Traditional Chinese medicine composition for treating juvenile depressive disorder caused by insufficient fluid blood and deficiency-heat internal disturbance as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating juvenile body fluid blood deficiency and deficiency-heat internal disturbance type depressive disorder and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by mass, 3-15 parts of fresh ginger, 6-15 parts of rhizoma pinellinae praeparata, 1-15 parts of cassia twigs, 3-15 parts of radix paeoniae alba, 3-15 parts of angelica sinensis, 3-12 parts of ligusticum wallichii, 5-15 parts of codonopsis pilosula and 3-15 parts of radix glehniae. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3-15 parts of raw liquorice, 6-24 parts of raw rehmannia root, 9-27 parts of ophiopogon root, 3-18 parts of moutan bark, 3-12 parts of raw gardenia, 3-12 parts of fructus aurantii and 6-24 parts of gypsum. The curative effect and safety evaluation research shows that the traditional Chinese medicine composition disclosed by the invention is remarkable in clinical curative effect and good in safety on juvenile body fluid blood deficiency and deficiency-heat internal disturbance type depressive disorder.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating adolescents' depressive disorder of deficiency of body fluid and blood and internal disturbance of deficiency heat, as well as a preparation method and application thereof. Background Art

[0002] The "China National Mental Health Development Report" shows that the depression risk detection rate among Chinese adolescents in 2020 was 24.6%, among which the risk detection rate of severe depression was 7.4%. Depressive disorders have become a major threat to the healthy growth of adolescents today (Editing Group of the "Guidelines for the Prevention and Treatment of Adolescent Depression Disorders with Integrated Traditional Chinese and Western Medicine", Psychosomatic Medicine Branch of the Chinese Association of Traditional Chinese Medicine, Psychosomatic Medicine Branch of the Chinese Medical Association. Guidelines for the Prevention and Treatment of Adolescent Depression Disorders with Integrated Traditional Chinese and Western Medicine [J]. Journal of Beijing University of Chinese Medicine, 2024, 47(06): 874-888.).

[0003] Traditional Chinese medicine does not have a name for depression disorder. Adolescent depression disorder belongs to the category of depression syndrome and depression disease in traditional Chinese medicine. Traditional Chinese medicine believes that it is a disease syndrome with sadness, worry, crying, restlessness, irritability, insomnia, loss of appetite, and mental confusion as the main symptoms. Emotional injury is the main factor inducing depression syndrome. The body's yang qi is insufficient, and it is difficult to maintain the normal operation of physiological functions, resulting in the loss of nourishment for the spirit. The continuous stimulation of external factors causes the body's qi, blood, and body fluids to be long-term depleted. Therefore, the clinical manifestations of depression are mostly mixed with deficiency and excess, and the course of the disease is lingering and recurring.

[0004] The Guidelines for the Prevention and Treatment of Adolescent Depression Disorders with Integrated Traditional Chinese and Western Medicine proposes five main syndrome types: liver qi stagnation, qi stagnation transforming into fire, phlegm qi stagnation, liver qi stagnation and spleen deficiency, and heart and spleen deficiency. There are also some syndrome types involving kidney yang deficiency, kidney yin deficiency, liver and gallbladder dampness and heat, and phlegm and fire disturbing the heart. Song Quanwu et al. observed in clinical practice that the most common tongue signs of adolescent patients with mixed anxiety and depression disorders are red tongue, greasy tongue coating, enlarged tongue, and tooth marks on the edge of the tongue. The most common pulse signs are thin pulse, string pulse, and slippery pulse. The common syndrome types are liver qi stagnation and spleen deficiency, spleen and stomach latent heat, spleen deficiency and dampness, kidney yang deficiency, and yin deficiency and fire excess (Song Quanwu, Zhou Xin, Yang Lingling, et al. Preliminary analysis of early stress factors and TCM syndrome distribution in adolescent mixed anxiety and depression disorders [J]. Chinese Journal of Traditional Chinese Medicine, 2023, 38(09): 4431-4437.). In addition, there is a theory of treating depression in children and adolescents from the perspective of liver yang deficiency (Zhang Ning, Zhang Hongxian, Guo Jianning, et al. Treating depression in children and adolescents from the perspective of liver yang deficiency [J]. Global Chinese Medicine, 2023, 16(08): 1624-1627.). In addition, some scholars have combined the physiological characteristics of children with "liver excess", "spleen deficiency" and "kidney deficiency" and believe that the pathogenesis of this disease is mainly due to liver failure to dredge and spleen failure to function, kidney yang deficiency, heart qi deficiency, and both heart and spleen deficiency.

[0005] The above-mentioned prior art shows that children and adolescents are more complicated in the etiology and pathogenesis of the disease and the prognosis of the disease due to their special constitution, and there are fewer literature reports on the clinical intervention of Chinese medicine drug therapy and non-drug therapy for depression in children and adolescents at present, which needs further study, and the overall therapeutic effect of the disease is not good. The inventor found in clinical work that many adolescent depression patients are women, and there are many manifestations such as low mood, lack of energy and laziness, dry mouth, poor appetite, small or normal menstrual flow, pale tongue, red tip, thin fur, and internal movement of the pulse channel, accompanied by hand temperature, red eyelids, body heat, upset, poor sleep, like to drink cool, constipation and other situations. At present, this type of patient is still lacking in effective Chinese medicine clinically, so it is still necessary to further study on syndrome differentiation and prescription for adolescent depression, cooperate with physical conditioning, so that the drug effect is better and more reliable, and the effect of treating both the symptoms and the root causes is achieved. Summary of the invention

[0006] The first purpose of the present invention is to provide a traditional Chinese medicine composition for treating adolescent depression caused by insufficient body fluid and blood and internal disturbance of deficiency heat. The second purpose of the present invention is to provide a method for preparing the traditional Chinese medicine composition. The third purpose of the present invention is to provide an application of the traditional Chinese medicine composition.

[0007] According to the first aspect of the present invention, a traditional Chinese medicine composition for treating adolescent depressive disorder of internal disturbance type due to deficiency of body fluid and blood and deficiency-heat is provided. The main active ingredients thereof include, by weight: 3-15 parts of ginger, 6-15 parts of pinellia, 1-15 parts of cassia twig, 3-15 parts of white peony root, 3-15 parts of angelica, 3-12 parts of chuanxiong, 5-15 parts of codonopsis pilosula, 3-15 parts of adenophora australis, 3-15 parts of raw liquorice, 6-24 parts of raw rehmannia root, 9-27 parts of ophiopogon, 3-18 parts of moutan bark, 3-12 parts of raw gardenia, 3-12 parts of fructus aurantii, and 6-24 parts of gypsum.

[0008] The inventors found in clinical work that many adolescent depression patients are female, and most of them have symptoms of insufficient body fluid and blood, such as low mood, shortness of breath and laziness to speak, dry mouth, poor appetite, scanty or normal menstruation, pale tongue, red tip, thin tongue coating, inward shift of pulse channels, etc., accompanied by heat symptoms such as warm hands, red eyelids, body heat, irritability, poor sleep, preference for cold drinks, constipation, etc., which may be related to long-term bad living and eating habits. It is considered to be a depression of insufficient body fluid and blood and internal disturbance of virtual heat.

[0009] The present invention is based on the fact that the depression of adolescents with insufficient body fluid and blood and internal disturbance of deficiency heat is caused by deficiency cold in Ren and Chong meridians and deficiency of qi and blood, and its symptom is internal disturbance of deficiency heat. The present invention treats the depression mainly by warming the meridians and dispersing cold, nourishing blood and clearing heat, and promoting body fluid and eliminating restlessness.

[0010] In the prescription, cinnamon twig and ginger warm the meridians and dispel cold; Banxia is pungent and opens the stomach qi, which can not only harmonize the stomach and calm the middle, but also work with Codonopsis and raw licorice to strengthen the spleen and harmonize the stomach, help remove blood stasis and regulate menstruation, and work with ginger to reduce adverse reactions and stop vomiting; white peony root, angelica root, and Chuanxiong nourish blood, activate blood circulation, and moisten dryness, to replenish the deficiency of Ren and Chong in young people; Codonopsis, Adenophora scutellariae, and Rehmannia root strengthen the spleen and lungs, nourish yin and benefit the stomach, and promote bowel movements; Ophiopogon japonicus, Paeonia suffruticosa, and raw Gardenia jasminoides clear heat and relieve restlessness; Citrus aurantium widens the middle and promotes qi; Gypsum is pungent, sweet, and very cold, and can produce fluid, quench thirst, and relieve restlessness; raw licorice harmonizes the flavors as a guiding drug. The combination of all the drugs can make the qi and blood mild, and the Ren and Chong can be warmed and nourished. The whole prescription is rigorous in composition, replenishing the deficiency and removing the excess, warming the meridians and nourishing the blood, clearing heat and removing restlessness, and producing fluid and quenching thirst. It can not only improve the patient's depression and physical discomfort, but also prevent the disease from worsening and recurring by regulating the constitution.

[0011] The sources of raw materials for this recipe are as follows:

[0012] Ginger: The fresh rhizome of Zingiber officinale Rosc., a plant of the Zingiberaceae family.

[0013] French Pinellia: processed product of Pinellia.

[0014] Cinnamon twig: The young branch of cinnamon Cinnamomum cassia Presl.

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

[0016] Angelica: The root of Angelica sinensis (Oliv) Diels., a plant of the Apiaceae family.

[0017] Chuanxiong: The dried rhizome of Ligusticum chuanxiong Hort., a plant of the Apiaceae family.

[0018] Codonopsis: The root of Codonopsis pilosula (Franch.) Nannf., C.pilosula Nannf.var. (Nannf.) LTShen or C.tangshen Oliv. of the Campanulaceae family.

[0019] Glehnia littoralis: The root of Glehnia littoralis F.Schmidtex Miq., a plant of the genus Glehnia in the family Apiaceae.

[0020] Raw licorice: fresh roots and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., plants of the genus Glycyrrhiza in the Leguminosae family.

[0021] Raw Rehmannia: fresh or dried tubers of Rehmannia glutinosa Libosch., a plant of the genus Rehmannia in the family Scrophulariaceae.

[0022] Ophiopogon japonicus: The tuberous root of Ophiopogon japonicus (Lf) Ker-Gawl. or Ophiopogon bodinieri Levl., a plant of the genus Ophiopogon in the Liliaceae family.

[0023] Peony bark: the dried root bark of Paeonia suffruticosa Andr., a plant of the genus Paeonia in the family Paeoniaceae.

[0024] Raw gardenia: the fresh ripe fruit of Cardenia jasminoides Ellis, a plant of the Rubiaceae family.

[0025] Citrus aurantium: the nearly ripe fruit of Citrus aurantium L. and its cultivated varieties of the Rutaceae family.

[0026] Gypsum: Sulfate gypsum mineral gypsum, mainly containing hydrated calcium sulfate (CaSO 4 ·H 2 O).

[0027] In some embodiments, the main active ingredients include, by mass: 6 parts of ginger, 9 parts of French pinellia, 3 parts of cinnamon twig, 6 parts of white peony root, 6 parts of angelica, 3 parts of chuanxiong, 6 parts of codonopsis pilosula, 6 parts of northern adenophora, 6 parts of raw licorice, 12 parts of raw rehmannia, 15 parts of ophiopogon, 6 parts of peony bark, 6 parts of raw gardenia, 6 parts of fructus aurantii, and 12 parts of gypsum.

[0028] In some embodiments, pharmaceutically acceptable adjuvants are also included. Specifically, the adjuvants used are carriers or excipients commonly used in the art, including but not limited to maltodextrin, starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), compressed tablets, etc., to help improve the stability or activity of the drug, or produce an acceptable taste or smell in the case of oral administration.

[0029] In some embodiments, the dosage form of the Chinese medicine composition is granules, decoction, tablets, capsules, oral liquid or pills, so as to facilitate clinical administration.

[0030] According to a second aspect of the present invention, a method for preparing the above-mentioned Chinese medicine composition for treating adolescents with depressive disorder of internal disturbance of deficiency heat and blood is provided. When the Chinese medicine composition is a granule, the preparation method comprises the following steps:

[0031] (1) The raw material drug is decocted twice with water. For the first decoction, water equivalent to 8-10 times the total weight of the raw material drug is added, heated to boiling, and kept slightly boiling for 1-2 hours, and a first decoction and a medicinal residue are obtained after separation; for the second decoction, the medicinal residue obtained after the first decoction is taken, water equivalent to 8-10 times the total weight of the raw material drug is added, heated to boiling, and kept slightly boiling for 1-2 hours, and a second decoction and a medicinal residue are obtained after separation; the first decoction and the second decoction are combined, and filtered to obtain a filtrate;

[0032] (2) the filtrate obtained in step (1) was concentrated under reduced pressure at a vacuum degree of -0.08 MPa and a temperature of 70° C. to a clear paste with a relative density of 1.15;

[0033] (3) adding excipients accounting for 10% of the total weight of the API to the clear paste obtained in step (2) and spray drying to obtain a dry paste powder, wherein the spray drying process parameters are: inlet air temperature 170° C., outlet air temperature 100° C.;

[0034] (4) adding auxiliary materials to the dry paste powder obtained in step (3), and mixing them in a mixer for 30 minutes to obtain a mixed powder;

[0035] (5) adding 90% by volume of an ethanol-water solution to the mixed powder obtained in step (4) to prepare a soft material, and granulating the soft material through a 12-40 mesh sieve to obtain wet granules;

[0036] (6) Drying the wet granules obtained in step (5) at 65°C to obtain

[0037] According to a third aspect of the present invention, there is provided use of the above-mentioned Chinese medicine composition for treating adolescent depression disorder of the type of body fluid and blood deficiency and internal disturbance of deficiency heat in the preparation of a medicine for treating depression disorder.

[0038] According to the fourth aspect of the present invention, there is provided the use of the above-mentioned Chinese medicine composition for treating adolescents' depressive disorder due to insufficient body fluid and blood, and internal disturbance of deficiency heat in the preparation of a medicine for treating adolescents' depressive disorder due to insufficient body fluid and blood, and internal disturbance of deficiency heat.

[0039] The beneficial effects of the present invention include:

[0040] (1) The present invention is based on the fact that the root cause of depression in adolescents with insufficient body fluid and blood and internal disturbance of deficiency heat is deficiency cold in Ren and Chong meridians and deficiency of qi and blood, and the symptom is internal disturbance of deficiency heat. The Chinese medicine composition of the present invention treats depression in adolescents with insufficient body fluid and blood and internal disturbance of deficiency heat by mainly using the treatment methods of warming the meridians and dispersing cold, nourishing blood and clearing heat, and promoting body fluid and relieving restlessness. It can not only improve the patient's depressive mood and physical discomfort, but also prevent the disease from getting worse and recurring by regulating the physical constitution, and has good therapeutic effect and reliable safety.

[0041] (2) The efficacy and safety evaluation studies have shown that the Chinese medicine composition of the present invention has significant clinical efficacy and good safety in treating adolescents with depressive disorders of the type of deficiency of body fluid and blood and internal disturbance of deficiency heat. DETAILED DESCRIPTION

[0042] The present invention is further described in detail below in conjunction with specific examples. Unless otherwise specified, the raw materials and reagents used in the present invention are all purchased from the market.

[0043] Example 1

[0044] The Chinese medicine granules for treating adolescents' depressive disorder of deficiency of body fluid and blood and internal disturbance of deficiency heat in this embodiment are prepared by the following method:

[0045] (1) Weigh out the raw materials ginger 6 g, French pinellia 9 g, cinnamon twig 3 g, white peony root 6 g, angelica 6 g, ligusticum chuanxiong 3 g, codonopsis pilosula 6 g, adenophora acuminata 6 g, raw liquorice 6 g, raw rehmannia root 12 g, ophiopogon 15 g, moutan bark 6 g, raw gardenia 6 g, fructus aurantii 6 g, gypsum 12 g;

[0046] (2) The above raw material drug is decocted twice with water. For the first decoction, water equivalent to 10 times the total weight of the raw material drug is added, heated to boiling, and kept at a slight boiling for 1.5 hours. After separation, a first decoction and a medicinal residue are obtained; for the second decoction, the medicinal residue obtained after the first decoction is taken, water equivalent to 8 times the total weight of the raw material drug is added, heated to boiling, and kept at a slight boiling for 1.5 hours. After separation, a second decoction and a medicinal residue are obtained; the first decoction and the second decoction are combined and filtered to obtain a filtrate;

[0047] (3) The filtrate obtained in step (2) was concentrated under reduced pressure (vacuum degree -0.08 MPa, temperature 70°C) to a clear paste with a relative density of 1.15 (60°C);

[0048] (4) adding maltodextrin in an amount of 10% by weight of the total weight of the API to the clear paste obtained in step (3) and spray drying the mixture to obtain a dry paste powder, wherein the spray drying process parameters are: inlet air temperature of 170° C., outlet air temperature of 100° C.;

[0049] (5) adding an appropriate amount of maltodextrin to the dry paste powder obtained in step (4), and mixing the mixture in a mixer for 30 minutes to obtain a mixed powder;

[0050] (6) adding 90% by volume of an ethanol-water solution to the mixed powder obtained in step (5) to prepare a soft material, and passing the soft material through a 12-mesh sieve to prepare granules, i.e., wet granules;

[0051] (7) Dry the wet granules obtained in step (6) at 65°C to obtain the obtained granules. The obtained granules are sealed and stored in a package of 6 g each. When taken, one package is taken once a day.

[0052] Example 2

[0053] The preparation method of the Chinese medicine granules for treating adolescent depressive disorder of internal disturbance type due to deficiency of body fluid and blood in this embodiment is basically the same as that in Example 1, except that step (1) is as follows: weigh raw materials 15 g of ginger, 15 g of pinellia tuber, 15 g of cassia twig, 15 g of white peony root, 15 g of angelica sinensis, 12 g of ligusticum chuanxiong, 15 g of codonopsis pilosula, 15 g of adenophora australis, 15 g of raw liquorice, 24 g of raw rehmannia root, 27 g of ophiopogon japonicus, 18 g of moutan bark, 12 g of raw gardenia jasminoides, 12 g of fructus aurantii, and 24 g of gypsum.

[0054] Example 3

[0055] The preparation method of the Chinese medicine granules for treating adolescent depressive disorder of internal disturbance type due to deficiency of body fluid and blood in this embodiment is basically the same as that in Example 1, except that step (1) is as follows: weigh raw materials: 3 g ginger, 6 g pinellia, 1 g cassia twig, 3 g white peony root, 3 g angelica, 6 g ligusticum, 5 g codonopsis, 3 g adenophora, 3 g raw liquorice, 6 g raw rehmannia, 9 g ophiopogon, 3 g moutan bark, 3 g raw gardenia, 3 g fructus aurantii, and 6 g gypsum.

[0056] In order to verify the therapeutic effect of the Chinese medicine composition of the present invention on adolescents with depressive disorders of internal disturbance of deficiency heat and blood, a study on the efficacy and safety evaluation of the Chinese medicine composition of the present invention was carried out. The research process and results are as follows:

[0057] 1. Inclusion criteria: ① Adolescent patients aged 12-18 years; ② Meet the ICD-10 diagnostic criteria for depressive disorders; ③ TCM syndrome differentiation belongs to deficiency of body fluid and blood, internal disturbance of deficiency heat, which is manifested as: a. dry mouth, poor appetite, scanty menstruation, pale red or red tip tongue, inward movement of pulse; b. warm hands, red eyelids, body heat, irritability, preference for cold drinks, constipation; meet 2 of each of a and b. ④ No other TCM drugs or non-drug treatments have been used in the past 4 weeks.

[0058] 2. Exclusion criteria: ① Patients with severe liver and kidney dysfunction, hematopoietic system, malignant tumors and other serious physical diseases; ② Patients with severe mental illness (schizophrenia, mania, paranoid psychosis and depression with obvious suicidal tendencies); ③ Patients with allergic constitution.

[0059] 3. General information: The research subjects were 20 adolescent patients with depressive disorder of deficiency of body fluid and blood, and internal disturbance of deficiency heat, who met the inclusion criteria and did not meet the exclusion criteria and were collected from the inpatient department of a psychiatric hospital in Zhongshan City from June 1, 2024 to September 10, 2024.

[0060] The 20 patients included in the study were randomly divided into two groups, a control group and a treatment group, with 10 patients in each group.

[0061] 4. Treatment methods:

[0062] (1) Control group: Fluoxetine (20 mg once a day), treatment for 2 weeks.

[0063] (2) Treatment group: Fluoxetine (20 mg once a day) and the Chinese medicine granules prepared in Example 1 (6 g per pack, one pack each time, once a day) were taken simultaneously. Treatment lasted for 2 weeks.

[0064] 5. Observation indicators: Before and after treatment, all patients were tested with the Hamilton Depression Rating Scale (HAMD). The HAMD scores before and after treatment were statistically analyzed using t-test. P < 0.05 indicated that the difference was statistically significant.

[0065] 6. Efficacy evaluation results:

[0066] The paired sample test results of HAMD scores before and after treatment are shown in Table 1.

[0067] Table 1 T-test results of HAMD scores before and after treatment in the two groups

[0068] Treatment Group Control group t P HAMD before treatment 31.9±6.008 32.2±10.861 -0.076 0.94 HAMD after treatment 18.1±5.685 27.5±8.25 -2.967 0.008 Difference before and after treatment -13.8±7.099 -4.7±6.783 -2.931 0.009

[0069] As can be seen from Table 1, there was no significant difference in the HAMD scores before treatment between the two groups (P=0.94>0.05), which was comparable. After treatment, compared with the control group, the HAMD score of the treatment group decreased significantly, and the difference was statistically significant (P=0.008<0.05). At the same time, the difference in the HAMD score before and after treatment in the treatment group was statistically significant compared with the control group (P=0.009<0.05). This shows that the Chinese medicine composition of the present invention can effectively treat adolescents with insufficient body fluid and blood, and depression disorder of internal disturbance of deficiency heat.

[0070] 7. Safety evaluation results

[0071] One case of diarrhea occurred in the treatment group, which improved after drug withdrawal. No significant abnormalities were found in the laboratory safety test indicators of the patients. The overall incidence of adverse reactions and adverse events was low, and most of them were mild adverse reactions. Treatment can be continued or medication can be continued after suspension.

[0072] The above research results show that the Chinese medicine composition for treating adolescents with depressive disorder of insufficient body fluid and blood and internal disturbance of deficiency heat of the present invention has significant clinical efficacy and good safety for adolescents with depressive disorder of insufficient body fluid and blood and internal disturbance of deficiency heat.

Claims

1. A Chinese medicine composition for treating adolescents with body fluid and blood deficiency and internal disturbance of deficiency-heat type depression, characterized in that: The main active ingredients include, by weight, 3-15 parts of ginger, 6-15 parts of French pinellia, 1-15 parts of cinnamon twig, 3-15 parts of white peony root, 3-15 parts of angelica, 3-12 parts of ligusticum chuanxiong, 5-15 parts of codonopsis pilosula, 3-15 parts of northern adenophora, 3-15 parts of raw licorice, 6-24 parts of raw rehmannia, 9-27 parts of ophiopogon, 3-18 parts of peony bark, 3-12 parts of raw gardenia, 3-12 parts of fructus aurantii, and 6-24 parts of gypsum.

2. The Chinese medicine composition for treating adolescents with insufficient body fluid and blood and internal disturbance of deficiency-heat type depression according to claim 1, characterized in that: The main active ingredients include, by mass, 6 parts of ginger, 9 parts of French pinellia, 3 parts of cinnamon twig, 6 parts of white peony root, 6 parts of angelica, 3 parts of ligusticum chuanxiong, 6 parts of codonopsis pilosula, 6 parts of northern adenophora, 6 parts of raw licorice, 12 parts of raw rehmannia, 15 parts of ophiopogon, 6 parts of peony bark, 6 parts of raw gardenia, 6 parts of fructus aurantii, and 12 parts of gypsum.

3. The Chinese medicine composition for treating adolescents with deficiency of body fluid and blood and internal disturbance of deficiency-heat type depression according to claim 1 or 2, characterized in that: Pharmaceutically acceptable excipients are also included.

4. The Chinese medicine composition for treating adolescents with deficiency of body fluid and blood and internal disturbance of deficiency-heat type depression according to claim 1 or 2, characterized in that: The dosage form of the Chinese medicine composition is granules, decoction, tablets, capsules, oral liquid or pills.

5. The method for preparing the Chinese medicine composition for treating adolescent depression caused by deficiency of body fluid and blood and internal disturbance of deficiency heat according to any one of claims 1 to 4, characterized in that: When the Chinese medicine composition is a granule, the preparation method thereof comprises the following steps: (1) The raw material drug is decocted twice with water. For the first decoction, water equivalent to 8-10 times the total weight of the raw material drug is added, heated to boiling, and kept slightly boiling for 1-2 hours, and a first decoction and a medicinal residue are obtained after separation; for the second decoction, the medicinal residue obtained after the first decoction is taken, water equivalent to 8-10 times the total weight of the raw material drug is added, heated to boiling, and kept slightly boiling for 1-2 hours, and a second decoction and a medicinal residue are obtained after separation; the first decoction and the second decoction are combined, and filtered to obtain a filtrate; (2) the filtrate obtained in step (1) was concentrated under reduced pressure at a vacuum degree of -0.08 MPa and a temperature of 70° C. to a clear paste with a relative density of 1.15; (3) adding excipients accounting for 10% of the total weight of the API to the clear paste obtained in step (2) and spray drying to obtain a dry paste powder, wherein the spray drying process parameters are: inlet air temperature 170° C., outlet air temperature 100° C.; (4) adding auxiliary materials to the dry paste powder obtained in step (3), and mixing them in a mixer for 30 minutes to obtain a mixed powder; (5) adding 90% by volume of an ethanol-water solution to the mixed powder obtained in step (4) to prepare a soft material, and granulating the soft material through a 12-40 mesh sieve to obtain wet granules; (6) Drying the wet granules obtained in step (5) at 65°C to obtain 6. Use of the Chinese medicine composition for treating adolescent depression due to deficiency of body fluid and blood and internal disturbance of deficiency heat as claimed in any one of claims 1 to 4 in the preparation of a medicine for treating depression.

7. Use of the Chinese medicine composition for treating adolescents' depressive disorder of insufficient body fluid and blood and internal disturbance of deficiency heat according to any one of claims 1 to 4 in the preparation of a medicament for treating adolescents' depressive disorder of insufficient body fluid and blood and internal disturbance of deficiency heat.