External traditional Chinese medicine composition for treating insomnia caused by deficiency of heart and spleen and application of external traditional Chinese medicine composition

Abstract

The invention relates to an external traditional Chinese medicine composition for treating insomnia caused by deficiency of heart and spleen. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-14 parts of longan aril, 10-14 parts of spina date seed (fried), 10-14 parts of astragalus membranaceus (fried), 10-14 parts of prepared rehmannia root, 8-12 parts of bighead atractylodes rhizome, 8-12 parts of angelica sinensis, 8-12 parts of poria cocos, 8-12 parts of ginseng, 6-10 parts of polygala tenuifolia, 4-8 parts of elecampane and 4-8 parts of liquorice (roasted). The patch has the effects of tonifying qi, enriching blood, tonifying spleen and nourishing heart. The traditional Chinese medicine can be used for treating heart-spleen deficiency insomnia caused by excessive thought, heart-spleen injury due to fatigue and qi-blood daily consumption. In the formula, the longan aril has the effects of tonifying heart and spleen, nourishing blood and tranquilizing mind, the fried spina date seed has the effects of tonifying liver and calming heart, arresting sweating and promoting salivation, the fried astragalus membranaceus has the effects of tonifying qi and tonifying middle-Jiao, tonifying spleen and nourishing blood, replenishing essence and benefiting marrow, the rhizoma atractylodis macrocephalae has the effects of tonifying spleen and harmonizing middle-Jiao, eliminating dampness and tonifying stomach, the Chinese angelica has the effects of replenishing blood and activating blood, regulating menstruation and relieving pain, the poria cocos has the effects of excreting dampness and promoting diuresis, tonifying spleen and nourishing heart, the ginseng has the effects of tonifying spleen and benefiting lung, restoring pulse and relieving desertion, and the polygala tenuifolia has the effects of soothing nerves and benefiting intelligence, radix aucklandiae has the effects of invigorating spleen and promoting qi circulation, relieving pain and removing food retention;

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to an external Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen and an application thereof. Background Art

[0002] Since the heart governs consciousness and the spleen governs blood production, if both the heart and spleen are deficient, insomnia is mostly caused by deficiency of Qi and blood, and malnutrition of the mind. Therefore, the symptoms of insomnia due to deficiency of both the heart and spleen are mostly manifested as follows: general fatigue, tiredness and laziness, pale complexion, insomnia and nightmares, even difficulty sleeping all night, being awakened in the sleep, accompanied by palpitations, or chest tightness and shortness of breath, loss of appetite, weight loss, pale tongue with white coating, and deep, thin and weak pulse.

[0003] Chinese Patent Literature CN 104324347A discloses a traditional Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen, which is composed of the following components: 20-40g of Ziziphus jujuba seed, 20-40g of Polygonum multiflorum, 20-40g of Pinellia ternata, 10-20g of Poria, 10-20g of Poria, 8-20g of Longan pulp, 5-15g of Polygala tenuifolia, 5-15g of Prunus persica, 5-15g of Carthamus tinctorius, 5-15g of Cyathula capitata, 5-15g of Ligusticum chuanxiong, 5-15g of Paeonia lactiflora, 5-15g of Citrus aurantium, 5-15g of Platycodon grandiflorum, 2-10g of Licorice, 1-8g of Ginger, and 1-8g of Ginseng. The beneficial effects of the present invention are: the traditional Chinese medicine composition of the present invention has an excellent therapeutic effect on insomnia caused by deficiency of both heart and spleen, and its cure rate is higher than 90.0%, and can reach up to 98.0%. The average cure rate is 95%, and the total effective rate is 100%. It is very suitable for treating insomnia caused by deficiency of both heart and spleen.

[0004] Chinese patent document CN114246902A discloses a Chinese medicine composition for treating insomnia and its preparation method. The Chinese medicine composition is a preparation made from the following raw materials in parts by weight: 8-12 parts of Rehmannia glutinosa, 8-12 parts of Chuanxiong, 8-12 parts of Angelica sinensis, 13-17 parts of White Peony Root, 13-17 parts of Cyperus rotundus, 13-17 parts of Dipsacus asper, 13-17 parts of Rhizoma Cyperi, 13-17 parts of Radix Achyranthis Bidentatae, 13-17 parts of Radix Bupleuri, 13-17 parts of Fructus Aurantii Immaturus, 8-12 parts of Radix Glycyrrhizae, 13-17 parts of Pericarpium Citrus Aurantii Immaturus, 28-32 parts of Atractylodes macrocephalae, 28-32 parts of Flos Albiziae, 28-32 parts of Caulis Polygoni Multiflori, and 28-32 parts of Caulis Millettiae. In the Chinese medicine composition, the raw materials complement each other and play the effects of nourishing blood and calming the mind, soothing the liver and relieving depression. The Chinese medicine composition can effectively treat patients with insomnia due to deficiency of both heart and spleen and liver depression, with a total effective rate of up to 90.60%. The traditional Chinese medicine composition of the present invention has good application prospects in preparing medicines for preventing and / or treating insomnia.

[0005] There are many traditional Chinese medicine compositions for treating insomnia due to deficiency of both heart and spleen, but they all have more or less disadvantages, such as too many medicinal ingredients, difficult to obtain materials, expensive price, unclear efficacy, poor therapeutic effect, etc. Therefore, there is an urgent need for a traditional Chinese medicine composition for treating insomnia due to deficiency of both heart and spleen, which has obvious effect, few medicinal ingredients, practical operability, high compliance, safety and effectiveness. Summary of the invention

[0006] The purpose of the present invention is to provide an external Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen and its application in view of the deficiencies in the prior art.

[0007] In the first aspect, the present invention provides an external Chinese medicine composition for treating insomnia due to deficiency of both heart and spleen, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-14 parts of longan pulp, 10-14 parts of Ziziphus jujuba seeds (fried), 10-14 parts of Astragalus (fried), 10-14 parts of Rehmannia glutinosa, 8-12 parts of Atractylodes macrocephala, 8-12 parts of Angelica sinensis, 8-12 parts of Poria cocos, 8-12 parts of Ginseng, 6-10 parts of Polygala tenuifolia, 4-8 parts of Costus root, and 4-8 parts of Licorice (roasted).

[0008] As a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 11-13 parts of longan pulp, 11-13 parts of spinach seeds (fried), 11-13 parts of astragalus (fried), 11-13 parts of cooked rehmannia, 9-11 parts of atractylodes, 9-11 parts of angelica, 9-11 parts of poria, 9-11 parts of ginseng, 7-9 parts of polygala, 5-7 parts of costus root, and 5-7 parts of licorice (roasted).

[0009] As another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 12 parts of longan pulp, 12 parts of Ziziphus jujuba seeds (fried), 12 parts of Astragalus (fried), 12 parts of Rehmannia glutinosa, 10 parts of Atractylodes macrocephala, 10 parts of Angelica sinensis, 10 parts of Poria cocos, 10 parts of ginseng, 8 parts of Polygala tenuifolia, 6 parts of Aucklandia lappa, and 6 parts of Licorice (roasted).

[0010] As another preferred example, the medicine of the Chinese medicine composition is an external patch.

[0011] In a second aspect, the present invention provides the use of a Chinese medicine composition in preparing a medicine for treating insomnia due to deficiency of both heart and spleen.

[0012] The method of use of the present invention is as follows: before going to bed, the patient disinfects the navel with an iodine cotton swab and then applies the Guipi patch, each application lasting 12 hours, and is used every other day for a total of 12 weeks.

[0013] The invention has the advantages that the patch can replenish qi and blood, strengthen the spleen and nourish the heart, and treat insomnia caused by excessive thinking, fatigue of the heart and spleen, and daily consumption of qi and blood due to deficiency of both heart and spleen.

[0014] The longan pulp of the present invention nourishes the heart and spleen, nourishes blood and calms the mind, the fried Chinese jujube seeds nourish the liver and soothe the mind, astringes sweat and produces body fluid, the fried astragalus nourishes qi and benefits the middle, strengthens the spleen and nourishes blood, the cooked rehmannia nourishes blood and nourishes yin, replenishes essence and benefits the marrow, the white atractylodes nourishes the spleen and harmonizes the middle, dries dampness and benefits the stomach, the angelica nourishes blood and activates blood circulation, regulates menstruation and relieves pain, the poria penetrates dampness and promotes diuresis, strengthens the spleen and nourishes the heart, the ginseng nourishes the spleen and benefits the lungs, restores the pulse and consolidates the body, the polygala tenuifolia calms the mind and improves intelligence, eliminates phlegm and reduces swelling, the costus root strengthens the spleen and promotes qi, relieves pain and eliminates accumulation, and the roasted licorice nourishes deficiency, nourishes blood, and regulates yin and yang. DETAILED DESCRIPTION

[0015] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0016] Example 1 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (I)

[0017] 12 parts of longan pulp, 12 parts of spinach seed (fried), 12 parts of astragalus (fried), 12 parts of cooked rehmannia, 10 parts of atractylodes, 10 parts of angelica, 10 parts of poria, 10 parts of ginseng, 8 parts of polygala, 6 parts of costusroot, 6 parts of liquorice (roasted).

[0018] Example 2 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (II)

[0019] 12 parts of longan pulp, 10 parts of spinach seed (fried), 14 parts of astragalus (fried), 11 parts of cooked rehmannia, 11 parts of atractylodes, 10 parts of angelica, 8 parts of poria, 12 parts of ginseng, 7 parts of polygala, 7 parts of costusroot, and 6 parts of liquorice (roasted).

[0020] Example 3 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (III)

[0021] 10 parts of longan pulp, 14 parts of spinach seed (fried), 11 parts of astragalus (fried), 13 parts of prepared rehmannia, 10 parts of atractylodes, 8 parts of angelica, 12 parts of poria, 9 parts of ginseng, 9 parts of polygala, 6 parts of costusroot, 4 parts of liquorice (roasted).

[0022] Example 4 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (IV)

[0023] 14 parts of longan pulp, 11 parts of spinach seed (fried), 13 parts of astragalus (fried), 12 parts of prepared rehmannia, 8 parts of atractylodes, 12 parts of angelica, 9 parts of poria, 11 parts of ginseng, 8 parts of polygala, 4 parts of costusroot, 8 parts of liquorice (roasted).

[0024] Example 5 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (V)

[0025] 11 parts of longan pulp, 13 parts of spinach seed (fried), 12 parts of astragalus (fried), 10 parts of prepared rehmannia, 12 parts of atractylodes, 9 parts of angelica, 11 parts of poria, 10 parts of ginseng, 6 parts of polygala, 8 parts of costusroot, 5 parts of liquorice (roasted).

[0026] Example 6 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (VI)

[0027] 13 parts of longan pulp, 12 parts of spinach seed (fried), 10 parts of astragalus (fried), 14 parts of cooked rehmannia, 9 parts of atractylodes, 11 parts of angelica, 10 parts of poria, 8 parts of ginseng, 10 parts of polygala, 5 parts of costusroot, 7 parts of liquorice (roasted).

[0028] Example 7 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (VII)

[0029] 12 parts of longan pulp, 14 parts of spinach seed (fried), 11 parts of astragalus (fried), 13 parts of prepared rehmannia, 10 parts of atractylodes, 8 parts of angelica, 12 parts of poria, 9 parts of ginseng, 9 parts of polygala, 6 parts of costusroot, 4 parts of liquorice (roasted).

[0030] Example 8 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (VIII)

[0031] 10 parts of longan pulp, 11 parts of spinach seed (fried), 13 parts of astragalus (fried), 12 parts of cooked rehmannia, 8 parts of atractylodes, 12 parts of angelica, 9 parts of poria, 11 parts of ginseng, 8 parts of polygala, 4 parts of costusroot, 8 parts of liquorice (roasted).

[0032] Example 9 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (IX)

[0033] 14 parts of longan pulp, 13 parts of spinach seed (fried), 12 parts of astragalus (fried), 10 parts of cooked rehmannia, 12 parts of atractylodes, 9 parts of angelica, 11 parts of poria, 10 parts of ginseng, 6 parts of polygala, 8 parts of costusroot, 5 parts of liquorice (roasted).

[0034] Example 10 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (ten)

[0035] 11 parts of longan pulp, 12 parts of spinach seed (fried), 10 parts of astragalus (fried), 14 parts of cooked rehmannia, 9 parts of atractylodes, 11 parts of angelica, 10 parts of poria, 8 parts of ginseng, 10 parts of polygala, 5 parts of costusroot, 7 parts of liquorice (roasted).

[0036] Example 11 External Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen (XI)

[0037] 13 parts of longan pulp, 10 parts of spinach seed (fried), 14 parts of astragalus (fried), 11 parts of cooked rehmannia, 11 parts of atractylodes, 10 parts of angelica, 8 parts of poria, 12 parts of ginseng, 7 parts of polygala, 7 parts of costusroot, and 6 parts of liquorice (roasted).

[0038] Example 12

[0039] Clinical Trials

[0040] 1 Clinical Data

[0041] 1.1 Case source

[0042] The cases observed in this study were all patients from the general practice clinic of Gonghexinlu Street Community Health Service Center.

[0043] 1.2 Diagnostic criteria

[0044] 1.2.1 Western medicine diagnostic criteria

[0045] (1) Difficulty falling asleep (taking more than 30 minutes to fall asleep);

[0046] (2) persistent sleep disturbance (≥2 awakenings throughout the night), early awakening, and decreased sleep time;

[0047] (3) Total sleep time is reduced (generally less than 6 hours), accompanied by daytime dysfunction, early awakening, and decreased sleep quality;

[0048] (4) Total sleep time: Total sleep time is reduced, usually less than 6 hours.

[0049] 1.2.2 Standards for TCM Syndrome Differentiation

[0050] Those who meet the diagnostic criteria for insomnia in the "Chinese Classification and Diagnostic Criteria for Mental Disorders, Third Edition", namely, difficulty falling asleep, frequent awakening, unstable sleep or inability to fall asleep after waking up, waking up too early in the morning, and sleeping less than 5 hours; (I) Diagnosis of TCM diseases

[0051] (1) Age: The age of onset is 18 ～ 65-year-old male patient.

[0052] (2) Main symptoms: dizziness, shallow sleep, easy awakening, and difficulty falling asleep again after waking up.

[0053] (3) Secondary symptoms: palpitations, memory loss, fatigue, loss of appetite, sallow complexion, and tasteless mouth. The three main symptoms plus two secondary symptoms are sufficient.

[0054] (4) Tongue and pulse: Pale tongue, white fur, and weak pulse.

[0055] (5) Patients who have given their informed consent and are willing to accept the treatment plan of this study and have signed the informed consent form. Patients who meet the criteria for disease diagnosis (1) and (2) and have more than ①-② of the secondary symptoms can be diagnosed by combining tongue and pulse.

[0056] (II) TCM Syndrome Diagnosis

[0057] Syndrome of deficiency of both heart and spleen: frequent dreams, easy awakening, palpitations, forgetfulness, fatigue, poor appetite, dizziness, accompanied by tiredness of limbs, pale complexion, pale tongue with thin coating, and thready and weak pulse.

[0058] 1.3 Inclusion criteria

[0059] (1) Meet the above-mentioned Chinese and Western medical diagnostic criteria for insomnia;

[0060] (2) According to TCM syndrome differentiation, it belongs to deficiency of both heart and spleen;

[0061] (3) Sleeping less than 5 hours a day;

[0062] (4) No serious organic disease, mental or nervous system disease;

[0063] (5) Male aged 18-65 years;

[0064] (6) No sedative drugs were used within 3 months before treatment.

[0065] 1.4 Exclusion criteria

[0066] (1) Patients with insomnia caused by mental disorders such as schizophrenia or anxiety disorder;

[0067] (2) Those who have used sedatives in the past month;

[0068] (3) Accompanied by dysfunction of important organs such as the heart, liver, and kidneys;

[0069] (4) Those with contraindications to relevant treatments.

[0070] 1.5 Elimination criteria

[0071] (1) Patients with poor compliance and those who stop treatment midway;

[0072] (2) Severe adverse reactions occurred and the patient was unable to continue the study;

[0073] (3) Patients who voluntarily give up treatment due to personal reasons and are unable to persist.

[0074] 1.6 Dropout Cases

[0075] (1) For subjects who withdraw from the trial due to adverse reactions, researchers should adopt appropriate response measures for the adverse reactions and record the adverse events in detail;

[0076] (2) For subjects who withdraw from the trial due to dissatisfaction with the treatment effect, the researchers will take appropriate compensatory treatment measures based on the actual situation;

[0077] (3) When a subject drops out, the researcher can contact the subject by phone, email, or home visit to ask for the reason, and complete the corresponding assessment items as much as possible;

[0078] (4) Fill in the “Summary of Treatment Completion” of the Case Report Form (CRF) and evaluate and analyze the patient’s compliance.

[0079] 2 Research Methods

[0080] 2.1 Grouping method

[0081] 100 patients with insomnia of heart and spleen deficiency type who met the inclusion criteria were randomly divided into the Guipitie group and the placebo group. The randomization was performed using a simple random method, using SPSS software to generate random numbers, which were kept by a dedicated person. The random numbers were immediately obtained by phone, text message or E-mail according to the order of the patients' visits for treatment. The trial strictly included patients according to the random design sequence.

[0082] 2.2 Treatment methods

[0083] The control group of 50 patients were treated with oral Xiaoyao Pills; the observation group of 50 patients were treated with Guipi Paste. The Guipi Paste was composed of 12g each of longan pulp, spiny jujube seeds (fried), astragalus (fried), and cooked rehmannia, 10g each of white atractylodes, angelica, poria, and ginseng, 8g of polygala, and 6g each of costus root and licorice (roasted).

[0084] 2.3 Treatment options

[0085] One course of treatment is 12 weeks.

[0086] 2.4 Evaluation Method

[0087] The control group was given Guipi Pills orally three times a day, 8 pills each time, for 12 consecutive weeks. The observation group disinfected the navel with an iodine cotton swab before going to bed and then applied Guipi Patch. Once a day, each time for 12 hours. Use it every other day for a total of 12 weeks. Both groups received 1 course of treatment. After the end of the course of treatment and after 30 days of follow-up, the clinical efficacy, Pittsburgh Sleep Quality Index and other indicators of the two groups were compared for clinical observation and evaluation.

[0088] 2.5 Clinical observation indicators

[0089] 2.5.1 Clinical efficacy

[0090] After the end of the treatment course and during the 30-day follow-up, the clinical efficacy was judged according to the relevant standards in the "Guidelines for Clinical Research of New Chinese Medicines". Clinical cure: sleep time returns to normal or the nighttime sleep time is more than 6 hours, the sleep is deep, and the patient is energetic after waking up; marked effect: sleep is significantly improved: the sleep time increases by more than 3 hours, and the sleep depth increases; effective: symptoms are alleviated, and the sleep time increases by less than 3 hours compared with before; ineffective: insomnia does not improve or worsens after treatment.

[0091] 2.5.2 Clinical efficacy evaluation

[0092] The Pittsburgh Sleep Quality Index (PSQI) was proposed by Buysse et al. in 1989. The PSQI scale consists of 19 self-assessment items and 5 other-assessment items, of which the 19th self-assessment item and the 5 other-assessment items are not included in the scoring. All items are divided into seven dimensions: subjective sleep quality, sleep onset time, sleep time, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function. Each component is scored from 0 to 3, and the cumulative score of each component is the total score of PSQI, which ranges from 0 to 21 points. The higher the score, the worse the sleep quality. Refer to the Pittsburgh Sleep Quality Index (PSQI) score changes.

[0093] 2.6 Observation time and follow-up methods

[0094] The clinical efficacy, Pittsburgh Sleep Quality Index (PSQI) score, sleep time and other indicators were observed and evaluated by outpatient follow-up or telephone interviews before and 2 weeks after treatment.

[0095] Statistical methods

[0096] SPSS23.0 statistical software was used for statistical analysis. The normality test was performed on the measurement data first. The data that met the normal distribution were expressed as mean ± standard deviation (), and those that did not meet the normal distribution were expressed as median (quartile) [Median (QL~QU)]. The two-sample t-test was used for inter-group comparison of those that met the normal distribution, and the paired t-test was used for intra-group comparison. Non-parametric tests were used for inter-group comparison of those that did not meet the normal distribution; count data were expressed as the number of cases (percentage), and the count data were tested using the X2 test. P < 0.05 was considered statistically significant.

[0097] 3. Research Results

[0098] 3.1 Clinical efficacy evaluation

[0099] The results of this study showed that in the treatment group, 20 cases were cured, 16 cases were markedly effective, 12 cases were effective, 2 cases were ineffective, and the total effective rate was 40%; in the control group, 18 cases were cured, 14 cases were markedly effective, 10 cases were effective, 8 cases were ineffective, and the total effective rate was 36%. The difference in the efficacy between the two groups was statistically significant (P<0.05), indicating that the efficacy of the treatment group was better than that of the control group.

[0100] 3.2 Pittsburgh Sleep Quality Index (PSQI) score

[0101] Pittsburgh Sleep Quality Index (PSQI) scores After treatment, the Pittsburgh Sleep Quality Index scores of the two groups of patients were lower than those before treatment, and the scores of the experimental group were lower than those of the control group, with statistically significant differences (P < 0.05), as shown in Table 1.

[0102] Table 1 Comparison of PSQI scores between the two groups (points)

[0103]

[0104] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for external use for treating insomnia due to deficiency of both heart and spleen, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-14 parts of longan pulp, 10-14 parts of spinach seeds (fried), 10-14 parts of astragalus (fried), 10-14 parts of cooked rehmannia, 8-12 parts of atractylodes, 8-12 parts of angelica, 8-12 parts of poria, 8-12 parts of ginseng, 6-10 parts of polygala, 4-8 parts of costusroot, and 4-8 parts of licorice (roasted).

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 11-13 parts of longan pulp, 11-13 parts of spinach seeds (fried), 11-13 parts of astragalus (fried), 11-13 parts of cooked rehmannia, 9-11 parts of atractylodes, 9-11 parts of angelica, 9-11 parts of poria, 9-11 parts of ginseng, 7-9 parts of polygala, 5-7 parts of costusroot, and 5-7 parts of liquorice (roasted).

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of longan pulp, 12 parts of spinach seeds (fried), 12 parts of astragalus (fried), 12 parts of cooked rehmannia, 10 parts of atractylodes, 10 parts of angelica, 10 parts of poria, 10 parts of ginseng, 8 parts of polygala, 6 parts of costusroot, and 6 parts of licorice (roasted).

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The medicine of the Chinese medicine composition is an external patch.

5. Use of the Chinese medicine composition according to any one of claims 1 to 3 in preparing a medicine for treating insomnia due to deficiency of both heart and spleen.

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