A traditional Chinese medicine composition for treating adolescent blood deficiency and heat disturbing type of depressive disorder, a preparation method and application thereof

Abstract

The application belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating adolescent blood and fluid deficiency and heat disturbing type depression disorder and a preparation method and application thereof. The main active ingredients of the traditional Chinese medicine composition include, in mass parts, ginger 3-15 parts, prepared pinellia 6-15 parts, cassia twig 1-15 parts, white peony root 3-15 parts, angelica 3-15 parts, chuanxiong 3-12 parts, radix codonopsis 5-15 parts, north adenosma 3-15 parts, raw licorice 3-15 parts, raw rehmannia 6-24 parts, maimendong 9-27 parts, cortex moutan 3-18 parts, raw gardenia 3-12 parts, fructus aurantii 3-12 parts, gypsum 6-24 parts. The efficacy and safety evaluation research shows that the traditional Chinese medicine composition has a significant clinical effect on adolescent blood and fluid deficiency and heat disturbing type depression disorder and is safe.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating depressive disorder of teenagers with insufficient body fluid and blood and internal disturbance of deficiency-heat, and its preparation method and application. Background Art

[0002] The "Report on the Development of National Mental Health in China" shows that in 2020, the detection rate of depressive risk among Chinese teenagers was 24.6%, of which the detection rate of severe depressive risk was 7.4%. Depressive disorder has become a major threat to the healthy growth of current teenagers (Compilation Group of "Guidelines for the Integrated Traditional Chinese and Western Medicine Prevention and Treatment of Teenager Depressive Disorder", Psychosomatic Medicine Branch of China Association of Chinese Medicine, Psychosomatic Medicine Branch of Chinese Medical Association. Guidelines for the Integrated Traditional Chinese and Western Medicine Prevention and Treatment of Teenager Depressive Disorder [J]. Journal of Beijing University of Traditional Chinese Medicine, 2024, 47(06): 874-888.).

[0003] Traditional Chinese medicine does not have the disease name of depressive disorder. Teenager depressive disorder belongs to the category of depression syndrome and depressive disease in traditional Chinese medicine. Traditional Chinese medicine believes that it is a disease syndrome mainly characterized by sorrow and crying, restlessness of mind, irritability and insomnia, loss of appetite, and mental trance. Emotional injury is the main factor inducing depression syndrome. The yang qi in the body is insufficient and it is difficult to maintain the normal operation of physiological functions, resulting in the mind losing nourishment. The continuous stimulation of external factors causes long-term deficiency and damage of qi, blood and body fluid in the body. Therefore, the clinical manifestations of depression are mostly mixed deficiency and excess, with a lingering and recurrent course.

[0004] The "Guidelines for the Integrated Traditional Chinese and Western Medicine Prevention and Treatment of Teenager Depressive Disorder" proposes five main syndrome types, namely liver qi stagnation, qi stagnation transforming into fire, phlegm qi stagnation, liver depression and spleen deficiency, heart and spleen deficiency. There are also some syndrome types involving kidney yang deficiency, kidney yin deficiency, damp-heat in liver and gallbladder, phlegm-fire disturbing the heart, etc. Song Quanwu et al. observed clinically that the most common tongue manifestations in adolescent patients with mixed anxiety and depressive disorder are red tongue, greasy tongue coating, enlarged tongue, tooth marks on the edge of the tongue, and the most common pulse manifestations are thready pulse, stringy pulse, slippery pulse. The common syndrome differentiations are liver depression and spleen deficiency syndrome, latent heat in spleen and stomach syndrome, spleen deficiency with dampness retention syndrome, kidney yang deficiency syndrome and yin fire hyperactivity syndrome (Song Quanwu, Zhou Xin, Yang Lingling, etc. Preliminary analysis of early stress factors and distribution of traditional Chinese medicine syndromes in adolescent mixed anxiety and depressive disorder [J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2023, 38(09): 4431-4437.). In addition, there is also the treatment of child and adolescent depressive disorder from the perspective of liver yang deficiency (Zhang Ning, Zhang Hongxian, Guo Jianning, etc. Treatment of child and adolescent depressive disorder from the perspective of liver yang deficiency [J]. Global Traditional Chinese Medicine, 2023, 16(08): 1624-1627.). In addition, some scholars combine the physiological characteristics of children with "liver being often excessive", "spleen being often insufficient", "kidney being often deficient", and believe that the pathogenesis of this disease is mainly liver qi not being dredged, combined with spleen failure in transportation, kidney yang deficiency, heart qi deficiency, and heart and spleen deficiency.

[0005] The aforementioned existing technologies indicate that children and adolescents, due to their unique physical constitution, present complex etiologies, pathogenesis, and prognoses for diseases. Furthermore, there is limited literature on clinical interventions for childhood and adolescent depression using traditional Chinese medicine (TCM) drugs and non-drug therapies, requiring further research. Overall, the treatment outcomes for these conditions are unsatisfactory. In clinical practice, the inventors have observed that many adolescent depression patients are female, often exhibiting symptoms such as low mood, lethargy, dry mouth, poor appetite, scanty or normal menstruation, pale tongue with a red tip and thin coating, and inward-shifted pulse. They may also experience warm hands, red eyelids, fever, irritability, poor sleep, preference for cold drinks, and constipation. Currently, effective TCM treatments for these patients are lacking. Therefore, further research is needed on syndrome differentiation and prescription for adolescent depression, combined with constitution regulation, to achieve better and more reliable efficacy and a comprehensive cure. Summary of the Invention

[0006] The first objective of this invention is to provide a traditional Chinese medicine composition for treating depression caused by deficiency of body fluids and blood and internal disturbance of deficiency heat in adolescents. The second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition. The third objective of this invention is to provide the application of the traditional Chinese medicine composition.

[0007] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating adolescent depression due to deficiency of body fluids and blood and internal disturbance of deficiency heat is provided. The main active ingredients, by weight, include: 3-15 parts of fresh ginger, 6-15 parts of prepared pinellia, 1-15 parts of cinnamon twig, 3-15 parts of white peony root, 3-15 parts of angelica, 3-12 parts of chuanxiong rhizome, 5-15 parts of codonopsis root, 3-15 parts of north ginseng, 3-15 parts of raw licorice root, 6-24 parts of raw rehmannia root, 9-27 parts of ophiopogon root, 3-18 parts of peony bark, 3-12 parts of raw gardenia fruit, 3-12 parts of immature bitter orange peel, and 6-24 parts of gypsum.

[0008] The inventor discovered in clinical work that many adolescent depression patients are female, and they often exhibit symptoms of insufficient body fluids and blood, such as low mood, lethargy, dry mouth, poor appetite, scanty or normal menstruation, pale tongue with a red tip and thin coating, and pulse shifting inward. They also have heat symptoms such as warm hands, red eyelids, fever, irritability, poor sleep, preference for cold drinks, and constipation. This may be related to long-term unhealthy lifestyle and dietary habits, and is considered to be a type of depression caused by insufficient body fluids and blood and internal disturbance of deficiency heat.

[0009] This invention is based on the principle that adolescent depression caused by insufficient body fluids and blood, and internal disturbance of deficiency heat, is fundamentally due to deficiency and cold in the Ren and Chong meridians and deficiency of Qi and blood, while its manifestation is internal disturbance of deficiency heat. This invention treats the condition by focusing on warming the meridians and dispelling cold, nourishing blood and clearing heat, and generating body fluids and relieving irritability.

[0010] The formula contains cinnamon twig and ginger to warm the meridians and dispel cold; prepared pinellia tuber, pungent and open, promotes the downward flow of stomach qi, not only harmonizing the stomach and calming the middle jiao, but also, when combined with codonopsis and raw licorice, strengthens the spleen and stomach, aiding in removing blood stasis and regulating menstruation; when combined with ginger, it relieves nausea and vomiting; white peony root, angelica root, and chuanxiong rhizome nourish blood, invigorate blood circulation, and moisten dryness, replenishing the deficiency of the Ren and Chong meridians in adolescents; codonopsis root, north ginseng, and raw rehmannia root strengthen the spleen and lungs, nourish yin and stomach, and promote bowel movements; ophiopogon root, peony bark, and raw gardenia fruit clear heat and relieve irritability; immature bitter orange peel regulates the middle jiao and promotes qi circulation; gypsum, pungent, sweet, and very cold, generates fluids, quenches thirst, and relieves irritability; raw licorice root harmonizes all the ingredients and serves as the guiding herb. The combination of these herbs warms the qi and blood, nourishing the Ren and Chong meridians. The entire formula is meticulously composed, replenishing deficiency and eliminating excess, warming the meridians and nourishing blood, clearing heat and relieving irritability, generating fluids and quenching thirst. It can not only improve the patient's depressive mood and physical discomfort, but also prevent the disease from worsening and recurring by regulating the constitution.

[0011] The raw materials for this formula come from the following sources:

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

[0013] Processed Pinellia: A processed product of Pinellia ternata.

[0014] Cinnamon twig: The tender branch of Cinnamomum cassia Presl, a plant belonging to the genus Cinnamomum in the family Lauraceae.

[0015] White peony root: The root of Paeonia lactiflora Pall., a plant belonging to the genus Paeonia in the family Ranunculaceae.

[0016] Angelica sinensis (Oliv) Diels., a plant belonging to the genus Angelica in the family Apiaceae.

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

[0018] Codonopsis pilosula: The root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. (Nannf.) L.Shen, or Codonopsis tangshen Oliv., all belonging to the genus Codonopsis of the family Campanulaceae.

[0019] North American ginseng: The root of *Glehnia littoralis* F.Schmidtex Miq., a plant belonging to the genus *Glehnia* of the family Apiaceae.

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

[0021] Rehmannia glutinosa: the fresh or dried tuberous root of Rehmannia glutinosa Libosch., a plant belonging to the genus Rehmannia in the family Scrophulariaceae.

[0022] Ophiopogon japonicus (Lf) Ker-Gawl. or Ophiopogon bodinieri Levl., belonging to the genus Ophiopogon of the family Liliaceae.

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

[0024] Raw gardenia: The fresh, ripe fruit of Gardenia jasminoides Ellis, a plant belonging to the Rubiaceae family and the Gardenia genus.

[0025] Citrus aurantium L. (a plant in the Rutaceae family) is a nearly ripe fruit of Citrus aurantium L. and its cultivated varieties.

[0026] Gypsum: A sulfate mineral of the gypsum group, mainly containing hydrated calcium sulfate (CaSO4·H2O).

[0027] In some embodiments, the main active ingredients, by weight, include: 6 parts ginger, 9 parts prepared pinellia, 3 parts cinnamon twig, 6 parts white peony root, 6 parts angelica root, 3 parts chuanxiong rhizome, 6 parts codonopsis root, 6 parts north ginseng, 6 parts raw licorice root, 12 parts raw rehmannia root, 15 parts ophiopogon root, 6 parts peony bark, 6 parts raw gardenia fruit, 6 parts immature bitter orange peel, and 12 parts gypsum.

[0028] In some embodiments, pharmaceutically acceptable excipients are also included. Specifically, the excipients 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), tablets, etc., to help improve the stability or activity of the drug, or to produce an acceptable taste or odor when taken orally.

[0029] In some embodiments, the dosage form of the traditional Chinese medicine composition is granules, decoction, tablets, capsules, oral liquid, or pills. This facilitates clinical administration.

[0030] According to a second aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition for treating adolescent depression due to deficiency of body fluids and blood and internal disturbance of deficiency heat is provided. When the traditional Chinese medicine composition is in granule form, the preparation method includes the following steps:

[0031] (1) Boil the raw materials twice with water. For the first decoction, add 8-10 times the amount of water equivalent to the total mass of the raw materials, heat to boiling, and keep simmering for 1-2 hours. After separation, obtain the first decoction and the dregs. For the second decoction, take the dregs obtained after the first decoction, add 8-10 times the amount of water equivalent to the total mass of the raw materials, heat to boiling, and keep simmering for 1-2 hours. After separation, obtain the second decoction and the dregs. Combine the first and second decoctions and filter to obtain the filtrate.

[0032] (2) The filtrate obtained in step (1) is 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) Add 10% of the total mass of the raw material to the ointment obtained in step (2) and then spray dry to obtain dry ointment powder. The spray drying process parameters are: air inlet temperature 170℃ and air outlet temperature 100℃.

[0034] (4) Add excipients to the dry powder obtained in step (3), and mix it with a mixer for 30 minutes to make it evenly mixed, so as to obtain a mixed powder;

[0035] (5) Add 90% ethanol-water solution to the mixed powder obtained in step (4) to make soft material, and granulate the soft material through a 12-40 mesh sieve to obtain wet granules.

[0036] (6) The wet granules obtained in step (5) are dried at 65°C to obtain the final product.

[0037] According to a third aspect of the present invention, the above-described traditional Chinese medicine composition for treating adolescent depression due to deficiency of body fluids and blood and internal disturbance of deficiency heat is provided for use in the preparation of a medicament for treating depression.

[0038] According to a fourth aspect of the present invention, the above-described traditional Chinese medicine composition for treating adolescent depression caused by deficiency of body fluids and blood and internal disturbance of deficiency heat is provided for use in the preparation of a medicament for treating adolescent depression caused by deficiency of body fluids and blood and internal disturbance of deficiency heat.

[0039] The beneficial effects of this invention include:

[0040] (1) This invention is based on the fact that the root cause of depression in adolescents with insufficient body fluids and blood and internal heat disturbance lies in the deficiency of Ren and Chong meridians and deficiency of Qi and blood, while the manifestation lies in internal heat disturbance. The Chinese medicine composition of this invention is mainly based on the treatment method of warming the meridians and dispelling cold, nourishing blood and clearing heat, and generating body fluids and relieving irritability to treat depression in adolescents with insufficient body fluids and blood and internal heat disturbance. It can not only improve the patient's depressive mood and physical discomfort, but also prevent the disease from aggravating and recurring by regulating the body constitution. The treatment effect is good and the safety is reliable.

[0041] (2) The efficacy and safety evaluation studies show that the traditional Chinese medicine composition of the present invention has significant clinical efficacy and good safety in treating adolescent depression caused by insufficient body fluids and blood and internal heat disturbance. Detailed Implementation

[0042] The present invention will be further described in detail below with reference to specific embodiments. Unless otherwise specified, all raw materials and reagents used in the present invention are commercially available.

[0043] Example 1

[0044] The traditional Chinese medicine granule for treating adolescent depression due to insufficient body fluids and blood, and internal heat disturbance, as described in this embodiment, is prepared by the following method:

[0045] (1) Weigh out the raw materials: 6g of fresh ginger, 9g of prepared pinellia, 3g of cinnamon twig, 6g of white peony root, 6g of angelica root, 3g of chuanxiong rhizome, 6g of codonopsis root, 6g of north ginseng root, 6g of raw licorice root, 12g of raw rehmannia root, 15g of ophiopogon root, 6g of peony bark, 6g of raw gardenia fruit, 6g of immature bitter orange peel, and 12g of gypsum.

[0046] (2) The above-mentioned raw materials are decocted twice with water. For the first decoction, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, and maintain a gentle boil for 1.5 hours. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, and maintain a gentle boil for 1.5 hours. After separation, the second decoction and the dregs are obtained. Combine the first decoction and the second decoction, and filter to obtain the filtrate.

[0047] (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℃);

[0048] (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℃.

[0049] (5) Add an appropriate amount of maltodextrin to the dry powder obtained in step (4), and mix it with a mixer for 30 minutes to make it evenly mixed, so as to obtain a mixed powder;

[0050] (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.

[0051] (7) Dry the wet granules obtained in step (6) at 65°C. Seal and store the obtained granules in 6g packets. Take one packet once a day.

[0052] Example 2

[0053] The preparation method of the Chinese herbal granules for treating adolescent depression caused by insufficient body fluids and blood and internal heat disturbance in this embodiment is basically the same as that in Example 1. The only difference is that step (1) is as follows: weigh out the raw materials: ginger 15g, prepared pinellia 15g, cinnamon twig 15g, white peony root 15g, angelica root 15g, chuanxiong rhizome 12g, codonopsis root 15g, north ginseng 15g, raw licorice root 15g, raw rehmannia root 24g, ophiopogon root 27g, peony bark 18g, raw gardenia fruit 12g, immature bitter orange peel 12g, and gypsum 24g.

[0054] Example 3

[0055] The preparation method of the Chinese herbal granules for treating adolescent depression caused by insufficient body fluids and blood and internal heat disturbance in this embodiment is basically the same as that in Example 1. The only difference is that step (1) is as follows: weigh out the raw materials: 3g of ginger, 6g of prepared pinellia, 1g of cinnamon twig, 3g of white peony root, 3g of angelica, 6g of chuanxiong rhizome, 5g of codonopsis root, 3g of north ginseng, 3g of raw licorice root, 6g of raw rehmannia root, 9g of ophiopogon root, 3g of peony bark, 3g of raw gardenia fruit, 3g of immature bitter orange peel, and 6g of gypsum.

[0056] To verify the therapeutic effect of the traditional Chinese medicine composition of the present invention on adolescents with depression due to deficiency of body fluids and blood and internal disturbance of deficiency heat, an efficacy and safety evaluation study was conducted on the traditional Chinese medicine composition of the present invention. The study process and results are as follows:

[0057] 1. Inclusion criteria: ① Adolescent patients aged 12-18 years; ② Meeting the ICD-10 diagnostic criteria for depressive disorders; ③ According to Traditional Chinese Medicine (TCM) diagnosis, the patient's condition is characterized by deficiency of body fluids and blood with internal heat disturbance, manifested as: a. dry mouth, poor appetite, scanty menstruation, pale red tongue or red tip, and inward shift of the pulse; b. warm hands, red eyelids, fever, irritability, preference for cold drinks, and constipation; possessing two of each of a and b; ④ No other TCM or non-drug treatments within the past 4 weeks.

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

[0059] 3. General Information: The study subjects were 20 adolescent patients with depression of the type with deficiency of body fluids and blood and internal heat disturbance, who met the inclusion criteria but did not meet the exclusion criteria and were collected from the inpatient department of a psychiatric hospital in Zhongshan City between June 1, 2024 and 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 (20mg once a day). Treatment for 2 weeks.

[0063] (2) Treatment group: Fluoxetine (20mg once a day), and concurrently, the traditional Chinese medicine granules prepared in Example 1 (one packet of 6g, one packet each time, once a day). Treatment lasted for 2 weeks.

[0064] 5. Observation indicators: The Hamilton Depression Rating Scale (HAMD) was used to test all patients before and after treatment. The HAMD scores before and after treatment were statistically analyzed using a t-test. P < 0.05 was considered statistically significant.

[0065] 6. Results of therapeutic efficacy evaluation:

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

[0067] Table 1. HAMD scores and t-test results 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 shown in Table 1, there was no significant difference in HAMD scores between the two groups before treatment (P = 0.94 > 0.05), indicating comparability. After treatment, compared with the control group, the HAMD score in the treatment group decreased significantly, with a statistically significant difference (P = 0.008 < 0.05). Furthermore, the difference in HAMD score before and after treatment in the treatment group was statistically significant compared with that in the control group (P = 0.009 < 0.05). This demonstrates that the traditional Chinese medicine composition of this invention can effectively treat adolescent depression caused by insufficient body fluids and internal heat.

[0070] 7. Safety evaluation results

[0071] One patient in the treatment group experienced diarrhea, which improved upon discontinuation of the medication. Laboratory safety indicators for the patient showed no significant abnormalities. The overall incidence of adverse reactions and events was low, and most were mild; treatment could be continued or the medication could be restarted after a temporary suspension.

[0072] The above research results show that the traditional Chinese medicine composition of the present invention for treating adolescent depression caused by insufficient body fluids and blood and internal heat has significant clinical efficacy and good safety.

Claims

1. A Chinese medicinal composition for treating juvenile blood deficiency and heat disturbing type of depressive disorder, characterized in that, The raw medicinal materials are prepared by the following quality parts: raw ginger 3-15 parts, prepared pinellia 6-15 parts, cassia twig 1-15 parts, white peony root 3-15 parts, angelica 3-15 parts, chuanxiong 3-12 parts, radix codonopsis 5-15 parts, north adenosma 3-15 parts, raw licorice 3-15 parts, raw rehmannia 6-24 parts, ophiopogon 9-27 parts, cortex moutan 3-18 parts, raw gardenia 3-12 parts, fructus aurantii 3-12 parts, gypsum 6-24 parts. 2.The traditional Chinese medicine composition for treating adolescent depression with blood deficiency and internal heat according to claim 1, characterized in that, The raw medicinal materials are prepared by the following quality parts: raw ginger 6 parts, prepared pinellia 9 parts, cassia twig 3 parts, white peony root 6 parts, angelica 6 parts, chuanxiong 3 parts, radix codonopsis 6 parts, north adenosma 6 parts, raw licorice 6 parts, raw rehmannia 12 parts, ophiopogon 15 parts, cortex moutan 6 parts, raw gardenia 6 parts, fructus aurantii 6 parts, gypsum 12 parts. 3.The traditional Chinese medicine composition for treating adolescent depression with blood deficiency and internal heat according to claim 1 or 2, characterized in that, It also includes pharmaceutically acceptable excipients.

4. The Chinese medicine composition of claim 1 or 2 for treating the depressive disorder with blood deficiency and internal heat in adolescents, characterized in that, The dosage form of the traditional Chinese medicine composition is granules, decoction, tablets, capsules, oral liquid or dripping pills.

5. The method for preparing the traditional Chinese medicine composition for treating the depressive disorder of the blood deficiency and the internal disturbance of heat in the teenagers according to any one of claims 1-4, characterized in that, The preparation method of the traditional Chinese medicine composition as granules includes the following steps: (1) decoct the raw medicinal materials with water twice, the first time, add 8-10 times of water to the total mass of the raw medicinal materials, heat to boiling, keep it slightly boiling for 1-2 hours, separate to get the first decoction and residue; the second time, take the residue after the first decoction, add 8-10 times of water to the total mass of the raw medicinal materials, heat to boiling, keep it slightly boiling for 1-2 hours, separate to get the second decoction and residue; combine the first and second decoctions, filter to get the filtrate; (2) reduce the pressure of the filtrate obtained in step (1) to-0.08 Mpa at 70℃, concentrate to clear paste with relative density of 1.15; (3) add 10% of the total mass of the raw medicinal materials to the clear paste obtained in step (2) as excipients, spray dry to get dry paste powder, the spray drying process parameters are: inlet air temperature 170℃, outlet air temperature 100℃; (4) add excipients to the dry paste powder obtained in step (3), mix for 30 minutes to make it uniform, get mixed powder; (5) add 90% ethanol-water solution to the mixed powder obtained in step (4) to make soft material, pass the soft material through 12-40 mesh sieve to granulate, get wet granules; (6) dry the wet granules obtained in step (5) at 65℃, get the granules.

6. The use of the traditional Chinese medicine composition for treating adolescent blood and fluid deficiency and internal disturbance of heat type depressive disorder in any one of claims 1-4 in the preparation of a drug for treating adolescent blood and fluid deficiency and internal disturbance of heat type depressive disorder.