Traditional Chinese medicine composition for improving sleep quality and preparation method and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition for improving sleep quality and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine, and the traditional Chinese medicine composition comprises urena lobata and ainsliaea fragrans. It is found for the first time that the urena lobata and ainsliaea fragrans are matched for use, the obtained traditional Chinese medicine composition can assist in prolonging the sleep time of pentobarbital sodium in mice and remarkably shortening the sleep latency time of pentobarbital sodium in mice, and the remarkable sleep quality improving effect is achieved. Meanwhile, in the preparation process, a decompression reflux extraction method is adopted, key parameters such as pressure and temperature in the extraction process are accurately controlled, the curative effect and the drug effect stability of the traditional Chinese medicine composition are effectively improved, a new method is provided for treating insomnia patients, and the traditional Chinese medicine composition has potential clinical application prospects and is wide in application.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for improving sleep quality, its preparation method and application. Background Art

[0002] Sleep, as an important physiological process of the human body, plays a crucial role in maintaining physical health, restoring physical strength and mental state. However, in modern society, with the accelerating pace of life, increasing work pressure and changing lifestyle, insomnia has become increasingly common and has become one of the common diseases affecting people's quality of life and health level. Insomnia not only causes people to be listless, inattentive and have memory loss during the day, but long-term insomnia may also trigger a series of physical and mental diseases, such as anxiety disorder, depression, cardiovascular diseases, etc., bringing a heavy burden to both individuals and society.

[0003] At present, the treatment methods for insomnia mainly include drug treatment and non-drug treatment. In terms of drug treatment, although some western medicines such as benzodiazepines and non-benzodiazepines can play a certain sleep-aiding effect in the short term, these drugs often have different degrees of side effects, such as the residual effect the next day, drug dependence, tolerance and possible impact on cognitive function, etc., which limit their long-term use. Non-drug treatment methods such as cognitive behavioral therapy and physical therapy, although having high safety, the treatment process is relatively complex, requiring patients to invest more time and energy, and the curative effect may vary from person to person, making it difficult to meet the needs of the vast number of insomnia patients.

[0004] Traditional Chinese medicine has a long history and rich experience in improving sleep quality. Traditional Chinese medicine shows unique advantages in the field of insomnia treatment with its natural, small side effects and multi-target effects. Many traditional Chinese medicine prescriptions and single Chinese medicines are considered to have the effect of calming the nerves and helping sleep, but there are still some deficiencies in the current traditional Chinese medicine products for improving sleep on the market. For example, the formulations of some products lack innovation, the curative effect is not significant enough, and the preparation process is not optimized enough, resulting in incomplete extraction of active ingredients, which affects the quality and effect of the products. Among them, Urena lobata and Ainsliaea fragrans Champ. as two Chinese medicinal materials with medicinal value, although each has its unique efficacy in traditional Chinese medicine theory, there is currently no relevant research report on using the two in combination to improve sleep quality. Summary of the Invention

[0005] To solve the above problems, the present invention provides a traditional Chinese medicine composition for improving sleep quality, its preparation method and application.

[0006] In the first aspect, the present invention provides a traditional Chinese medicine composition for improving sleep quality, and the traditional Chinese medicine composition includes Urena lobata and Ainsliaea fragrans Champ.

[0007] Furthermore, the weight ratio of Urena lobata L. and Ainsliaea fragrans Champ. is (1 - 2):(10 - 15).

[0008] Furthermore, the weight ratio of Urena lobata L. and Ainsliaea fragrans Champ. is 1.5:13.

[0009] In a second aspect, based on the same inventive concept, the present invention provides a method for preparing a traditional Chinese medicine composition for improving sleep quality according to any one of the first aspect, the preparation method comprising the following steps: Crush and mix Urena lobata L. and Ainsliaea fragrans Champ. to obtain a mixed material; Add the mixed material to water for extraction under reduced pressure by reflux, then filter and concentrate and dry the obtained aqueous extract to obtain the traditional Chinese medicine composition.

[0010] Furthermore, the working condition parameters of the extraction under reduced pressure by reflux include: the extraction pressure is 7 kPa - 15 kPa, the extraction temperature is 47°C - 61°C, the extraction times are 1 - 3 times, and the extraction time for each time is 60 - 90 minutes.

[0011] Furthermore, the pressure of the extraction under reduced pressure by reflux is 11 kPa.

[0012] Furthermore, the temperature of the extraction under reduced pressure by reflux is 55°C.

[0013] Furthermore, the weight ratio of the mixed material and the water is 1:(5 - 10).

[0014] In a third aspect, based on the same inventive concept, the present invention provides an application of a traditional Chinese medicine composition for improving sleep quality according to any one of the first aspect or a traditional Chinese medicine composition obtained by using the preparation method of the traditional Chinese medicine composition for improving sleep quality according to any one of the second aspect in the preparation of a product for improving sleep quality.

[0015] Furthermore, the product includes at least one of drugs and health products.

[0016] The above technical solutions provided by the embodiments of the present invention have at least the following advantages compared with the prior art: The embodiments of the present invention provide a traditional Chinese medicine composition for improving sleep quality, its preparation method and application. The present invention first discovers that by using Urena lobata L. and Ainsliaea fragrans Champ. in combination, the obtained traditional Chinese medicine composition can assist in prolonging the sleep time of mice with sodium pentobarbital and significantly shortening the sleep latency of mice with sodium barbital, showing a significant effect of improving sleep quality. At the same time, in the preparation process, the present invention adopts the extraction method under reduced pressure by reflux. By precisely controlling key parameters such as pressure and temperature during the extraction process, the efficacy and pharmacodynamic stability of the traditional Chinese medicine composition are effectively improved, providing a new method for treating insomnia patients, having potential clinical application prospects and wide uses. Detailed implementation manners

[0017] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Apparently, the described embodiments are only a part rather than all of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0018] Unless otherwise specifically stated, all kinds of raw materials, reagents, instruments and equipment used in the present invention can be obtained through market purchase or can be prepared by existing methods.

[0019] The technical concept of the present invention is as follows: Urena lobata L. is the dried aerial part of the plant Urena lobata L. of the family Malvaceae. Modern pharmacological studies have shown that Urena lobata L. contains various chemical components, such as flavonoids, phenolic acids, volatile oils, etc. These components have various pharmacological activities such as anti-inflammatory, antioxidant, antibacterial, etc. Urena lobata L. Ainsliaea fragrans Champ. is the dried whole herb of the plant Ainsliaea fragrans Champ. of the genus Ainsliaea in the family Compositae. Research has shown that Ainsliaea fragrans Champ. is rich in chemical components such as terpenoids, flavonoids, steroids, etc., and has effects such as anti-inflammatory, analgesic, and immunomodulatory effects.

[0020] Therefore, the present invention is optimized by fully combining the research results of modern medicine. For the first time, Urena lobata L. and Ainsliaea fragrans Champ. are used in combination, and the dosage ratio and preparation process are further screened to prepare a traditional Chinese medicine composition for improving sleep quality, providing a new method for treating insomnia patients, having potential clinical application prospects and wide uses. Ainsliaea fragrans Champ. Ainsliaea fragrans Champ.

[0021]

[0021]

[0022] The following further elaborates the present invention in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. The experimental methods without specific conditions noted in the following embodiments are generally determined according to national standards. If there is no corresponding national standard, they are carried out according to general international standards, conventional conditions, or conditions recommended by the manufacturer.

[0023] Example 1

[0024] This example provides a traditional Chinese medicine composition for improving sleep quality. The traditional Chinese medicine composition is composed of Urena lobata L. and Ainsliaea fragrans Champ., and the weight ratio of Urena lobata L. to Ainsliaea fragrans Champ. is 1.5:13.

[0025] The preparation method of the above-mentioned traditional Chinese medicine composition for improving sleep quality includes the following steps: Crush and mix Urena lobata and Ainsliaea fragrans Champ., to obtain a mixed material; Add the said mixed material into water for reduced-pressure reflux extraction, then filter and concentrate and dry the obtained aqueous extract to obtain the said traditional Chinese medicine composition; Wherein, the pressure of the reduced-pressure reflux extraction is 11 kPa, the temperature of the reduced-pressure reflux extraction is 55 °C, the extraction times are 2 times, the extraction time for each time is 75 minutes, and the weight ratio of the mixed material to the water is 1:8.

[0026] Example 2

[0027] This example provides a traditional Chinese medicine composition for improving sleep quality. The said traditional Chinese medicine composition is composed of Urena lobata and Ainsliaea fragrans Champ., and the weight ratio of Urena lobata to Ainsliaea fragrans Champ. is 1:10.

[0028] The preparation method of the above traditional Chinese medicine composition for improving sleep quality comprises the following steps: Crush and mix Urena lobata and Ainsliaea fragrans Champ., to obtain a mixed material; Add the said mixed material into water for reduced-pressure reflux extraction, then filter and concentrate and dry the obtained aqueous extract to obtain the said traditional Chinese medicine composition; Wherein, the pressure of the reduced-pressure reflux extraction is 7 kPa, the temperature of the reduced-pressure reflux extraction is 47 °C, the extraction times are 2 times, the extraction time for each time is 90 minutes, and the weight ratio of the mixed material to the water is 1:10.

[0029] Example 3

[0030] This example provides a traditional Chinese medicine composition for improving sleep quality. The said traditional Chinese medicine composition is composed of Urena lobata and Ainsliaea fragrans Champ., and the weight ratio of Urena lobata to Ainsliaea fragrans Champ. is 2:15.

[0031] The preparation method of the above traditional Chinese medicine composition for improving sleep quality comprises the following steps: Crush and mix Urena lobata and Ainsliaea fragrans Champ., to obtain a mixed material; Add the said mixed material into water for reduced-pressure reflux extraction, then filter and concentrate and dry the obtained aqueous extract to obtain the said traditional Chinese medicine composition; Wherein, the pressure of the reduced-pressure reflux extraction is 15 kPa, the temperature of the reduced-pressure reflux extraction is 61 °C, the extraction times are 2 times, the extraction time for each time is 60 minutes, and the weight ratio of the mixed material to the water is 1:5.

[0032] Example 4

[0033] This example provides a traditional Chinese medicine composition for improving sleep quality and its preparation method. The difference from Example 1 is only that: the weight ratio of Urena lobata and Ainsliaea fragrans Champ. is adjusted to 1:1; the remaining steps and parameters are the same.

[0034] Example 5

[0035] This example provides a traditional Chinese medicine composition for improving sleep quality and its preparation method. The difference from Example 1 is only that: the vacuum reflux extraction process is adjusted to atmospheric reflux extraction process, the specific reflux extraction pressure is 1 standard atmosphere, and the reflux extraction temperature is 105°C; the remaining steps and parameters are the same.

[0036] Test Example In this example, direct sleep test, extended pentobarbital sodium sleep time test, subthreshold dose hypnosis test of pentobarbital sodium and sleep latency test of sodium barbital in mice were carried out with healthy ICR male mice as experimental objects according to the test methods disclosed in the prior art to investigate the effects of the traditional Chinese medicine compositions obtained in Examples 1 - 5 above on improving sleep quality. The specific details are as follows: 1. Experimental animals Healthy ICR male mice with a body weight of 18 - 22 g and SPF level were selected. Before the experiment, the mice were placed in an environment with a temperature of 22 ± 2°C and a relative humidity of 50 ± 10% for adaptive feeding for 1 week, with free access to food and water. During the experiment, the health status of the mice was closely observed, and the mice with poor mental state and obvious disease symptoms were excluded to ensure the quality of the experimental animals and the reliability of the experimental results.

[0037] 2. Preparation of sample liquid medicine The traditional Chinese medicine compositions obtained in Examples 1 - 5 were respectively prepared into sample aqueous liquid medicines with a concentration of 50 mg / mL. A calibrated measuring tool was used to accurately weigh the traditional Chinese medicine composition and distilled water to ensure the accuracy of the liquid medicine concentration. The prepared liquid medicine should be stored at 4°C and used within 24 hours to ensure the stability of the liquid medicine.

[0038] 3. Experimental grouping A blank control group, Example 1 group, Example 2 group, Example 3 group, Example 4 group and Example 5 group were set up for each test, with 12 mice in each group. Appropriately increasing the sample size can improve the statistical power of the experimental results and reduce experimental errors. Each group of animals was gavaged at a gavage volume of 20 ml / kg·bw, and the blank control group was gavaged with an equal volume of distilled water. The gavage operation should be gentle and accurate to avoid damaging the esophagus and stomach of the mice.

[0039] 4. Test method (I) Direct sleep test After the last intragastric administration of the test substance, observe whether sleep occurs. Sleep is indicated by the disappearance of the righting reflex. When the mouse is placed in the dorsal recumbent position, if it fails to right itself autonomously within 60 seconds, it is determined that the righting reflex has disappeared and the mouse has entered sleep. The recovery of the righting reflex indicates that the animal has awakened, and the time from the disappearance to the recovery of the righting reflex is the animal's sleep time. Continuously observe for 6 hours after administration, record the status of the mice every 30 minutes, and record the number of sleeping animals and the sleep time of the mice in each group.

[0040] (2) Pentobarbital Sodium Sleep Duration Prolongation Test Before conducting the formal experiment, first conduct a preliminary experiment to determine the pentobarbital sodium dose (50 mg / kg·bw) that can make 100% of the animals fall asleep and the sleep time does not exceed 2 hours. After the animals are given distilled water and different concentrations of the test substance for the last time, 10 - 15 minutes before the peak effect, intraperitoneally inject pentobarbital sodium into each group of animals. The injection dose is 50 mg / kg·bw, the injection volume is 1.0 mL / 100g·bw, and the concentration of pentobarbital sodium prepared with physiological saline is 5 mg / mL. Using the disappearance of the righting reflex as an indicator, observe whether the test substance can prolong the sleep time induced by pentobarbital sodium.

[0041] (3) Subthreshold Dose Hypnotic Test of Pentobarbital Sodium Before the formal experiment, first conduct a preliminary experiment to determine that the subthreshold dose of pentobarbital sodium is 25 mg / kg·bw, the injection volume is 1.0 mL / 100g·bw, that is, the maximum subthreshold dose of pentobarbital sodium at which 80 - 90% of the mice do not have the righting reflex disappear. After the animals are given distilled water and different concentrations of the test substance for the last time, 10 - 15 minutes before the peak effect, intraperitoneally inject the maximum subthreshold hypnotic dose of pentobarbital sodium into each group of animals, and record the number of sleeping animals (those with the righting reflex disappearing for more than 1 minute) within 30 minutes.

[0042] (4) Barbiturate Sodium Sleep Latency Test Before conducting the formal experiment, first conduct a preliminary experiment to determine the barbiturate sodium dose (300 mg / kg·bw) that can make 100% of the animals fall asleep and the sleep time does not exceed 1 hour. 20 minutes after the animals are given distilled water and different concentrations of the test substance for the last time, intraperitoneally inject barbiturate sodium into each group of animals. The injection dose is 300 mg / kg·bw, the injection volume is 1.0 mL / 100g·bw, the concentration of barbiturate sodium prepared is 30 mg / mL, and 20 mL of this concentration of barbiturate sodium is prepared with physiological saline. Using the disappearance of the righting reflex as an indicator, observe the effect of the test substance on the sleep latency of barbiturate sodium.

[0043] 5. Statistical analysis of the test results Use SPSS 26.0 software to statistically analyze the experimental data results. The data are expressed as mean ± standard deviation, as shown in Table 1, Table 2, Table 3, and Table 4 specifically.

[0044] Table 1 Results of direct sleep test after 30 days of oral administration of traditional Chinese medicine composition Test group Animals that fell asleep (number) Blank control group 0 Example 1 group 0 Example 2 group 0 Example 3 group 0 Example 4 group 0 Example 5 group 0 As can be seen from Table 1, no direct sleep phenomenon occurred in each group.

[0045] Table 2 Results of pentobarbital sodium sleep time extension test after 30 days of oral administration of traditional Chinese medicine composition Test group Sleep time (min) Blank control group 51.2±11.9 Example 1 group 69.8±13.6 Example 2 group 62.5±12.7 Example 3 group 64.4±14.1 Example 4 group 55.0±11.3 Example 5 group 59.7±12.5 As can be seen from Table 2, compared with the blank control group, the sleep time of mice in each group given the traditional Chinese medicine compositions obtained in Examples 1-5 was significantly prolonged, and the effect of Example 1 was the best.

[0046] Table 3 Results of pentobarbital sodium subthreshold dose hypnosis test after 30 days of oral administration of traditional Chinese medicine composition Test group Animals that fell asleep (number) Blank control group 3 Example 1 group 3 Example 2 group 3 Example 3 group 4 Example 4 group 3 Example 5 group 4 As can be seen from Table 3, there was no significant difference in the number of animals falling asleep with pentobarbital sodium subthreshold dose in each dose group.

[0047] Table 4 Results of barbital sodium sleep latency test after 30 days of oral administration of traditional Chinese medicine composition Test group Sleep latency (min) Blank control group 62.1±12.9 Example 1 group 39.3±10.5 Example 2 group 48.7±12.1 Example 3 group 43.1±11.8 Example 4 group 54.9±12.4 Example 5 group 52.2±11.6 As can be seen from Table 4, compared with the blank control group, the sleep latency of mice in each group given the traditional Chinese medicine compositions obtained in Examples 1-5 was reduced.

[0048] In summary, the present invention first discovered that combining Urena lobata and Ainsliaea fragrans can obtain a traditional Chinese medicine composition that can assist in prolonging the sleep time of pentobarbital sodium in mice and significantly shortening the sleep latency of barbital sodium in mice, showing a significant effect on improving sleep quality. At the same time, in the preparation process, the present invention adopts the decompression reflux extraction method, and effectively improves the curative effect and medicinal efficacy stability of the traditional Chinese medicine composition by precisely controlling key parameters such as pressure and temperature in the extraction process, providing a new method for treating insomnia patients, having potential clinical application prospects and wide uses.

[0049] Various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity and should not be construed as a rigid limitation on the scope of the present invention; therefore, it should be considered that the range description has specifically disclosed all possible sub-ranges and single values within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within that range, such as 1, 2, 3, 4, 5, and 6, and this applies regardless of the range. Additionally, whenever a numerical range is indicated herein, it means including any recited number (fraction or integer) within the indicated range.

[0050] The above are only specific embodiments of the present invention, enabling those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for improving sleep quality, characterized in that, The traditional Chinese medicine composition comprises Urena lobata and Ainsliaea fragrans Champ.

2. The traditional Chinese medicine composition for improving sleep quality according to claim 1, wherein, The weight ratio of Urena lobata to Ainsliaea fragrans Champ. is (1 - 2) : (10 - 15).

3. The traditional Chinese medicine composition for improving sleep quality according to claim 1, wherein, The weight ratio of Urena lobata to Ainsliaea fragrans Champ. is 1.5 :

13.

4. A method for preparing a traditional Chinese medicine composition for improving sleep quality according to any one of claims 1 to 3, characterized in that, The preparation method comprises the following steps: Crush and mix Urena lobata and Ainsliaea fragrans Champ. to obtain a mixed material; Add the mixed material into water for reduced-pressure reflux extraction, then filter and concentrate and dry the obtained water extract to obtain the traditional Chinese medicine composition.

5. The preparation method of the traditional Chinese medicine composition for improving sleep quality according to claim 4, characterized in that, The working condition parameters of the reduced-pressure reflux extraction include: the extraction pressure is 7 kPa - 15 kPa, the extraction temperature is 47 °C - 61 °C, the extraction times are 1 - 3 times, and the extraction time for each time is 60 - 90 minutes.

6. The preparation method of the traditional Chinese medicine composition for improving sleep quality according to claim 5, wherein, The pressure of the reduced-pressure reflux extraction is 11 kPa.

7. The preparation method of the traditional Chinese medicine composition for improving sleep quality according to claim 6, characterized in that, The temperature of the reduced-pressure reflux extraction is 55 °C.

8. The preparation method of the traditional Chinese medicine composition for improving sleep quality according to claim 4, wherein, The weight ratio of the mixed material to water is 1 : (5 - 10).

9. Use of the traditional Chinese medicine composition for improving sleep quality according to any one of claims 1 - 3 or the traditional Chinese medicine composition obtained by the preparation method of the traditional Chinese medicine composition for improving sleep quality according to any one of claims 4 - 8 in the preparation of a product for improving sleep quality.

10. The application according to claim 9, characterized in that, The product includes at least one of drugs and health products.