Traditional Chinese medicine composition and application thereof in relieving anxiety

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and application thereof in prevention and / or treatment of anxiety disorder. The traditional Chinese medicine composition comprises extracts of hypericum leaf, valerian root, rose, chamomile and the like, and the traditional Chinese medicine composition for relieving anxiety disorder and anxiety mood is designed by adopting a volatile component extraction and refining technical system integrating biological enzymolysis, fractional distillation and multi-element extraction. The technical problems of low extraction efficiency, low yield, low purity, poor effect and the like of a traditional method are solved, the extraction rate, the content of active substances in a purified product and the biological activity of the purified product are remarkably improved, and the effect of preventing and / or treating anxiety disorder is remarkable.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition and its application in relieving anxiety. Background Art

[0002] Anxiety disorder is one of the most common types of mental disorders, including separation anxiety disorder and selective mutism, specific phobia, social anxiety disorder, generalized anxiety disorder, panic disorder and agoraphobia. The prevalence of anxiety disorder is relatively high, usually with a chronic course, and can lead to the occurrence of different types of comorbidities. According to the statistics of the World Health Organization (WHO), the global prevalence of anxiety disorder is 3.6%, and its lifetime prevalence is as high as 32%. In 2022, the number of people with anxiety disorder in China was 95 million, and the prevalence of anxiety disorder has reached 5%. One-third of people have felt that life is becoming more and more anxious. Severe anxiety disorder is usually accompanied by dangerous behaviors such as self-harm and suicide. Recent studies have found that anxiety disorder can increase the suicide risk of patients by 4 times. If an anxious patient also suffers from other mood-related mental disorders, the suicide rate can increase to 12 times. At present, WHO has listed it as the ninth leading cause of disability related to health.

[0003] Anxiety disorder has a high incidence and a long course, and may even be lifelong. This will not only lead to problems of low personal quality of life and heavy family economic burden, but also lead to serious social medical pressure and high suicide rate.

[0004] Although modern medicine has made some progress in the research of anxiety disorder, its pathogenesis is extremely complex and there is still no consensus. However, according to the physiological change rules of patients with anxiety disorder and the long-term research of anti-anxiety drugs, some hypotheses about the pathogenesis of anxiety disorder have gradually been proposed to explain the pathogenesis of anxiety disorder and the internal mechanism of anti-anxiety drugs to play a therapeutic effect. At present, the neurotransmitter hypothesis and the neuroendocrine hypothesis are widely recognized in the pathogenesis of anxiety disorder. The neurotransmitter hypothesis generally believes that the hyperfunction of 5-HT, NE, Glu and the hypofunction of GABA are the pathophysiological basis for the occurrence and development of anxiety disorder. The neuroendocrine hypothesis believes that abnormal activities of the hypothalamic-pituitary-adrenal axis, hypothalamic-pituitary-gonadal axis, neuropeptides, neurosteroids, etc. will induce anxiety disorder.

[0005] Currently, the pharmacological treatment of anxiety disorders mainly relies on the use of benzodiazepines and 5-HT1A receptor agonists. However, since these two types of drugs can only alleviate the symptoms of anxiety and cannot completely cure anxiety disorders, and long-term use of benzodiazepines may cause central adverse reactions such as daytime sleepiness or sedation, while 5-HT1A receptor agonists have a slow onset of action and usually take 2-4 weeks to become effective. Therefore, based on the current situation that existing therapeutic drugs fail to meet the needs of alleviating or treating anxiety disorders, developing new substances with anxiolytic effects and no toxic side effects, and preparing dosage forms and administration methods that are easily acceptable to patients are the most direct ways to relieve anxiety disorders and anxiety emotions, improve the living standards of patients, and reduce social problems.

[0006] Studying how to effectively prevent and treat anxiety disorders has become a social problem that urgently needs to be solved. Currently, most of the therapeutic drugs are chemical drugs, which have problems such as poor therapeutic effects, easy recurrence of the disease after drug withdrawal, and large side effects. Summary of the Invention

[0007] To overcome the deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for relieving anxiety disorders and anxiety emotions. The composition uses plant extracts, such as Hypericum perforatum L., Rosa rugosa Thunb., Valeriana officinalis L., and Chamomilla recutita (L.) Rauschert, as the core components, and constructs a technical system for extracting and refining volatile components that integrates "biological enzymolysis - fractional distillation - multi-component extraction". This solves the technical problems of low extraction efficiency, low yield, low purity, and poor effect in traditional methods, and significantly improves the extraction rate, the content of active substances in the purified product, and the biological activity.

[0008] The traditional Chinese medicine composition of the present invention comprises the following traditional Chinese medicine raw materials in the following weight ratios:

[0009] Hypericum perforatum L. leaf extract 40 - 90 parts by weight, Valeriana officinalis L. root extract 5 - 15 parts by weight

[0010] Rosa rugosa Thunb. extract 12 - 30 parts by weight, Chamomilla recutita (L.) Rauschert extract 6 - 20 parts by weight;

[0011] Further preferably:

[0012] Hypericum perforatum L. leaf extract 50 - 70 parts by weight, Valeriana officinalis L. root extract 8 - 15 parts by weight

[0013] Rosa rugosa Thunb. extract 18 - 25 parts by weight, Chamomilla recutita (L.) Rauschert extract 12 - 18 parts by weight;

[0014] Even more preferably:

[0015] Hypericum perforatum L. leaf extract 65 parts by weight, Valeriana officinalis L. root extract 11 parts by weight

[0016] Rosa rugosa Thunb. extract 20 parts by weight, Chamomilla recutita (L.) Rauschert extract 15 parts by weight.

[0017] The traditional Chinese medicine composition described in the present invention can be prepared into an oral preparation together with pharmaceutical excipients, preferably one or more of granules, tablets, pills, capsules or liquid oral preparations; more preferably tablets or granules.

[0018] Use of the traditional Chinese medicine composition or traditional Chinese medicine preparation described in the present invention in relieving anxiety disorders.

[0019] The anxiety disorders include, but are not limited to, separation anxiety disorder and selective mutism, specific phobia, social anxiety disorder, generalized anxiety disorder, panic disorder and agoraphobia.

[0020] The present invention analyzes the main components of preferred medicinal plants such as Hypericum perforatum, Valeriana officinalis, Rosa rugosa and Chamomilla recutita, optimizes the types of enzyme preparations and the enzymatic hydrolysis process, and designs a fractional distillation collection strategy. Combining the secondary solvent extraction of the distillation residue and the distillate, a volatile component extraction and refining technology system integrating "biological enzymatic hydrolysis - fractional distillation - multiple extraction" is constructed to realize the full extraction and efficient separation of active components in the volatile extracts of different medicinal plants, and form the core functional traditional Chinese medicine raw material composition for relieving anxiety disorder.

[0021] The preparation method of the extract of the core components of the above-mentioned traditional Chinese medicine composition is as follows:

[0022] The core component raw materials are dried, crushed and screened, and passed through a 30 - 80 mesh sieve to obtain fine traditional Chinese medicine powder; the enzyme preparation, water and the fine traditional Chinese medicine powder are mixed, and the control parameters such as the solid - liquid ratio, time and temperature of the enzymatic hydrolysis system are optimized. After heat - preserving enzymatic hydrolysis extraction, the volatile component distillates of each medicinal plant are prepared by steam distillation + fractional collection method, and the distillation residue is collected. The residue is subjected to secondary extraction with a solvent, followed by solid - liquid separation, distillation purification, and then centrifugation, filtration, concentration, sterilization and drying to obtain the extract of the core components.

[0023] Preferably, the enzyme preparation is one or more of cellulase, pectinase, ferulic acid esterase, protease.

[0024] Preferably, the solvent is one or more of ethanol, 1,3 - butanediol, isocetane.

[0025] Preferably, the mass ratio of the enzyme preparation, the enzyme preparation, water and the fine traditional Chinese medicine powder is 1:300 - 500:50 - 80.

[0026] More preferably, the mass ratio of the enzyme preparation, the enzyme preparation, water and the fine traditional Chinese medicine powder is 1:400:75.

[0027] Preferably, the temperature of the heat - preserving enzymatic hydrolysis extraction is 30 - 50 °C, and the time of the heat - preserving enzymatic hydrolysis extraction is 0.5 - 2 h.

[0028] More preferably, the temperature of the heat preservation enzymatic extraction is 45°C, and the time of the heat preservation enzymatic extraction is 1 h.

[0029] Preferably, the temperature of the secondary extraction with a solvent is 75 - 90°C, and the time is 1 - 3 h.

[0030] More preferably, the temperature of the secondary extraction with a solvent is 85°C, and the time is 2 h.

[0031] Preferably, the sieving is through a 60 - mesh sieve.

[0032] It should be noted that the traditional Chinese medicine composition provided by the present disclosure is based on the understanding of the pathogenesis and treatment principles of anxiety disorder in traditional Chinese medicine, combined with the achievements of modern pharmacological research. Its pharmacology is as follows:

[0033] Hypericum perforatum: Its main active ingredients include hypericin and hyperforin, etc., which have significant antidepressant effects and are used as the monarch drug; Rosa rugosa: It has the effects of promoting qi and relieving depression, and is suitable for symptoms such as chest tightness and emotional depression caused by stagnation of liver qi, and is used as the minister drug; Valeriana officinalis: It is usually used for calming the nerves, relieving anxiety and insomnia, and is used as the assistant drug; Chamomilla recutita: It has the effects of clearing heat and detoxifying, and dispersing wind - heat, and is used as the envoy drug.

[0034] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0035] The present invention adopts a high - efficiency preparation technology system for volatile components of medicinal plants that integrates "biological enzymatic hydrolysis - fractional distillation - multi - extraction", realizes the full extraction and efficient separation of active components in volatile components of different medicinal plants, and forms a core component extract for relieving anxiety disorder. Compared with the traditional distillation technology, its extraction rate, the content of active substances in the purified product, and biological activity have all been significantly improved.

[0036] The core component extract prepared by this preparation technology system is further made into a traditional Chinese medicine composition preparation, which has a significant therapeutic effect on relieving anxiety disorder. In order to verify the therapeutic effect of the traditional Chinese medicine composition, through pharmacodynamic animal experiments and clinical case verification experiments, the results show that the traditional Chinese medicine composition provided by the present invention can effectively treat depression. Detailed implementation manners

[0037] In order to make the purpose and technical solutions of the present invention clearer, the following further describes the present invention with reference to the embodiments. However, the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. Those skilled in the art should understand that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0038] The pharmaceutical composition (granules) in Example 1

[0039] Prescription:

[0040] Dosage (g) Hypericum perforatum L. extract 65 Valeriana officinalis L. extract 11 Rosa rugosa Thunb. extract 20 Chamomilla recutita (L.) Rauschert extract 15

[0041] Preparation method:

[0042] The core component raw materials are dried, crushed and screened, passed through a 60-mesh sieve to obtain fine traditional Chinese medicine powder; the cellulase preparation, water and the fine traditional Chinese medicine powder are mixed, and the mass ratio of the enzyme preparation, water and the fine traditional Chinese medicine powder is controlled to be 1:400:75. After heat-preserved enzymatic hydrolysis extraction, the volatile component distillates of each medicinal plant are prepared by steam distillation + fractional collection method, and the distillation residue is collected. The residue is subjected to secondary extraction with ethanol, followed by solid-liquid separation, distillation purification, and then centrifugation, filtration, concentration, sterilization and drying to obtain the core component extract. Then, excipients such as microcrystalline cellulose, starch, crospovidone, talc powder are added to make soft materials, granulated, dried and sized to obtain the granule.

[0043] The pharmaceutical composition (granule) in Example 2

[0044] Prescription:

[0045] Dosage (g) Hypericum perforatum L. extract 70 Valeriana officinalis L. extract 15 Rosa rugosa Thunb. extract 25 Chamomilla recutita (L.) Rauschert extract 18

[0046] Preparation method:

[0047] The core component raw materials are dried, crushed and screened, passed through a 60-mesh sieve to obtain fine traditional Chinese medicine powder; the cellulase preparation, water and the fine traditional Chinese medicine powder are mixed, and the mass ratio of the cellulase preparation, water and the fine traditional Chinese medicine powder is controlled to be 1:300:50. After heat-preserved enzymatic hydrolysis extraction, the volatile component distillates of each medicinal plant are prepared by steam distillation + fractional collection method, and the distillation residue is collected. The residue is subjected to secondary extraction with ethanol and 1,3-butanediol, followed by solid-liquid separation, distillation purification, and then centrifugation, filtration, concentration, sterilization and drying to obtain the core component extract. Then, excipients such as microcrystalline cellulose, starch, crospovidone, talc powder are added to make soft materials, granulated, dried and sized to obtain the granule.

[0048] The pharmaceutical composition (tablet) in Example 3

[0049] Prescription:

[0050] Dosage (g) Hypericum perforatum L. extract 50 Valeriana officinalis L. extract 8 Rosa rugosa Thunb. extract 18 Chamomilla recutita (L.) Rauschert extract 12

[0051] Preparation method:

[0052] The core component raw materials are dried, pulverized, and screened through a 60-mesh sieve to obtain fine traditional Chinese medicine powder. The cellulase preparation, water, and the fine traditional Chinese medicine powder are mixed, and the mass ratio of the enzyme preparation, water, and the fine traditional Chinese medicine powder is controlled to be 1:500:80. After heat-preserving enzymatic hydrolysis extraction, the volatile component distillates of each medicinal plant are prepared by steam distillation + fractional collection method, and the distillation residue is collected. Ethanol and isoparaffin are used for secondary extraction, followed by solid-liquid separation, distillation purification, and then centrifugation, filtration, concentration, sterilization, and drying to obtain the core component extract. Then, excipients such as microcrystalline cellulose, starch, crospovidone, and talc powder are added to make soft materials, granulated, dried, and tabletted to obtain tablets.

[0053] Drug composition (tablets) in Example 4

[0054] Prescription:

[0055] Dosage (g) Hypericum perforatum L. extract 40 Valeriana officinalis L. extract 5 Rosa rugosa Thunb. extract 12 Chamomilla recutita (L.) Rauschert extract 6

[0056] Preparation method:

[0057] The core component raw materials are dried, pulverized, and screened through a 60-mesh sieve to obtain fine traditional Chinese medicine powder. The cellulase and pectinase preparations, water, and the fine traditional Chinese medicine powder are mixed, and the mass ratio of the enzyme preparation, water, and the fine traditional Chinese medicine powder is controlled to be 1:400:75. After heat-preserving enzymatic hydrolysis extraction, the volatile component distillates of each medicinal plant are prepared by steam distillation + fractional collection method, and the distillation residue is collected. Ethanol and isoparaffin are used for secondary extraction, followed by solid-liquid separation, distillation purification, and then centrifugation, filtration, concentration, sterilization, and drying to obtain the core component extract. Then, excipients such as microcrystalline cellulose, starch, crospovidone, and talc powder are added to make soft materials, granulated, dried, and tabletted to obtain tablets.

[0058] Drug composition (pills) in Example 5

[0059] Prescription:

[0060] Dosage (g) Hypericum perforatum L. extract 90 Valeriana officinalis L. extract 15 Rosa rugosa Thunb. extract 30 Chamomilla recutita (L.) Rauschert extract 20

[0061] Preparation method:

[0062] The core component raw materials are dried, pulverized and screened through a 60-mesh sieve to obtain fine traditional Chinese medicine powder; the cellulase preparation, water and the fine traditional Chinese medicine powder are mixed, and the mass ratio of the enzyme preparation, water and the fine traditional Chinese medicine powder is controlled to be 1:400:75. After heat-preserving enzymatic hydrolysis extraction, the volatile component distillates of each medicinal plant are prepared by steam distillation + fractional collection method, and the distillation residue is collected. It is subjected to secondary extraction with ethanol, solid-liquid separation, distillation purification, and then centrifugation, filtration, concentration, sterilization and drying to obtain the core component extract. Then it is decocted twice with yellow rice wine and filtered; the above-mentioned fine powder is used to make pills with the decoction solution, dried, and the pills are obtained.

[0063] Comparative Example 1 traditional Chinese medicine composition (granules), compared with Example 1, the difference is only that the ratio of the core component extract is different, specifically:

[0064] Dosage (g) Hypericum perforatum L. extract 100 Valeriana officinalis L. extract 20 Rosa rugosa Thunb. extract 10 Chamomilla recutita (L.) Rauschert extract 25 。

[0065] Comparative Example 2 traditional Chinese medicine composition (granules), compared with Example 1, the difference is only that the mass ratio of the enzyme preparation, water and the fine traditional Chinese medicine powder is 1:100:100.

[0066] Comparative Example 3 traditional Chinese medicine composition (tablets), compared with Example 1, the difference is only that the steam distillation + fractional collection method is not used to prepare the volatile component distillates of each medicinal plant.

[0067] Comparative Example 4 traditional Chinese medicine composition (tablets), compared with Example 1, the difference is only that the secondary extraction with a solvent is not carried out.

[0068] Comparative Example 5 traditional Chinese medicine composition (pills), compared with Example 1, the difference is only that the heat-preserving enzymatic hydrolysis extraction treatment is not carried out with the addition of an enzyme preparation.

[0069] Determination of the content of the extract of the core formula components of traditional Chinese medicine

[0070] ① Hypericum perforatum extract

[0071] Determined by the high performance liquid chromatography method (General Principles 0512).

[0072] Chromatographic conditions and system suitability test Use octadecylsilane chemically bonded silica gel as the filler; use acetonitrile - 0.1% phosphoric acid solution (16:84) as the mobile phase; the detection wavelength is 360 nm. The number of theoretical plates calculated by the hyperoside peak should not be less than 3000.

[0073] Preparation of the reference substance solution Weigh an appropriate amount of hyperoside reference substance accurately, dissolve it in methanol to make a solution containing 32 μg per 1 ml, and that's it.

[0074] Preparation of the test solution: Weigh accurately about 0.4 g of the powder of this product (passed through No. 3 sieve), place it in a stoppered conical flask, accurately add 50 ml of 60% ethanol, weigh, heat under reflux for 1 hour, cool, weigh again, make up the lost weight with 60% ethanol, shake well, filter, and take the subsequent filtrate, that is obtained.

[0075] Assay method: Accurately pipette 10 μl each of the reference solution and the test solution, inject into the liquid chromatograph, and determine, then it can be obtained.

[0076] Calculated on the dried basis, this product contains hyperoside (C 21 H 20 O 12 ) not less than 0.10%.

[0077] ② Valerian root extract

[0078] Determine according to the volatile oil determination method (General Principles 2204, Volume IV, Chinese Pharmacopoeia 2020 Edition).

[0079] This product contains not less than 0.60% (ml / g) of volatile oil.

[0080] ③ Rose extract

[0081] Determine according to the hot extraction method under the alcohol-soluble extract determination method (General Principles 2201), using 20% ethanol as the solvent, not less than 28.0%.

[0082] ④ Chamomile extract

[0083] Determine according to the high performance liquid chromatography method (General Principles 0512). Calculated on the dried basis, this product contains not less than 0.20% of chlorogenic acid.

[0084] In accordance with the content detection regulations of the Pharmacopoeia (2020 Edition), the extracts of each core component raw material prepared by using the volatile component extraction and refining technology system of "biological enzymolysis - fractional distillation - multi - extraction" of the present invention all meet the content requirements of the Pharmacopoeia (2020 Edition), as shown in Table 1 specifically:

[0085] Table 1 Results of the extract content of each core component raw material in the present invention

[0086]

[0087] Pharmacodynamic verification examples

[0088] 1. Test grouping

[0089] Experimental group: The traditional Chinese medicine composition (granules) obtained by the method of Example 1;

[0090] Control group 1: The granules of Comparative Example 1;

[0091] Control group 2: The granule of Comparative Example 2;

[0092] Control group 3: The tablet of Comparative Example 3;

[0093] Control group 4: The tablet of Comparative Example 4;

[0094] Control group 5: The pill of Comparative Example 5;

[0095] Control group 6: Fluoxetine hydrochloride capsules (purchased from Eli Lilly Suzhou Pharmaceutical Co., Ltd.); dosage 4 mg / kg / animal;

[0096] Blank group: Administered with distilled water by gavage at 10 ml / kg / animal;

[0097] For the experimental group and Control groups 1 - 5, the administration method is to dissolve the composition with warm water and then administer it by gavage, with a dosage of 10 mg / kg / animal; each group of animals was gavaged with the corresponding drug for 20 days.

[0098] 2. Test materials

[0099] Self - made open - field reaction chamber: 28 cm high, 40 cm long at the bottom, inner wall painted black, and the bottom evenly divided into 25 small squares.

[0100] Water container: A 20 cm×15 cm container with a water depth of 11 cm; water temperature 25 °C.

[0101] SPF - level male Kunming mice, weighing 20 ± 2 g, 10 mice in each group.

[0102] 3. Test methods

[0103] For each test group, the experiment was carried out 1 h after drug administration on the 20th day.

[0104] Open - field experiment: Take the self - made open - field reaction chamber, put 1 mouse in the center grid of the open box each time, and then observe. There are two raters who respectively rate the activity of 1 mouse within 5 min and record the number of grid crossings starting from the center of the bottom. After each mouse's experiment, the device was cleaned with a cleaner. Each mouse was only tested once.

[0105] Swimming experiment: First, train the mice to swim for 10 min, and test 24 h later: Put a single mouse into the water container, after 2 min of adaptation, record the cumulative immobile time (s) within 4 min. Immobility means that the mouse stops struggling in the water or floats, with only small limb movements to keep its head above the water surface. Each mouse was only tested once.

[0106] The measurement results of the spontaneous activity of the mice in each test group and the measurement results of the immobile time of the mice were averaged, as shown in Table 2.

[0107]

[0108] Note: Compared with the blank group, *P<0.05, **P<0.01

[0109] As can be seen from Table 2, compared with the blank group, there were almost no differences in the spontaneous activities of mice in each drug-administered group. This indicates that the composition provided by the present invention has no central nervous system excitatory effect, and false positives caused by the shortening of the immobility time of mice in the forced swimming test due to central excitatory effects can be excluded.

[0110] After forced swimming, compared with the blank group, the composition provided by the present invention can significantly shorten the immobility time of mice in the forced swimming test; compared with Control Groups 1-6, after the composition provided by the present invention was used, the immobility time of mice in the forced swimming test was also shortened, indicating that the product provided by the present invention has an antidepressant effect.

[0111] Clinical trial verification

[0112] Eighty patients diagnosed with depression were selected, with an average age of 32.6±3.6 years and a disease duration of 2.8±0.4 years; they were randomly divided into 8 groups, and the male-female ratio in each group was 1:1.

[0113] The diagnostic criteria for the patients conformed to ICD-10. The traditional Chinese medicine clinical manifestations of this disease were mental trance, restlessness of mind, suspicion and easy startle, sadness and crying easily, mood swings, low mood, taciturnity, or dancing and gesturing, etc., with a pale tongue and a thready pulse. The Hamilton Depression Scale (HAMD scale) was used for scoring.

[0114] The experimental group and Control Groups 1 to 5 were the same as in Experimental Example 1; the administration method was 5 g / time, taken orally with warm water once in the morning and once in the evening;

[0115] The administration method of the fluoxetine hydrochloride capsules in Control Group 6 was referred to the instructions.

[0116] The experiment lasted for 2 months. Before and after treatment, HAMD scores were taken, and the curative effect was judged according to the HAMD score reduction rate: a score reduction rate of ≥75% was considered cured, ≥50% was considered markedly effective, ≥25% was considered effective, and <25% was considered ineffective.

[0117] Table 3 Investigation form of treatment situation

[0118] Cured Markedly effective Effective Ineffective Experimental group 5 3 2 0 Control group 1 1 3 3 3 Control group 2 1 2 3 4 Control group 3 1 3 2 4 Control group 4 0 3 3 4 Control group 5 1 3 3 3 Control group 6 2 3 3 1 Blank group 0 0 0 10

[0119] As can be seen from the content recorded in Table 3, the composition provided by the present invention can effectively treat depression, and the treatment effect is better than that of the drug in Control Group 6. During the follow-up visit after treatment, it was found that most of the patients in Control Group 6 had adverse reactions after taking the fluoxetine hydrochloride capsules, including symptoms such as nausea, vomiting, insomnia, drowsiness, headache, etc., but the patients in the experimental group and Control Groups 1-5 did not have adverse reactions.

[0120] From the data of Control Groups 1-5, it can be seen that the traditional Chinese medicine composition provided by the volatile component extraction and refining technology system integrating "biological enzymolysis - fractional distillation - multiple extraction" of the present invention has a synergistic effect. If the preparation method is changed or certain steps or parameters of the preparation method are changed, it will significantly affect the therapeutic effect of the drug.

[0121] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a drug for preventing and / or treating anxiety, characterized in that: The Chinese medicine composition comprises the following Chinese medicine raw materials in weight ratio: Hypericum perforatum extract 40-90 parts by weight Valerian root extract 5-15 parts by weight 12-30 parts by weight of rose extract; 6-20 parts by weight of chamomile extract.

2. The use according to claim 1, characterized in that: The Chinese medicine composition comprises the following Chinese medicine raw materials in weight ratio: Hypericum perforatum extract 50-70 parts by weight Valerian root extract 8-15 parts by weight 18-25 parts by weight of rose extract; 12-18 parts by weight of chamomile extract.

3. The use according to claim 2, characterized in that: The Chinese medicine composition comprises the following Chinese medicine raw materials in weight ratio: Hypericum perforatum extract 65 parts by weight Valerian root extract 11 parts by weight 20 parts by weight of rose extract and 15 parts by weight of chamomile extract.

4. The use according to claim 1, characterized in that: The preparation method of the extract of the Chinese medicinal raw material of the above-mentioned Chinese medicinal composition is as follows: The Chinese medicine raw materials are dried, crushed and sieved, and sieved through 30-80 meshes to obtain Chinese medicine fine powder; an enzyme preparation, water and the Chinese medicine fine powder are mixed, and the control parameters of the enzymatic hydrolysis system such as solid-liquid ratio, time, temperature, etc. are optimized. After heat preservation and enzymatic hydrolysis extraction, a steam distillation + segmented collection method is used to prepare a distillate of volatile components of each medicinal plant, and the distillation residue is collected, and a solvent is used for secondary extraction. After solid-liquid separation and distillation purification, centrifugation, filtration, concentration, sterilization and drying are performed, and a core component extract is obtained.

5. The use according to claim 4, characterized in that: The enzyme preparation is one or more of cellulase, pectinase, ferulic acid esterase and protease.

6. The use according to claim 5, characterized in that: The mass ratio of the enzyme preparation, the enzyme preparation, water and the traditional Chinese medicine fine powder is 1:400:

75.

7. The use according to claim 4, characterized in that: The solvent is one or more of ethanol, 1,3-butanediol, and isohexadecane.

8. The use according to claim 4, characterized in that: The temperature of the heat preservation enzymatic hydrolysis is 45° C., and the time of the heat preservation enzymatic hydrolysis is 1 hour; the temperature of the secondary extraction with solvent is 85° C., and the time is 2 hours; the sieving is a 60-mesh sieve.

9. The use according to claim 1, characterized in that: The Chinese medicine composition can be prepared into an oral preparation with pharmaceutical excipients; preferably one or more of granules, tablets, pills, capsules or liquid oral preparations; more preferably tablets or granules.

10. The use according to claim 1, characterized in that: Such anxiety disorders include, but are not limited to, separation anxiety disorder and selective mutism, specific phobias, social anxiety disorder, generalized anxiety disorder, panic disorder, and agoraphobia.

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