Special medicine for treating deficiency of qi and blood and insomnia and dreaminess and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicines, and particularly discloses a special medicine for treating deficiency of qi and blood and insomnia and dreaminess and a preparation method thereof. The bulk drugs of the special medicine comprise semen cuscutae, glossy privet fruits, mulberries, ginseng, astragalus membranaceus, angelica sinensis, spina date seeds, schisandra chinensis, fructus lycii, caulis clematidis armandii and semen plantaginis. The special medicine provided by the invention has the effects of nourishing liver and kidney, reinforcing qi, nourishing blood, calming heart, relieving restlessness and the like, comprehensive conditioning is carried out, the problems of kidney deficiency, qi deficiency, blood deficiency and the like can be remarkably improved, the symptoms of dizziness, tinnitus, soreness and weakness of waist and knees, insomnia, dreaminess and the like are relieved, the preparation method is simple and controllable, and the safety and effectiveness of the medicine can be improved.

Description

Technical Field

[0001] The present application relates to the field of Chinese medicine preparations, and more specifically, to a special medicine for treating qi and blood deficiency and insomnia and dreaminess and a preparation method thereof. Background Art

[0002] As a traditional Chinese medicine, Chinese medicine has unique effects on regulating human functions and treating chronic diseases. Symptoms such as dizziness, tinnitus, sore waist and knees, insomnia and dreaminess are common health problems for modern people, and their history can be traced back to ancient medical literature. These symptoms are often closely related to Chinese medicine theories such as dysfunction of human internal organs, insufficient qi and blood, and liver and kidney yin deficiency. With the rapid development of social economy, the pace of life has accelerated, and work pressure has increased. The incidence of these symptoms has shown a clear upward trend.

[0003] At present, the drugs used to treat these symptoms on the market are mainly divided into two categories: traditional Chinese medicine and Western medicine. Western medicines such as benzodiazepines and barbiturates are mainly used to treat sleep disorders, but they are often accompanied by side effects such as headaches, drowsiness, and dizziness, and they cause a certain burden on organs such as the liver and kidneys. Although traditional Chinese medicines such as Liuwei Dihuang Pills and Anshenbu Nao Liquid can relieve symptoms to a certain extent, they mostly focus on the treatment of a single symptom, and it is difficult to comprehensively take into account multiple symptoms such as dizziness, tinnitus, soreness of the waist and knees, and insomnia and dreaminess, and the efficacy is slow, and some patients respond poorly. Therefore, it is urgent to develop a safe and efficient Chinese medicine composition to solve this problem. Summary of the invention

[0004] In order to solve the above problems, the present application provides a special medicine for treating qi and blood deficiency and insomnia and dreaminess and a preparation method thereof.

[0005] This application adopts the following technical solutions: In the first aspect, the present application provides a special medicine for treating qi and blood deficiency and insomnia, and its raw materials include the following medicinal materials: Cuscuta australis, Ligustrum lucidum, mulberry, ginseng, astragalus, angelica, spiny jujube seed, Schisandra chinensis, wolfberry, Caulis Akebia and Plantago seed.

[0006] Furthermore, the raw materials include, by weight: 45-50 parts of Cuscuta seeds, 45-50 parts of Ligustrum lucidum fruits, 38-43 parts of mulberries, 38-43 parts of ginseng, 38-43 parts of astragalus, 38-43 parts of angelica, 38-43 parts of spiny jujube seeds, 30-35 parts of Schisandra chinensis, 30-35 parts of wolfberry fruits, 18-23 parts of Caulis Atractylodes macrocephala, and 18-23 parts of Plantago seeds.

[0007] The special medicine obtained through the above technical scheme has significant effects of invigorating the kidney, replenishing qi and nourishing blood. It can improve symptoms such as dizziness, tinnitus, soreness of the waist and knees, fatigue and weakness caused by kidney deficiency and qi deficiency. At the same time, it also has a good therapeutic effect on qi and blood deficiency and insomnia.

[0008] Among the above-mentioned medicinal materials, Cuscuta has the effects of nourishing the kidney and replenishing essence, nourishing the liver and improving eyesight. It can replenish both yin and yang, both kidney yin and kidney yang, and is a "product that balances yin and yang". Ligustrum lucidum has the effects of nourishing the liver and kidney, improving eyesight and blackening hair. Modern pharmacological studies have confirmed that it can enhance immunity and has anti-aging and three highs (blood pressure, blood sugar, blood lipids) and other effects. Mulberry has the effects of nourishing yin and blood, promoting body fluid and moistening dryness. Ginseng has the effects of greatly replenishing vital energy, replenishing the spleen and lungs, promoting body fluid and nourishing blood, calming the mind and improving intelligence. It is an important medicine for replenishing qi, which can enhance the body's immune function and improve the body's anti-stress ability. Astragalus has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting body fluid and nourishing blood. It is also a good medicine for replenishing qi, which can enhance the body's immune function and promote hematopoietic function. Angelica has the effects of replenishing blood and promoting blood circulation, regulating menstruation and relieving pain. It is an important medicine for replenishing blood, which can significantly promote the body's hematopoietic function and increase the content of red blood cells, white blood cells and hemoglobin. Lycium barbarum has the effects of nourishing the liver and kidney, improving the essence and eyesight. Chuanmutong has the effects of diuresis, relieving stranguria, clearing the heart and eliminating troubles. Plantago has the effects of clearing heat, promoting diuresis, and removing dampness and relieving stranguria.

[0009] In this prescription, for the main symptoms such as dizziness, tinnitus, soreness of waist and knees, insomnia and dreaminess, Cuscuta and Ligustrum lucidum are used as the main drugs. Both of them have the effect of nourishing liver and kidney, and can treat the main pathogenesis of liver and kidney yin deficiency. Mulberry, ginseng, astragalus, angelica and wolfberry are used as the ministers. Mulberry and wolfberry further nourish the liver and kidney, and strengthen the therapeutic effect of the main drug; astragalus replenishes qi and raises yang, and angelica replenishes blood and activates blood circulation. The two work together to treat the combined symptoms of qi and blood deficiency, and assist the main drug to improve overall health. Ziziphus jujuba seed nourishes the heart and liver, calms the heart and relieves restlessness, and Schisandra chinensis astringes and consolidates, replenishes qi and promotes fluid production. Both can assist the main and minister drugs in treating combined symptoms such as insomnia and dreaminess, and can also reconcile the medicinal properties to prevent the main and minister drugs from being too strong. Chuanmutong and Plantago seed are both diuretics and stranguria relievers. They can guide the damp heat in the body to be discharged through urine, which helps to improve the symptoms caused by damp heat or water retention. At the same time, they can also harmonize the medicines to a certain extent, making the prescription more mild.

[0010] This prescription is rigorously matched, and the effects of the drugs are coordinated. It has both the main attack direction (main drug) and auxiliary strength (minister drug), as well as adjuvants and guiding drugs to coordinate the properties of the drugs and prevent bias. It comprehensively regulates symptoms such as dizziness, tinnitus, soreness of waist and knees, insomnia and dreaminess through nourishing the liver and kidney, replenishing qi and blood, calming the mind and relieving restlessness. These symptoms are often related to TCM pathological mechanisms such as liver and kidney deficiency, qi and blood deficiency, and restlessness. The drugs in the prescription can treat these pathological mechanisms.

[0011] Preferably, in the above-mentioned raw materials, the total weight of Caulis Atractylodes and Plantago is X, and the total weight of Cuscuta australis and Ligustrum lucidum is Y, and X and Y satisfy the following relationship: Y=2.5X-4.

[0012] The inventors found that the content of Caulis Scutellariae and Plantago asiatica in the prescription would affect the effect of the whole prescription, especially the efficacy of the main drugs Cuscuta chinensis and Ligustrum lucidum. The experiment found that when the four met the above relationship, the prescription showed excellent therapeutic effects on dizziness, tinnitus, soreness of waist and knees, insomnia and dreaminess, and had good safety and no side effects.

[0013] Furthermore, the above-mentioned raw material medicine also includes 13-18 parts by weight of oligopeptide.

[0014] Preferably, the amino acid sequence of the above oligopeptide is: Leucine-Phenylalanine-Tyrosine-Proline-Proline-Isoleucine-Proline-Arginine.

[0015] Oligopeptides are short-chain peptide compounds composed of several amino acids, which have multiple biological activities and effects, but also have some potential side effects. The inventors performed proteolysis on the extract of Sophora japonica to obtain the oligopeptide of the above amino acid sequence, which is a short peptide formed by 8 amino acids. The experiment found that in the process of preparing the special medicine, the appropriate addition of a certain amount of the above oligopeptide can promote the absorption and utilization of the active substance, thereby improving the therapeutic effect on dizziness, tinnitus, soreness of waist and knees, insomnia and dreaminess.

[0016] In a second aspect, the present application provides a method for preparing the above-mentioned special medicine, characterized in that it comprises: Step S1: taking the following medicinal materials by weight: Cuscuta australis, Ligustrum lucidum, mulberry, ginseng, astragalus, angelica, spiny jujube seed, schisandra chinensis, wolfberry, chuanxiong and plantain, and crushing and mixing them to obtain raw medicinal powder; Step S2: mixing part of the raw material powder with a solvent to extract the active substance to obtain an extract; Step S3: Concentrate the extract into an extract, add auxiliary materials and the remaining raw material powder, and prepare the product.

[0017] Furthermore, the above-mentioned drug extraction method is a water decoction method, comprising: (1) taking 20-30% of the raw drug powder, soaking it in 9-10 times the amount of 40-60% ethanol solution for 10-14 hours, and then performing the first reflux extraction for 1.5-2.5 hours; (2) refluxing the obtained medicinal residue with 6-7 times the amount of 40-60% ethanol solution for a second extraction, and the extraction time is 1.5-2.5 hours; (3) The obtained medicinal residue is then subjected to a third reflux extraction with 4-5 times the amount of 40-60% ethanol solution, and the extraction time is 0.8-1.2 h; (4) refluxing the obtained medicinal residue with 8-9 times the amount of water for a fourth extraction, and the extraction time is 0.8-1.2 h; (5) The drug solutions obtained from the above four reflux extractions are combined and concentrated to an extract with a relative density of 1.05 to 1.10 (60°C).

[0018] Through the above preparation method, on the one hand, by subjecting part of the medicinal materials to multiple reflux extractions, different extraction solvents, extraction times, and material-liquid ratios are used to enhance the extraction effect, thereby extracting the medicinal ingredients in the medicinal materials to the maximum extent; at the same time, the remaining medicinal materials are directly powdered for use as medicine, so that all substances in the medicinal materials can be used as medicine, thereby improving the stability and utilization of the final special medicine, thereby ensuring the efficacy.

[0019] Furthermore, the above-mentioned drug extraction method further comprises the following steps before performing the first reflux extraction: The powders of Chinese angelica, ginseng and dodder seeds are mixed, pre-treated by supercritical extraction process, ethylene is used as supercritical fluid and ethyl acetate is used as entrainer to obtain extract, and the extract and medicinal residue are obtained after reduced pressure concentration; Mix the drug residue with other drug powders and put them into reflux extraction; The extract is mixed with the extract and the remaining 70-80% of the raw material powder, and auxiliary materials are added to prepare the product.

[0020] Furthermore, the process parameters of the above-mentioned supercritical fluid extraction are: extraction temperature of 22-24° C., extraction pressure of 12-17 MPa, extraction time of 40-80 min, extraction agent flow rate of 13-15 kg / h, and entrainer addition amount of 3-5%.

[0021] In this preferred embodiment, supercritical fluid extraction technology is used to adjust the temperature and pressure to accurately control the extraction performance of ethylene. At the same time, ethyl acetate is added as an entrainer to improve the solvent properties of ethylene, so that it can effectively dissolve and extract the active components with lower polarity in angelica, ginseng and dodder seeds under supercritical conditions, while avoiding the destruction of the structure of heat-sensitive components in angelica and dodder seeds, thereby ensuring the therapeutic effect.

[0022] Furthermore, the above-mentioned raw material medicine also includes 2-5 parts by weight of oligopeptide, and the preparation method also includes: The extract is mixed with the extractum and the remaining 70-80% of the raw material powder, and then mixed with the oligopeptide, and auxiliary materials are added to prepare the preparation; the amino acid sequence of the oligopeptide is: leucine-phenylalanine-tyrosine-proline-proline-isoleucine-proline-arginine.

[0023] The addition of oligopeptides promotes the absorption and utilization of the active components, reduces the probability of side effects, and improves the overall efficacy of the special medicine.

[0024] In summary, this application has the following beneficial effects: 1. The prescription of the special medicine provided by the present application is rigorous in compatibility, and the effects of the drugs are coordinated with each other. There are both main attack directions (Cuscuta and Ligustrum lucidum), auxiliary forces (Mulberry, Ginseng, Astragalus, Angelica and Lycium barbarum), as well as adjuvants (Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis) and messenger drugs (Caulis Atractylodes and Semen Plantagoe) that can reconcile the properties of the medicine and prevent bias. Due to symptoms such as dizziness, tinnitus, soreness of the waist and knees, insomnia and dreaminess, it is often related to the pathogenesis of traditional Chinese medicine such as liver and kidney deficiency, deficiency of both qi and blood, and restlessness. The special medicine provided by the present application is comprehensively conditioned through the effects of nourishing the liver and kidney, replenishing qi and nourishing blood, calming the mind and eliminating vexation, and can significantly improve the problems of kidney deficiency, qi deficiency, blood deficiency, etc., relieve symptoms such as dizziness, tinnitus, soreness of the waist and knees, insomnia and dreaminess, and the preparation method is simple and controllable, which can improve the safety and effectiveness of the drug.

[0025] 2. In the preferred technical solution, the present application adds an oligopeptide with a specific amino acid sequence during the preparation of the special medicine, which can promote the absorption and utilization of the medicinal substance, reduce the probability of side effects, and enhance the therapeutic effect on dizziness, tinnitus, soreness of waist and knees, insomnia and dreaminess.

[0026] 3. In the preferred technical scheme, in the preparation method, supercritical fluid extraction technology is first used, with ethylene as the supercritical fluid and ethyl acetate as the entrainer, to separate the low-polarity active components and thermosensitive substances in Angelica sinensis, ginseng and Cuscuta australis, so as to avoid the destruction of the structure of the thermosensitive components in the subsequent reflux extraction, thereby ensuring the therapeutic effect. DETAILED DESCRIPTION

[0027] The embodiments of the present invention will be described in detail below in conjunction with examples. However, those skilled in the art will understand that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention. The specific conditions not specified in the examples are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used without indicating the manufacturer are all conventional products that can be purchased commercially.

[0028] The specific embodiments of the present invention are described in detail below. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention. Example

[0029] Example 1 This embodiment provides a special medicine for treating qi and blood deficiency and insomnia and dreaminess, and the raw materials thereof include, by weight: 48 parts of Cuscuta seeds, 48 ​​parts of Ligustrum lucidum fruits, 40 parts of Morus alba, 40 parts of Ginseng, 40 parts of Astragalus, 40 parts of Angelica sinensis, 40 parts of Semen Ziziphi Spinosae, 32 parts of Schisandrae Chinensis, 32 parts of Lycium barbarum, 20 parts of Caulis Atractylodes macrocephala, and 20 parts of Plantago seeds.

[0030] The total weight of Caulis Atractylodes and Plantago is X, and the total weight of Cuscuta australis and Ligustrum lucidum is Y. X and Y satisfy the following relationship: Y=2.5X-4.

[0031] The preparation method of the special medicine comprises the following steps: (1) Take the following medicinal materials by weight: Cuscuta chinensis, Ligustrum lucidum, mulberry, ginseng, astragalus, angelica, spiny jujube seed, Schisandra chinensis, wolfberry, Caulis chuanxiong and Plantago asiatica, grind and mix to obtain raw medicinal powder, and divide the raw medicinal powder into two parts; (2) taking 25% of the raw drug powder, soaking it in 9 times the amount of 50% ethanol solution for 12 hours, and then performing the first reflux extraction for 2 hours, filtering to obtain the drug solution and drug residue; (3) refluxing the obtained medicinal residue with 7 times the amount of 50% ethanol solution for a second time for 2 hours, and filtering to obtain the medicinal solution and medicinal residue; (4) The obtained medicinal residue is subjected to a third reflux extraction with 5 times the amount of 50% ethanol solution for 1 hour, and the medicinal solution and medicinal residue are filtered; (5) The obtained medicinal residue was subjected to a fourth reflux extraction with 9 times the amount of water for 1 hour, and the medicinal solution and medicinal residue were filtered; (6) The drug solutions obtained from the four reflux extractions are combined and concentrated under reduced pressure to obtain an extract with a relative density of 1.05 to 1.10 (60° C.).

[0032] (7) Mix the extract with the remaining 75% of the raw material powder, and then add excipients to prepare the product.

[0033] Example 2 This embodiment provides a special medicine for treating qi and blood deficiency and insomnia and dreaminess, and the raw materials thereof include, by weight: 45 parts of Cuscuta seeds, 50 parts of Ligustrum lucidum fruits, 43 parts of Morus alba, 43 parts of Ginseng, 38 parts of Astragalus, 38 parts of Angelica sinensis, 38 parts of Semen Ziziphi Spinosae, 35 parts of Schisandrae Chinensis, 30 parts of Lycium barbarum, 20 parts of Caulis Atractylodes macrocephala, and 18 parts of Plantago seeds.

[0034] The total weight of Caulis Atractylodes and Plantago is X, and the total weight of Cuscuta australis and Ligustrum lucidum is Y. X and Y satisfy the following relationship: Y=2.5X+1.

[0035] Example 3 This embodiment provides a special medicine for treating qi and blood deficiency and insomnia and dreaminess, and the raw materials thereof include, by weight: 50 parts of Cuscuta seeds, 45 parts of Ligustrum lucidum fruits, 43 parts of Morus alba, 38 parts of Ginseng, 43 parts of Astragalus, 43 parts of Angelica sinensis, 43 parts of Semen Ziziphi Spinosae, 30 parts of Schisandrae Chinensis, 35 parts of Lycium barbarum, 18 parts of Caulis Atractylodes macrocephala, and 20 parts of Plantago seeds.

[0036] The total weight of Caulis Atractylodes and Plantago is X, and the total weight of Cuscuta australis and Ligustrum lucidum is Y. X and Y satisfy the following relationship: Y=2.5X+1.

[0037] Example 4 The difference between this embodiment and embodiment 1 is that (the other components are the same): 15 parts of oligopeptide are also included, and the amino acid sequence of the oligopeptide is: Leucine-Phenylalanine-Tyrosine-Proline-Proline-Isoleucine-Proline-Arginine.

[0038] The preparation method thereof is different from that of Example 1 in that the extract is mixed with the remaining 75% of the raw material powder, the oligopeptide is added to disperse and mix, and then the auxiliary materials are added to prepare the preparation.

[0039] Example 5 The difference between this embodiment and embodiment 4 is that (the other components are the same): the oligopeptide is 13 parts.

[0040] Example 6 The difference between this embodiment and embodiment 4 is that (the other components are the same): the oligopeptide is 18 parts.

[0041] Example 7 The difference between this embodiment and embodiment 1 is that the preparation method further comprises: Take 25% of the raw drug powder, use ethylene as a supercritical fluid and ethyl acetate as an entrainer, perform supercritical extraction to obtain an extract, and then reduce the pressure and concentrate to obtain an extract and a drug residue; the process parameters of the supercritical fluid extraction are: extraction temperature of 23°C, extraction pressure of 14Mpa, extraction time of 60min, extraction agent flow rate of 14kg / h, and the addition amount of the entrainer is 4%.

[0042] The obtained medicinal residue was subjected to reflux extraction four times (the method is the same as that of Example 1) to obtain an extract with a relative density of 1.07 (60° C.); the extract, the extract and the remaining 75% of the raw material powder were mixed, and then auxiliary materials were added to prepare the preparation.

[0043] Example 8 The difference between this embodiment and embodiment 1 is that the preparation method further comprises: Take 25% of the raw drug powder, use ethylene as a supercritical fluid and ethyl acetate as an entrainer, perform supercritical extraction to obtain an extract, and then reduce the pressure and concentrate to obtain an extract and a drug residue; the process parameters of the supercritical fluid extraction are: extraction temperature of 22°C, extraction pressure of 12Mpa, extraction time of 80min, extraction agent flow rate of 15kg / h, and the addition amount of the entrainer is 3%.

[0044] The obtained medicinal residue was subjected to reflux extraction four times (the method is the same as that of Example 1) to obtain an extract with a relative density of 1.05 (60° C.); the extract, the extract and the remaining 75% of the raw medicinal powder were mixed, and then auxiliary materials were added to prepare the preparation.

[0045] Example 9 The difference between this embodiment and embodiment 1 is that the preparation method further comprises: Take 25% of the raw drug powder, use ethylene as a supercritical fluid and ethyl acetate as an entrainer, perform supercritical extraction to obtain an extract, and then reduce the pressure and concentrate to obtain an extract and a drug residue; the process parameters of the supercritical fluid extraction are: extraction temperature of 24°C, extraction pressure of 17Mpa, extraction time of 40min, extraction agent flow rate of 13kg / h, and the addition amount of the entrainer is 5%.

[0046] The obtained medicinal residue was subjected to reflux extraction four times (the method is the same as that of Example 1) to obtain an extract with a relative density of 1.10 (60° C.); the extract, the extract and the remaining 75% of the raw medicinal powder were mixed, and then auxiliary materials were added to prepare the preparation.

[0047] Example 10 The difference between this embodiment and embodiment 4 is that the preparation method further comprises: Take 25% of the raw drug powder, use ethylene as a supercritical fluid and ethyl acetate as an entrainer, perform supercritical extraction to obtain an extract, and then reduce the pressure and concentrate to obtain an extract and a drug residue; the process parameters of the supercritical fluid extraction are: extraction temperature of 23°C, extraction pressure of 14Mpa, extraction time of 60min, extraction agent flow rate of 14kg / h, and the addition amount of the entrainer is 4%.

[0048] The obtained drug residue was subjected to reflux extraction four times (the method is the same as that of Example 1) to obtain an extract with a relative density of 1.07 (60° C.); the extract, the extract and the oligopeptide were mixed with the remaining 75% of the raw drug powder, and then auxiliary materials were added to prepare the drug.

[0049] Comparative Example Comparative Example 1 The difference between this comparative example and Example 1 is that the raw material contains 20 parts of Plantago seeds and does not contain Caulis Atractylodes macrocephala.

[0050] Comparative Example 2 The difference between this comparative example and Example 1 is that the raw material contains 20 parts of Akebia trifoliata and no Plantago asiatica.

[0051] Comparative Example 3 The difference between this comparative example and Example 1 is that the raw materials include Akebia trifoliata and Plantago asiatica.

[0052] Performance testing 1. Experimental methods: 1. Effect on Qi and Blood Deficiency Take Kunming mice (18-22g), 120, randomly divided into 9 groups, 10 in each group, half male and half female in each group.Except control group mice, the remaining mice were bled 1ml at the tail respectively, causing hemorrhagic anemia model, and intragastric administration was performed after 24h.The experimental group was given intragastric administration of the special medicine provided by embodiment 1,4,7,10 and comparative example 1-3 respectively, and the medicine was prepared with distilled water before use, and the dosage of each intragastric administration was 10g crude drug / kg, and the distilled water of the same volume of the control group and the model group was intragastrically administered.Continuous administration for 7 days, once a day, after the last administration 2h, the tail blood was taken to measure the hemoglobin value, and the results were recorded in Table 1.

[0053] 2. Effects on the sleep time of mice Take Kunming mice (18-22g), 110, randomly divided into 8 groups, 10 in each group, half male and half female in each group. Experimental group is respectively given to the special medicine gavage provided by embodiment 1,4,7,10 and comparative example 1-3, and medicine is prepared with distilled water before use, and the dosage of each gavage is 10g crude drug / kg, and the distilled water of the same volume of gavage in control group and model group is given. Continuous administration 7 days, once a day. After the last administration 1h, intraperitoneal injection of sodium pentobarbital 40mg / kg, observe the disappearance of righting reflex and recovery time of mice, record the duration of sleep, observe 2h in total, and the sleep time exceeds 2h person and calculates with 2h, and the results are recorded in table 1.

[0054] 1. Experimental results Table 1. As shown in Table 1, the hemoglobin content of mice in the experimental group was greater than that in the model group and close to that in the control group, which indicates that the special medicine provided by the present application is helpful in improving the symptoms of qi and blood deficiency. At the same time, the sleep time was also much longer than that in the control group, which indicates that the special medicine is helpful in improving sleep.

[0055] Comparative Examples 1-3 compared with Example 1 show that the Caulis Scutellariae and Plantago Seed in the formula are very important for improving the efficacy of the medicine. The lack of these two medicinal materials will greatly weaken the efficacy of the special medicine; at the same time, when the amount of Caulis Scutellariae and Plantago Seed added satisfies the relationship Y=2.5X-4 with the amount of Cuscuta Sinensis and Ligustrum Lucidum Fruit, the therapeutic effect shown is the best.

[0056] Compared with Example 4, when the oligopeptide of a specific sequence is added to the formula, the effect of improving qi and blood deficiency and sleep is significantly enhanced, which shows that the addition of the oligopeptide can further promote the absorption and utilization of the active substance and improve the efficacy.

[0057] Compared with Example 10, when supercritical extraction is preferentially used to separate the low-polarity active components and thermosensitive substances in Angelica sinensis, ginseng and Cuscuta australis in the preparation method, it helps to improve the utilization rate of the medicinal materials, so that the active ingredient content in the final medicine is higher and the efficacy is better.

[0058] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A special medicine for treating qi and blood deficiency and insomnia, characterized in that: Its APIs include the following medicinal materials: Cuscuta australis, Ligustrum lucidum, mulberry, ginseng, astragalus, angelica, spiny jujube seed, schisandra chinensis, wolfberry, Sichuan atractylodes and plantain.

2. The special medicine for treating qi and blood deficiency and insomnia according to claim 1, characterized in that: In terms of weight, the raw materials include: 45-50 parts of Cuscuta seeds, 45-50 parts of Ligustrum lucidum fruits, 38-43 parts of mulberries, 38-43 parts of ginseng, 38-43 parts of astragalus, 38-43 parts of angelica, 38-43 parts of spiny jujube seeds, 30-35 parts of Schisandra chinensis, 30-35 parts of wolfberry fruits, 18-23 parts of Caulis Atractylodes macrocephala, and 18-23 parts of Plantago seeds.

3. The special medicine for treating qi and blood deficiency and insomnia and dreaminess according to claim 2, characterized in that: In the raw material medicine, the total weight of Caulis Atractylodes and Plantago is X, and the total weight of Cuscuta australis and Ligustrum lucidum is Y, and X and Y satisfy the following relationship: Y=2.5X-4.

4. The special medicine for treating qi and blood deficiency and insomnia and dreaminess according to claim 2, characterized in that: The raw material medicine also includes 13-18 parts by weight of oligopeptide.

5. The special medicine for treating qi and blood deficiency and insomnia and dreaminess according to claim 4, characterized in that: The amino acid sequence of the oligopeptide is: Leucine--Phenylalanine-Tyrosine-Proline-Proline-Isoleucine-Proline-Arginine.

6. A method for preparing a special medicine according to any one of claims 1 to 5, characterized in that: It includes: The following medicinal materials are taken by weight: Cuscuta, Ligustrum lucidum, mulberry, ginseng, astragalus, angelica, spiny jujube seed, schisandra, wolfberry, chuanmutong and plantain, and crushed and mixed to obtain raw material powder; Mixing part of the raw material powder with a solvent to extract the active substance to obtain an extract; The extract is concentrated into an extract, and auxiliary materials and the remaining part of the raw material powder are added to prepare the product.

7. The method for preparing the special medicine according to claim 6, characterized in that: The method for extracting the drug is a water decoction method, comprising: (1) taking 20-30% of the raw material powder, soaking it in 9-10 times the amount of 40-60% ethanol solution for 10-14 hours, and then performing the first reflux extraction for 1.5-2.5 hours; (2) The obtained medicinal residue is subjected to a second reflux extraction with 6-7 times the amount of 40-60% ethanol solution, and the extraction time is 1.5-2.5 hours; (3) The obtained medicinal residue is then subjected to a third reflux extraction with 4-5 times the amount of 40-60% ethanol solution, and the extraction time is 0.8-1.2 h; (4) The obtained medicinal residue is subjected to a fourth reflux extraction with 8-9 times the amount of water, and the extraction time is 0.8-1.2 h; (5) The drug solutions obtained from the above four reflux extractions are combined and concentrated into an extract with a relative density of 1.05 to 1.10 (60°C).

8. The method for preparing the special medicine according to claim 7, characterized in that: The method for drug extraction also includes the following steps before performing the first reflux extraction: The powders of the Chinese angelica, ginseng and dodder seeds are mixed, pre-treated by a supercritical extraction process, ethylene is used as a supercritical fluid, ethyl acetate is used as an entrainer, an extract is obtained, and the extract and the medicinal residue are obtained after reduced pressure concentration; Mixing the medicinal residue with other medicinal material powders and subjecting them to reflux extraction; The extract is mixed with the extract and the remaining 70-80% of the raw material powder, and auxiliary materials are added to prepare the product.

9. The method for preparing the special medicine according to claim 8, characterized in that: The process parameters of the supercritical fluid extraction are: extraction temperature of 22-24° C., extraction pressure of 12-17 Mpa, extraction time of 40-80 min, extraction agent flow rate of 13-15 kg / h, and entrainer addition amount of 3-5%.

10. The method for preparing the special medicine according to claim 8, characterized in that: The raw material medicine also includes 2-5 parts by weight of oligopeptide, and the preparation method also includes: The extract is mixed with the extract and the remaining 70-80% of the raw material powder, and then mixed with the oligopeptide, and auxiliary materials are added to prepare the product; The amino acid sequence of the oligopeptide is: leucine-phenylalanine-tyrosine-proline-proline-isoleucine-proline-arginine.

Images