Traditional Chinese medicine composition for treating tumor-related insomnia

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating tumor-related insomnia, which is prepared from the following raw material medicines in parts by weight: 30-60 parts of Huai wheat, 6-9 parts of rhizoma anemarrhenae, 9-15 parts of lily, 9-15 parts of jujube and 9-12 parts of honey-fried licorice root. Aiming at the symptoms and pathogenesis of the tumor-related insomnia, the traditional Chinese medicine composition adopts the treatment principles of regulating yin and yang, tranquilizing mind by nourishing the heart and regulating the middle warmer and relieving spasm, has the advantages of cheap raw materials, simplicity and convenience in preparation, convenience in use and small side effect, can be taken for a long time, and has obvious curative effect through years of clinical application and observation and analysis. The traditional Chinese medicine composition disclosed by the invention has a relatively good clinical curative effect on tumor-related insomnia.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating tumor-related insomnia. Background Art

[0002] Cancer-related insomnia (CRI), also known as tumor-related sleep disorder, is characterized by significant and persistent sleep disturbances during tumor development and treatment. The incidence of sleep disorders in the general population is significantly lower than in cancer patients. CRI is a secondary sleep disorder and is common in cancer patients, particularly those with thyroid and breast cancer. It is more common in women than in men, possibly due to neuroendocrine hormone changes. Furthermore, because CRI is primarily a malignant tumor, the sleep disturbances associated with it are often persistent, and treatment is generally long and slow to respond, making complete cure difficult. CRI places a significant physical and psychological burden on patients. Psychologically, it can easily lead to negative emotional reactions, such as frequent irritability, restlessness, anxiety, depression, and fatigue. Physically, it can cause weakened immunity, memory loss, and physiological dysfunction, severely impacting normal life and treatment, leading to loss of work ability and inability to engage in normal social activities. Furthermore, CRI can lead to poor prognosis and decreased survival rates.

[0003] CRI, also known as insomnia, is classified as "insomnia" in Traditional Chinese Medicine. The "Inner Canon of Medicine" describes it as "inability to sleep" and "unable to close one's eyes." "Treatise on Blood Symptoms: Sleeping and Sleeping" states: "Insomnia caused by heart disease...is characterized by restlessness and restlessness." This demonstrates that the heart governs the mind and the seat of the spirit, and a restless mind leads to sleepless nights. The causes and pathogenesis of insomnia are numerous and complex, primarily due to external factors, diet, emotions, chronic illness, and physical constitution, leading to visceral disturbances, imbalances in yin and yang, and disharmony between the Ying and Wei systems. The disease primarily affects the heart, closely related to the spleen, stomach, liver, gallbladder, and kidneys. This is primarily due to imbalances in the Ying and Wei systems, a disharmony between qi, blood, yin and yang, with yin failing to restrain yang and yang failing to enter the yin compartment, resulting in a malfunction of yin and yang.

[0004] Traditional Chinese Medicine (TCM) offers unique advantages in treating CRI. CRI falls under the category of "insomnia." Through research and analysis of its etiology and pathogenesis, and taking a holistic approach, TCM utilizes syndrome differentiation and treatment based on the principles of yin and yang, the nutrient and defensive systems, qi and blood, and the internal organs. This approach emphasizes both exterior and interior treatment. Beyond treating tumors, TCM simultaneously harmonizes yin and yang, nourishes the heart and calms the mind, and alleviates urgency, ultimately improving patients' sleep quality. Therefore, TCM treatment for CRI offers the advantages of minimal side effects and high patient compliance.

[0005] However, there is no report on a traditional Chinese medicine composition for treating tumor-related insomnia with few side effects and long-term use. Summary of the Invention

[0006] The purpose of the present invention is to address the deficiencies in the prior art and provide a traditional Chinese medicine composition for treating tumor-related insomnia which has few side effects and can be taken for a long time.

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for treating tumor-related insomnia, which is composed of the following raw materials in parts by weight: 30-60 parts of Huai wheat, 6-9 parts of Anemarrhena asphodeloides, 9-15 parts of Lilium, 9-15 parts of Jujube, and 9-12 parts of Radix Glycyrrhizae.

[0008] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of Huai wheat, 9 parts of Anemarrhena asphodeloides, 9 parts of Lilium, 9 parts of Jujube, and 9 parts of Radix Glycyrrhizae.

[0009] The second aspect of the present invention provides a Chinese medicine compound preparation having the Chinese medicine composition as an active ingredient, wherein the Chinese medicine compound preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

[0010] Furthermore, the dosage form of the Chinese medicine preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

[0011] Furthermore, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0012] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating tumor-related insomnia.

[0013] Furthermore, the Chinese medicine composition is used in combination with a sedative and hypnotic drug in the preparation of a drug for treating tumor-related insomnia, wherein the sedative and hypnotic drug is Stilnox, Estazolam, Alprazolam, Diazepam or Clonazepam.

[0014] A fourth aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine compound preparation in the preparation of a medicine for treating tumor-related insomnia.

[0015] Furthermore, the tumor-related insomnia is pathologically diagnosed as a malignant tumor, has typical insomnia symptoms, and the traditional Chinese medicine syndrome type is heart and liver yin deficiency type.

[0016] Furthermore, the tumor-related insomnia is tumor-related insomnia in female patients.

[0017] The Chinese medicine compound preparation of the present invention is based on many years of clinical practice, guided by traditional Chinese medicine theory, and carefully selected and formulated. The monarch drug Huaimai wheat in the prescription has the effects of nourishing the heart and liver, nourishing yin and relieving restlessness. Anemarrhena as an adjuvant has the effects of clearing away heat and purging fire, nourishing yin and moistening dryness. Lily is sweet and slightly bitter, slightly cold in nature, and can enter the heart meridian. It is a product that nourishes yin, clears the heart and calms the mind, and relieves restlessness and depression. It is also an adjuvant. Jujube is sweet and warm in nature. It has the effects of replenishing qi and blood, calming the mind, regulating the body's defense system, tonifying the spleen and stomach, and harmonizing the properties of the medicine. It is beneficial to the dryness that is blocked in the upper part, and is an adjuvant in the prescription. Roasted licorice is a guiding drug that replenishes heart qi, replenishes yin fluid, and harmonizes liver qi while protecting the qi of the spleen and stomach. The five medicines are used together to harmonize yin and yang, nourish the heart and calm the mind, and harmonize the middle and relieve urgency, which is in line with the core pathogenesis of tumor-related insomnia or sleep disorders.

[0018] The advantages of the present invention are:

[0019] The present invention addresses the symptoms and pathogenesis of tumor-related insomnia, employing the therapeutic principles of harmonizing yin and yang, nourishing the heart and calming the mind, and relieving urgency. The Chinese medicinal composition utilizes inexpensive raw materials, is simple to prepare, convenient to use, has minimal side effects, and can be taken long-term. Years of clinical application and observational analysis have demonstrated that the Chinese medicinal composition of the present invention exhibits excellent clinical efficacy in treating tumor-related insomnia. Given that tumor-related insomnia is prevalent in a high proportion of cancer patients, causing significant physical and mental distress to patients, and that current sleep aid treatments are ineffective and prone to relapse upon discontinuation of medication, the Chinese medicinal compound preparation provided by the present invention has promising application prospects. DETAILED DESCRIPTION

[0020] The specific implementation methods provided by the present invention are described in detail below with reference to the examples.

[0021] Example 1: Chinese medicine composition of the present invention

[0022] The drug is composed of the following raw materials in parts by weight: 30 parts of Huai wheat, 9 parts of Anemarrhena asphodeloides, 9 parts of Lilium, 9 parts of Jujube, and 9 parts of Radix Glycyrrhizae.

[0023] Example 2: Chinese medicine composition of the present invention

[0024] The drug is composed of the following raw materials in parts by weight: 40 parts of Huai wheat, 8 parts of Anemarrhena asphodeloides, 10 parts of Lilium, 10 parts of Jujube, and 10 parts of Radix Glycyrrhizae.

[0025] Example 3: Chinese medicine composition of the present invention

[0026] The drug is composed of the following raw materials in parts by weight: 50 parts of Huai wheat, 7 parts of Anemarrhena asphodeloides, 12 parts of Lilium, 12 parts of Jujube, and 11 parts of Radix Glycyrrhizae.

[0027] Example 4: Chinese medicine composition of the present invention

[0028] The preparation is composed of the following raw materials in parts by weight: 60 parts of Huai wheat, 6 parts of Anemarrhena asphodeloides, 15 parts of Lilium, 15 parts of Jujube, and 12 parts of Radix Glycyrrhizae.

[0029] Example 5: Preparation of the Chinese medicine composition decoction of the present invention

[0030] The conventional preparation method of Chinese herbal decoction is adopted, that is, the raw materials of Chinese herbal medicine are weighed according to any weight ratio of Examples 1-4, and water is added to boil to form a decoction.

[0031] Example 6: Preparation of Chinese medicine composition tablets / capsules of the present invention

[0032] Weigh each Chinese medicinal raw material according to any weight ratio of Examples 1-4, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract. Dry and crush the extract to form granules, add pharmaceutical excipients, and press it into tablets or fill it into capsules.

[0033] Example 7: Preparation of the Chinese medicine composition pills / oral liquid / syrup of the present invention

[0034] According to any weight ratio of Examples 1-4, the raw materials of the Chinese medicine are weighed, ground, decocted, the supernatant is taken, and concentrated to a thick extract; appropriate pharmaceutical excipients (such as sugar, honey, benzoyl propionic acid or ethyl paraben) are added to prepare pills, oral liquids or syrups.

[0035] Example 8: Preparation of the Chinese medicine composition granules of the present invention

[0036] Place 37.296 kg of honey-roasted licorice root, 37.296 kg of lily bulbs, 124.32 kg of Huai wheat, 37.296 kg of Anemarrhena asphodeloides, and 24.864 kg of jujube slices into the equipment. Add 7 times the amount of water for the first batch, bring to a boil, and simmer for 1 hour. Add 6 times the amount of water for the second batch, bring to a boil, and simmer for 0.5 hours. Collect the liquid for later use. Turn on the equipment's vacuum pump to extract the liquid for concentration. Combine all the liquids and concentrate to an extract with a relative density of 1.14-1.15 (at 75-85°C). Transfer the extract to a mixing tank, add an appropriate amount of dextrin, and stir thoroughly. Spray dry the mixture, then dry granulate. Inner packaging: 5 g / bag (equivalent to 31.5 g of slices).

[0037] Example 9: Clinical Trial

[0038] (1) Case source: The cases were collected from 90 patients with malignant tumors and insomnia in the outpatient clinic and ward of the First Oncology Department (Internal Medicine) of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2023 to February 2024, with informed consent.

[0039] (II) Inclusion criteria: (1) Patients diagnosed with malignant tumors by pathology; (2) Patients with typical insomnia symptoms that meet the diagnostic criteria of Western medicine, with a PSQI score greater than 7 points; (3) Female, aged over 18 years, with stable vital signs, an expected survival period of more than 6 months, and clear consciousness; (4) Patients with no major organ dysfunction and an NRS score of 0-3 points; (5) Patients who have taken sedative hypnotic drugs (benzodiazepines, non-benzodiazepines, antidepressants, hormone replacement drugs) for more than or equal to 1 month before enrollment. (6) Patients with traditional Chinese medicine syndrome type of heart and liver yin deficiency. (7) Patients with good compliance, understanding and agreement to participate in this study, and signed informed consent.

[0040] (III) Exclusion criteria: (1) Patients with serious heart, kidney, liver or blood system diseases, pregnant or breastfeeding patients, and mental patients; (2) Patients with intracranial tumors and cognitive impairment; (3) Patients with known allergies to the ingredients of this Chinese medicine; (4) Patients who are currently participating in or have participated in other drug clinical trials within 4 weeks; (5) Patients who have undergone tumor-related surgery, chemotherapy or radiotherapy within the past month; (6) Patients who had sleep disorders before suffering from malignant tumors; (7) Patients who have recently suffered severe psychological trauma, such as the death of relatives or friends.

[0041] (IV) Research Methods

[0042] 1. Baseline Data: 90 patients were randomly divided into a traditional Chinese medicine (TCM) group and a Western medicine (WM) group according to a random number table. Forty-five patients were included in the treatment group (one patient in the treatment group was lost to follow-up, and one patient was excluded for voluntarily stopping medication not in accordance with the trial plan). A total of 43 patients were enrolled. Forty-five patients were included in the control group (one patient in the control group was lost to follow-up). A total of 44 patients were enrolled. Age: Treatment group: 66.00 (63.00, 69.00) years; control group: 69.00 (64.75, 72.00) years. Staging: In the treatment group, there were 15 cases (34.88%) in stage I, 5 cases (11.63%) in stage II, 9 cases (20.93%) in stage III, and 14 cases (32.56%) in stage IV; in the control group, there were 16 cases (36.36%) in stage I, 6 cases (13.64%) in stage II, 10 cases (22.73%) in stage III, and 12 cases (27.27%) in stage IV. Tumor type: In the treatment group, there were 21 patients with lung cancer (48.84%), 10 patients with female reproductive system tumors (23.26%), 7 patients with digestive tract system tumors (16.28%), 2 patients with urinary system tumors (4.65%), 2 patients with breast tumors (4.65%), and 1 patient with head and neck tumors (2.33%); in the control group, there were 20 patients with lung cancer (45.45%), 9 patients with female reproductive system tumors (20.45%), 9 patients with digestive tract system tumors (20.45%), 5 patients with breast tumors (11.36%), and 1 patient with urinary system tumors (2.27%). Type of sleeping pill: In the treatment group, 23 patients (53.49%) took estazolam, 16 patients (37.21%) took Stiloxetine, 2 patients (4.65%) took diazepam, and 2 patients (4.65%) took clonazepam. In the control group, 20 patients (45.45%) took estazolam, 19 patients (43.18%) took Stiloxetine, 3 patients (6.82%) took alprazolam, and 2 patients (4.55%) took clonazepam. All comparisons between the groups were P>0.05, indicating no statistically significant differences between the groups. General information was comparable at baseline between the two groups.

[0043] 2. Medication: The control group received a single sleeping pill for a total of 8 weeks. The control group maintained the sedative and hypnotic medications (Sinox, Estazolam, Alprazolam, Diazepam, and Clonazepam) that the subjects were taking prior to enrollment, taking one tablet orally once nightly. The experimental group received the Chinese herbal granules of the present invention (prepared using the method of Example 5) in addition to the control group, taking one 5g bag (1 bag) once nightly with an appropriate amount of boiled water. Treatment course: The treatment course was 8 weeks for both groups. When taking Chinese herbal medicine, the prescriptions for both the control and experimental groups must not contain herbs with sleep-promoting properties (such as Ziziphus jujuba seeds, Poria cocos, Polygonum multiflorum, Albizia julibrissin bark, Albizia julibrissin flower, Platycladus orientalis, Dragon bone, Oyster shell, and Magnetite).

[0044] (V) Observation indicators:

[0045] The main efficacy evaluation indicator was the Pittsburgh Sleep Quality Index, which was evaluated before treatment, at the end of the fourth week, after treatment, and 2 weeks after the end of treatment.

[0046] Secondary efficacy evaluation indicators were anxiety and depression assessment (including the Hamilton Anxiety Scale (HAMA) and the 17-item Hamilton's Depression Scale (HAMD). Assessments were performed before and after treatment.

[0047] (VI) Criteria for determining efficacy:

[0048] The PSQI (PSQI) consists of 19 self-assessment items and 5 peer-assessed items, assessing sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disturbances, hypnotic medication, and daytime dysfunction. Each component is scored from 0 to 3, and the sum of these scores creates a total PSQI score ranging from 0 to 21. Higher scores indicate worse sleep quality. Cured: PSQI improvement of 75% to 100%. Significantly effective: improvement of 50% to 74%. Effective: improvement of 25% to 49%. Ineffective: improvement of <25%. PSQI reduction rate is calculated using a scoring method: (pre-treatment score - post-treatment score) / pre-treatment score * 100%. HAMA: Developed by Hamilton in 1959, this is a peer-rated scale. It is selected based on the patient's individual state. It consists of 14 items, scored 0 to 4 points, with a total score ranging from 0 to 56. Higher scores indicate more pronounced anxiety. A total score of 29 or higher indicates severe anxiety; 21 or higher indicates definitely significant anxiety; 14 or higher indicates definitely anxiety; 7 or higher indicates possible anxiety; and <7 indicates no anxiety. HAMD-17: Developed by Hamilton in 1959, this is a peer-rated scale with 17 items. A score >7 and ≤17 indicates mild depression; a score >17 and ≤24 indicates moderate depression; and a score >24 indicates severe depression.

[0049] (VII) Data Analysis

[0050] The data from this study were analyzed using SPSS 27.0 software. For statistical analysis of measurement data, the t-test was used for data that conformed to a normal distribution; otherwise, the rank sum test was used. Repeated measurements were analyzed using analysis of variance for repeated measures data, while non-normally distributed data were analyzed using generalized estimating equations. For statistical analysis of count data, the chi-square test and Fisher's exact test were often used. A P < 0.05 level indicated statistical significance, while a P > 0.05 indicated no statistical significance.

[0051] (8) Results:

[0052] ① Pittsburgh Sleep Quality Index Evaluation

[0053] Before treatment, the subjects showed no statistically significant differences in bedtime to sleep onset, actual sleep time, and sleep efficiency (P>0.05), indicating comparability. Regarding bedtime to sleep onset time, after eight weeks of treatment, the treatment group experienced a decrease in sleep onset time from 90.35±60.47 minutes to 32.67±24.24 minutes, while the control group experienced a decrease from 87.84±63.52 minutes to 36.82±23.82 minutes. Intra-group comparisons revealed statistically significant differences between the two groups before and after treatment (P<0.001). Inter-group comparisons revealed a decrease in sleep onset time of 57.67±7.14 minutes in the treatment group and 51.02±7.05 minutes in the control group, with no statistically significant difference between the two groups (P>0.05). This suggests that after eight weeks of treatment, both groups experienced improvements in sleep onset time. After 8 weeks of treatment, actual sleep time increased from 4.92±0.72 hours before treatment to 6.24±0.73 hours in the treatment group, while it increased from 5.05±0.76 hours before treatment to 5.99±0.67 hours in the control group. Intra-group comparisons showed statistically significant differences between the two groups (P<0.05). Inter-group comparisons showed that actual sleep time increased by 1.33±0.10 hours in the treatment group and by 0.94±0.10 hours in the control group (P<0.05). This indicates that after 8 weeks of treatment, both groups showed improvements in actual sleep time, with the treatment group showing superior improvement in actual sleep time compared to the control group. Sleep efficiency increased from 58.2±12.9% before treatment to 73.1±12.5% in the treatment group, while it increased from 56.9±8.6% before treatment to 67.5±7.8% in the control group. Intra-group comparisons showed statistically significant differences between the two groups before and after treatment (P < 0.05). Inter-group comparisons revealed that sleep efficiency increased by 14.9 ± 1.4% in the treatment group and by 10.5 ± 1.4% in the control group (P < 0.05). This suggests that after 8 weeks of treatment, both groups improved sleep efficiency, with the treatment group showing superior improvement compared to the control group. See Table 1.

[0054] Table 1 Comparison of PSQI raw data between the two groups of subjects ( ± s)

[0055]

[0056] The total scores of PSQI and the scores of seven dimensions such as sleep quality in the two groups of subjects at the four time points did not meet the normal distribution. The generalized estimating equation was used to analyze the intervention effect.

[0057] The results showed that there was a statistically significant main effect between the two groups for the PSQI total score and the scores on the three dimensions of sleep quality, sleep efficiency, and hypnotic medication (P < 0.05). There was also a statistically significant main effect of time on the PSQI total score and the seven dimensions (P < 0.05). There was also an interaction between the group and time factors on the PSQI total score and the seven dimensions (P < 0.05). See Table 2.

[0058] Table 2 Generalized estimating equations for the total score and each dimension score of the PSQI in the two groups of subjects

[0059]

[0060] ② HAMA score

[0061] Total score: The control group's score decreased from 15.500±3.427 to 11.409±2.960; the treatment group's score decreased from 15.953±2.919 to 8.209±2.989; P<0.05, with statistically significant difference.

[0062] Anxious mood: The control group's score decreased from 2.455±0.627 to 1.614±0.841; the treatment group's score decreased from 2.488±0.551 to 1.023±0.831; P<0.05, with statistically significant difference.

[0063] Tension: The control group's score showed no significant change; the treatment group's score dropped from 2.209±0.773 to 1.163±0.785; P<0.05, indicating a statistically significant difference.

[0064] Insomnia: The control group's score dropped from 3.409±0.583 to 1.750±0.943; the treatment group's score dropped from 3.465±0.631 to 0.837±0.871; P<0.05, with statistically significant difference.

[0065] Cognitive function: There was no significant change in the control group's score; in the treatment group, the score dropped from 1.767±0.996 to 1.581±0.794; P>0.05, and the difference between the two groups was not statistically significant.

[0066] Depressive mood: The control group's score dropped from 2.000±0.610 to 1.659±0.608; the treatment group's score dropped from 2.116±0.625 to 1.349±0.529; P<0.05, with statistically significant difference.

[0067] Sensory system symptoms: The scores of the control group did not change significantly; those of the treatment group decreased from 0.326±0.644 to 0.233±0.571; P>0.05, the difference between the two groups was not statistically significant.

[0068] Gastrointestinal system symptoms: The scores of the control group did not change significantly; those of the treatment group decreased from 1.628±1.001 to 0.837±0.998; P<0.05, indicating statistically significant difference.

[0069] Autonomic nervous system symptoms: The control group's score decreased from 1.114±0.689 to 0.273±0.499; the treatment group's score decreased from 0.953±0.653 to 0.233±0.427; P>0.05, the difference between the two groups was not statistically significant.

[0070] For the remaining symptoms, P > 0.05, there were no statistically significant differences. In summary, both groups were able to reduce HAMA scores, and the treatment group was significantly superior to the control group in improving anxiety. See Table 3 for details.

[0071] Table 3 Comparison of HAMA scores between the two groups of subjects ( ± s, minutes)

[0072]

[0073] Note: Compared with before treatment, # P<0.05; compared with the control group, *P<0.05.

[0074] ③HAMD score

[0075] The results showed that there was no statistically significant difference in the total HAMD scores between the treatment and control groups before treatment (P>0.05). However, there was a statistically significant difference in the total HAMD scores between the two groups after treatment (P<0.05), with the treatment group scoring lower than the control group (see Table 4).

[0076] Table 4 Comparison of total HAMD scores before and after treatment in the two groups

[0077]

[0078] ④Safety evaluation

[0079] Before treatment and two months after treatment, there were no significant abnormalities in routine blood tests, liver and kidney function, and urine and feces in the two groups (P>0.05). This shows that there was no significant effect on routine serum tests and urine and feces in the two groups, and both treatment regimens were safe.

[0080] The Chinese medicine composition of the present invention has significant therapeutic effects in treating female patients with tumor-related insomnia, can improve the patients' insomnia symptoms, reduce anxiety and depression, and has no obvious adverse reactions.

[0081] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art may make various equivalent modifications or substitutions without departing from the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating tumor-related insomnia, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30-60 parts of Huai wheat, 6-9 parts of Anemarrhena asphodeloides, 9-15 parts of Lilium, 9-15 parts of Jujube, and 9-12 parts of Radix Glycyrrhizae.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of Huai wheat, 9 parts of Anemarrhena asphodeloides, 9 parts of Lilium, 9 parts of Jujube, and 9 parts of Radix Glycyrrhizae.

3. A Chinese medicine compound preparation with the Chinese medicine composition according to claim 1 or 2 as an active ingredient, characterized in that: The traditional Chinese medicine compound preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

4. The Chinese medicine compound preparation according to claim 3, characterized in that The dosage form of the traditional Chinese medicine preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

5. The Chinese medicinal compound preparation according to claim 4, characterized in that: The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

6. Use of the traditional Chinese medicine composition according to claim 1 or 2 in preparing a medicament for treating tumor-related insomnia.

7. The use according to claim 6, characterized in that The invention relates to an application of the traditional Chinese medicine composition in combination with a sedative and hypnotic drug in the preparation of a drug for treating tumor-related insomnia.

8. The use according to claim 7, characterized in that The sedative and hypnotic drug is Stilnox, Estazolam, Alprazolam, Diazepam or Clonazepam.

9. Use of the traditional Chinese medicine compound preparation according to any one of claims 3 to 5 in preparing a medicament for treating tumor-related insomnia.

10. The use according to claim 6 or 9, characterized in that: The tumor-related insomnia is pathologically diagnosed as a malignant tumor, has typical insomnia symptoms, and the traditional Chinese medicine syndrome type is heart and liver yin deficiency type.

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