Traditional Chinese medicine oral spray for improving insomnia and enhancing immunity and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine oral spray for improving insomnia and enhancing immunity and a preparation method thereof. The traditional Chinese medicine oral spray comprises the following components: a schisandra chinensis extract, ganoderma lucidum polysaccharide, a spina date seed extract, an American ginseng extract and a liquorice extract. Ganoderma lucidum has the effects of tonifying qi, soothing the nerves and relieving cough and asthma, and the extract obtained through water extraction contains ganoderma lucidum polysaccharide, so that sleep is improved, neurasthenia is relieved, and neurasthenia is relieved; the spina date seed is a traditional Chinese medicine, is sweet and sour in taste and mild and warm in nature, has the effects of nourishing the heart, benefiting the liver and soothing the nerves, is extracted from natural traditional Chinese medicines, and is stable in functional component, controllable in quality and exact in curative effect; the oral spray preparation can be quickly absorbed through oral capillary vessels and has high bioavailability.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine oral spray for improving insomnia and enhancing immunity, and a preparation method thereof. Background Art

[0002] In modern society, life, work and study are stressful and fast-paced. People suffering from insomnia are getting younger and younger. Different degrees of insomnia also affect physical health accordingly. Severe insomnia can even lead to depression. The clinical manifestations of insomnia are insufficient sleep time, insufficient sleep depth, inability to eliminate fatigue, etc. In mild cases, it is difficult to fall asleep, and in severe cases, it is unable to sleep at night, feeling weak after getting up, having headaches, palpitations, etc., which seriously affect normal life and work.

[0003] Most of the drugs for treating insomnia on the market are Western medicines, sedatives or hypnotic drugs. Long-term use will cause side effects such as dependence, drug resistance, and memory loss. Compared with Western medicines, natural Chinese medicines that promote sleep have better effects and safety, and are more cost-effective for young people.

[0004] In TCM theory, the imbalance of yin and yang among the five internal organs, the interaction between the heart and kidney, the malnutrition of the mind, and kidney deficiency and yin deficiency cause the body's functions to be in a state of over-excitement, making it impossible to fall asleep. Summary of the invention

[0005] In order to solve the technical problems existing in the above-mentioned prior art, the present invention proposes an important composition for improving insomnia and enhancing immunity, a Chinese medicine oral spray and a preparation method thereof. In the Chinese medicine composition of the present invention, Ganoderma lucidum can replenish qi and calm the mind, relieve cough and asthma, and the extract obtained by water extraction contains Ganoderma lucidum polysaccharide, which can improve sleep, relieve neurasthenia, and help relieve neurasthenia; Ziziphus jujuba seed is a Chinese medicine, which tastes sweet and sour, is mild and warm in nature, has the effects of nourishing the heart and liver, and calming the mind, is extracted from natural Chinese medicine, has stable effective ingredients, controllable quality, and definite efficacy; the oral spray preparation is absorbed quickly through the oral capillaries and has high bioavailability.

[0006] The technical solution of the present invention is achieved in this way:

[0007] One of the purposes of the present invention is to provide a Chinese medicine composition for improving insomnia and enhancing immunity, comprising the following raw materials in parts by weight: 20-40 parts of Schisandra chinensis, 20-30 parts of Ganoderma lucidum, 50-75 parts of Ziziphus jujuba seeds, 20-40 parts of American ginseng, 20-40 parts of Platycladus orientalis seeds, and 60-100 parts of Licorice.

[0008] Preferably, the Chinese medicine composition and conventional pharmaceutical excipients can be made into sprays, capsules, and granules.

[0009] The second object of the present invention is to provide a Chinese medicine oral spray for improving insomnia and enhancing immunity, wherein the Chinese medicine oral spray is made of the above-mentioned Chinese medicine composition and conventional pharmaceutical excipients.

[0010] The third object of the present invention is to provide a method for preparing a Chinese medicine oral spray for improving insomnia and enhancing immunity, the preparation method comprising the following steps:

[0011] (1) Preparation of Chinese medicine extracts: Ganoderma lucidum, American ginseng, cypress seed, and licorice are respectively prepared by water extraction to obtain ganoderma polysaccharide, American ginseng extract, cypress seed extract, and licorice extract; Schisandra chinensis extract is prepared by enzymatic hydrolysis; and Ziziphus jujuba seed extract is prepared by alcohol extraction;

[0012] (2) Preparation of Chinese medicine oral spray: The schisandra extract, zhining polysaccharide, American ginseng extract, licorice extract, spiny jujube seed extract, and platycladus seed extract obtained in step 1 are weighed in a mixing tank according to a proportion, heated to 80-100° C., stirred for 20-40 minutes, allowed to stand overnight, and the supernatant is filled to prepare an oral spray.

[0013] Preferably, the preparation method of the Schisandra extract is: crush the Schisandra and then sieve it, place the product in a reactor, add deionized water, the mass ratio of Schisandra to deionized water is 10:100-200, reflux extraction for 4-8 hours, cool to room temperature, centrifuge and separate to obtain the Schisandra extract.

[0014] Preferably, the preparation method of the cypress seed extract is: crush the cypress seed and then sieve it, place the product in a reactor, add deionized water, the mass ratio of cypress seed to deionized water is 10:100-200, reflux extraction for 4-8 hours, cool to room temperature, centrifuge and separate to obtain the cypress seed extract.

[0015] Preferably, the preparation method of the Zhining polysaccharide is as follows: the Ganoderma lucidum is crushed, the wall is broken, and the filter is filtered, and the supernatant is enzymatically hydrolyzed with glucanase at 20-30°C for 6-8h, and then the enzyme is inactivated at 100-105°C, the supernatant is allowed to stand, separated, and purified water is added to heat and reflux for 4-6h, cooled to room temperature, and centrifuged to obtain the supernatant Zhining polysaccharide solution.

[0016] Preferably, the preparation method of the American ginseng extract is: crush the American ginseng and then sieve it, place the product in a reactor, add deionized water, the mass ratio of American ginseng to deionized water is 10:100-200, reflux extraction for 4 to 8 hours, cool to room temperature, centrifuge and separate to obtain the American ginseng extract.

[0017] Preferably, the preparation method of the Chinese jujube seed extract is: crush the Chinese jujube seed and then sieve it, place the product in a reactor, add 75% ethanol, the mass ratio of Chinese jujube seed to ethanol is 10:80-120, soak and extract at 20-40°C for 12-24h, centrifuge and separate to obtain the Chinese jujube seed extract.

[0018] Preferably, the preparation method of the licorice extract is: pulverize the licorice and then sieve it, place the product in a reactor, add deionized water, the mass ratio of licorice to deionized water is 10:100-120, reflux extraction for 4-6 hours, cool to room temperature, centrifuge and separate to obtain the licorice extract.

[0019] The obtained oral spray comprises, by weight, 20-40 ml of Schisandra chinensis extract, 20-30 ml of Ganoderma lucidum extract, 50-75 ml of Ziziphus jujuba seed extract, 20-40 ml of American ginseng extract, 20-40 ml of Platycladus orientalis seed extract, 60-100 ml of Licorice extract per 1000 ml, and the rest is made up with purified water.

[0020] Modern pharmacological research has shown that Schisandra chinensis can promote the production of body fluids and replenish qi, calm the nerves and nourish the kidneys, improve the body's immune capacity, resist fatigue, astringe the body's body fluids, and nourish the lungs and kidneys. It can treat nervous system diseases and cardiovascular diseases. It can enhance the excitatory function of the central nervous system. It can improve the body's immune capacity. It can relieve fatigue, improve work efficiency, enhance the contractile function of the heart, improve blood circulation, and regulate the vascular system. It can also improve the function of the lungs, has obvious cough and expectorant effects, can also regulate the secretion of gastric juice, protect the liver, and has an inhibitory effect on Staphylococcus aureus.

[0021] Ganoderma lucidum replenishes qi and calms the mind, relieves cough and asthma. The extract obtained by water extraction contains ganoderma polysaccharide, which is a health-preserving and conditioning medicine that can significantly improve sleep conditions by adjusting the human nerves, internal organs and immune system. It can resist oxidation, delay aging, remove harmful substances from the body, and protect cell tissues and organs. It improves sleep and relieves neurasthenia, helps relieve neurasthenia, and stimulates the pituitary gland, which can enhance memory and invigorate the spirit. It has a calming and regulating effect on the central nervous system, slightly relaxes muscles, and can improve the patient's body immunity.

[0022] Ziziphus jujuba seed is a traditional Chinese medicine with sweet and sour taste, mild and warm nature. It has the effects of nourishing the heart and liver and calming the nerves. Patients with forgetfulness, insomnia and nightmares can achieve good therapeutic effects by taking Ziziphus jujuba seed appropriately.

[0023] Platycodon cypress seed is mild in nature and sweet in taste. It enters the heart meridian, kidney meridian, and large intestine meridian. It nourishes the heart and calms the mind, stops sweating, and is commonly used to treat insomnia, palpitations, and night sweats due to yin deficiency.

[0024] American ginseng can treat insomnia, especially insomnia caused by physical weakness due to dryness and heat. American ginseng contains some ingredients that can improve the central nervous system, achieve the effects of calming the mind, eliminating fatigue, and enhancing memory. It has very good therapeutic effects on insomnia, irritability, anxiety, memory loss and Alzheimer's disease. After American ginseng is extracted with water, it has a very good effect on improving insomnia symptoms, improving immunity, and especially improving related blood pressure and blood sugar. It has a good effect on blood pressure changes and difficulty falling asleep caused by diseases such as hypertension, coronary heart disease, and cerebral thrombosis.

[0025] The symptoms of this prescription are all caused by insufficient liver blood and internal heat due to yin deficiency. The liver stores blood, and blood houses the soul; the heart stores the spirit, and blood nourishes the heart. If the liver blood is insufficient, the soul will not stay in the house; the heart will lose its nourishment, and the yin deficiency will generate internal heat, and the internal heat will disturb the heart, so there will be insomnia, palpitations and restlessness. It is advisable to nourish blood to calm the mind and clear heat to eliminate restlessness. In the prescription, the Chinese date seed is used as the main ingredient. With its sweet and sour nature, it enters the meridians of the heart and liver, nourishes blood and nourishes the liver, and calms the mind and calms the mind. American ginseng replenishes qi and nourishes yin, clears heat and produces body fluid; Ganoderma lucidum replenishes qi and calms the mind, relieves cough and asthma, and is a minister medicine, which is combined with the main medicine to help calm the mind and eliminate restlessness. It is supplemented with cypress seeds to calm the mind and calm the mind, nourish yin and moisten dryness, clear heat and eliminate restlessness, and Schisandra chinensis nourishes the heart and kidneys, improves the body's immune ability, resists fatigue, astringes the body's body fluids, and nourishes the lungs and kidneys. Licorice is used to harmonize the middle and relieve urgency, and to reconcile the various medicines. The combination of these medicines can treat both the symptoms and the root cause, nourish the middle and clear the body, and replenish the body while promoting circulation. Together, they have the effects of nourishing blood and calming the mind, clearing away heat and relieving restlessness.

[0026] The fourth object of the present invention is to provide a device for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity, comprising a bottle sorting device, a rotating device, a filling device, a plugging device, a capping device and a capping device;

[0027] The bottle unscrambling device is used to sort the empty bottles and then transport them to the rotating device; the bottle unscrambling device includes a bottle unscrambling machine, and the bottle feeding track of the bottle unscrambling machine is connected to the bottle feeding port of the rotating device;

[0028] The rotating device can drive the bottles placed thereon to rotate successively to the bottom of the filling device, the plugging device, the capping device and the capping device;

[0029] The filling device can fill the prepared Chinese medicine oral spray into the empty bottle on the rotating device; the filling device includes a filling head that can move up and down, and a filling tube is arranged on the filling head;

[0030] The plugging device can press the bottle cork onto the bottle mouth after filling; the plugging device includes a plug vibration box and a plugging head, the plug vibration box can make the bottle cork fall to the bottle mouth through vibration, the plugging head can move up and down, and the plugging head can press the bottle cork onto the bottle mouth;

[0031] The capping device can cap the inner cap onto the bottle mouth equipped with the bottle stopper; the capping device comprises an inner cap vibration box and a capping head, the inner cap vibration box can make the inner cap fall to the bottle mouth by vibration, the capping head can move up and down, and the capping head can cap the inner cap onto the bottle mouth;

[0032] The capping device can press the outer cap onto the bottle mouth with the inner cap; the capping device comprises a cap hanging part and a capping head, the cap hanging part is used to fix the outer cap, and the capping head can move up and down to press the outer cap onto the bottle mouth.

[0033] Beneficial Effects

[0034] The beneficial effects of the present invention are summarized as follows:

[0035] 1. Extracted from natural Chinese medicine, the active ingredients are stable, the quality is controllable, and the efficacy is definite;

[0036] 2. Oral spray preparations are absorbed quickly through the oral capillaries and have high bioavailability;

[0037] 3. The raw materials are easy to obtain, and the extraction process is simple and easy to scale up. Among the raw materials involved in the present invention, Ganoderma lucidum, American ginseng, and licorice are extracted by water, Schisandra chinensis is extracted by enzymatic hydrolysis, and Ziziphus jujuba seeds are extracted by alcohol extraction, which is safe and effective, with a simple process and good market prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 : A schematic diagram of the structure of the device for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to the present invention;

[0039] Figure 2 : A schematic diagram of the side structure of the device for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to the present invention;

[0040] Figure 3 : A photo of the device for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to the present invention;

[0041] In the figure, 1: bottle unscrambling device; 2: rotating device; 3: filling device; 4: plugging device; 5: capping device; 6: capping device; 7: bottle unscrambling machine; 8: bottle feeding track; 9: filling head; 10: filling tube; 11: plug vibration box; 12: plugging head; 13: inner cover vibration box; 14: capping head; 15: cap hanging place; 16: capping head; 17: bottle outlet; 18: control panel. DETAILED DESCRIPTION

[0042] In order to deepen the understanding of the present invention, the Chinese medicine composition for improving insomnia and enhancing immunity of the present invention will be further described in detail below with reference to examples and drawings. The examples are only used to explain the present invention and do not constitute a limitation on the protection scope of the present invention.

[0043] Example 1

[0044] A method for preparing a Chinese medicine oral spray for improving insomnia and enhancing immunity, the formula is composed of Chinese medicines of Schisandra chinensis, Ganoderma lucidum, Ziziphus jujuba seeds, American ginseng, and Licorice through extraction process, wherein Schisandra chinensis is extracted by enzymatic hydrolysis, Ganoderma lucidum, American ginseng, Platycladus orientalis seeds, and Licorice is extracted by water, and Ziziphus jujuba seeds are extracted by alcohol. The specific preparation method is as follows:

[0045] (1) Preparation of Schisandra chinensis extract: The Schisandra chinensis was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:100, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain the Schisandra chinensis extract;

[0046] (2) Preparation of Semen Platycladi Extract: The Semen Platycladi was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:100, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain Schisandra chinensis extract;

[0047] (3) Preparation of Zhining polysaccharide: crush and break the wall of Ganoderma lucidum by weight, filter and hydrolyze the supernatant with glucanase, heat at 20°C for 6 hours, inactivate the enzyme at 100°C, let stand, separate and take the supernatant, add purified water and heat under reflux for 4 hours, cool to room temperature, and centrifuge to obtain the supernatant Zhining polysaccharide solution;

[0048] (4) Preparation of American ginseng extract: American ginseng was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:100, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain the American ginseng extract;

[0049] (5) Preparation of Semen Ziziphi Spinosae Extract: The Semen Ziziphi Spinosae was crushed and sieved, and the product was placed in a reactor, and 75% ethanol was added at a mass ratio of (10:80), and the mixture was soaked and extracted at 20° C. for 12 h, and centrifuged to obtain Semen Ziziphi Spinosae Extract;

[0050] (6) Preparation of licorice extract: Grind licorice and sieve the licorice. Place the product in a reactor and add deionized water at a mass ratio of 10:100. Reflux extraction for 4 hours, cool to room temperature, and centrifuge to obtain a licorice extract.

[0051] After the above-mentioned liquid medicine is prepared, it is weighed by weight in a mixing tank, heated to 80° C. and stirred for 20 minutes, left to stand overnight, and the supernatant is filled to prepare a spray.

[0052] The liquid medicine prepared by the above process contains, by weight, 20 ml of Schisandra chinensis extract, 20 ml of Ganoderma lucidum polysaccharide, 50 ml of Ziziphus jujuba seed extract, 20 ml of American ginseng extract, 60 ml of Licorice extract in every 1000 ml, and the rest is made up with purified water.

[0053] Example 2

[0054] A method for preparing a Chinese medicine oral spray for improving insomnia and enhancing immunity, the formula is composed of Chinese medicines such as Schisandra chinensis, Ganoderma lucidum, Ziziphus jujuba seeds, American ginseng, and Licorice through extraction processes, wherein Schisandra chinensis is extracted by enzymatic hydrolysis, Ganoderma lucidum, American ginseng, Platycladus orientalis seeds, and Licorice is extracted by water, and Ziziphus jujuba seeds are extracted by alcohol, and the specific method is as follows:

[0055] (1) Preparation of Schisandra chinensis extract: The Schisandra chinensis was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:110, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain the Schisandra chinensis extract;

[0056] (2) Preparation of Semen Platycladi Extract: The Semen Platycladi was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:110, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain Schisandra chinensis extract;

[0057] (3) Preparation of Zhining polysaccharide: crush and break the wall of Ganoderma lucidum by weight, filter and hydrolyze the supernatant with glucanase, heat at 25°C for 8h, inactivate the enzyme at 100°C, let stand, separate and take the supernatant, add purified water and heat under reflux for 4h, cool to room temperature, and centrifuge to obtain the supernatant Zhining polysaccharide solution;

[0058] (4) Preparation of American ginseng extract: American ginseng was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:110, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain the American ginseng extract;

[0059] (5) Preparation of Semen Ziziphi Spinosae Extract: The Semen Ziziphi Spinosae was crushed and sieved, the product was placed in a reactor, 75% ethanol was added at a mass ratio of (10:100), the mixture was soaked and extracted at 20°C for 12 hours, and centrifuged to obtain Semen Ziziphi Spinosae Extract;

[0060] (6) Preparation of licorice extract: Grind licorice and sieve the licorice. Place the product in a reactor and add deionized water at a mass ratio of 10:110. Reflux extraction for 4 hours, cool to room temperature, and centrifuge to obtain a licorice extract.

[0061] After the above-mentioned liquid medicine is prepared, it is weighed by weight in a mixing tank, heated to 85° C. and stirred for 30 minutes, left to stand overnight, and the supernatant is filled to prepare a spray.

[0062] The medicinal liquid prepared by the above process contains, by weight, 30 ml of Schisandra chinensis extract, 25 ml of Ganoderma lucidum polysaccharide, 50 ml of Ziziphus jujuba seed extract, 20 ml of American ginseng extract, 60 ml of Glycyrrhiza uralensis extract per 1000 ml, and the rest is made up with purified water. Specific embodiment 3

[0064] A method for preparing a Chinese medicine oral spray for improving insomnia and enhancing immunity, the formula is composed of Chinese medicines such as Schisandra chinensis, Ganoderma lucidum, Ziziphus jujuba seeds, American ginseng, Platycladus orientalis seeds, and Licorice root, etc., through extraction processes, wherein Schisandra chinensis is extracted by enzymatic hydrolysis, Ganoderma lucidum, American ginseng, and Licorice root are extracted by water, and Ziziphus jujuba seeds are extracted by alcohol, and the specific method is as follows:

[0065] (1) Preparation of Schisandra chinensis extract: The Schisandra chinensis was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:120, refluxed for 4 hours, cooled to room temperature, and centrifuged to obtain the Schisandra chinensis extract;

[0066] (2) Preparation of Semen Platycladi Extract: The Semen Platycladi was crushed and sieved, the product was placed in a reactor, deionized water was added at a mass ratio of 10:120, refluxed for 4.5 hours, cooled to room temperature, and centrifuged to obtain Schisandra chinensis extract;

[0067] (3) Preparation of Zhining polysaccharide: crush and break the wall of Ganoderma lucidum by weight, filter and hydrolyze the supernatant with glucanase, at 30°C for 8h, inactivate the enzyme at 105°C, let stand, separate and take the supernatant, add purified water and heat under reflux for 6h, cool to room temperature, and centrifuge to obtain the supernatant Zhining polysaccharide solution;

[0068] (4) Preparation of American ginseng extract: Grind American ginseng and sieve it, place the product in a reactor, add deionized water (preferably 10:200), reflux extraction for 8 hours, cool to room temperature, and centrifuge to obtain American ginseng extract;

[0069] (5) Preparing a Chinese jujube seed extract: grinding and sieving the Chinese jujube seeds, placing the product in a reactor, adding 75% ethanol (preferably 10:120), soaking and extracting at 40° C. for 24 hours, and centrifuging to obtain a Chinese jujube seed extract;

[0070] (6) Preparation of licorice extract: Grind licorice and sieve the licorice. Place the product in a reactor, add deionized water (preferably 10:120), reflux for 6 hours, cool to room temperature, and centrifuge to obtain a licorice extract.

[0071] After the above-mentioned liquid medicine is prepared, it is weighed by weight in a mixing tank, heated to 100° C. and stirred for 40 minutes, left to stand overnight, and the supernatant is filled to prepare a spray.

[0072] The liquid medicine prepared by the above process contains, by weight, 40 ml of Schisandra chinensis extract, 24 ml of Ganoderma lucidum polysaccharide, 55 ml of Ziziphus jujuba seed extract, 30 ml of American ginseng extract, 80 ml of Licorice extract in every 1000 ml, and the rest is made up with purified water.

[0073] Experimental example

[0074] Clinical Data

[0075] 1. General information: There are 30 patients in this group, including 15 males and 15 females; aged 30 to 75 years old, with an average age of 55 years old.

[0076] 2. Case selection: Patients with poor sleep due to insufficient Qi and blood as the main manifestation, such as difficulty falling asleep, easy waking after sleeping, frequent dreams, low voice, shortness of breath, dull complexion, spontaneous sweating, pale lips and tongue, numbness of hands and feet, scanty menstruation, etc. are the subjects of observation.

[0077] 3. Observation method: Orally take the Chinese medicine oral spray prepared in Example 2 of the present invention, and use it according to the instructions for use (spray it into the mouth and hold it sublingually, swallow it 1-2 minutes after absorption, and spray 6-9 times each time. Once a day, take it before going to bed. To ensure the absorption effect, you can drink water 15 minutes after taking it. You need to drink more water from the second day after taking it (it is recommended to drink ≥ 2L of water per day) to promote body circulation and accelerate absorption and metabolism.) Stop using other similar drugs or health products 3 weeks before using this product.

[0078] 4. Observation items: How fast you fall asleep, whether the number of awakenings during the night is reduced, dreaming, sleep duration, mood changes

[0079] 5. Results: Through clinical observation of 30 cases, the product was 100% effective in improving sleep, of which 34.17% were significantly effective, 53.33% were effective, and 12.50% felt good.

[0080] Stability test

[0081] The stability of three batches of oral spray produced continuously was investigated according to the guiding principles of stability test for drug preparations in the Chinese Pharmacopoeia. The stability test was carried out using a long-term test method under the packaging conditions of the oral spray. The inspection items included properties, content determination, microbial limits, etc. The test results are shown in Tables 1 to 3.

[0082] Test conditions: Temperature: 25℃±2℃

[0083] Relative humidity: 60% ± 10%

[0084] Observation period: 0, 6, 12, 18 months

[0085] Test samples: 1. Product batch number: 210811, 210812, 210813

[0086] 2. Production date: 2021.08.11, 2021.08.12, 2021.08.13

[0087] 3. Specification: 30ml / bottle

[0088] 4. Output: 100 / batch

[0089] Result analysis and conclusion: Three batches of samples produced continuously were tested in accordance with the draft quality standards for preparations and the provisions of the Chinese Pharmacopoeia. The results showed that in the 18-month long-term test, all indicators met the requirements and there were no significant changes.

[0090] According to the test results, it can be preliminarily determined that:

[0091] 1. The storage conditions of this preparation are sealed, which can fully meet the requirements and effectively ensure that the quality of this preparation does not change under this storage condition.

[0092] 2. The oral spray packaging form for pharmaceutical packaging is suitable for this preparation, which plays a sealing role and achieves the purpose of ensuring the stability of the preparation quality within the validity period.

[0093] 3. The stability of this preparation can reach more than 18 months.

[0094] Table 1 210811 batch long-term test data

[0095]

[0096] Table 2 210812 batch long-term test data

[0097]

[0098]

[0099] Table 3 210812 batch long-term test data

[0100]

[0101]

[0102] Example 4

[0103] A device for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity, comprising a bottle unscrambling device 1, a rotating device 2, a filling device 3, a plugging device 4, a capping device 5 and a capping device 6;

[0104] The bottle unscrambling device is used to sort the empty bottles and then transport them to the rotating device; the bottle unscrambling device includes a bottle unscrambling machine 7, and the bottle feeding track 8 of the bottle unscrambling machine is connected to the bottle feeding port of the rotating device 2;

[0105] The rotating device 2 can drive the bottles placed thereon to rotate successively to the bottom of the filling device 3, the plugging device 4, the capping device 5 and the capping device 6;

[0106] The filling device 3 can fill the prepared Chinese medicine oral spray into the empty bottles on the rotating device; the filling device includes a filling head 9 that can move up and down, and the filling head 9 is provided with two filling tubes 10, which can fill two bottles at the same time;

[0107] The plugging device 4 can press the bottle cork onto the bottle mouth after filling; the plugging device includes a plug vibration box 11 and a plugging head 12, the plug vibration box 11 can make the bottle cork fall to the bottle mouth by vibration, and the plugging head 12 can move up and down, and the plugging head 12 can press the bottle cork onto the bottle mouth;

[0108] The capping device 5 can cap the inner cap onto the bottle mouth with the bottle stopper; the capping device comprises an inner cap vibration box 13 and a capping head 14, the inner cap vibration box can make the inner cap fall to the bottle mouth by vibration, the capping head can move up and down, and the capping head can cap the inner cap onto the bottle mouth;

[0109] The capping device 6 can press the outer cap onto the bottle mouth with the inner cap; the capping device includes a cap hanging part 15 and a capping head 16, the cap hanging part is used to fix the outer cap, and the capping head can move up and down to press the outer cap onto the bottle mouth.

[0110] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for improving insomnia and enhancing immunity, It is characterized in that The invention comprises the following raw materials in parts by weight: 20-40 parts of schisandra chinensis, 20-30 parts of ganoderma lucidum, 50-75 parts of spiny jujube seeds, 20-40 parts of American ginseng and 60-100 parts of liquorice.

2. The Chinese medicine composition for improving insomnia and enhancing immunity according to claim 1, Features: The Chinese medicine composition and conventional pharmaceutical auxiliary materials can be made into sprays, capsules and granules.

3. A Chinese medicine oral spray for improving insomnia and enhancing immunity. Features: The Chinese medicine oral spray is made of the Chinese medicine composition according to claim 1 and conventional pharmaceutical excipients.

4. The method for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to claim 3, It is characterized in that The following steps are involved: (1) Preparation of Chinese herbal medicine extracts: Ganoderma lucidum, American ginseng, and licorice were extracted by water to obtain ganoderma polysaccharide, American ginseng extract, and licorice extract, respectively; Schisandra chinensis was hydrolyzed to obtain Schisandra chinensis extract; and Ziziphus jujuba seed was extracted by alcohol to obtain Ziziphus jujuba seed extract; (2) Preparation of Chinese medicine oral spray: The Schisandra chinensis extract, Zhining polysaccharide, American ginseng extract, Licorice extract, and Ziziphus jujuba seed extract obtained in step 1 are weighed in a mixing tank according to a proportion, heated and stirred, allowed to stand, and the supernatant is filled to prepare an oral spray.

5. The method for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to claim 4, Features: The preparation method of the schisandra extract comprises the following steps: crushing schisandra and then sieving, placing the product in a reactor, adding deionized water, wherein the mass ratio of schisandra to deionized water is 10:100-200, reflux extraction for 4-8 hours, cooling to room temperature, and centrifuging to obtain the schisandra extract.

6. The method for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to claim 4, Features: The preparation method of the Zhining polysaccharide is as follows: crush, break the wall and filter the Ganoderma lucidum, then enzymolyze the supernatant with glucanase at 20-30°C for 6-8h, then inactivate the enzyme at 100-105°C, let it stand, separate and take the supernatant, add purified water and heat to reflux for 4-6h, cool to room temperature, and centrifuge to obtain the supernatant Zhining polysaccharide solution.

7. The method for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to claim 4, Features: The preparation method of the American ginseng extract is as follows: crush American ginseng and then sieve it, place the product in a reactor, add deionized water, the mass ratio of American ginseng to deionized water is 10:100-200, reflux extraction for 4-8 hours, cool to room temperature, centrifuge and separate, and obtain the American ginseng extract.

8. The method for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to claim 4, Features: The preparation method of the Chinese jujube seed extract is as follows: crushing the Chinese jujube seeds and then sieving them, placing the product in a reactor, adding 75% ethanol, the mass ratio of the Chinese jujube seeds to the ethanol being 10:80-120, soaking and extracting at 20-40° C. for 12-24 hours, and centrifuging to obtain the Chinese jujube seed extract.

9. The method for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity according to claim 4, Features: The preparation method of the licorice extract comprises the following steps: crushing licorice and then sieving the licorice, placing the product in a reactor, adding deionized water, wherein the mass ratio of licorice to deionized water is 10:100-120, reflux extraction for 4-6 hours, cooling to room temperature, and centrifuging to obtain the licorice extract.

10. A device for preparing the Chinese medicine oral spray for improving insomnia and enhancing immunity as claimed in claim 3, Features: The device comprises a bottle unscrambling device, a rotating device, a filling device, a plugging device, a capping device and a capping device; The bottle unscrambling device is used to sort the empty bottles and then transport them to the rotating device; the bottle unscrambling device includes a bottle unscrambling machine, and the bottle feeding track of the bottle unscrambling machine is connected to the bottle feeding port of the rotating device; The rotating device can drive the bottles placed thereon to rotate successively to the bottom of the filling device, the plugging device, the capping device and the capping device; The filling device can fill the prepared Chinese medicine oral spray into the empty bottle on the rotating device; the filling device includes a filling head that can move up and down, and a filling tube is arranged on the filling head; The plugging device can press the bottle cork onto the bottle mouth after filling; the plugging device includes a plug vibration box and a plugging head, the plug vibration box can make the bottle cork fall to the bottle mouth through vibration, the plugging head can move up and down, and the plugging head can press the bottle cork onto the bottle mouth; The capping device can cap the inner cap onto the bottle mouth equipped with the bottle stopper; the capping device comprises an inner cap vibration box and a capping head, the inner cap vibration box can make the inner cap fall to the bottle mouth by vibration, the capping head can move up and down, and the capping head can cap the inner cap onto the bottle mouth; The capping device can press the outer cap onto the bottle mouth with the inner cap; the capping device comprises a cap hanging part and a capping head, the cap hanging part is used to fix the outer cap, and the capping head can move up and down to press the outer cap onto the bottle mouth.

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