Traditional Chinese medicine exosome compound

Abstract

The invention discloses a traditional Chinese medicine exosome compound which comprises the following traditional Chinese medicine compositions: 20% of spina date seeds, 20% of poria cocos, 10% of liquorice, 10% of lily, 10% of barley, 10% of ginseng, 10% of lotus seeds and 10% of red dates. According to the milk exosome composition, the medicinal and edible traditional Chinese medicine extract and the milk exosome composition are used as raw materials, and the traditional Chinese medicines and the milk exosome are reasonably matched and have a synergistic promotion effect. Experiments prove that the combination of the traditional Chinese medicine composition and the milk exosome has a synergistic effect, the medicine effect is better than that of the traditional Chinese medicine composition or the milk exosome which is independently used, and the application of the exosome in health care and conditioning is further enriched.

Description

Technical Field

[0001] The present invention relates to the technical field of health food and medicine, and in particular to a traditional Chinese medicine exosome complex. Background Art

[0002] Insomnia is the most common type of sleep disorder in clinical practice, which usually refers to the patient's subjective experience of insufficient sleep time and / or quality, which affects daily life. Insomnia is manifested as difficulty falling asleep (it takes more than 30 minutes to fall asleep), sleep maintenance disorders, early awakening, decreased sleep quality and reduced total sleep time (usually less than 6 hours), and also causes daytime dysfunction. Insomnia is generally accompanied by symptoms such as poor spirits, drowsiness, irritability, or depression during the day. Insomnia may increase the risk of traffic accidents, and may also cause people to lack concentration, fatigue at work, and poor learning results. Insomnia may be short-term, lasting from a few days to a week, or it may be long-term, lasting more than a month.

[0003] Epidemiological survey results show that the prevalence of chronic insomnia is between 6% and 30%.

[0004] Traditional Chinese medicine prescriptions have certain advantages in treating insomnia. The prior art discloses a variety of traditional Chinese medicine compositions that can be used to treat insomnia. For example, Chinese patent application "A pharmaceutical composition for treating insomnia and depression" (CN106421467A) discloses a pharmaceutical composition for treating insomnia, which includes the following raw materials in parts by weight: 4-20 parts of Albizzia julibrissin, 2-15 parts of Bupleurum chinense, 4-30 parts of Ziziphus jujuba seeds, 2-15 parts of Angelica sinensis, 4-30 parts of White Peony Root, 2-15 parts of Albizzia julibrissin, 2-15 parts of Polygala tenuifolia, 10-40 parts of Polygala chinensis, 5-40 parts of Jujube, 10-40 parts of Triticum tiliaceum, 1-12 parts of Licorice, 2-15 parts of Acorus calamus, and 2-15 parts of Mentha arvense. Long-term use of traditional Chinese medicine can cause psychological stress in patients and side effects of the medicine. In addition, many people find it difficult to accept the taste of traditional Chinese medicine. Therefore, it is necessary to provide an edible product for treating insomnia. Summary of the invention

[0005] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0006] The present invention discloses a traditional Chinese medicine exosome complex, which is made of the following ingredients and their weight percentages: a traditional Chinese medicine composition of 20% of Chinese jujube seeds, 20% of Poria cocos, 10% of liquorice, 10% of lily, 10% of barley, 10% of ginseng, 10% of lotus seeds and 10% of red dates. The exosome composition is a complex of 0.1% of milk exosomes and the above-mentioned traditional Chinese medicine mixed extracts.

[0007] As a preferred technical solution of the present invention, the preparation of the exosome composition comprises the following steps:

[0008] Step 1, weigh 20g of sour jujube kernel, 20g of Poria cocos, 10g of licorice, 10g of lily, 10g of barley, 10g of ginseng, 10g of lotus seeds, and 10g of red dates for later use;

[0009] Step 2: Add 10 times the total weight of the drug in water (m / v), soak for 1-2 hours, boil over high heat, then simmer for 30 minutes over low heat, filter, and retain the filtrate.

[0010] Step 3: Add 5 times the total weight of the drug in water m / v to the residue, boil over high heat, then simmer over low heat for 20 minutes, filter, and retain the filtrate 2;

[0011] Step 4: Combine filtrates 1 and 2, concentrate under reduced pressure to about 150 g, add 0.1 g of milk exosomes, mix well, and freeze-dry under vacuum to obtain the product.

[0012] As a preferred technical solution of the present invention, the Chinese medicine exosome complex includes one or more food or pharmaceutically acceptable excipients and diluents.

[0013] As a preferred technical solution of the present invention, the Chinese medicine exosome complex is a solid oral preparation or a liquid oral preparation.

[0014] As a preferred technical solution of the present invention, the exosomes are extracellular vesicles with a diameter of 30-150 nm.

[0015] As a preferred technical solution of the present invention, the use of the Chinese medicine exosome complex described in any one of claims 1-5 in the preparation of a product for regulating insomnia.

[0016] The beneficial effects of the present invention are:

[0017] 1. This Chinese medicine exosome complex uses exosomes as raw materials to prepare an exosome composition for regulating insomnia, which can improve sleep and insomnia and has no toxic side effects, thus developing a new use of exosomes;

[0018] 2. This Chinese medicine exosome complex, through the Chinese medicine exosome complex with the function of regulating insomnia, uses Chinese medicine extracts and exosome compositions as raw materials, and rationally combines Chinese medicine with exosomes, so that the two play a synergistic role. It has been verified by experiments that the combination of the two has a synergistic effect, and the efficacy is better than that of the Chinese medicine composition alone, overcoming the shortcomings of the long medication time and drug side effects of the Chinese medicine alone; the present invention further enriches the application of exosomes in Chinese medicine;

[0019] 3. The Chinese medicine exosome complex provides an application of the Chinese medicine exosome complex in the preparation of a product for treating insomnia.

[0020] 4. Exosomes are the smallest extracellular vesicles, with a diameter of 30–150nm, and are usually divided into cell-derived and body fluid-derived. In past studies, the use of exosomes for disease treatment has been very common due to their small size, low cytotoxicity, high drug loading and good tolerance. Milk exosomes have special properties different from cell-derived exosomes. Most milk exosomes are derived from milk. Due to their low cost, high yield and high safety, their application as an oral drug delivery system has greatly increased in recent years. Milk exosomes have been used as drug carriers to treat many diseases. Milk exosomes also have preventive and therapeutic effects on certain diseases, can prevent colorectal cancer, and have anti-inflammatory effects. Cow milk and breast milk exosomes have specific therapeutic effects on colitis, and can also slow the onset of arthritis, reduce cartilage loss and bone marrow inflammation. In addition, cow milk exosomes and goat milk exosomes also have certain antiviral capabilities, which has opened up a new path for the study of milk exosomes to treat viral diseases. In order to further exert the physiological effects of exosomes, the exosome composition is combined with the traditional Chinese medicine composition, and by optimizing the ratio of exosomes and the ratio of traditional Chinese medicine components, an exosome traditional Chinese medicine complex that can effectively improve the effect of regulating insomnia is finally obtained. The present invention not only expands the application of exosomes, but also enriches the application of exosomes in traditional Chinese medicine, and has high practical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention.

[0022] In the attached picture:

[0023] Figure 1 It is a schematic diagram of the steps for preparing an exosome composition of a traditional Chinese medicine exosome complex of the present invention. DETAILED DESCRIPTION

[0024] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0025] Example 1: Preparation of a Chinese medicine exosome complex for treating insomnia

[0026] Weigh 20g of sour jujube seeds, 20g of poria, 10g of licorice, 10g of lily, 10g of barley, 10g of ginseng, 10g of lotus seeds, and 10g of red dates, add 10 times the total weight of water m / v of the total weight of the drugs, soak for 1-2h, boil over high heat, simmer for 30min, filter, and retain filtrate one; add 5 times the total weight of water m / v of the drugs to the residue, boil over high heat, simmer for 20min, filter, and retain filtrate two; combine filtrates one and two, concentrate under reduced pressure to about 150g, add 0.1g of milk exosomes, mix evenly, and vacuum freeze-dry to obtain.

[0027] Example 2: Preparation of a Chinese medicinal and edible herbal composition (without exosomes) for treating insomnia Weigh 20 g of Chinese jujube kernel, 20 g of Poria cocos, 10 g of licorice, 10 g of lily, 10 g of barley, 10 g of ginseng, 10 g of lotus seeds, and 10 g of red dates, add 10 times the total weight of water (m / v) of the total weight of the drugs, soak for 1 to 2 hours, boil over high heat, simmer over low heat for 30 minutes, filter, and retain filtrate one; add 5 times the total weight of the drugs (m / v) of water (m / v) to the residue, boil over high heat, simmer over low heat for 20 minutes, filter, and retain filtrate two; combine filtrates one and two, concentrate under reduced pressure to about 150 g, and freeze-dry in vacuum to obtain the product.

[0028] Example 3: Preparation of Chinese herbal exosome composition capsules for treating insomnia

[0029] The steps are the same as those in Example 1. Before the final freeze drying, an appropriate amount of starch is added to obtain dry granules, which are then filled into capsules using a capsule filling machine. Usage: Take twice a day, 4 capsules each time.

[0030] Example 4: Preparation of Chinese herbal exosome composition granule capsules for treating insomnia

[0031] The steps are the same as those in Example 1. Before the final freeze drying, an appropriate amount of starch is added to obtain dry granules, which are packed into 10-gram bags. Usage: one bag per day.

[0032] Example 5: Clinical efficacy and safety of the drug of the present invention. 65 patients with insomnia were selected to conduct clinical observation on the therapeutic efficacy of the drug capsule of Example 1. All 65 patients had typical symptoms of insomnia, which lasted for more than 1 month. There were 30 males and 35 females, with a minimum age of 25 years old and a maximum age of 60 years old, and an average age of 37 years old. Systemic diseases such as pain, fever, cough, surgery, etc., as well as those caused by external environmental interference factors, those with serious primary diseases such as cardiovascular, lung, liver, kidney and hematopoietic system, and mental illness were excluded. The capsule of Example 1 was taken orally, twice a day, 4 capsules each time, and the treatment time was 3 months;

[0033] Efficacy evaluation criteria: Cured: sleep time returns to normal or sleep time at night is more than 6 hours, sleep is deep, and wakes up energetic. Remarkable effect: sleep is significantly improved, sleep time increases by more than 3 hours, and sleep depth increases. Effective: symptoms are alleviated, and sleep time increases by less than 3 hours compared with before. Ineffective: insomnia has no significant improvement or worsens after treatment. After 3 months of treatment, 65 patients were cured, 49 were markedly effective, 11 were ineffective, and 5 were ineffective. The total effective rate was 92%, and a relatively satisfactory effect was achieved.

[0034] Example 6: Blank control test. Starch mixed with 0.1% milk exosomes was used to make capsules, and 10 patients with insomnia were selected and clinically observed according to the method of Example 5. After three months, the total effective rate was 0%.

[0035] Example 7: Control experiment. 65 patients with insomnia were selected to conduct clinical observation on the therapeutic efficacy of the drug capsule of Example 2. The method was the same as that of Example 5. After 3 months of treatment, 39 of the 65 patients were cured, 9 were significantly effective, and 17 were ineffective. The total significant efficacy was 74%, which was worse than that of the milk exosome complex (Example 5). The experiment showed that the Chinese medicine exosome composition has obvious advantages in regulating insomnia.

[0036] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention is described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine exosome complex, characterized in that: The invention is prepared from the following ingredients and their weight percentages: a Chinese medicine composition of 20% Chinese jujube kernel, 20% Poria cocos, 10% liquorice, 10% lily, 10% barley, 10% ginseng, 10% lotus seed and 10% red date; the exosome composition is a complex of 0.1% milk exosomes and the above-mentioned mixed extracts of Chinese medicines.

2. A Chinese medicine exosome complex according to claim 1, characterized in that: The preparation of the exosome composition comprises the following steps: Step 1, weigh 20g of sour jujube kernel, 20g of Poria cocos, 10g of licorice, 10g of lily, 10g of barley, 10g of ginseng, 10g of lotus seeds, and 10g of red dates for later use; Step 2: Add 10 times the total weight of the drug in water (m / v), soak for 1-2 hours, boil over high heat, then simmer for 30 minutes over low heat, filter, and retain the filtrate. Step 3: Add 5 times the total weight of the drug in water m / v to the residue, boil over high heat, then simmer over low heat for 20 minutes, filter, and retain the filtrate 2; Step 4: Combine filtrates 1 and 2, concentrate under reduced pressure to about 150 g, add 0.1 g of milk exosomes, mix well, and freeze-dry under vacuum to obtain the product.

3. A Chinese medicine exosome complex according to claim 1, characterized in that: The traditional Chinese medicine exosome complex comprises one or more foods or pharmaceutically acceptable excipients and diluents.

4. A Chinese medicine exosome complex according to claim 1, characterized in that: The Chinese medicine exosome complex is a solid oral preparation or a liquid oral preparation.

5. The Chinese medicine exosome complex according to claim 1, characterized in that: The exosomes are extracellular vesicles with a diameter of 30–150 nm.

6. A Chinese medicine exosome complex according to claim 1, characterized in that: The use of the Chinese medicine exosome complex described in any one of claims 1-5 in the preparation of a product for treating insomnia.

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