Bowel-warming traditional Chinese medicine application composition capable of bidirectionally regulating gastrointestinal motility and preparation method of bowel-warming traditional Chinese medicine application composition

Abstract

The invention provides an internal-organ-warming traditional Chinese medicine application composition capable of bidirectionally regulating gastrointestinal motility and a preparation method, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine is prepared from the following raw materials in parts by weight: 10-15 parts of rhizoma zingiberis, 10-15 parts of cortex cinnamomi, 20-25 parts of folium artemisiae argyi, 10-15 parts of fennel, 6-9 parts of fructus evodiae, 10-15 parts of radix aucklandiae, 10-20 parts of flos carthami and 10-15 parts of rhizoma atractylodis. The bowel-warming traditional Chinese medicine application composition capable of bidirectionally regulating gastrointestinal motility provides a new choice for gastrointestinal motility weakening or hyperfunction, the preparation method provides a better pure traditional Chinese medicine preparation for patients with gastrointestinal motility weakening or hyperfunction, and the clinical curative effect of the bowel-warming traditional Chinese medicine application composition is remarkable.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to an intestinal warming traditional Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility and a preparation method thereof. Background Art

[0002] Constipation is one of the common clinical diseases, especially among the elderly and bedridden patients. Constipation affects gastrointestinal function, causes bloating, affects eating, and causes malnutrition in bedridden patients. Constipation is a predisposing factor for critical illness. Constipation can induce cardiovascular accidents and have serious consequences. Western medicine treatment usually has a temporary effect with oral laxatives, enemas, suppositories, etc. Chinese medicine patch treatment has a slow onset of effect and is clinically used for long-term bedridden prevention of cerebrovascular disease. For the treatment of other constipations, acupoint patch treatment is added on the basis of Western medicine treatment (emergency clinical application) to play a lasting role and avoid drug diarrhea caused by oral medications. The effect and purpose of the patch is to restore the patient's gastrointestinal function to normal. Summary of the invention

[0003] The purpose of the present invention is to propose a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility and a preparation method, so as to provide a new choice for weakened or hyperactive gastrointestinal motility, and its preparation method provides a better pure Chinese medicine preparation for patients with weakened or hyperactive gastrointestinal motility, and its clinical efficacy is significant.

[0004] The technical solution of the present invention is achieved in this way:

[0005] The invention provides a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility, which is prepared from the following raw materials: dried ginger, cinnamon bark, wormwood leaf, fennel, evodia rutaecarpa, costusroot, safflower and atractylodes.

[0006] As a further improvement of the present invention, the drug is prepared from the following raw materials by weight: 10-15 parts of dried ginger, 10-15 parts of cinnamon, 20-25 parts of wormwood, 10-15 parts of fennel, 6-9 parts of evodia rutaecarpa, 10-15 parts of costusroot, 10-20 parts of safflower, and 10-15 parts of atractylodes.

[0007] As a further improvement of the present invention, the drug is prepared from the following raw materials by weight: 11-14 parts of dried ginger, 11-14 parts of cinnamon, 22-24 parts of mugwort, 11-14 parts of fennel, 7-8 parts of evodia rutaecarpa, 11-14 parts of costusroot, 12-17 parts of safflower, and 11-14 parts of atractylodes.

[0008] As a further improvement of the present invention, the drug is prepared from the following raw materials in parts by weight: 12 parts of dried ginger, 12 parts of cinnamon bark, 23 parts of wormwood leaf, 12 parts of fennel, 7 parts of evodia rutaecarpa, 13 parts of costusroot, 15 parts of safflower, and 12 parts of atractylodes.

[0009] The present invention further protects a method for preparing the above-mentioned composition, comprising the following steps:

[0010] (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil;

[0011] (2) Mix and crush the dried ginger, wormwood leaves and atractylodes lancea, add to water, heat to boiling and extract, repeat the extraction 2-3 times, filter, combine and concentrate the filtrates, and dry to obtain a water extract;

[0012] (3) Mixing Evodia rutaecarpa, fennel and safflower, crushing them, adding them to a mixed solvent, heating and refluxing for extraction, repeating the extraction 2-3 times, filtering, combining and concentrating the filtrates, removing the solvent under reduced pressure, and drying to obtain an oil extract;

[0013] (4) The water extract and the oil extract are mixed and added into the extraction oil, and the mixture is stirred and mixed evenly to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0014] As a further improvement of the present invention, the conditions of the supercritical fluid extraction in step (1) are pressure 25-35MPa, temperature 40-50°C, time 120-200min, the entrainer is an ethanol solution, the ethanol content in the ethanol solution is 15-35wt%, and the amount of the entrainer added is 2-5wt%.

[0015] As a further improvement of the present invention, the mass of the water in step (2) is 5-10 times that of the medicinal powder, and the time for heating to boiling extraction is 2-4 hours.

[0016] As a further improvement of the present invention, the mass of the mixed solvent in step (3) is 4-7 times that of the medicinal powder, and the time of the heating reflux extraction is 1-3 hours.

[0017] As a further improvement of the present invention, the mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 3-5:10.

[0018] As a further improvement of the present invention, the stirring and mixing time in step (4) is 10-20 minutes.

[0019] The present invention has the following beneficial effects:

[0020] The bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility of the present invention provides a new choice for weakened or hyperactive gastrointestinal motility. In addition to aiding defecation, it also has the effect of treating diarrhea. The bidirectional regulation and the preparation method thereof provide a better pure Chinese medicine preparation for patients with weakened or hyperactive gastrointestinal motility, and the clinical efficacy is significant. DETAILED DESCRIPTION

[0021] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] Example 1

[0023] This embodiment provides a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0024] Raw material composition (by weight): 10 parts of dried ginger, 10 parts of cinnamon bark, 20 parts of wormwood leaves, 10 parts of fennel, 6 parts of evodia rutaecarpa, 10 parts of costusroot, 10 parts of safflower, and 10 parts of atractylodes.

[0025] The preparation method comprises the following steps:

[0026] (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil;

[0027] The supercritical fluid extraction conditions are as follows: pressure 25 MPa, temperature 40° C., time 120 min, entrainer is ethanol solution, the ethanol content in the ethanol solution is 15 wt%, and the entrainer addition amount is 2 wt%;

[0028] (2) Mix and crush dried ginger, mugwort leaves, and atractylodes lancea, add 5 times the mass of water, heat to boiling and extract for 2 h, repeat the extraction twice, filter, combine and concentrate the filtrates, and dry to obtain a water extract;

[0029] (3) Mix Evodia rutaecarpa, fennel and safflower, crush them, add them to a 4-fold mass of mixed solvent, heat and reflux to extract for 1 h, repeat the extraction twice, filter, combine and concentrate the filtrates, remove the solvent under reduced pressure, and dry to obtain an oil extract;

[0030] The mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 3:10;

[0031] (4) The water extract and the oil extract were mixed and added to the extraction oil, and the mixture was stirred for 10 minutes to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0032] Example 2

[0033] This embodiment provides a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0034] Raw material composition (by weight): 15 parts of dried ginger, 15 parts of cinnamon bark, 25 parts of wormwood leaves, 15 parts of fennel, 9 parts of evodia rutaecarpa, 15 parts of costusroot, 20 parts of safflower, and 15 parts of atractylodes.

[0035] The preparation method comprises the following steps:

[0036] (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil;

[0037] The supercritical fluid extraction conditions are: pressure 35 MPa, temperature 50° C., time 200 min, entrainer is ethanol solution, the ethanol content in the ethanol solution is 35 wt%, and the entrainer addition amount is 5 wt%;

[0038] (2) Mix and crush dried ginger, mugwort leaves, and atractylodes lancea, add 10 times the mass of water, heat to boiling and extract for 4 hours, repeat the extraction 3 times, filter, combine and concentrate the filtrates, and dry to obtain a water extract;

[0039] (3) Mix Evodia rutaecarpa, fennel and safflower, crush them, add them to a mixed solvent of 7 times the mass, heat and reflux for extraction for 3 hours, repeat the extraction 3 times, filter, combine and concentrate the filtrates, remove the solvent under reduced pressure, and dry to obtain an oil extract;

[0040] The mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 5:10;

[0041] (4) The water extract and the oil extract are mixed and added to the extraction oil, and stirred for 20 minutes to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0042] Example 3

[0043] This embodiment provides a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0044] Raw material composition (by weight): 11 parts of dried ginger, 11 parts of cinnamon bark, 22 parts of wormwood leaves, 11 parts of fennel, 7 parts of evodia rutaecarpa, 11 parts of costusroot, 12 parts of safflower, and 11 parts of atractylodes.

[0045] The preparation method comprises the following steps:

[0046] (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil;

[0047] The supercritical fluid extraction conditions are as follows: pressure 27 MPa, temperature 42° C., time 140 min, entrainer is ethanol solution, the ethanol content in the ethanol solution is 17 wt %, and the entrainer addition amount is 2.5 wt %;

[0048] (2) Mix and crush dried ginger, mugwort leaves, and atractylodes lancea, add 6 times the mass of water, heat to boiling and extract for 3 hours, repeat the extraction twice, filter, combine and concentrate the filtrates, and dry to obtain a water extract;

[0049] (3) Mix Evodia rutaecarpa, fennel and safflower, crush them, add them to a 5-fold mass of mixed solvent, heat and reflux for extraction for 2 h, repeat the extraction twice, filter, combine and concentrate the filtrates, remove the solvent under reduced pressure, and dry to obtain an oil extract;

[0050] The mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 4:10;

[0051] (4) The water extract and the oil extract were mixed and added to the extraction oil, and the mixture was stirred for 12 minutes to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0052] Example 4

[0053] This embodiment provides a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0054] Raw material composition (by weight): 14 parts of dried ginger, 14 parts of cinnamon bark, 24 parts of wormwood leaves, 14 parts of fennel, 8 parts of evodia rutaecarpa, 14 parts of costusroot, 17 parts of safflower, and 14 parts of atractylodes.

[0055] The preparation method comprises the following steps:

[0056] (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil;

[0057] The supercritical fluid extraction conditions are as follows: pressure 32 MPa, temperature 48° C., time 180 min, entrainer is ethanol solution, the ethanol content in the ethanol solution is 32 wt %, and the entrainer addition amount is 4 wt %;

[0058] (2) Mix and crush dried ginger, mugwort leaves, and atractylodes lancea, add 9 times the mass of water, heat to boiling and extract for 3 hours, repeat the extraction 3 times, filter, combine and concentrate the filtrates, and dry to obtain a water extract;

[0059] (3) Mix Evodia rutaecarpa, fennel and safflower, crush them, add them to a 6-fold mass of mixed solvent, heat and reflux for extraction for 2 h, repeat the extraction 3 times, filter, combine and concentrate the filtrates, remove the solvent under reduced pressure, and dry to obtain an oil extract;

[0060] The mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 4:10;

[0061] (4) The water extract and the oil extract were mixed and added to the extraction oil, and the mixture was stirred for 18 minutes to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0062] Example 5

[0063] This embodiment provides a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0064] Raw material composition (by weight): 12 parts of dried ginger, 12 parts of cinnamon bark, 23 parts of wormwood leaves, 12 parts of fennel, 7 parts of evodia rutaecarpa, 13 parts of costusroot, 15 parts of safflower, and 12 parts of atractylodes.

[0065] The preparation method comprises the following steps:

[0066] (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil;

[0067] The supercritical fluid extraction conditions are: pressure 30 MPa, temperature 45° C., time 150 min, the entrainer is an ethanol solution, the ethanol content in the ethanol solution is 25 wt%, and the entrainer addition amount is 3 wt%;

[0068] (2) Mix and crush dried ginger, mugwort leaves, and atractylodes lancea, add 7 times the mass of water, heat to boiling and extract for 3 hours, repeat the extraction 3 times, filter, combine and concentrate the filtrates, and dry to obtain a water extract;

[0069] (3) Mix Evodia rutaecarpa, fennel and safflower, crush them, add them to a 5-fold mass of mixed solvent, heat and reflux for extraction for 2 h, repeat the extraction twice, filter, combine and concentrate the filtrates, remove the solvent under reduced pressure, and dry to obtain an oil extract;

[0070] The mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 4:10;

[0071] (4) The water extract and the oil extract were mixed and added to the extracted oil, and the mixture was stirred for 15 minutes to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

[0072] Test Example 1

[0073] Kunming mice were randomly divided into a normal group and an experimental group of embodiments 1-5, 6 mice in each group. Each group of mice was fasted before the corresponding drug was given, and water was not allowed for 16h. The warming fu Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility was evenly applied to the mouse navel. The normal group replaced the composition with sodium carboxymethyl cellulose. After administration for 5min the next day, each group was gavaged with a blue semisolid nutrient paste (0.2g of blue dextran, 1.0g of dextran sulfate, and 6.0g of corn starch were put into 10mL of distilled water and fully mixed), and the gavage volume was 0.5mL per group, and mice were killed by neck dislocation after 10min, and gastrointestinal tissue was taken out, and the distance from the pylorus to the advancement of the blue semisolid nutrient paste and the full length of the small intestine were measured. The stomach was subsequently cut off and weighed, and the stomach was cut open along the greater curvature of the stomach to rinse and dry, and the net weight of the stomach was weighed, and the gastric emptying rate was calculated.

[0074] Gastric emptying rate (%) = 1-(total stomach weight-net stomach weight / total stomach weight) × 100%;

[0075] Small intestine propulsion rate (%) = distance from pylorus to blue semisolid nutrient paste / total length of small intestine × 100%.

[0076] The results are shown in Table 1.

[0077] Table 1

[0078] Group Gastric emptying rate (%) Small intestinal propulsion rate (%) Normal group 59.25 58.91 Example 1 73.15 67.37 Example 2 74.10 67.44 Example 3 72.05 67.02 Example 4 73.22 67.82 Example 5 75.19 68.89

[0079] As can be seen from the above table, the bowel-warming Chinese medicine patch compositions for bidirectionally regulating gastrointestinal motility prepared in Examples 1-5 of the present invention have the effect of significantly promoting gastrointestinal emptying.

[0080] Healthy mice were killed by dislocating the neck, and the ileum was taken out and placed in Krebs solution. After cleaning, it was cut into 1.0-1.5 cm long intestinal segments and fixed in an isolated organ bath. The water temperature was maintained at 37.5°C, and a mixed gas of 95% O2 and 5% CO2 was introduced. The resting tension was set to 1g, and the drug was added after 30 minutes of equilibrium. The warming fu Chinese medicine patch composition for bidirectional regulation of gastrointestinal motility prepared in Examples 1-5 was added in a trace amount by the concentration accumulation method, and the final concentration was 0.3 mg / mL. The physiological signal acquisition system recorded the changes in the contraction curve 1 minute before and after the addition of the drug, and calculated the contraction amplitude and frequency change rate.

[0081] Contraction amplitude change rate (%) = average contraction amplitude after administration / average contraction amplitude before administration × 100%;

[0082] Contraction frequency change rate (%) = average contraction frequency after administration / average contraction frequency before administration × 100%.

[0083] The results are shown in Table 2.

[0084] Table 2

[0085] Group Contraction amplitude change rate (%) Contraction frequency change rate (%) Normal group 122.54 88.95 Example 1 142.13 95.66 Example 2 144.05 96.15 Example 3 143.96 95.78 Example 4 145.05 96.10 Example 5 146.77 96.79

[0086] It can be seen from the above table that the bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility prepared in Examples 1-5 of the present invention has an obvious effect of promoting the contraction of ileal smooth muscle.

[0087] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility, characterized in that: It is prepared from the following raw materials: dried ginger, cinnamon, mugwort, fennel, evodia rutaecarpa, costus root, safflower, and atractylodes.

2. The composition according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 10-15 parts of dried ginger, 10-15 parts of cinnamon bark, 20-25 parts of wormwood leaf, 10-15 parts of fennel, 6-9 parts of evodia rutaecarpa, 10-15 parts of costusroot, 10-20 parts of safflower and 10-15 parts of atractylodes.

3. The composition according to claim 2, characterized in that The invention is prepared from the following raw materials in parts by weight: 11-14 parts of dried ginger, 11-14 parts of cinnamon bark, 22-24 parts of wormwood leaves, 11-14 parts of fennel, 7-8 parts of evodia rutaecarpa, 11-14 parts of costusroot, 12-17 parts of safflower and 11-14 parts of atractylodes.

4. The composition according to claim 3, characterized in that The invention is prepared from the following raw materials in parts by weight: 12 parts of dried ginger, 12 parts of cinnamon bark, 23 parts of wormwood leaf, 12 parts of fennel, 7 parts of evodia rutaecarpa, 13 parts of costusroot, 15 parts of safflower and 12 parts of atractylodes.

5. A method for preparing the composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: (1) mixing costusroot and cinnamon bark, and extracting by supercritical fluid to obtain an extract oil; (2) Mix and crush dried ginger, wormwood leaves, and atractylodes lancea, add to water, heat to boiling and extract, repeat the extraction 2-3 times, filter, combine and concentrate the filtrates, and dry to obtain a water extract; (3) Mixing Evodia rutaecarpa, fennel and safflower, crushing them, adding them to a mixed solvent, heating and refluxing for extraction, repeating the extraction 2-3 times, filtering, combining and concentrating the filtrates, removing the solvent under reduced pressure, and drying to obtain an oil extract; (4) The water extract and the oil extract are mixed and added into the extraction oil, and the mixture is stirred and evenly mixed to prepare a bowel-warming Chinese medicine patch composition for bidirectionally regulating gastrointestinal motility.

6. The preparation method according to claim 5, characterized in that: The conditions of supercritical fluid extraction in step (1) are pressure 25-35MPa, temperature 40-50°C, time 120-200min, the entrainer is ethanol solution, the ethanol content in the ethanol solution is 15-35wt%, and the amount of entrainer added is 2-5wt%.

7. The preparation method according to claim 5, characterized in that: The mass of the water in step (2) is 5-10 times that of the medicinal powder, and the time for heating to boiling extraction is 2-4 hours.

8. The preparation method according to claim 5, characterized in that: The mass of the mixed solvent in step (3) is 4-7 times that of the medicinal powder, and the time of the heating reflux extraction is 1-3 hours.

9. The preparation method according to claim 5, characterized in that: The mixed solvent is a mixed solvent of ethyl acetate and ethanol, with a mass ratio of 3-5:

10.

10. The preparation method according to claim 5, characterized in that: The stirring and mixing time in step (4) is 10-20 minutes.