Body pain and stasis removing decoction granules and preparation process thereof

Abstract

The invention discloses a body pain and stasis removing decoction granule and a preparation process thereof, and relates to the technical field of traditional Chinese medicine preparations, and the preparation process comprises the following steps: step 1, distillation extraction: taking ligusticum wallichii, notopterygium root, myrrh, angelica sinensis and rhizoma cyperi, and carrying out steam distillation extraction to obtain decoction dregs and distilled volatile oil; step 2, inclusion treatment: mixing the distilled volatile oil with a cyclodextrin inclusion material, and carrying out inclusion and drying treatment to obtain a volatile oil inclusion compound; step 3, decocting and concentrating: mixing the medicine residue with gentiana macrophylla, peach kernel, safflower, liquorice, trogopterus dung, achyranthes bidentata and earthworm to obtain a decoction material, adding water into the decoction material, decocting to obtain a decoction, and concentrating to obtain a concentrated solution; and 4, preparing granules, namely performing spray drying on the concentrated solution to obtain extract powder, adding dextrin into the extract powder, uniformly mixing, granulating, drying, finally adding a volatile oil clathrate compound, and uniformly mixing to obtain the body pain and stasis removing decoction granules. The food has the effects of being good in eating effect, safe to eat and easy to carry.

Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine preparations, and in particular to a Shentong Zhuyu Decoction granule and a preparation process thereof. Background Art

[0002] Shentong Zhuyu Decoction is a traditional Chinese medicine prescription. Its effects are to promote blood circulation, remove blood stasis, promote menstruation, relieve pain, dispel wind and remove dampness. Shentong Zhuyu Decoction is composed of Chinese Gentian, Chuanxiong, peach kernel, safflower, liquorice, Notopterygium, myrrh, angelica, aconiti lobata, cyperus rotundus, Achyranthes bidentata, earthworm and other drugs. Shentong Zhuyu Decoction can treat blood stasis, and with the addition of rheumatism, shoulder pain, pain in the waist and legs caused by the obstruction of the meridians, and body pain such as fasciitis that does not heal for a long time, Shentong Zhuyu Decoction can be used to treat it.

[0003] The Chinese patent application document with publication number CN118948777A discloses a kind of shentongzhuyu granules and its preparation method and quality detection method. The preparation method of the shentongzhuyu granules comprises the following steps: S1: extraction: soaking the main components in water, decocting and extracting to obtain a shentongzhuyu decoction extract; the main components are qinjiao, chuanxiong, peach kernel, safflower, liquorice, qianghuo, myrrh, angelica, lindera, cyperus, achyranthes bidentata and earthworm; S2: concentration and drying: decompressing and concentrating the obtained shentongzhuyu decoction extract to obtain an extract, drying the extract to obtain a dry paste powder; S3: molding: adding sucrose powder to the dry paste powder, using ethanol with a volume concentration of 75% to 80% as a wetting agent, mixing and granulating, sieving to obtain wet granules; the weight ratio of the dry paste powder to the sucrose powder is 1:1-2; S4: drying the wet granules to obtain shentongzhuyu granules.

[0004] However, the preparation method of the shentong zhuyu granules involves extraction by soaking in water and boiling, which will cause the easily evaporable components in the main component to volatilize and affect the extraction rate. As the components volatilize, the amounts of the components in the finally obtained shentong zhuyu granules will be uncertain, and there are problems of low accuracy and unstable quality. While seriously affecting the efficacy of the medicine, there are safety risks for patients' consumption, which needs to be improved. Summary of the invention

[0005] In view of this, the first purpose of this application is to provide a preparation process of Shentong Zhuyu Decoction granules to achieve the purpose of good edible effect, safe consumption and easy carrying. The specific scheme is as follows: A preparation process of Shentong Zhuyu Decoction granules comprises the following steps: Step 1, distillation extraction: extracting Chuanxiong, Qianghuo, Myrrh, Angelica, and Cyperus by steam distillation to obtain drug residues and distilled volatile oil; Step 2, inclusion treatment: mixing the distilled volatile oil with the cyclodextrin inclusion material, subjecting the mixture to inclusion treatment and drying to obtain a volatile oil inclusion compound; Step 3, decoction and concentration: mixing the medicinal residue with qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm to obtain a decoction material, adding water to the decoction material and decocting the decoction material to obtain a decoction liquid and concentrating the decoction liquid to obtain a concentrate; Step 4, granular medicine preparation: spray-dry the concentrated solution to obtain extract powder, add dextrin to the extract powder, mix well, granulate and dry, finally add volatile oil inclusion compound, mix well to obtain Shentong Zhuyu Decoction granules.

[0006] Preferably: in step 2, the cyclodextrin inclusion material includes amino acid modified sulfobutyl ether-β-CD; the amino acid modified sulfobutyl ether-β-CD is modified with glutamic acid, cysteine ​​and glycine, and the modification method is to mix sulfobutyl ether-β-CD with glutamic acid, cysteine ​​and glycine at 100g:0.5-1mol respectively and dissolve them in a triethanolamine aqueous solution for stirring and refluxing, and the reflux time is 12-18h.

[0007] Preferably: the cyclodextrin inclusion material further comprises butyryl-β-cyclodextrin and chitosan, and the mass ratio of butyryl-β-cyclodextrin and chitosan to the amino acid-modified sulfobutyl ether-β-CD is 5-8:0.1-1:0.1-0.3; and the chitosan is hydroxyalkyl chitosan.

[0008] Preferably: in step 2, the mixing is performed by mixing ethanol aqueous solution with distilled volatile oil to obtain volatile oil ethanol liquid, mixing cyclodextrin inclusion material with water to obtain cyclodextrin inclusion material aqueous solution, and then dropping the volatile oil ethanol liquid into the cyclodextrin inclusion material aqueous solution; the mass ratio of the distilled volatile oil to the ethanol aqueous solution is 1:10-20, and the ethanol aqueous solution is 5-10% ethanol aqueous solution; the mass ratio of cyclodextrin inclusion material to water in the cyclodextrin inclusion material aqueous solution is 1:3-5, and the mass ratio of the distilled volatile oil to the cyclodextrin inclusion material is 1:1.4-1.6; the inclusion is performed by stirring the cyclodextrin inclusion material aqueous solution, controlling the temperature of the cyclodextrin inclusion material aqueous solution to 75-85°C, and then dropping the volatile oil ethanol liquid into the cyclodextrin inclusion material aqueous solution, stirring at a constant temperature for 3 hours after the dropwise addition is completed, and finally cooling and filtering to obtain the volatile oil inclusion compound that has not been dried.

[0009] Preferably: in step 3, the mass ratio of water to decoction is 6-8:1; the decoction is performed twice, and the decoction time for each time is 1 hour, and the decoction liquid is filtered out each time, and the two decoction liquids are combined and then evaporated and concentrated at high temperature to obtain a concentrated liquid, and the concentrated liquid is 1 / 6-1 / 16 of the mass of water.

[0010] Preferably: in step 4, the mass ratio of dextrin to extract powder is 3.6-4.8:1.

[0011] Preferably: in step 1, the mass ratio of Chuanxiong, Notopterygium, Myrrha, Angelica and Cyperus is 7-8:3.5-4:7-8:11-11.4:3.5-4.

[0012] Preferably: in step 3, the mass ratio of Gentiana macrophylla, peach kernel, safflower, liquorice, aconiti lobata, Achyranthes bidentata and Pheretima is 3.5-4:11-11.4:11-11.4:7-8:7-8:11-11.4:7-8.

[0013] Preferably: the mass ratio of the gentiana macrophylla, chuanxiong, peach kernel, safflower, liquorice, notopterygium wilfordii, myrrh, angelica sinensis, aconiti lobata, cyperus rotundus, achyranthes bidentata, and earthworm is as follows: 3.73:7.46:11.19:11.19:7.46:3.73:7.46:11.19:7.46:3.73:7.46:11.19:7.46.

[0014] The second object of the present application is to provide a Shentong Zhuyu Decoction granule, including one prepared by the preparation process of the Shentong Zhuyu Decoction granule as described above.

[0015] Through the above scheme, it can be known that the present application provides a Shentong Zhuyu Decoction granule and its preparation process, the preparation process of the Shentong Zhuyu Decoction granule has the purpose of convenient process and effective retention of the volatile components of the drug, thereby effectively ensuring the stability of the prepared Shentong Zhuyu Decoction granule, while overcoming the problems of large dosage, inaccurate dosage, inconvenient to carry and take, and inability to commercialize the traditional Chinese medicine decoction, so that the prepared preparation has the effect of accurate dosage, stable quality, convenient to take, and suitable for commercial mass production. The Shentong Zhuyu Decoction granule has the effects of good edible effect, safe to eat and easy to carry. DETAILED DESCRIPTION

[0016] The following will be clearly and completely described in conjunction with the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0017] It should be mentioned that after the cyclodextrin inclusion material is obtained by reflux treatment, it still needs to go through reduced pressure distillation, precipitation, filtration, purification, recrystallization and other steps to improve the purity, which will not be elaborated here.

[0018] A preparation process of Shentong Zhuyu Decoction granules comprises the following steps: Step 1, distillation extraction: extract Chuanxiong, Notopterygium, Myrrha, Angelica and Cyperus by steam distillation in a mass ratio of 7-8:3.5-4:7-8:11-11.4:3.5-4 to obtain drug residues and distilled volatile oil.

[0019] Step 2, inclusion treatment: the distilled volatile oil is mixed with the cyclodextrin inclusion material, and then subjected to inclusion and drying treatment to obtain a volatile oil inclusion compound.

[0020] The cyclodextrin inclusion material includes amino acid modified sulfobutyl ether-β-CD. The amino acid modified sulfobutyl ether-β-CD is modified with glutamic acid, cysteine ​​and glycine, and the modification method is to mix sulfobutyl ether-β-CD with glutamic acid, cysteine ​​and glycine at 100g:0.5-1mol respectively and dissolve in a triethanolamine aqueous solution for stirring and refluxing, and the reflux time is 12-18h.

[0021] It should be mentioned that the mixing is to mix ethanol aqueous solution with distilled volatile oil to obtain volatile oil ethanol solution, to mix cyclodextrin inclusion material with water to obtain cyclodextrin inclusion material aqueous solution, and then drop the volatile oil ethanol solution into the cyclodextrin inclusion material aqueous solution. The mass ratio of distilled volatile oil to ethanol aqueous solution is 1:10-20, and the ethanol aqueous solution is 5-10% ethanol aqueous solution. The mass ratio of cyclodextrin inclusion material to water in the cyclodextrin inclusion material aqueous solution is 1:3-5. The mass ratio of distilled volatile oil to cyclodextrin inclusion material is 1:1.4-1.6. The inclusion is to stir the cyclodextrin inclusion material aqueous solution, control the temperature of the cyclodextrin inclusion material aqueous solution to 75-85°C, and then drop the volatile oil ethanol solution into the cyclodextrin inclusion material aqueous solution. After the dropwise addition is completed, it is stirred at a constant temperature for 3 hours, and finally cooled and filtered to obtain the volatile oil inclusion compound without drying treatment.

[0022] Step 3, decoction and concentration: mix the medicinal residue with qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm to obtain a decoction, wherein the mass ratio of qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm is 3.5-4:11-11.4:11-11.4:7-8:7-8:11-11.4:7-8, add water to the decoction and decoct to obtain a decoction, which is then concentrated to obtain a concentrate.

[0023] The mass ratio of water to decoction material is 6-8:1; the decoction is performed twice, and the decoction time for each decoction is 1 hour, and the decoction liquid is filtered out each time, and the two decoction liquids are combined and then evaporated and concentrated at high temperature to obtain a concentrated liquid, and the concentrated liquid is 1 / 6-1 / 16 of the mass of water.

[0024] Step 4, granular medicine: spray-dry the concentrated solution to obtain extract powder, add dextrin to the extract powder, control the mass ratio of dextrin to extract powder to be 3.6-4.8:1, mix evenly, granulate and dry, finally add volatile oil inclusion compound, mix evenly to obtain Shentong Zhuyu Decoction granules.

[0025] A Shentong Zhuyu Decoction granule is prepared by using the preparation process of the Shentong Zhuyu Decoction granule as described above.

[0026] The Shentong Zhuyu Decoction granules are convenient to carry, not prone to deterioration and have improved drug stability when used.

[0027] Of course, butyryl-β-cyclodextrin and chitosan may also be added to the cyclodextrin inclusion material in a mass ratio of 5-8:0.1-1:0.1-0.3 to amino acid-modified sulfobutyl ether-β-CD. The chitosan is hydroxyalkyl chitosan.

[0028] It should be mentioned that in the specific embodiments of the present application, the mass ratio of Gentiana macrophylla, Ligustrum lucidum, peach kernel, safflower, liquorice, Notopterygium wilfordii, myrrh, angelica sinensis, Aconiti lobata, Cyperus rotundus, Achyranthes bidentata, and Pheretima is 3.73:7.46:11.19:11.19:7.46:3.73:7.46:11.19:7.46:3.73:11.19:7.46.

[0029] Embodiment 1 A preparation process of Shentong Zhuyu Decoction granules comprises the following steps: Step 1, distillation extraction: extract Rhizoma Chuanxiong, Rhizoma Notopterygii, Myrrha, Radix Angelicae Sinensis and Rhizoma Cyperi by steam distillation to obtain drug residues and distilled volatile oil.

[0030] Step 2, inclusion treatment: the distilled volatile oil is mixed with the cyclodextrin inclusion material, and then subjected to inclusion and drying treatment to obtain a volatile oil inclusion compound.

[0031] The cyclodextrin inclusion material includes amino acid modified sulfobutyl ether-β-CD. The amino acid modified sulfobutyl ether-β-CD is modified with glutamic acid, cysteine ​​and glycine, and the modification method is to mix sulfobutyl ether-β-CD with glutamic acid, cysteine ​​and glycine at 100g:0.5mol respectively and dissolve in a triethanolamine aqueous solution for stirring and refluxing, and the reflux time is 12h.

[0032] It should be mentioned that the mixing is to mix ethanol aqueous solution with distilled volatile oil to obtain volatile oil ethanol solution, to mix cyclodextrin inclusion material with water to obtain cyclodextrin inclusion material aqueous solution, and then drop the volatile oil ethanol solution into the cyclodextrin inclusion material aqueous solution. The mass ratio of distilled volatile oil to ethanol aqueous solution is 1:10, and the ethanol aqueous solution is 5% ethanol aqueous solution. The mass ratio of cyclodextrin inclusion material to water in the cyclodextrin inclusion material aqueous solution is 1:3. The mass ratio of distilled volatile oil to cyclodextrin inclusion material is 1:1.4. The inclusion is to stir the cyclodextrin inclusion material aqueous solution, control the temperature of the cyclodextrin inclusion material aqueous solution to 75°C, and then drop the volatile oil ethanol solution into the cyclodextrin inclusion material aqueous solution. After the dropwise addition is completed, it is stirred at a constant temperature for 3 hours, and finally the volatile oil inclusion compound without drying treatment is obtained by cooling and suction filtration.

[0033] Step 3, decoction and concentration: mix the medicinal residue with qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm to obtain a decoction, add water to the decoction and decoct to obtain a decoction liquid, and concentrate to obtain a concentrated liquid.

[0034] Among them, the mass ratio of water to decoction is 6:1; the decoction is performed twice, and the decoction time for each time is 1 hour, and the decoction liquid is filtered out each time, and the two decoction liquids are combined and then evaporated and concentrated at high temperature to obtain a concentrated liquid, and the concentrated liquid is 1 / 6 of the mass of water.

[0035] Step 4, granular medicine preparation: spray-dry the concentrated solution to obtain extract powder, add dextrin to the extract powder, control the mass ratio of dextrin to extract powder to be 3.6:1, mix evenly, granulate and dry, finally add volatile oil inclusion compound, mix evenly to obtain Shentong Zhuyu Decoction granules.

[0036] A Shentong Zhuyu Decoction granule is prepared by using the preparation process of the Shentong Zhuyu Decoction granule as described above.

[0037] The Shentong Zhuyu Decoction granules are convenient to carry, not prone to deterioration and have improved drug stability when used.

[0038] Embodiment 2 A preparation process of Shentong Zhuyu Decoction granules comprises the following steps: Step 1, distillation extraction: extract Rhizoma Chuanxiong, Rhizoma Notopterygii, Myrrha, Radix Angelicae Sinensis and Rhizoma Cyperi by steam distillation to obtain drug residues and distilled volatile oil.

[0039] Step 2, inclusion treatment: the distilled volatile oil is mixed with the cyclodextrin inclusion material, and then subjected to inclusion and drying treatment to obtain a volatile oil inclusion compound.

[0040] The cyclodextrin inclusion material includes amino acid modified sulfobutyl ether-β-CD. The amino acid modified sulfobutyl ether-β-CD is modified with glutamic acid, cysteine ​​and glycine, and the modification method is to mix sulfobutyl ether-β-CD with glutamic acid, cysteine ​​and glycine at 100g:0.75mol respectively and dissolve in a triethanolamine aqueous solution for stirring and refluxing, and the reflux time is 15h.

[0041] It should be mentioned that the mixing is to mix ethanol aqueous solution with distilled volatile oil to obtain volatile oil ethanol liquid, to mix cyclodextrin inclusion material with water to obtain cyclodextrin inclusion material aqueous solution, and then drop the volatile oil ethanol liquid into the cyclodextrin inclusion material aqueous solution. The mass ratio of distilled volatile oil to ethanol aqueous solution is 1:15, and the ethanol aqueous solution is 7% ethanol aqueous solution. The mass ratio of cyclodextrin inclusion material to water in the cyclodextrin inclusion material aqueous solution is 1:4. The mass ratio of distilled volatile oil to cyclodextrin inclusion material is 1:1.5. The inclusion is to stir the cyclodextrin inclusion material aqueous solution, control the temperature of the cyclodextrin inclusion material aqueous solution to 80°C, and then drop the volatile oil ethanol liquid into the cyclodextrin inclusion material aqueous solution. After the dropwise addition is completed, it is stirred at a constant temperature for 3 hours, and finally the volatile oil inclusion compound without drying treatment is obtained by cooling and suction filtration.

[0042] Step 3, decoction and concentration: mix the medicinal residue with qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm to obtain a decoction, add water to the decoction and decoct to obtain a decoction liquid, and concentrate to obtain a concentrated liquid.

[0043] Among them, the mass ratio of water to decoction is 7:1; the decoction is performed twice, and the decoction time for each time is 1 hour, and the decoction liquid is filtered out each time, and the two decoction liquids are combined and then evaporated and concentrated at high temperature to obtain a concentrated liquid, and the concentrated liquid is 1 / 10 of the mass of water.

[0044] Step 4, granular medicine preparation: spray-dry the concentrated solution to obtain extract powder, add dextrin to the extract powder, control the mass ratio of dextrin to extract powder to be 4.2:1, mix evenly, granulate and dry, finally add volatile oil inclusion compound, mix evenly to obtain Shentong Zhuyu Decoction granules.

[0045] A Shentong Zhuyu Decoction granule is prepared by using the preparation process of the Shentong Zhuyu Decoction granule as described above.

[0046] The Shentong Zhuyu Decoction granules are convenient to carry, not prone to deterioration and have improved drug stability when used.

[0047] Embodiment 3 A preparation process of Shentong Zhuyu Decoction granules comprises the following steps: Step 1, distillation extraction: extract Chuanxiong, Qianghuo, Myrrh, Angelica, and Cyperus by steam distillation to obtain drug residues and distilled volatile oil.

[0048] Step 2, inclusion treatment: the distilled volatile oil is mixed with the cyclodextrin inclusion material, and then subjected to inclusion and drying treatment to obtain a volatile oil inclusion compound.

[0049] The cyclodextrin inclusion material includes amino acid modified sulfobutyl ether-β-CD. The amino acid modified sulfobutyl ether-β-CD is modified with glutamic acid, cysteine ​​and glycine, and the modification method is to mix sulfobutyl ether-β-CD with glutamic acid, cysteine ​​and glycine at 100g:1mol respectively and dissolve in a triethanolamine aqueous solution for stirring and refluxing, and the reflux time is 18h.

[0050] It should be mentioned that the mixing is to mix ethanol aqueous solution with distilled volatile oil to obtain volatile oil ethanol solution, to mix cyclodextrin inclusion material with water to obtain cyclodextrin inclusion material aqueous solution, and then drop the volatile oil ethanol solution into the cyclodextrin inclusion material aqueous solution. The mass ratio of distilled volatile oil to ethanol aqueous solution is 1:20, and the ethanol aqueous solution is 10% ethanol aqueous solution. The mass ratio of cyclodextrin inclusion material to water in the cyclodextrin inclusion material aqueous solution is 1:5. The mass ratio of distilled volatile oil to cyclodextrin inclusion material is 1:1.6. The inclusion is to stir the cyclodextrin inclusion material aqueous solution, control the temperature of the cyclodextrin inclusion material aqueous solution to 85°C, and then drop the volatile oil ethanol solution into the cyclodextrin inclusion material aqueous solution. After the dropwise addition is completed, it is stirred at a constant temperature for 3 hours, and finally the volatile oil inclusion compound without drying treatment is obtained by cooling and suction filtration.

[0051] Step 3, decoction and concentration: mix the medicinal residue with qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm to obtain a decoction, add water to the decoction and decoct to obtain a decoction liquid, and concentrate to obtain a concentrated liquid.

[0052] Among them, the mass ratio of water to decoction is 8:1; the decoction is performed twice, and the decoction time for each time is 1 hour, and the decoction liquid is filtered out each time, and the two decoction liquids are combined and then evaporated and concentrated at high temperature to obtain a concentrated liquid, and the concentrated liquid is 1 / 16 of the mass of water.

[0053] Step 4, granular medicine: spray-dry the concentrated solution to obtain extract powder, add dextrin to the extract powder, control the mass ratio of dextrin to extract powder to be 3.6-4.8:1, mix evenly, granulate and dry, finally add volatile oil inclusion compound, mix evenly to obtain Shentong Zhuyu Decoction granules.

[0054] A Shentong Zhuyu Decoction granule is prepared by using the preparation process of the Shentong Zhuyu Decoction granule as described above.

[0055] The Shentong Zhuyu Decoction granules are convenient to carry, not prone to deterioration and have improved drug stability when used.

[0056] Embodiment 4 The difference between Example 4 and Example 2 is that the cyclodextrin inclusion material in Example 4 further includes butyryl-β-cyclodextrin and chitosan, and the mass ratio of butyryl-β-cyclodextrin and chitosan to the amino acid modified sulfobutyl ether-β-CD is 5:0.1:0.1; and the chitosan is hydroxyalkyl chitosan.

[0057] Embodiment 5 The difference between Example 5 and Example 2 is that the cyclodextrin inclusion material in Example 5 further includes butyryl-β-cyclodextrin and chitosan, and the mass ratio of butyryl-β-cyclodextrin and chitosan to the amino acid modified sulfobutyl ether-β-CD is 6:0.5:0.2; and the chitosan is hydroxyalkyl chitosan.

[0058] Embodiment 6 The difference between Example 6 and Example 2 is that the cyclodextrin inclusion material in Example 6 further includes butyryl-β-cyclodextrin and chitosan, and the mass ratio of butyryl-β-cyclodextrin and chitosan to the amino acid modified sulfobutyl ether-β-CD is 8:1:0.3; and the chitosan is hydroxyalkyl chitosan.

[0059] Comparative Example 1 The difference between Comparative Example 1 and Example 2 is that β-CD is used as the cyclodextrin inclusion material in Comparative Example 1.

[0060] Comparative Example 2 The difference between Comparative Example 2 and Example 2 is that in Comparative Example 2, sulfobutyl ether-β-CD is used as the cyclodextrin inclusion material.

[0061] Comparative Example 3 The difference between Comparative Example 3 and Example 2 is that the amino acid-modified sulfobutyl ether-β-CD used in Comparative Example 3 is sulfobutyl ether-β-CD modified with glutamic acid.

[0062] test: 1. Test the content of ligustilide in volatile oil inclusion complex; 2. Test the inclusion effect, and use the phase solubility method to test whether there is a capacity-enhancing effect (I, II, III, IV, and V are used to represent the degree of gradual improvement of the capacity-enhancing effect); 3. To test the inclusion stability, the content of ligustilide was determined by extracting volatile oil inclusion complexes. Taking the mass fraction at 0d as 100%, the relative mass fractions of ligustilide at 3d, 10d, 30d and 60d were calculated respectively.

[0063] Performance tests were conducted on Examples 1 to 4 and Comparative Examples 1 to 3, and the test results are shown in Table 1 below.

[0064] Table 1 Performance test results

[0065] It can be seen from Table 1 above that the amino acid-modified sulfobutyl ether-β-CD of the present application can promote the effect of improving the α-1,4 glycosidic bond connection, thereby significantly improving the stability of the inclusions. At the same time, when the amino acid-modified sulfobutyl ether-β-CD is mixed with distilled volatile oil, it will fully contain distilled extract components such as gentiopicroside, ferulic acid, hydroxysafflor yellow A, amygdalin and ligustilide, so that the overall composition of the volatile oil inclusion complex is stable, and after being applied to the preparation of the Shentong Zhuyu Decoction Granules, it can ensure the stability of the efficacy of the Shentong Zhuyu Decoction Granules, the accurate dosage and the stable quality, so that it is suitable for commercial large-scale production.

[0066] It should be mentioned that the present application provides a Shentong Zhuyu Decoction granule and a preparation process thereof, the preparation process of the Shentong Zhuyu Decoction granule has the purpose of being convenient in process and effectively retaining the volatile components of the drug, thereby effectively ensuring the stability of the prepared Shentong Zhuyu Decoction granule, while overcoming the problems of large dosage, inaccurate dosage, inconvenient to carry and take, and inability to commercialize the traditional Chinese medicine decoction, so that the prepared preparation has the effect of accurate dosage, stable quality, convenient to take, and suitable for commercial mass production. The Shentong Zhuyu Decoction granule has the effects of good edible effect, safe to eat, and easy to carry.

[0067] The "first", "second", "third", "fourth", etc. (if any) referred to in this application are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchangeable where appropriate, so that the embodiments described herein can be implemented in an order other than that described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method or device comprising a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods or devices.

[0068] It should be noted that the descriptions involving "first", "second", etc. in this application are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in this field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by this application.

[0069] Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the method of the present application and its core idea. At the same time, for those skilled in the art, according to the idea of ​​the present application, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as a limitation on the present application.

Claims

1. A preparation process of Shentong Zhuyu Decoction granules, characterized in that: The steps include: Step 1, distillation extraction: extracting Chuanxiong, Notopterygium wilfordii, Myrrha sinensis, Angelica sinensis, and Cyperus rotundus by steam distillation to obtain drug residues and distilled volatile oil; Step 2, inclusion treatment: mixing the distilled volatile oil with the cyclodextrin inclusion material, subjecting the mixture to inclusion treatment and drying to obtain a volatile oil inclusion compound; Step 3, decoction and concentration: mixing the medicinal residue with qinjiao, peach kernel, safflower, liquorice, truncatum, achyranthes bidentata and earthworm to obtain a decoction material, adding water to the decoction material and decocting the decoction material to obtain a decoction liquid and concentrating the decoction liquid to obtain a concentrate; Step 4, granular medicine preparation: spray-dry the concentrated solution to obtain extract powder, add dextrin to the extract powder, mix well, granulate and dry, finally add volatile oil inclusion compound, mix well to obtain Shentong Zhuyu Decoction granules.

2. The preparation process of the Shentong Zhuyu Decoction granules according to claim 1, characterized in that: In step 2, the cyclodextrin inclusion material includes amino acid modified sulfobutyl ether-β-CD; the amino acid modified sulfobutyl ether-β-CD is modified with glutamic acid, cysteine ​​and glycine, and the modification method is to mix sulfobutyl ether-β-CD with glutamic acid, cysteine ​​and glycine at 100g:0.5-1mol respectively and dissolve them in a triethanolamine aqueous solution for stirring and refluxing, and the reflux time is 12-18h.

3. The preparation process of the Shentong Zhuyu Decoction granules according to claim 2, characterized in that: The cyclodextrin inclusion material also includes butyryl-β-cyclodextrin and chitosan, and the mass ratio of butyryl-β-cyclodextrin and chitosan to the amino acid modified sulfobutyl ether-β-CD is 5-8:0.1-1:0.1-0.3; the chitosan is hydroxyalkyl chitosan.

4. The preparation process of the Shentong Zhuyu Decoction granules according to claim 1, characterized in that: In step 2, the mixing is performed by mixing ethanol aqueous solution with distilled volatile oil to obtain volatile oil ethanol liquid, mixing cyclodextrin inclusion material with water to obtain cyclodextrin inclusion material aqueous solution, and then dropping the volatile oil ethanol liquid into the cyclodextrin inclusion material aqueous solution; the mass ratio of the distilled volatile oil to the ethanol aqueous solution is 1:10-20, and the ethanol aqueous solution is 5-10% ethanol aqueous solution; the mass ratio of cyclodextrin inclusion material to water in the cyclodextrin inclusion material aqueous solution is 1:3-5, and the mass ratio of the distilled volatile oil to the cyclodextrin inclusion material is 1:1.4-1.6; the inclusion is performed by stirring the cyclodextrin inclusion material aqueous solution, controlling the temperature of the cyclodextrin inclusion material aqueous solution to 75-85°C, and then dropping the volatile oil ethanol liquid into the cyclodextrin inclusion material aqueous solution, stirring at a constant temperature for 3 hours after the dropwise addition is completed, and finally cooling and filtering to obtain the volatile oil inclusion compound that has not been dried.

5. The preparation process of the Shentong Zhuyu Decoction granules according to claim 1, characterized in that: In step 3, the mass ratio of water to decoction is 6-8:1; the decoction is performed twice, and the decoction time for each time is 1 hour, and the decoction liquid is filtered out each time, and the two decoction liquids are combined and concentrated by high-temperature evaporation to obtain a concentrated liquid, and the concentrated liquid is 1 / 6-1 / 16 of the mass of water.

6. The preparation process of the Shentong Zhuyu Decoction granules according to claim 1, characterized in that: In step 4, the mass ratio of dextrin to extract powder is 3.6-4.8:

1.

7. The preparation process of the Shentong Zhuyu Decoction granules according to claim 1, characterized in that: In step 1, the mass ratio of Chuanxiong, Notopterygium, Myrrh, Angelica and Cyperus is 7-8:3.5-4:7-8:11-11.4:3.5-4.

8. The preparation process of the Shentong Zhuyu Decoction granules according to claim 7, characterized in that: In step 3, the mass ratio of Gentiana macrophylla, peach kernel, safflower, liquorice, aconiti lobata, Achyranthes bidentata and Pheretima is 3.5-4:11-11.4:11-11.4:7-8:7-8:11-11.4:7-8.

9. The preparation process of the Shentong Zhuyu Decoction granules according to claim 8, characterized in that: The mass ratio of the gentiana macrophylla, chuanxiong, peach kernel, safflower, liquorice, notopterygium wilfordii, myrrh, angelica sinensis, aconiti lobata, cyperus rotundus, achyranthes bidentata, and earthworm is as follows: 3.73:7.46:11.19:11.19:7.46:3.73:7.46:11.19:7.46:3.73:11.19:7.46。 10. A Shentong Zhuyu Decoction granule, characterized in that: The method comprises preparing the Shentong Zhuyu Decoction granules by using the preparation process of the Shentong Zhuyu Decoction granules as described in any one of claims 1 to 9.

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