects through anti-stress.

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