Jingzhi mind calming oral liquid as well as preparation method and application thereof

Abstract

The invention relates to Jingzhi mind calming oral liquid as well as a preparation method and application thereof. The preparation method comprises the following steps: crushing and sieving rhizoma acori graminei and tortoise plastron, carrying out CO2 supercritical extraction, adding an extract into a separation kettle for separation, collecting volatile oil for storage, and concentrating the rest extract under reduced pressure to prepare a concentrated solution; crushing a mixture of polygala tenuifolia, rhodiola rosea and fossil fragments, adding an ethanol solution for ultrasonic reflux extraction, collecting an ethanol extracting solution, adding compound enzyme into filter residues for fermentation, enzyme deactivation and ultrasonic extraction, merging with the ethanol extracting solution, and concentrating under reduced pressure to prepare a concentrated solution; taking a proper amount of honey to prepare refined honey, putting the volatile oil, the concentrated solution and the refined honey into a preparation tank, adding an aqueous solution containing potassium sorbate, uniformly mixing, filtering, and sub-packaging to obtain the product. Compared with the existing national standard method, the preparation method provided by the invention has the advantages of simpler steps, improved extraction efficiency, more effective component extraction amount, shortened total time and reduced cost, and has very important clinical application value and commercial value.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a Jingzhi Anshen Oral Liquid, a preparation method thereof and uses thereof. Background Art

[0002] The implementation standard of Jingzhi Anshen Oral Liquid is the national drug standard WS-5126(B-0126)-2002, and it is a non-prescription drug for insomnia in internal medicine. Jingzhi Anshen Oral Liquid has the effects of regulating yin and yang, replenishing qi and calming the mind, and is used for neurasthenia, with symptoms such as insomnia and dreaminess, feverishness at night, dizziness and vertigo, memory loss, and fatigue.

[0003] Currently, the preparation method of Jingzhi Anshen Oral Liquid recorded in the national drug standard is relatively complex. Specifically: 160 g of Rhodiola rosea is extracted three times by heating under reflux with 50%-60% ethanol, 3 hours for the first and second times, 2 hours for the third time. The extraction liquids are combined, filtered, and the filtrate is recovered from ethanol until there is no ethanol smell, concentrated to a thick paste with a relative density of 1.30-1.40 (60 °C), added with 3 times the amount of water, and sedimented twice with water, each time standing for 48 hours. The supernatant is taken, filtered, and the filtrate is concentrated to a ratio of 1:1 (mL / g) with the crude drug amount and reserved; 50 g of Dragon Bone and 100 g of Polygala tenuifolia are decocted three times with water, 3 hours for the first and second times, 2 hours for the third time. The decoction liquids are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.30-1.40 (60 °C). The thick paste is added with 3 times the amount of 80% ethanol and precipitated twice with ethanol, each time standing for 48 hours. The supernatant is collected, recovered from ethanol until there is no ethanol smell, and concentrated to a ratio of 1:1 (mL / g) with the crude drug amount and reserved; 100 g of Plastrum Testudinis is decocted three times with water, 3 hours each time. The decoction liquids are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.10-1.20 (40 °C) and reserved; 100 g of Acorus tatarinowii is placed in a volatile oil extraction tank and decocted three times with water, 2 hours for the first and second times, 1 hour for the third time. The volatile oil is collected and stored separately. The decoction liquids are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.30-1.40 (60 °C). The thick paste is added with 3 times the amount of 80% ethanol and precipitated twice with ethanol, each time standing for 48 hours. The supernatant is taken, the ethanol is recovered, and concentrated to a ratio of 1:1 (mL / g) with the crude drug amount and reserved; 700 g of honey is made into refined honey. The above refined honey, concentrated liquid, and volatile oil are placed in a preparation tank, 24 mL of 10% potassium sorbate aqueous solution is slowly added, adjusted to 1000 mL with water, mixed evenly, filtered, and sub-packed to obtain the product.

[0004] However, the above preparation method is very complex. The whole preparation process involves multiple steps, including extraction, filtration, concentration, ethanol precipitation, water precipitation, etc. The operation is complex and error-prone, and the operation time of each step is relatively long. In addition, the above preparation method uses solvents such as ethanol multiple times, increasing the production cost and resource consumption.

[0005] In view of this, developing a new preparation method that can overcome the above-mentioned defects and deficiencies in the existing preparation methods and is suitable for commercial production of Jingzhi Anshen Oral Liquid with higher curative effects will have very important clinical application value and commercial value. Summary of the Invention

[0006] In view of the above situation, in order to overcome the defects of the prior art, the present invention provides a Jingzhi Anshen Oral Liquid, its preparation method and uses. Compared with the existing national standard method, the preparation method of the present invention has simpler steps, higher extraction efficiency, more extraction amount of active ingredients, shorter overall time and lower cost, and has very important clinical application value and commercial value.

[0007] Specifically, the present invention is realized through the following technical solutions:

[0008] In the first aspect, the present invention provides a preparation method of Jingzhi Anshen Oral Liquid, and the preparation method includes the following steps:

[0009] Step 1: Crush Acorus tatarinowii and Plastron carapax and sieve them through a 30-40 mesh sieve, add them to an extraction kettle and seal it. First, perform supercritical extraction with CO at a temperature of 40-50 °C and a pressure of 15-25 MPa for 20-40 min, then perform supercritical extraction with CO at a temperature of 50-60 °C and a pressure of 25-30 MPa for 20-40 min, and finally perform supercritical extraction with CO at a temperature of 60-70 °C and a pressure of 30-35 MPa for 20-40 min. Add the extract to a separation kettle for separation, collect the volatile oil and store it separately, and concentrate the remaining extract under reduced pressure to make a concentrated solution; 2 supercritical extraction with CO 2 supercritical extraction with CO 2 supercritical extraction with CO

[0010] Step 2: Crush the mixture of Polygala tenuifolia, Rhodiola rosea and Os Draconis, extract it twice with a 70%-90% v / v ethanol solution for 30 min each time by ultrasonic reflux extraction, with the reflux temperature being 60-70 °C. Collect the ethanol extract, add the filter residue for compound enzyme fermentation, inactivate the enzyme, and perform ultrasonic extraction at a temperature of 20-30 °C for 15-20 min, then combine it with the ethanol extract and concentrate it under reduced pressure to make a concentrated solution;

[0011] Step 3: Take an appropriate amount of honey to make refined honey, place the volatile oil and concentrated solution prepared in Step 1, the concentrated solution prepared in Step 2, and the refined honey prepared in Step 3 in a preparation tank, slowly add an appropriate amount of aqueous solution containing an appropriate amount of potassium sorbate, mix well, filter, and subpackage to obtain the product.

[0012] As an alternative, in the above preparation method, by weight, the Jingzhi Anshen Oral Liquid is made from the following raw materials: 80 - 120 parts of Polygala tenuifolia, 80 - 120 parts of Acorus tatarinowii, 80 - 120 parts of Plastrum Testudinis, 140 - 180 parts of Rhodiola rosea, 40 - 60 parts of Os Draconis, and 500 - 1000 parts of honey.

[0013] As an alternative, in the above preparation method, by weight, the Jingzhi Anshen Oral Liquid is made from the following raw materials: 100 parts of Polygala tenuifolia, 100 parts of Acorus tatarinowii, 100 parts of Plastrum Testudinis, 160 parts of Rhodiola rosea, 50 parts of Os Draconis, and 700 parts of honey.

[0014] As an alternative, in the above preparation method, in step 1, the pressure of the separation kettle is 0.1 - 0.5 MPa, the temperature is 30 - 40 °C, and the rest of the extract is concentrated under reduced pressure until the ratio of the volume to the mass of the crude drug is 1:1 to form a concentrated solution.

[0015] As an alternative, in the above preparation method, in step 2, the ratio of the mixture of Polygala tenuifolia, Rhodiola rosea and Os Draconis to ethanol is 1:3 - 4. The mixture of the ethanol extract and the residue extract is concentrated under reduced pressure until the ratio of the volume to the mass of the crude drug is 1:1 to form a concentrated solution. The composite enzyme is one or more of the following: cellulase, protease, pectinase, amylase or xylanase.

[0016] As an alternative, in the above preparation method, in step 2, the composite enzyme is cellulase, pectinase and xylanase.

[0017] As an alternative, in the above preparation method, in step 2, the mass ratio range of cellulase:pectinase:xylanase is (2 - 4):(2 - 4):(3 - 5).

[0018] More preferably, in step 2, the mass ratio of cellulase:pectinase:xylanase is 3:3:4.

[0019] In the second aspect, the present invention provides the Jingzhi Anshen Oral Liquid prepared by the above preparation method, and the content of the active ingredients in the Jingzhi Anshen Oral Liquid is increased.

[0020] Preferably, the content of the active ingredient salidroside in the Jingzhi Anshen Oral Liquid is increased.

[0021] In the third aspect, the present invention provides the use of the Jingzhi Anshen Oral Liquid described in the second aspect above in the preparation of a drug for preventing or treating insomnia, and the drug has the efficacy of regulating yin and yang and replenishing qi and calming the mind.

[0022] As an alternative, in the above uses, the drug is used to treat neurasthenia, with symptoms such as insomnia and dreaminess, fever and restlessness at night, dizziness and vertigo, memory loss, and fatigue.

[0023] The present invention has the following beneficial effects compared with the prior art:

[0024] (1) Compared with the existing national standard method, the preparation method of the present invention has simpler steps, higher extraction efficiency, more extraction amount of active ingredients, shorter overall time and lower cost.

[0025] (2) The results of pharmacological experiments show that Jingzhi Anshen Oral Liquid prepared by the method of the present invention has higher curative effects in terms of calming the nerves and helping sleep compared with the commercially available products prepared by the national standard method. Detailed implementation manners

[0026] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the scope of the present invention.

[0027] For those where specific technologies or conditions are not indicated in the embodiments, the technologies or conditions described in the literature in this field are followed, or the product instructions are followed. For reagents or instruments where the manufacturer is not indicated, they are all conventional products that can be obtained through regular channels.

[0028] The experimental methods in the following embodiments are all conventional methods unless otherwise specified. The test materials used in the following embodiments are all commercially available products unless otherwise specified.

[0029] Preparation example:

[0030] Example 1

[0031] A preparation method of Jingzhi Anshen Oral Liquid, calculated by weight, the Jingzhi Anshen Oral Liquid is made from the following raw materials: 100 g of Polygala tenuifolia, 100 g of Acorus tatarinowii, 100 g of Plastrum Testudinis, 160 g of Rhodiola rosea, 50 g of Fossilia Ossis Mastodi, and 700 g of honey.

[0032] The preparation method includes the following steps:

[0033] Step 1: Crush Acorus tatarinowii and Plastrum Testudinis through a 40-mesh sieve, add them to an extraction kettle and seal it. First, perform supercritical extraction with CO at a temperature of 45°C and a pressure of 20 MPa for 30 min, then perform supercritical extraction with CO at a temperature of 55°C and a pressure of 25 MPa for 30 min, and finally perform supercritical extraction with CO at a temperature of 65°C and a pressure of 30 MPa for 2 30 min, then perform supercritical extraction with CO at a temperature of 55°C and a pressure of 25 MPa for 30 min, and finally perform supercritical extraction with CO at a temperature of 65°C and a pressure of 30 MPa for 2 30 min, and finally perform supercritical extraction with CO at a temperature of 65°C and a pressure of 30 MPa for 2Perform supercritical extraction for 30 min, add the extract into the separation kettle for separation. The pressure of the separation kettle is 0.5 MPa and the temperature is 35 °C. Collect the volatile oil and store it separately. Concentrate the remaining extract under reduced pressure until the ratio of volume to mass of the crude drug is 1:1 to prepare a concentrated solution;

[0034] Step 2: Crush the mixture of Polygala tenuifolia, Rhodiola rosea and Os Draconis, extract twice with 75% v / v ethanol solution for 30 min each time. The material-liquid ratio of the mixture of Polygala tenuifolia, Rhodiola rosea and Os Draconis to ethanol is 1:3. Perform ultrasonic reflux extraction at a reflux temperature of 65 °C. Collect the ethanol extract. Add the filter residue for compound enzyme fermentation, inactivate the enzyme, perform ultrasonic extraction at a temperature of 20 - 30 °C for 15 - 20 min, and combine it with the ethanol extract. Concentrate the mixture of the ethanol extract and the filter residue extract under reduced pressure until the ratio of volume to mass of the crude drug is 1:1 to prepare a concentrated solution. The compound enzyme is cellulase, pectinase and xylanase, and the mass ratio of cellulase:pectinase:xylanase is 3:3:4;

[0035] Step 3: Take the prescribed amount of honey to prepare refined honey. Place the volatile oil and concentrated solution prepared in Step 1, the concentrated solution prepared in Step 2 and the refined honey prepared in Step 3 in a preparation tank, slowly add 24 mL of an aqueous solution containing 10% potassium sorbate, add water to make up to 1000 mL, mix well, filter, divide into portions, and obtain the product.

[0036] Comparative Example 1 (changing the type of raw material drug subjected to supercritical extraction treatment)

[0037] A preparation method of Jingzhi Anshen Oral Liquid. Calculated by weight parts, the Jingzhi Anshen Oral Liquid is made from the following raw medicinal materials: 100 g of Polygala tenuifolia, 100 g of Acorus tatarinowii, 100 g of Plastrum Testudinis, 160 g of Rhodiola rosea, 50 g of Os Draconis, and 700 g of honey.

[0038] The preparation method includes the following steps:

[0039] Step 1: Crush Acorus tatarinowii, Rhodiola rosea and Plastrum Testudinis through a 40-mesh sieve, add them to the extraction kettle and seal it. First, perform CO 2 supercritical extraction for 30 min at a temperature of 45 °C and a pressure of 20 MPa, then perform CO 2 supercritical extraction for 30 min at a temperature of 55 °C and a pressure of 25 MPa, and finally perform CO 2 supercritical extraction for 30 min at a temperature of 65 °C and a pressure of 30 MPa. Add the extract into the separation kettle for separation. The pressure of the separation kettle is 0.5 MPa and the temperature is 35 °C. Collect the volatile oil and store it separately. Concentrate the remaining extract under reduced pressure until the ratio of volume to mass of the crude drug is 1:1 to prepare a concentrated solution;

[0040] Step 2: Crush the mixture of Polygala tenuifolia and Ostreae Fossilia, extract it twice with 75% v / v ethanol solution for 30 minutes each time. The material-liquid ratio of the mixture of Polygala tenuifolia and Ostreae Fossilia to ethanol is 1:3. Perform ultrasonic reflux extraction at a reflux temperature of 65°C, collect the ethanol extract. Add the filter residue for compound enzyme fermentation, inactivate the enzyme, perform ultrasonic extraction at a temperature of 20 - 30°C for 15 - 20 minutes, combine it with the ethanol extract, and concentrate the mixture of the ethanol extract and the filter residue extract under reduced pressure to a volume-to-mass ratio of 1:1 with the crude drug amount to make a concentrated solution. The compound enzyme is cellulase, pectinase, and xylanase, and the mass ratio of cellulase:pectinase:xylanase is 3:3:4;

[0041] Step 3: Take the prescription amount of honey to make refined honey. Place the volatile oil prepared in Step 1, the concentrated solution, the concentrated solution prepared in Step 2, and the refined honey prepared in Step 3 in a preparation tank, slowly add 24 mL of an aqueous solution containing 10% potassium sorbate, add water to make up to 1000 mL, mix well, filter, divide into portions, and you will get it.

[0042] Comparative Example 2 (changing the type of complex enzyme)

[0043] A preparation method of Jingzhi Anshen Oral Liquid. Calculated by weight parts, the Jingzhi Anshen Oral Liquid is made from the following raw materials: 100 g of Polygala tenuifolia, 100 g of Acori Tatarinowii Rhizoma, 100 g of Plastrum Testudinis, 160 g of Rhodiola rosea, 50 g of Ostreae Fossilia, and 700 g of honey.

[0044] The preparation method includes the following steps:

[0045] Step 1: Crush Acori Tatarinowii Rhizoma and Plastrum Testudinis through a 40-mesh sieve, add them to an extraction kettle and seal it. First, perform supercritical extraction with CO at a temperature of 45°C and a pressure of 20 MPa for 30 minutes, then perform supercritical extraction with CO at a temperature of 55°C and a pressure of 25 MPa for 30 minutes, and finally perform supercritical extraction with CO at a temperature of 65°C and a pressure of 30 MPa for 30 minutes. Add the extract to a separation kettle for separation. The pressure of the separation kettle is 0.5 MPa and the temperature is 35°C. Collect the volatile oil and store it separately, and concentrate the remaining extract under reduced pressure to a volume-to-mass ratio of 1:1 with the crude drug amount to make a concentrated solution; 2 supercritical extraction for 30 min, then perform supercritical extraction with CO at a temperature of 55°C and a pressure of 25 MPa for 30 min, and finally perform supercritical extraction with CO at a temperature of 65°C and a pressure of 30 MPa for 30 min. Add the extract to a separation kettle for separation. The pressure of the separation kettle is 0.5 MPa and the temperature is 35°C. Collect the volatile oil and store it separately, and concentrate the remaining extract under reduced pressure to a volume-to-mass ratio of 1:1 with the crude drug amount to make a concentrated solution; 2 supercritical extraction for 30 min, and finally perform supercritical extraction with CO at a temperature of 65°C and a pressure of 30 MPa for 30 min. Add the extract to a separation kettle for separation. The pressure of the separation kettle is 0.5 MPa and the temperature is 35°C. Collect the volatile oil and store it separately, and concentrate the remaining extract under reduced pressure to a volume-to-mass ratio of 1:1 with the crude drug amount to make a concentrated solution; 2 supercritical extraction for 30 min, add the extract to a separation kettle for separation. The pressure of the separation kettle is 0.5 MPa and the temperature is 35°C. Collect the volatile oil and store it separately, and concentrate the remaining extract under reduced pressure to a volume-to-mass ratio of 1:1 with the crude drug amount to make a concentrated solution;

[0046] Step 2: Crush the mixture of Polygala tenuifolia, Rhodiola rosea, and Dragon's Bone, extract it twice with 75% v / v ethanol solution for 30 minutes each time. The material-liquid ratio of the mixture of Polygala tenuifolia, Rhodiola rosea, and Dragon's Bone to ethanol is 1:3. Perform ultrasonic reflux extraction at a reflux temperature of 65°C. Collect the ethanol extract. Add the filter residue to a composite enzyme for fermentation, inactivate the enzyme, perform ultrasonic extraction at a temperature of 20 - 30°C for 15 - 20 minutes, and combine it with the ethanol extract. Concentrate the mixture of the ethanol extract and the filter residue extract under reduced pressure until the ratio of the volume to the mass of the crude drug is 1:1 to prepare a concentrated solution. The composite enzyme is cellulase and xylanase, and the mass ratio of cellulase:pectinase:xylanase is 6:4;

[0047] Step 3: Take the prescribed amount of honey to make refined honey. Place the volatile oil and concentrated solution prepared in Step 1, the concentrated solution prepared in Step 2, and the refined honey prepared in Step 3 in a preparation tank, slowly add 24 mL of an aqueous solution containing 10% potassium sorbate, add water to make up to 1000 mL, mix well, filter, and divide into portions to obtain the product.

[0048] Comparative Example 3 (adopting the preparation method recorded in the national standard WS-5126(B-0126)-2002)

[0049] A preparation method of Jingzhi Anshen Oral Liquid, the preparation method comprising the following steps: 160 g of Rhodiola rosea is refluxed and extracted three times with 50%-60% ethanol by heating, for 3 hours each time for the first and second times, and 2 hours for the third time. The extraction solutions are combined, filtered, and the ethanol in the filtrate is recovered until there is no alcohol smell, and concentrated to a thick paste with a relative density of 1.30-1.40 (60 °C). Add 3 times the amount of water, precipitate twice with water, let stand for 48 hours each time, take the supernatant, filter, and concentrate the filtrate to a ratio of 1:1 (mL / g) with the crude drug amount, and set aside; 50 g of fossil fragments of dragon bone and 100 g of Polygala tenuifolia are decocted three times with water, for 3 hours each time for the first and second times, and 2 hours for the third time. The decoction solutions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.30-1.40 (60 °C). Add 3 times the amount of 80% ethanol to the thick paste, precipitate twice with alcohol, let stand for 48 hours each time, collect the supernatant, recover the ethanol until there is no alcohol smell, and concentrate to a ratio of 1:1 (mL / g) with the crude drug amount, and set aside; 100 g of Plastron carapacis is decocted three times with water, 3 hours each time. The decoction solutions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.10-1.20 (40 °C), and set aside; 100 g of Acorus tatarinowii is placed in a volatile oil extraction tank, decocted three times with water, for 2 hours each time for the first and second times, and 1 hour for the third time. The volatile oil is collected and stored separately. The decoction solutions are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.30-1.40 (60 °C). Add 3 times the amount of 80% ethanol to the thick paste, precipitate twice with alcohol, let stand for 48 hours each time, take the supernatant, recover the ethanol, and concentrate to a ratio of 1:1 (mL / g) with the crude drug amount, and set aside; 700 g of honey is made into refined honey. The above refined honey, concentrated solution, and volatile oil are placed in a preparation tank, slowly add 24 mL of 10% potassium sorbate aqueous solution, add water to make up to 1000 mL, mix evenly, filter, and divide into portions to obtain the product.

[0050] Effect verification example:

[0051] Effect Example 1: Preparation properties of Jingzhi Anshen Oral Liquid prepared by the method of the present invention

[0052] The various preparation properties of the Jingzhi Anshen Oral Liquid prepared by the method of the present invention are shown in Table 1 below. For the specific detection methods, refer to the corresponding national standard WS-5126(B-0126)-2002. The results show that the Jingzhi Anshen Oral Liquid (Example 1) prepared by the method of the present invention is superior to the existing methods in terms of the properties and the detection indexes of the main active ingredient content, especially showing a significant advantage in the main active ingredient content index. In addition, it can be seen from the experimental results in Table 1 that supercritical extraction of Rhodiola rosea does not increase the content of the main active ingredient salidroside (see Comparative Example 1), and introducing a specific type of composite enzyme combination is also a key improvement point of the preparation method of the present invention. After introducing the specific type of composite enzyme combination, on the one hand, it can increase the extraction amount of the main active ingredient salidroside, and on the other hand, it can also improve the properties of the oral liquid preparation (see Comparative Example 2). 2 After supercritical extraction, it does not increase the content of the main active ingredient salidroside (see Comparative Example 1), and introducing a specific type of composite enzyme combination is also a key improvement point of the preparation method of the present invention. After introducing the specific type of composite enzyme combination, on the one hand, it can increase the extraction amount of the main active ingredient salidroside, and on the other hand, it can also improve the properties of the oral liquid preparation (see Comparative Example 2).

[0053] Table 1

[0054]

[0055] Effect Example 2: Evaluation of the sedative effect of Jingzhi Anshen Oral Liquid prepared by the method of the present invention

[0056] Male ICR mice (purchased from Liaoning Changsheng Biotechnology Co., Ltd.), weighing 18 - 22 g. After one week of adaptive feeding, they were randomly divided into a model group, an Example 1 group, a Comparative Example 1 group, a Comparative Example 2 group, and a Comparative Example 3 group, with 8 mice in each group.

[0057] In this effect example, the sedative effect was evaluated by the light - dark box experiment. Specifically, the inside of an open wooden box was divided into a light box and a dark box. The light box accounted for 3 / 5 of the box, and the dark box accounted for 2 / 5 of the box. They were separated by a partition, and a square opening was made at the bottom of the partition. The inside of the light box was painted white, and an incandescent lamp was placed above. The inside of the dark box was painted black, and a red lamp was placed above. The bottom of the box was marked with squares with a side length of 9 cm.

[0058] The model group was intragastrically administered with normal saline, and the Example 1 group, the Comparative Example 1 group, the Comparative Example 2 group, and the Comparative Example 3 group were intragastrically administered with the oral liquid prepared in the above - mentioned preparation example part, at a dose of 5.0 g / kg. The administration volume for each group was 0.2 mL / 10 g. Every day, the mice were placed in the dark box with the red lamp not powered on and the incandescent lamp in the light box illuminated, causing the mice to be anxious for 5 min each day for 5 consecutive days. In addition, the mice were administered once a day for 5 consecutive days. 1 h after the last administration, the mice were placed in the center of the light box with their backs facing the partition, and the number of shuttles of the mice in the light - dark box within 5 min was observed. The more shuttles, the more severe the anxiety of the mice.

[0059] SPSS 23.0 statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviation (mean ± SD); one - way analysis of variance (One - way ANOVA) was used for comparison between multiple groups. For those with homogeneous variance test, LSD test was used, and for those with inhomogeneous variance, non - parametric test was performed using the Euskal - walli SH method; P < 0.05 was considered statistically significant.

[0060] The experimental results are shown in Table 2 below. The experimental results show that compared with the model group, the oral liquids prepared by each experimental group have sedative effects on mice to varying degrees, and among them, the oral liquid prepared by the Example 1 group has the strongest anti - anxiety effect. In addition, the anti - anxiety effect of the Jingzhi Anshen Oral Liquid prepared by the method of the present invention is significantly better than that of the commercially available Jingzhi Anshen Oral Liquid (Comparative Example 3) prepared by the conventional method of the prior art.

[0061] Table 2

[0062] Group Number of shuttling times (times) Model group 215±13 Example 1 <![CDATA[84±8 ***,## > Comparative Example 1 <![CDATA[126±9 ***,# > Comparative Example 2 <![CDATA[107±15 *** > Comparative Example 3 <![CDATA[153±21 ** >

[0063] Note: Compared with the model group, ** p < 0.01, *** p < 0.001; compared with the control example 3 group, # p < 0.05, ## p < 0.01.

[0064] Effect Example 3: Evaluation of the sleep-aiding effect of Jingzhi Anshen Oral Liquid prepared by the method of the present invention

[0065] Male ICR mice (purchased from Liaoning Changsheng Biotechnology Co., Ltd.), 18 - 22 g. After one week of adaptive feeding, they were randomly divided into a model group, an example 1 group, a control example 1 group, a control example 2 group, and a control example 3 group, with 12 mice in each group.

[0066] In this effect example, sodium pentobarbital was used to induce mouse experiments to evaluate the sleep - promoting effect. The model group was given normal saline by gavage, and the example 1 group, the control example 1 group, the control example 2 group, and the control example 3 group were given the oral liquid prepared in the above - mentioned preparation example part by gavage, at a dose of 5.0 g / kg. The administration volume of each group was 0.2 mL / 10 g. Administer the drug once a day for 5 consecutive days. The experiment started 1 h after the last administration. The effect of each experimental group on the sleep incidence rate of mice within 30 min after sodium pentobarbital induction was investigated. Sleep was judged by the disappearance of the righting reflex. When the mouse was placed in the dorsal recumbent position, it could immediately right its body position. If it could not right its body position within 30 - 60 seconds, it was considered that the righting reflex disappeared and it entered sleep.

[0067] Sleep incidence rate = number of sleeping mice / total number of mice × 100%

[0068] The experimental results are shown in Table 3 below. The experimental results show that compared with the model group, the oral liquids prepared by each experimental group have different degrees of sleep - promoting effects on mice, and among them, the oral liquid prepared by the example 1 group has the strongest sleep - promoting effect. In addition, the sleep - promoting effect of the Jingzhi Anshen Oral Liquid prepared by the method of the present invention is significantly better than that of the commercially available Jingzhi Anshen Oral Liquid (control example 3) prepared by the conventional method of the prior art.

[0069] Table 3

[0070] Group Sleep incidence rate (%) Model group 25.00(2 / 10) Example 1 83.33(10 / 12) Comparative Example 1 58.33(7 / 12) Comparative Example 2 66.67(8 / 12) Comparative Example 3 50.00(6 / 12)

[0071] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. A method for preparing Jingzhi Anshen oral liquid, characterized in that: The preparation method comprises the following steps: Step 1: crush the Acorus calamus and tortoise shell through a 30-40 mesh sieve, add them into an extraction kettle and seal them, first perform CO2 supercritical extraction at a temperature of 40-50° C. and a pressure of 15-25 MPa for 20-40 min, then perform CO2 supercritical extraction at a temperature of 50-60° C. and a pressure of 25-30 MPa for 20-40 min, and finally perform CO2 supercritical extraction at a temperature of 60-70° C. and a pressure of 30-35 MPa for 20-40 min, add the extract into a separation kettle for separation, collect the volatile oil and store it separately, and concentrate the remaining extract under reduced pressure to prepare a concentrated solution; Step 2: grind the mixture of Polygala tenuifolia, Rhodiola rosea and Os Dracaena, extract twice with 70%-90% v / v ethanol solution, each time for 30 minutes, perform ultrasonic reflux extraction at a reflux temperature of 60-70° C., collect the ethanol extract, add the filter residue to the complex enzyme for fermentation, inactivate the enzyme, perform ultrasonic extraction at a temperature of 20-30° C. for 15-20 minutes, combine with the ethanol extract, and concentrate under reduced pressure to prepare a concentrated solution; Step 3: Take an appropriate amount of honey to make refined honey, put the volatile oil and concentrated solution prepared in step 1, the concentrated solution prepared in step 2 and the refined honey prepared in step 3 into a preparation tank, slowly add an appropriate amount of aqueous solution containing an appropriate amount of potassium sorbate, mix well, filter, and package to obtain the product.

2. The preparation method according to claim 1, characterized in that: The Jingzhi Anshen oral liquid is prepared from the following raw materials in parts by weight: 80-120 parts of Polygala tenuifolia, 80-120 parts of Acorus calamus, 80-120 parts of Tortoise shell, 140-180 parts of Rhodiola rosea, 40-60 parts of Dragon bone, and 500-1000 parts of honey.

3. The preparation method according to claim 2, characterized in that: The Jingzhi Anshen oral liquid is prepared from the following raw materials in parts by weight: 100 parts of Polygala tenuifolia, 100 parts of Acorus calamus, 100 parts of Tortoise shell, 160 parts of Rhodiola rosea, 50 parts of Dragon bone and 700 parts of honey.

4. The preparation method according to claim 1, characterized in that: In step 1, the pressure of the separation kettle is 0.1-0.5 MPa, the temperature is 30-40° C., and the remaining extract is concentrated under reduced pressure to a ratio of 1:1 in volume to mass with the crude drug to prepare a concentrated solution.

5. The preparation method according to claim 1, characterized in that: In step 2, the solid-liquid ratio of the mixture of Polygala tenuifolia, Rhodiola rosea and Osso dioica to ethanol is 1:3-4, and the mixture of the ethanol extract and the residue extract is concentrated under reduced pressure to a ratio of 1:1 to the volume and mass of the crude drug to prepare a concentrated solution, and the complex enzyme is one or more of the following: cellulase, protease, pectinase, amylase or xylanase.

6. The preparation method according to claim 5, characterized in that: In step 2, the complex enzyme is cellulase, pectinase and xylanase.

7. The preparation method according to claim 6, characterized in that: In step 2, the mass ratio of cellulase:pectinase:xylanase is in the range of (2-4):(2-4):(3-5).

8. Jingzhi Anshen oral liquid prepared by the preparation method according to any one of claims 1 to 7, characterized in that: The content of effective ingredients in the Jingzhi Anshen oral liquid is increased.

9. Use of the Jingzhi Anshen oral liquid according to claim 8 in the preparation of a medicament for preventing or treating insomnia, characterized in that: The medicine has the effects of regulating yin and yang, invigorating qi and calming the mind.

10. The use according to claim 9, characterized in that: The medicine is used to treat neurasthenia, with symptoms of insomnia, dreaminess, restlessness at night, dizziness, memory loss, fatigue and weakness.

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