Preparation method and application of gamma-aminobutyric acid embedded cassava starch-beta-cyclodextrin nanoparticles

Abstract

The invention discloses a preparation method and application of cassava starch-beta-cyclodextrin nanoparticles embedded with gamma-aminobutyric acid, and the preparation method comprises the following steps: step 1), preparing nanoparticles from cassava starch suspension and beta-cyclodextrin, and then preparing a solution; and 2) preparing a gamma-aminobutyric acid solution, and mixing the prepared gamma-aminobutyric acid solution with the nanoparticle solution in the step 1). The cassava starch-beta-cyclodextrin nanoparticles of gamma-aminobutyric acid can improve the stability of gamma-aminobutyric acid, further improve the sleep quality of gamma-aminobutyric acid, and have practical application value in medicine production.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and specifically relates to a preparation method and application of cassava starch-beta-cyclodextrin nanoparticles embedded with gamma-aminobutyric acid. Background Art

[0002] γ-Aminobutyric acid is a neurotransmitter and an important inhibitory neuromodulator. It is widely present in animals and microorganisms. It inhibits the excitability of neurons by binding to receptors, thereby regulating neurotransmission and neural electrical activity. It is essential for maintaining the balance and normal function of the nervous system, and has multiple biological functions such as regulating neurotransmission, sleep, mood, and neural development.

[0003] However, the effect of adding γ-aminobutyric acid to food in the prior art is not ideal. The present invention has found through research that preparing γ-aminobutyric acid into cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid can improve its stability and medicinal effect. Summary of the invention

[0004] In view of the problem that the use effect of γ-aminobutyric acid in the prior art is not ideal, the present invention provides a preparation method and application of cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid. It is found through research that the cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid prepared by the present invention can improve the stability of γ-aminobutyric acid, and the cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid have a good effect of regulating and improving sleep.

[0005] The present invention first provides a method for preparing cassava starch-β-cyclodextrin nanoparticles embedded with γ-aminobutyric acid, which comprises the following steps:

[0006] Step 1), preparing nanoparticles (TS-β-CD-NPs) using cassava starch suspension and β-cyclodextrin, and then preparing a solution;

[0007] Step 2), prepare a γ-aminobutyric acid solution, and mix the prepared γ-aminobutyric acid solution with the TS-β-CD-NPs solution of step 1) to obtain γ-aminobutyric acid cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs).

[0008] The present invention also provides the use of cassava starch-β-cyclodextrin nanoparticles of gamma-aminobutyric acid obtained by the preparation method of the present invention in the preparation of drugs for protecting the nervous system.

[0009] The present invention also provides the use of cassava starch-β-cyclodextrin nanoparticles of gamma-aminobutyric acid obtained by the preparation method of the present invention in the preparation of drugs for improving sleep.

[0010] The present invention also provides a pharmaceutical composition, which contains γ-aminobutyric acid cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs) obtained by the preparation method of the present invention.

[0011] The present invention has the following beneficial effects:

[0012] 1) The embedding rate of γ-aminobutyric acid in the cassava starch-β-cyclodextrin nanoparticles of γ-aminobutyric acid prepared by the preparation method of the present invention is greatly improved, and the stability of γ-aminobutyric acid is also improved.

[0013] 2) The cassava starch-β-cyclodextrin nanoparticles of γ-aminobutyric acid prepared by the preparation method of the present invention improve the medicinal effect of γ-aminobutyric acid in improving sleep, and have practical application value in pharmaceutical production. DETAILED DESCRIPTION

[0014] In order to make the purpose, 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. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Unless otherwise expressly stated, throughout the specification and claims, the term "comprising" or its variations such as "including" or "including" will be understood to include the stated components or steps, without excluding other material components or steps.

[0015] In addition, in order to better illustrate the present invention, numerous specific details are given in the following detailed description.

[0016] Those skilled in the art will appreciate that the present invention can be implemented without certain specific details. In some embodiments, raw materials, methods, means, etc. that are well known to those skilled in the art are not described in detail in order to highlight the main purpose of the present invention.

[0017] Unless otherwise defined, all scientific and technical terms used in the present invention have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention relates.

[0018] In the present invention, the structural formula and Chinese name of the compound used are as follows:

[0019] In the present invention, the term "TS" refers to tapioca starch;

[0020] The term "β-CD" is β-cyclodextrin;

[0021] The term “CS” is corn starch;

[0022] The term “NPs” refers to nanoparticles;

[0023] The term "GABA" is gamma-aminobutyric acid.

[0024] The term "GABA-TS-β-CD-NPs" refers to tapioca starch-β-cyclodextrin nanoparticles of γ-aminobutyric acid.

[0025] In the present invention, the term "room temperature" refers to that the temperature of an article is close to or the same as the temperature of a space (e.g., a place in a fume hood in which the article is located). Typically, the room temperature is about 20°C to about 30°C, or about 22°C to 27°C, or about 25°C.

[0026] The present invention first provides a method for preparing cassava starch-β-cyclodextrin nanoparticles embedded with γ-aminobutyric acid, which comprises the following steps:

[0027] Step 1), using cassava starch suspension and β-cyclodextrin to prepare cassava starch and β-cyclodextrin nanoparticles, and then preparing cassava starch and β-cyclodextrin nanoparticle solution; the preparation of the cassava starch suspension includes the following steps: 1) dissolving cassava starch in water, heating up for gelatinization, and then cooling to room temperature; 2) ultrasonicating the gelatinized product obtained in step 1; the water described in step 1) is preferably deionized water; the heating gelatinization temperature is 80-100°C, preferably 90°C; the gelatinization time is 0.5-5h, preferably 1h; cooling is cooled with running water. Step 2) The gelatinized product is ultrasonically treated in two stages, the first stage is ultrasonically treated at 600W for 30-60min, and the second stage is ultrasonically treated at 300W for adding an organic solvent, the organic solvent is preferably ethanol, and then ultrasonically treated for 10-40min. It further includes the step of removing the organic solvent by rotation.

[0028] Step 2), prepare a γ-aminobutyric acid solution, and mix the prepared γ-aminobutyric acid solution with the nanoparticle solution of step 1) to obtain γ-aminobutyric acid cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs).

[0029] Preferably, in the above preparation method, the preparation of the cassava starch suspension in step 1) further comprises the step of removing the organic solvent by rotation.

[0030] Preferably, in the above preparation method, in step 1), the mass ratio of cassava starch to β-cyclodextrin is 1:5-5:1, preferably 1:2-2:1, and particularly preferably 1:2, 1:1, 2:1.

[0031] Preferably, in the above preparation method, the preparation of cassava starch and β-cyclodextrin nanoparticles in step 1) further comprises the following process: mixing the cassava starch suspension and β-cyclodextrin, dissolving them in deionized water, stirring at 40-60°C for 4-8h, stirring evenly, centrifuging, and freeze-drying to obtain cassava starch and β-cyclodextrin nanoparticles. Preferably, stirring is performed at 50°C and the stirring speed is 700rpm;

[0032] Preferably, in the above preparation method, in step 1), preparing nanoparticles with cassava starch and β-cyclodextrin and then preparing the solution further comprises the following process: dissolving the cassava starch and β-cyclodextrin nanoparticles obtained by freeze drying to obtain a nano suspension.

[0033] The above preparation method, step 2) prepares a γ-aminobutyric acid solution, and mixes it with the nanoparticle solution of step 1) comprises the following steps: dissolving γ-aminobutyric acid in deionized water to obtain a γ-aminobutyric acid solution, and then dissolving the γ-aminobutyric acid solution, potato starch and β-cyclodextrin nanoparticles to obtain a nanosuspension, mixing and stirring the mixture evenly, and freeze-drying to obtain GABA-TS-β-CD-NPs.

[0034] The GABA-TS-β-CD-NPs prepared under the preferred preparation conditions of the present invention have better performance, for example, the embedding rate and medicinal effect of γ-aminobutyric acid are improved.

[0035] The present invention also provides an application of the GABA-TS-β-CD-NPs obtained according to the preparation method of the present invention in preparing drugs for protecting the nervous system.

[0036] The present invention also provides an application of the GABA-TS-β-CD-NPs obtained according to the preparation method of the present invention in the preparation of a drug for improving sleep.

[0037] The present invention also provides a pharmaceutical composition, which contains the GABA-TS-β-CD-NPs obtained according to the above preparation method of the present invention.

[0038] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be considered as limiting the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be obtained commercially.

[0039] Example 1. Preparation of cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid

[0040] 2g of cassava starch was dissolved in 100mL of deionized water, mixed thoroughly, and heated in a 90℃ water bath for 1 hour until completely gelatinized. Subsequently, it was quickly cooled to room temperature with running water, followed by ultrasonic treatment at 600W for 30 minutes. Thereafter, 50mL of anhydrous ethanol was added under 300W ultrasonic conditions, and ultrasonic treatment was continued for 30 minutes, and then the ethanol was removed by rotary evaporation to obtain a cassava starch suspension. The obtained cassava starch suspension was mixed with 2g of β-cyclodextrin and fixed to 100ml with deionized water. The mixture was magnetically stirred at 700rpm for 6 hours at 50℃ to ensure sufficient mixing. After stirring, centrifugation was performed and TS-β-CD-NPs were obtained by freeze drying. 300mg of TS-β-CD-NPs was dissolved in 10mL of deionized water to obtain a nanosuspension. At the same time, 60mg of γ-aminobutyric acid was dissolved in 5mL of deionized water to obtain a γ-aminobutyric acid solution. The obtained γ-aminobutyric acid solution was mixed with the above nanosuspension and stirred evenly at 600 rpm, and finally cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs) encapsulating γ-aminobutyric acid were obtained by freeze-drying.

[0041] Example 2 Preparation of cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid

[0042] 2g of cassava starch was dissolved in 100mL of deionized water, mixed thoroughly, and heated in a 90℃ water bath for 1 hour until completely gelatinized. Subsequently, it was quickly cooled to room temperature with running water, followed by ultrasonic treatment at 300W for 30 minutes. Thereafter, 50mL of anhydrous ethanol was added under 300W ultrasonic conditions, and ultrasonic treatment was continued for 30 minutes, and then the ethanol was removed by rotary evaporation to obtain a cassava starch suspension. The obtained cassava starch suspension was mixed with 2g of β-cyclodextrin and fixed to 100ml with deionized water. The mixture was magnetically stirred at 700rpm for 6 hours at 50℃ to ensure sufficient mixing. After stirring, centrifugation was performed and TS-β-CD-NPs were obtained by freeze drying. 300mg of TS-β-CD-NPs was dissolved in 10mL of deionized water to obtain a nanosuspension. At the same time, 60mg of γ-aminobutyric acid was dissolved in 5mL of deionized water to obtain a γ-aminobutyric acid solution. The γ-aminobutyric acid solution was mixed with the nanosuspension and stirred evenly at 600 rpm, and finally cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs) encapsulating γ-aminobutyric acid were obtained by freeze-drying.

[0043] Example 3 Preparation of corn starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid

[0044] 2g corn starch was dissolved in 100mL deionized water, mixed thoroughly, and heated in a 90℃ water bath for 1 hour until completely gelatinized. Subsequently, it was quickly cooled to room temperature with running water, followed by ultrasonic treatment at 600W for 30 minutes. Thereafter, 50mL of anhydrous ethanol was added under 300W ultrasonic conditions, and ultrasonic treatment was continued for 30 minutes, and then the ethanol was removed by rotary evaporation to obtain a corn starch suspension. The obtained corn starch suspension was mixed with 2g of β-cyclodextrin and fixed to 100ml with deionized water. The mixture was magnetically stirred at 700rpm for 6 hours at 50℃ to ensure sufficient mixing. After stirring, centrifugation was performed and TS-β-CD-NPs were obtained by freeze drying. 300mg TS-β-CD-NPsNPs were dissolved in 10mL deionized water to obtain a nanosuspension. At the same time, 60mg of γ-aminobutyric acid was dissolved in 5mL deionized water to obtain a γ-aminobutyric acid solution. The γ-aminobutyric acid solution was mixed with the nanosuspension and stirred evenly at 600 rpm, and finally the γ-aminobutyric acid-encapsulated corn starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs) were obtained by freeze-drying.

[0045] Example 4 Preparation of γ-aminobutyric acid-encapsulated cassava starch-β-cyclodextrin nanoparticles

[0046] 2g of cassava starch was dissolved in 100mL of deionized water, mixed thoroughly, and heated in a 90℃ water bath for 1 hour until completely gelatinized. Subsequently, it was quickly cooled to room temperature with running water, followed by ultrasonic treatment at 600W for 30 minutes. Thereafter, 50mL of anhydrous ethanol was added under 300W ultrasonic conditions, and ultrasonic treatment was continued for 30 minutes, and then the ethanol was removed by rotary evaporation to obtain a cassava starch suspension. The obtained cassava starch suspension was mixed with 4g of β-cyclodextrin and fixed to 100ml with deionized water. The mixture was magnetically stirred at 700rpm for 6 hours at 50℃ to ensure sufficient mixing. After stirring, centrifugation was performed and TS-β-CD-NPs were obtained by freeze drying. 300mg of TS-β-CD-NPs was dissolved in 10mL of deionized water to obtain a nanosuspension. At the same time, 60mg of γ-aminobutyric acid was dissolved in 5mL of deionized water to obtain a γ-aminobutyric acid solution. The γ-aminobutyric acid solution was mixed with the nanosuspension and stirred evenly at 600 rpm, and finally γ-aminobutyric acid-encapsulated cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs) were obtained by freeze-drying.

[0047] Example 5 Preparation of cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid

[0048] 2g of cassava starch was dissolved in 100mL of deionized water, mixed thoroughly, and heated in a 90℃ water bath for 1 hour until completely gelatinized. Subsequently, it was quickly cooled to room temperature with running water, followed by ultrasonic treatment at 600W for 30 minutes. Thereafter, 50mL of anhydrous ethanol was added under 300W ultrasonic conditions, and ultrasonic treatment was continued for 30 minutes, and then the ethanol was removed by rotary evaporation to obtain a cassava starch suspension. The obtained cassava starch suspension was mixed with 1g of β-cyclodextrin and fixed to 100ml with deionized water. The mixture was magnetically stirred at 700rpm for 6 hours at 50℃ to ensure sufficient mixing. After stirring, centrifugation was performed and TS-β-CD-NPs were obtained by freeze drying. 300mg of TS-β-CD-NPs was dissolved in 10mL of deionized water to obtain a nanosuspension. At the same time, 60mg of γ-aminobutyric acid was dissolved in 5mL of deionized water to obtain a γ-aminobutyric acid solution. The γ-aminobutyric acid solution was mixed with the nanosuspension and stirred evenly at 600 rpm, and finally cassava starch-β-cyclodextrin nanoparticles (GABA-TS-β-CD-NPs) encapsulating γ-aminobutyric acid were obtained by freeze-drying.

[0049] Example 6 Determination of γ-aminobutyric acid embedding rate

[0050] The free GABA content in the supernatant of GABA-TS-β-CD-NPs and GABA-CS-β-CD-NPs was detected by HPLC. Prepare 1 ml of GABA-TS-β-CD-NPs and GABA-CS-β-CD-NPs nanoparticle suspension, centrifuge for 30 seconds in a high-speed refrigerated centrifuge, wash the precipitate three times with an equal volume of ultrapure water, collect all the supernatant, filter it through a 0.22 μm filter membrane, add it to the liner tube, and place it in a liquid phase vial for detection. The embedding rate calculation method is as follows:

[0051]

[0052] Where: M1 represents the total amount of GABA added (mg), M2 represents the amount of free (unencapsulated) GABA (mg)

[0053] Table 1 Test results of encapsulation efficiency of GABA-TS-β-CD-NPs and GABA-CS-β-CD-NPs

[0054]

[0055] Example 7 In vitro simulated digestion experiment

[0056] 1. Preparation of artificial gastric juice and artificial intestinal juice

[0057] Artificial gastric juice: add pepsin to an appropriate amount of 0.1mol / L HCl solution to control the final concentration to 4mg / mL. Artificial intestinal juice: add trypsin to an appropriate amount of 0.1mol / L sodium bicarbonate solution to control the final concentration to 2mg / mL, and then mix with an equal volume of 12mg / mL sodium bile salt.

[0058] 2. In vitro simulated digestion experiment

[0059] Prepare four 100mL stoppered conical flasks, add 25mL of physiological saline and 4mL of artificial gastric juice respectively, mix well, and adjust the pH value to 2.0-2.5 with hydrochloric acid standard solution. Add 15mg of GABA standard product to two of them, and add an equal amount of GABA-TS-β-CD-NPs prepared in Example 1 to the other two. After mixing, extract the solution once, then add NaHCO3 and put it in a constant temperature water bath at 37℃ for shaking (100r / min) for 2h. Take two bottles of artificial gastric juice for digestion for 1h and then add artificial intestinal juice for digestion.

[0060] Add 4 ml of normal saline to the above solution digested with artificial gastric juice for 1 h, adjust the pH of the solution to 6.5-7.0 with 0.5 mol / L NaHCO3 solution, and shake in a constant temperature water bath (37°C, 100 r / min). Then add 18 mL of artificial intestinal juice, adjust the pH to 7.0-7.5, and shake in a constant temperature water bath (37°C, 100 r / min) for 3 h.

[0061] All the sample solutions were filtered using a 0.22 um filter membrane after ice bath, ultrasonically treated for 20 min, and analyzed by HPLC.

[0062] According to the content of GABA and GABA-TS-β-CD-NPs measured by HPLC after simulated digestion in vitro, after 2 hours of simulated gastric juice digestion, the degradation rate of GABA was 25.3%, and the degradation rate of GABA-TS-β-CD-NPs was 14.5%; after 3 hours of simulated intestinal juice digestion, the degradation rate of GABA was 37.9%, and the degradation rate of GABA-TS-β-CD-NPs was 21.2%. GABA-TS-β-CD-NPs can effectively reduce the degradation rate of GABA in the gastric environment, and be targeted to the intestine to exert its effect, thereby improving the utilization rate of GABA to a certain extent.

[0063] Example 8 Evaluation of the sleep effect of GABA-CS-CNC-NPs

[0064] 80 quarantined male ICR mice (SPF grade) were selected and randomly divided into 8 groups (n = 10) according to body weight, including normal control group, diazepam tablet group (1.3 mg / kg), GABA low, medium and high dose groups (50, 100, 150 mg / kg), GABA-TS-β-CD-NPs low, medium and high dose groups (50, 100, 150 mg / kg). After 1 week of adaptive feeding, mice were continuously gavaged once a day for 7 days. All mice received sample management and behavioral tests between 9:00 and 11:00 AM.

[0065] Pentobarbital sodium prolongs sleep time experiment

[0066] 30 min after the last gavage, all mice were intraperitoneally injected with a suprathreshold dose of sodium pentobarbital (50 mg / kg), and the mice were placed on a warm pad (37 °C) with their abdomen facing upward. The sleep latency (the time from the start of sodium pentobarbital injection to the disappearance of the righting reflex) and sleep duration (the time from the disappearance of the righting reflex to the recovery of the righting reflex) were recorded, and mice that did not fall asleep within 15 min were excluded from the experiment.

[0067] Subthreshold dose hypnosis experiment of sodium pentobarbital

[0068] 30 min after the last oral gavage, all mice were intraperitoneally injected with a subthreshold dose of sodium pentobarbital (40 mg / kg), and the mice were placed on a warm pad (37 °C) with their abdomen facing upward. The loss of righting reflex for more than 1 min was used as the criterion for falling asleep, and the number of mice falling asleep in each group was recorded.

[0069] Table 2 Pentobarbital sodium prolongs sleep time experiment (n=10)

[0070]

[0071] Note: GABA-TS-β-CD-NPs in Table 2 were prepared according to the method of Example 1. * is compared with the control group, P < 0.05, ** is compared with the control group, P < 0.001; # is compared with the GABA high-dose group, P < 0.05

[0072] Table 3 Subthreshold dose hypnosis experiment of sodium pentobarbital (n=10)

[0073]

[0074] Note: The GABA-TS-β-CD-NPs in Table 3 were prepared according to the method of Example 1.

[0075] As shown in Tables 2 and 3, the results of the sodium pentobarbital sleep time extension experiment and the sodium pentobarbital subthreshold dose hypnosis experiment were positive, proving that GABA-TS-β-CD-NPs have the effect of improving sleep, and the high-dose group of GABA-TS-β-CD-NPs significantly improved the sleep extension time of mice compared with the high-dose group of GABA.

[0076] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing cassava starch-β-cyclodextrin nanoparticles embedded with γ-aminobutyric acid, characterized in that: The steps include: Step 1), using cassava starch suspension and β-cyclodextrin to prepare nanoparticles, and then preparing cassava starch and β-cyclodextrin nanoparticle solution; the mass ratio of cassava starch to β-cyclodextrin is 1:5-5:1; the preparation of the cassava starch suspension includes the following steps: 1) dissolving cassava starch in water, heating up for gelatinization, and then cooling to room temperature; the water is deionized water; the heating and gelatinization temperature is 80-100°C; the gelatinization time is 0.5-5h; cooling is done with running water; 2) ultrasonically treating the gelatinized material obtained in step 1; Step 2), prepare a γ-aminobutyric acid solution, and mix the prepared γ-aminobutyric acid solution with the cassava starch and β-cyclodextrin nanoparticle solution obtained in step 1) to obtain cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid.

2. The preparation method according to claim 1, characterized in that: The heating gelatinization temperature is 90°C.

3. The preparation method according to claim 2, characterized in that: The gelatin is ultrasonically treated in two stages. The first stage is ultrasonically treated at 600W for 30-60min. The second stage is ultrasonically treated at 300W for 10-40min by adding an organic solvent, which is ethanol.

4. The preparation method according to claim 3, characterized in that: The paste ultrasonic process further comprises the step of removing the organic solvent by rotation.

5. The preparation method according to claim 4, characterized in that: In step 1), the mass ratio of cassava starch to β-cyclodextrin is 1:2-2:

1.

6. The preparation method according to claim 5, characterized in that: The preparation of cassava starch suspension and β-cyclodextrin nanoparticles in step 1) also includes the following process: mixing the cassava starch suspension and β-cyclodextrin, dissolving them in deionized water, stirring at 40-60° C. for 4-8 hours, stirring evenly, centrifuging, and freeze-drying to obtain cassava starch and β-cyclodextrin nanoparticles.

7. The preparation method according to claim 6, characterized in that: In step 1), the nanoparticles are prepared by using cassava starch and β-cyclodextrin, and then the solution is prepared, which further comprises the following process: the cassava starch and β-cyclodextrin nanoparticles obtained by freeze drying are dissolved in deionized water to obtain a suspension of cassava starch and β-cyclodextrin nanoparticles.

8. The preparation method according to claim 1, characterized in that: Step 2), preparing a γ-aminobutyric acid solution, and mixing the prepared γ-aminobutyric acid solution with the cassava starch and β-cyclodextrin nanoparticle solution of step 1), comprising the following steps: dissolving γ-aminobutyric acid in deionized water to obtain a γ-aminobutyric acid solution, and then dissolving the γ-aminobutyric acid solution, yam starch and β-cyclodextrin nanoparticles to obtain a nanosuspension, mixing and stirring the γ-aminobutyric acid solution, and freeze-drying to obtain cassava starch-β-cyclodextrin nanoparticles encapsulating γ-aminobutyric acid.

9. Use of cassava starch-β-cyclodextrin nanoparticles embedded with γ-aminobutyric acid obtained by the preparation method according to claim 1 in the preparation of drugs for improving sleep.

10. A pharmaceutical composition, characterized in that The invention relates to cassava starch-β-cyclodextrin nanoparticles containing γ-aminobutyric acid embedded therein obtained by the preparation method according to claim 1.

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