Application of white flower salvia miltiorrhiza powder in medicine for treating insomnia

By using Baihua Salvia powder combined with other Chinese medicinal materials and extracts, a variety of insomnia treatment drug compositions were prepared, which solved the problem of large side effects and insignificant effects of the drugs in the prior art, and achieved efficient insomnia treatment effects.

CN120154653APending Publication Date: 2025-06-17JINAN SUNNYPHARMACY
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Patent Information

Application Number
CN202510533491.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-27
Publication Date
2025-06-17

AI Technical Summary

Technical Problem

The prior art has problems such as having great side effects of drugs, strong long-term use dependence and insignificant effects in the treatment of insomnia. Non-drug treatment methods are not convenient, and patients are not highly adhered to, making it difficult to promote.

Method used

Using white flower salvia powder as the main ingredient, combined with other Chinese herbal materials and extracts, a variety of insomnia treatment pharmaceutical compositions, including powders, capsules or tablets, are prepared for the treatment of different types of insomnia.

Benefits of technology

White Flower Salvia powder significantly shortens the sleep time of mice and prolongs sleep time. In clinical applications, it has shown high efficiency and significant therapeutic effects on different types of insomnia patients, with a total effective efficiency of more than 90.0%.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention belongs to the field of traditional Chinese medicines, and provides application of white flower salvia miltiorrhiza powder in a medicine for treating insomnia. The invention further provides a composition containing the white flower salvia miltiorrhiza powder. The composition is used for treating heart-spleen deficiency type insomnia, yin deficiency and fire excess type insomnia, heart deficiency and timidity type insomnia, phlegm-heat internal disturbance type insomnia or liver depression transforming into fire type insomnia. The invention provides new indications of the white flower radix salviae miltiorrhizae, and expands the application range of the white flower radix salviae miltiorrhizae in medicines.
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Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a new application of Salvia miltiorrhiza Bge. f. alba powder. Background Art

[0002] Disclosing the information of this background art is intended to enhance the understanding of the overall background of the present invention, and it is not necessarily regarded as an admission or an implication in any form that this information constitutes the prior art already known to those of ordinary skill in the art.

[0004] Insomnia belongs to the category of "inability to fall asleep" in traditional Chinese medicine. Inability to fall asleep refers to a class of diseases caused by the loss of nourishment of the mind or the uneasiness of the mind, characterized by the inability to obtain normal sleep frequently. The main manifestations are insufficient sleep time and depth. In mild cases, it is difficult to fall asleep, waking up from time to time, or being unable to fall asleep again after waking up, or having a light sleep, and in severe cases, not being able to fall asleep all night. Although there are many causes of insomnia, the core pathogenesis is the preponderance of yang and decline of yin. The preponderance of yang leads to the restlessness of the mind, and the decline of yin leads to the loss of nourishment of the mind. The imbalance between yin and yang results in the occurrence of insomnia. However, medical experts in past dynasties have different interpretations of its pathogenesis, such as the theory of yin and yang, the theory of nutrient qi and defensive qi, the theory of zang-fu organs, and the theory of qi and blood. Currently, the relatively recognized classification of TCM syndromes of insomnia is divided into 5 categories, namely the syndrome of deficiency of both heart and spleen, the syndrome of hyperactivity of fire due to yin deficiency, the syndrome of deficiency of both heart and gallbladder qi, the syndrome of internal disturbance of phlegm-heat, and the syndrome of liver-fire transforming into fire.

[0005] The overall treatment goal of insomnia is to increase the effective sleep time, improve the daytime impairment related to insomnia, reduce or eliminate the transformation of short-term insomnia disorder into chronic insomnia disorder, and reduce the risk of co-existing somatic diseases or mental disorders related to insomnia. Since the pathogenesis of insomnia has not been clarified yet, there is no clear cure plan formulated based on the disease mechanism. All treatment plans are oriented towards alleviating the symptoms of patients.

[0006] Drug treatment is currently the main treatment method for insomnia. Most of the commonly used drugs are sedative and hypnotic drugs, and anti-anxiety and anti-depressant drugs are also used in the treatment of insomnia. However, drug treatment has problems such as large side effects, dependence on long-term use, and unclear effects. To avoid the side effects brought by the drugs for treating insomnia in clinical practice and further relieve the symptoms of patients with poor efficacy in drug treatment, non-drug treatment methods play an important role in the treatment and prognosis of insomnia. However, due to the relative lack of convenience of such treatment methods, the general compliance of patients is not high, and it is difficult to be popularized.

[0007] The causes of insomnia are complex. The greatest feature and advantage of traditional Chinese medicine in treating insomnia is its ability to differentiate syndromes and treat according to different inducing causes of insomnia. The syndrome differentiation types of insomnia in traditional Chinese medicine are mainly divided into the types of deficiency of both heart and spleen, hyperactivity of fire due to yin deficiency, timidity of heart and qi deficiency, internal disturbance of phlegm-heat, and liver depression transforming into fire, etc., and the therapeutic principles of replenishing qi and nourishing blood, strengthening the spleen and nourishing the heart, nourishing blood, calming the mind, nourishing yin and clearing heat, nourishing yin and blood, tonifying the heart and calming the mind, clearing heat and resolving phlegm, soothing the liver and relieving depression, etc. are respectively adopted for treatment. However, traditional Chinese medicine believes that regardless of the type of insomnia, blood stasis is a common syndrome type in various types of insomnia, so drugs promoting blood circulation and removing blood stasis are often used in combination. Salvia miltiorrhiza is bitter and cold, and belongs to the heart and liver meridians, and has the functions of promoting blood circulation to remove blood stasis and clearing the heart and relieving restlessness. Therefore, Salvia miltiorrhiza is often used in the prescriptions for treating insomnia in traditional Chinese medicine.

[0008] White-flowered Salvia miltiorrhiza is a folk medicine and has not been included in the legal standards. There is no systematic understanding of its medicinal properties, so there are no relevant records and studies on its treatment of insomnia. Summary of the Invention

[0009] In view of the problems in the prior art, the present invention provides an application of white-flowered Salvia miltiorrhiza powder in the treatment of insomnia.

[0010] To achieve the above object, the present invention adopts the following technical solutions.

[0011] An application of white-flowered Salvia miltiorrhiza powder in the preparation of a drug for treating insomnia.

[0012] The insomnia is of the type of deficiency of both heart and spleen, hyperactivity of fire due to yin deficiency, timidity of heart and qi deficiency, internal disturbance of phlegm-heat, or liver depression transforming into fire.

[0013] The drug further contains other active ingredients, including traditional Chinese medicines and extracts of traditional Chinese medicines.

[0014] The dosage form of the drug is selected from powder, capsule or tablet.

[0015] A drug composition for treating insomnia, comprising white-flowered Salvia miltiorrhiza powder.

[0016] Preferably, the above composition is prepared from 2 - 6 kg of white-flowered Salvia miltiorrhiza powder, 2 - 6 kg of licorice, 4 - 8 kg of wheat, 6 - 12 kg of Chinese dates, 4 - 8 kg of Chinese yam, 4 - 8 kg of Schisandra chinensis, 2 - 4 kg of Ziziphus jujuba var. spinosa, 4 - 8 kg of mulberry as raw materials; or, prepared from 2 - 6 kg of white-flowered Salvia miltiorrhiza powder, 9 - 16 kg of Coptis chinensis, 4 - 8 kg of Scutellaria baicalensis, 4 - 8 kg of Paeonia lactiflora, 6 - 12 kg of raw Rehmannia glutinosa, 6 - 12 kg of prepared Rehmannia glutinosa, 2 - 6 kg of donkey-hide gelatin as raw materials; or, prepared from 2 - 6 kg of white-flowered Salvia miltiorrhiza powder, 6 - 12 kg of ginseng, 6 - 12 kg of Acorus tatarinowii, 6 - 12 kg of Poria cocos, 6 - 12 kg of Polygala tenuifolia, 4 - 8 kg of Ophiopogon japonicus, 4 - 8 kg of Atractylodes macrocephala, 4 - 8 kg of Ziziphus jujuba var. spinosa as raw materials; or, It is prepared from 2 - 6 kg of white flower Salvia miltiorrhiza powder, 9 - 16 kg of Bupleurum chinense, 3 - 6 kg of Dragon's Bone, 3 - 6 kg of Scutellaria baicalensis, 3 - 6 kg of Ginseng, 3 - 6 kg of Cinnamon Twig, 3 - 6 kg of Poria cocos, 4 - 8 kg of Pinellia ternata, 4 - 8 kg of Rheum officinale, 3 - 6 kg of Oyster, and 16 - 20 kg of Chinese date as raw materials.

[0017] More preferably, the above - mentioned composition is prepared from 3 kg of white flower Salvia miltiorrhiza powder, 3 kg of Licorice root, 6 kg of Wheat, 9 kg of Chinese date, 6 kg of Chinese yam, 6 kg of Schisandra chinensis, 3 kg of Ziziphus jujuba var. spinosa, and 6 kg of Mulberry as raw materials; or, It is prepared from 3 kg of white flower Salvia miltiorrhiza powder, 12 kg of Coptis chinensis, 6 kg of Scutellaria baicalensis, 6 kg of Paeonia lactiflora, 9 kg of Rehmannia glutinosa, 9 kg of Prepared Rehmannia root, and 3 kg of Colla Corii Asini as raw materials; or, It is prepared from 3 kg of white flower Salvia miltiorrhiza powder, 9 kg of Ginseng, 9 kg of Acorus tatarinowii, 9 kg of Poria cocos, 9 kg of Polygala tenuifolia, 6 kg of Ophiopogon japonicus, 6 kg of Atractylodes macrocephala, and 6 kg of Ziziphus jujuba var. spinosa as raw materials; or, It is prepared from 3 kg of white flower Salvia miltiorrhiza powder, 12 kg of Bupleurum chinense, 4.5 kg of Dragon's Bone, 4.5 kg of Scutellaria baicalensis, 4.5 kg of Ginseng, 4.5 kg of Cinnamon Twig, 4.5 kg of Poria cocos, 6 kg of Pinellia ternata, 6 kg of Rheum officinale, 4.5 kg of Oyster, and 18 kg of Chinese date as raw materials.

[0018] The present invention has the following advantages: The present invention provides new indications for white flower Salvia miltiorrhiza, expanding the application scope of white flower Salvia miltiorrhiza in drugs. Detailed implementation manners

[0019] The following further illustrates the present invention in conjunction with embodiments, but the present invention is not limited by the following embodiments.

[0020] Example 1 Improvement effect of white flower Salvia miltiorrhiza on insomnia mouse model Take white flower Salvia miltiorrhiza and Salvia miltiorrhiza, respectively crush them into fine powders (pass through 80 - mesh sieve), and mix them evenly to obtain white flower Salvia miltiorrhiza powder and Salvia miltiorrhiza powder. Add the two powders into 0.9% sodium chloride injection solution to prepare 20% white flower Salvia miltiorrhiza powder suspension and 20% Salvia miltiorrhiza powder suspension.

[0021] SPF grade KM male mice (provided by Jinan Pengyue Experimental Animal Breeding Co., Ltd., production license number: SCXK (Lu) 20220006), weighing 18-20g, 90 mice, adaptive feeding for 6 days, 10 mice were taken as the blank group, and the rest were intraperitoneally injected with 450mg / kg of PCPA (p-chlorophenylalanine) suspension prepared with 0.9% sodium chloride injection for 2 consecutive days. The blank control group was intraperitoneally injected with the same volume of 0.9% sodium chloride injection. When the model group mice showed circadian rhythm disorders and reduced sleep, it indicated that the insomnia model was successfully established. The mice with successful modeling were randomly divided into 4 groups, each with 10 mice, namely the model control group, the positive drug group, the white flower salvia powder (high dose group), and the salvia powder (high dose group).

[0022] The model control group and the blank control group were given normal saline by gavage; the positive drug group was given estazolam suspension (0.0075 mg•ml -1 ) intragastrically; 4.56 g / kg·d (equivalent to 30 g / d for human crude drugs) for the white flower salvia miltiorrhiza powder group and 4.56 g / kg·d (equivalent to 30 g / d for human crude drugs) for the salvia miltiorrhiza powder group. The drugs were administered continuously for 7 days.

[0023] 30 minutes after the last oral administration of the test drug, each group of mice was intraperitoneally injected with a threshold dose of sodium pentobarbital (32 mg / kg). Based on the disappearance of the righting reflex, the sleep latency and sleep duration of each group of mice were observed and recorded.

[0024] Table 1 Sleep latency and sleep duration of mice treated with different methods ▲ Compared with the model group P <0.05; * Compared with the Danshen powder group P <0.05.

[0025] The experimental results show that both Danshen powder and white danshen powder can shorten the time for mice to fall asleep and prolong their sleep time, which is significantly different from the model group, but not significantly different from the blank control group. Compared with the Danshen powder group, the mice in the white danshen powder group fell asleep faster and slept longer.

[0026] Application Example 1 The therapeutic effect of Salvia miltiorrhiza and its compound preparation on insomnia 1. Diagnostic criteria and case inclusion criteria TCM diagnostic criteria (according to TCM Disease Diagnosis and Efficacy Criteria): (1) In mild cases, the person has difficulty falling asleep or wakes up easily after falling asleep and cannot fall asleep again after waking up. In severe cases, the person cannot fall asleep all night. (2) Often accompanied by headache, dizziness, palpitations, forgetfulness, and frequent dreams; (3)No abnormalities were found through various system and laboratory examinations.

[0027] Western medicine diagnostic criteria (refer to "Diagnosis and Treatment of Insomnia Disorders in China"): To diagnose a patient with insomnia, A - F need to be met simultaneously.

[0028] A. Chief complaints: 1. Difficulty falling asleep; 2. Difficulty maintaining sleep; 3. Waking up earlier than the expected wake - up time; 4. Refusing to go to bed at the appropriate time; 5. Difficulty falling asleep without the intervention of parents or caregivers; B. Daytime functional impairment: 1. Fatigue or lack of energy; 2. Decreased attention, concentration, or memory; 3. Impairment of social, family, occupational, or academic functions; 4. Irritability or excitability; 5. Daytime sleepiness; 6. Behavioral problems (such as hyperactivity, impulsivity, or aggression); 7. Lack of drive, energy, or motivation; 8. Prone to making mistakes or having accidents; 9. Worry about sleep quality; C. These abnormalities in sleep and wakefulness cannot be fully explained by inappropriate sleep opportunities (such as sufficient sleep time) or inappropriate sleep environments (such as dark, quiet, safe, and comfortable environments); Chronic D. ≥ 3 times / week; E. ≥ 3 months; F. Cannot be explained by other sleep disorders; Or short - term E. < 3 months; F. Cannot be explained by other sleep disorders; F. Cannot be explained by other sleep disorders.

[0029] Patients who meet the diagnostic criteria of both traditional Chinese and Western medicine, diagnosed as insomnia by Western medicine or as "insomnia" by traditional Chinese medicine, are included, and those with combined severe organ diseases such as liver, kidney, and lung diseases, or malignant tumors are excluded.

[0030] 2. Treatment of insomnia with Salvia miltiorrhiza var. alba 30 patients were included, including 12 males and 18 females. There were 10 patients aged 20 - 60 years and 20 patients over 60 years old, with an average age of 62.1 years.

[0031] Treatment method: Take Salvia miltiorrhiza var. alba, crush it into fine powder (pass through an 80 - mesh sieve), and fill it into capsules (each capsule contains 0.5 g of Salvia miltiorrhiza var. alba powder). The dosage for patients is 4 capsules each time, 3 times a day. 7 days is a treatment course, and there are 3 treatment courses in total.

[0032] Efficacy judgment: According to the "Diagnostic and Therapeutic Efficacy Criteria for Traditional Chinese Medical Syndromes": (1) Cured: Normal sleep, accompanied by the disappearance of symptoms; (2) Improved: Prolonged sleep time, accompanied by symptom improvement; (3) Not cured: No change in symptoms.

[0033] Results: 10 cases were clinically cured, 17 cases improved, and 3 cases were ineffective. The total effective rate was 90.0%. Among them, 25 patients showed efficacy after one course of treatment.

[0034] 3. Insomnia of the syndrome of deficiency of both heart and spleen According to the following syndrome criteria: having frequent dreams and easy to wake up, or being hazy and not real, palpitations and forgetfulness, dizziness and vertigo, fatigue and weakness, sallow complexion; pale tongue, thin coating, thready and weak pulse; 40 patients with insomnia of the syndrome of deficiency of both heart and spleen were included, including 17 males and 23 females, 16 patients aged 20 - 60 years old, and 24 patients over 60 years old. The average age was 49.8 years.

[0035] Treatment method: Take Salvia miltiorrhiza alba, crush it into fine powder (pass through 80 - mesh sieve), and reserve. Take 3 kg of Glycyrrhiza uralensis Fisch., 6 kg of Triticum aestivum L., 9 kg of Ziziphus jujuba Mill., 6 kg of Dioscorea opposita Thunb., 6 kg of Schisandra chinensis (Turcz.) Baill., 3 kg of Ziziphus spinosa Hu., and 6 kg of Morus alba L., decoct twice with water, each time for 2 hours, combine the decoction liquid, concentrate, spray - dry, mix the spray - dried powder with 3 kg of Salvia miltiorrhiza alba powder, and fill into capsules (each capsule contains 0.5 g). The medication method for patients is 4 capsules each time, 3 times a day. 7 days is a course of treatment, and there are 3 courses of treatment in total.

[0036] At the same time, it was compared with Guipi Pills for treating insomnia of the syndrome of deficiency of both heart and spleen. There were 38 patients in the Guipi Pills group, including 16 males and 22 females, 11 patients aged 20 - 60 years old, and 17 patients over 60 years old. The average age was 48.5 years. The medication method for patients is 6 g each time, 3 times a day. 7 days is a course of treatment, and there are 3 courses of treatment in total.

[0037] Efficacy judgment: According to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes and Diseases" (1) Cured: Normal sleep, accompanied by the disappearance of symptoms; (2) Improved: Prolonged sleep time, accompanied by the improvement of symptoms; (3) Not cured: No change in symptoms.

[0038] Table 2 Clinical experimental results of Salvia miltiorrhiza alba powder in the treatment of insomnia of the syndrome of deficiency of both heart and spleen ▲ Indicates p < 0.05 compared with the Guipi Pills group.

[0039] The results are shown in Table 2. The total effective rate of the Salvia miltiorrhiza alba powder formula group was significantly higher than that of the Guipi Pills group.

[0040] 4. Insomnia of the syndrome of yin deficiency and fire hyperactivity According to the following syndrome criteria: restlessness and insomnia, or sometimes sleeping and sometimes waking up, feverish sensation in the palms and soles, dizziness and tinnitus, forgetfulness, flushing of the cheeks and hectic fever, dry mouth with little saliva. Red tongue, little coating, thready and rapid pulse; 38 patients with insomnia of the syndrome of yin deficiency and fire hyperactivity were included, including 12 males and 16 females, 20 patients aged 20 - 60 years old, and 18 patients over 60 years old. The average age was 49.2 years.

[0041] Treatment method: Take Salvia miltiorrhiza var. alba and donkey-hide gelatin, and crush them into fine powders (pass through 80-mesh sieve) respectively for standby. Take 12 kg of Coptis chinensis, 6 kg of Scutellaria baicalensis, 6 kg of Paeonia lactiflora, 9 kg of raw Rehmannia glutinosa, and 9 kg of prepared Rehmannia glutinosa, decoct them twice with water for 2 hours each time, combine the decoction liquids, concentrate, and spray-dry. Mix the spray-dried powder with 3 kg of Salvia miltiorrhiza var. alba powder and 3 kg of donkey-hide gelatin powder, and fill into capsules (each capsule contains 0.5 g). The medication method for patients is 4 capsules each time, 3 times a day. 7 days is a treatment course, and there are 3 treatment courses in total.

[0042] At the same time, it was compared with Zhibai Dihuang Pills for treating insomnia of yin deficiency and fire hyperactivity type. There were 30 patients in the Zhibai Dihuang Pills group, including 12 males and 18 females, 12 patients aged 20 - 60 years, and 18 patients over 60 years old, with an average age of 49.8 years. The medication method for patients is 6 g each time, 2 times a day. 7 days is a treatment course, and there are 3 treatment courses in total.

[0043] Efficacy judgment: Conduct according to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes and Diseases" (1) Cured: Normal sleep, accompanied by the disappearance of symptoms; (2) Improved: Prolonged sleep time, accompanied by the improvement of symptoms; (3) Not cured: No change in symptoms.

[0044] Table 3 Clinical experimental results of Salvia miltiorrhiza var. alba powder in treating insomnia of yin deficiency and fire hyperactivity type ▲ Indicates p < 0.05 compared with the Zhibai Dihuang Pills group.

[0045] The results are shown in Table 3. The total effective rate of the Salvia miltiorrhiza var. alba powder formula group is significantly higher than that of the Zhibai Dihuang Pills group.

[0046] 5. Insomnia of heart deficiency and timidness type According to the following syndrome criteria: Dreamy sleep and easy to startle at night, palpitations and timidity; Pale tongue, thin coating, and thready and wiry pulse, 52 patients were included, including 22 males and 30 females, 22 patients aged 20 - 60 years, and 30 patients over 60 years old, with an average age of 52.3 years.

[0047] Treatment method: Take Salvia miltiorrhiza var. alba and crush it into fine powder (pass through 80-mesh sieve) for standby. Take 9 kg of ginseng, 9 kg of Acorus tatarinowii, 9 kg of Poria cocos, 9 kg of Polygala tenuifolia, 6 kg of Ophiopogon japonicus, 6 kg of Atractylodes macrocephala, and 6 kg of Ziziphus jujuba var. spinosa, decoct them twice with water for 2 hours each time, combine the decoction liquids, concentrate, and spray-dry. Mix the spray-dried powder with 3 kg of Salvia miltiorrhiza var. alba powder, and fill into capsules (each capsule contains 0.5 g). The medication method for patients is 4 capsules each time, 3 times a day. 7 days is a treatment course, and there are 3 treatment courses in total.

[0048] At the same time, it was compared with Anshen Wendan Pills for treating insomnia of the heart deficiency and timidness type. There were 39 patients in the Anshen Wendan Pills group, including 17 males and 22 females. Among them, 17 patients were aged from 20 to 60 years old, and 22 patients were over 60 years old. The average age was 50.8 years. The medication method for patients was 7.5 g each time, twice a day. 7 days was one course of treatment, and there were 3 courses in total.

[0049] Efficacy judgment: It was carried out according to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes" (1) Cured: Normal sleep and disappearance of accompanying symptoms; (2) Improved: Prolonged sleep time and improvement of accompanying symptoms; (3) Not cured: No change in symptoms.

[0050] Table 4 Clinical experimental results of white-flowered Salvia miltiorrhiza powder in treating insomnia of the heart deficiency and timidness type ▲ Indicates p < 0.05 compared with the Anshen Wendan Pills group.

[0051] The results are shown in Table 4. The total effective rate of the white-flowered Salvia miltiorrhiza powder formula group was significantly higher than that of the Anshen Wendan Pills group.

[0052] 6. Insomnia of the liver depression transforming into fire type According to the following syndrome criteria: restlessness and inability to fall asleep, irritability, chest tightness and hypochondriac pain, headache and flushed face, red eyes, bitter taste in the mouth, constipation and yellow urine; red tongue, yellow coating, and string-taut and rapid pulse, 53 patients were included, including 22 males and 31 females. Among them, 47 patients were aged from 20 to 60 years old, and 6 patients were over 60 years old. The average age was 48.8 years.

[0053] Treatment method: Take white-flowered Salvia miltiorrhiza, crush it into fine powder (pass through 80-mesh sieve), and set aside; take 12 kg of Bupleurum chinense, 4.5 kg of Fossilia Ossis Mastodi, 4.5 kg of Scutellaria baicalensis, 4.5 kg of Ginseng, 4.5 kg of Ramulus Cinnamomi, 4.5 kg of Poria cocos, 6 kg of Pinellia ternata, 6 kg of Rheum officinale, 4.5 kg of Concha Ostreae, 18 kg of Jujube, decoct twice with water, 2 hours each time, combine the decoction liquids, concentrate, spray-dry, mix the spray-dried powder with 3 kg of white-flowered Salvia miltiorrhiza powder, fill into capsules, 0.5 g per capsule. The medication method for patients was 4 capsules each time, three times a day. 7 days was one course of treatment, and there were 3 courses in total.

[0054] At the same time, it was compared with Xiegan Anshen Pills for treating insomnia of the liver depression transforming into fire type. There were 36 patients in the Xiegan Anshen Pills group, including 16 males and 20 females. Among them, 22 patients were aged from 20 to 60 years old, and 14 patients were over 60 years old. The average age was 49.2 years. The medication method for patients was 6 g each time, twice a day. 7 days was one course of treatment, and there were 3 courses in total.

[0055] Efficacy judgment: It was carried out according to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes" (1) Cured: Normal sleep and disappearance of accompanying symptoms; (2) Improved: Prolonged sleep time and improvement of accompanying symptoms; (3) Not cured: No change in symptoms.

[0056] Table 5 Clinical Experimental Results of White-flowered Salvia Miltiorrhiza Powder in the Treatment of Insomnia of Liver Depression Transforming into Fire Type ▲ Indicates p < 0.05 compared with the Xiegan Anshen Pills group.

[0057] As shown in Table 5, in the white-flowered Salvia Miltiorrhiza formula group, 14 cases were clinically cured, 35 cases improved, and 4 cases were ineffective, with a total effective rate of 92.5%; among them, 46 patients showed efficacy after one course of treatment, and its total effective rate was significantly better than that of the Xiegan Anshen Pills group.

[0058] From the diagnosis and treatment effects of the above-mentioned insomnia patients with different syndrome classifications, it can be seen that white-flowered Salvia Miltiorrhiza alone or in compound has a good therapeutic effect on insomnia.

[0059] The above are only examples of the present application and are not intended to limit the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included within the scope of the claims of the present application.

Claims

1. Application of white salvia miltiorrhiza powder in preparing medicine for treating insomnia.

2. The use according to claim 1, characterized in that: The insomnia is of the heart and spleen deficiency type, yin deficiency and hyperactivity of fire type, heart deficiency and timidity type, phlegm-heat internal disturbance type or liver depression transforming into fire type.

3. The use according to claim 1, characterized in that: The medicine also contains other active ingredients.

4. The use according to claim 3, characterized in that: The other effective ingredients are traditional Chinese medicine or traditional Chinese medicine extracts.

5. The use according to claim 1, characterized in that: The dosage form of the drug is selected from powder, capsule or tablet.

6. A pharmaceutical composition for treating insomnia, characterized in that: Contains Salvia miltiorrhiza powder.

7. The composition according to claim 6, characterized in that Made from 2-6kg white salvia powder, 2-6kg liquorice, 4-8kg wheat, 6-12kg jujube, 4-8kg yam, 4-8kg schisandra chinensis, 2-4kg spiny jujube kernel, and 4-8kg mulberry; or, Made from 2-6kg of white salvia powder, 9-16kg of coptis root, 4-8kg of scutellaria root, 4-8kg of peony root, 6-12kg of raw rehmannia root, 6-12kg of cooked rehmannia root, and 2-6kg of donkey hide gelatin; or, Made from 2-6kg of white salvia powder, 6-12kg of ginseng, 6-12kg of calamus, 6-12kg of poria, 6-12kg of polygala, 4-8kg of ophiopogon, 4-8kg of atractylodes, 4-8kg of spiny date seeds; or, The raw materials are 2~6kg of white salvia miltiorrhiza powder, 9~16kg of bupleurum, 3~6kg of dragon bone, 3~6kg of scutellaria, 3~6kg of ginseng, 3~6kg of cassia twig, 3~6kg of poria, 4~8kg of pinellia, 4~8kg of rhubarb, 3~6kg of oyster and 16~20kg of jujube.

8. The composition according to claim 6, characterized in that Made from 3kg of white salvia powder, 3kg of liquorice, 6kg of wheat, 9kg of jujube, 6kg of yam, 6kg of schisandra chinensis, 3kg of spiny jujube kernels, and 6kg of mulberry; or, Made from 3kg of white salvia powder, 12kg of coptis root, 6kg of scutellaria root, 6kg of peony root, 9kg of raw rehmannia root, 9kg of cooked rehmannia root and 3kg of donkey hide gelatin; or, Made from 3kg of white salvia miltiorrhiza powder, 9kg of ginseng, 9kg of calamus, 9kg of poria, 9kg of polygala, 6kg of ophiopogon, 6kg of atractylodes, and 6kg of spiny jujube seeds; or, The raw materials are 3kg of white salvia miltiorrhiza powder, 12kg of bupleurum, 4.5kg of dragon bone, 4.5kg of scutellaria, 4.5kg of ginseng, 4.5kg of cassia twig, 4.5kg of poria, 6kg of pinellia, 6kg of rhubarb, 4.5kg of oyster and 18kg of jujube.