CN108403797B

CN108403797B - Abdomen warming patch and preparation method thereof

Info

Publication number: CN108403797B
Application number: CN201810460325.6A
Authority: CN
Inventors: 张华�; 朱继军; 方孟香; 刘晓静
Original assignee: Shandong University of Traditional Chinese Medicine
Current assignee: Shandong University of Traditional Chinese Medicine
Priority date: 2018-05-15
Filing date: 2018-05-15
Publication date: 2023-04-07
Anticipated expiration: 2038-05-15
Also published as: CN108403797A

Abstract

The invention belongs to the field of medical health care medicines, and particularly relates to an abdomen warming patch and a preparation method thereof. The abdomen warming patch is prepared from the following raw materials in parts by mass, namely folium artemisiae argyi, prepared monkshood and cinnamon, wherein the mass ratio of the raw materials is 8-10:4-5:0.5-1. The prepared monkshood, the cinnamon and the folium artemisiae argyi used in the traditional Chinese medicine composition are matched with each other, the effects complement each other, and the traditional Chinese medicine composition can effectively treat the lumbago and the abdominal pain before and during menstruation caused by deficiency-cold of qi and blood and cold stagnation of uterus.

Description

Abdomen warming patch and preparation method thereof

Technical Field

The invention belongs to the field of medical health care medicines, and particularly relates to an abdomen warming patch and a preparation method thereof.

Background

Dysmenorrhea is one of the most common gynecological symptoms, and refers to those with lower abdominal pain, sagging and distension before and after menstruation or during menstruation, accompanied by soreness of waist or other discomforts, and the symptoms seriously affect the quality of life. The dysmenorrhea is divided into primary dysmenorrhea and secondary dysmenorrhea, wherein the primary dysmenorrhea refers to dysmenorrhea caused by genital organ anergy lesion; secondary dysmenorrhea refers to dysmenorrhea caused by pelvic organic diseases, such as endometriosis and adenomyosis.

The TCM holds that the occurrence of this disease is closely related to the periodic physiological changes of Chong and ren meridians and uterus. The main pathogenesis of the dysmenorrhea is that the vital energy is internally hidden or the essence and blood are deficient, and the physiological change of qi and blood of Chong and ren meridians before and after the menstrual period is more sudden, so that the qi and blood circulation of the uterus is not smooth, obstruction causes pain, or the uterus is not nourished, and the deficiency causes pain, so that the dysmenorrhea is attacked. Common types of dysmenorrhea include kidney qi deficiency, qi and blood deficiency, qi stagnation and blood stasis, congealing cold and blood stasis, and damp-heat accumulation.

At present, similar external medicines such as moxibustion are used for treating the disease. Moxibustion is a very traditional quality method, a moxa stick is ignited, the moxa stick is baked around the navel of a patient, local heat generated after baking is utilized to go deep into the body, blood circulation is promoted, and abdominal pain is relieved. However, moxibustion is inconvenient to use and needs to be used in a private place, and patients cannot move or work at the same time and are not portable when using the moxibustion.

Disclosure of Invention

The invention aims to solve the technical problem of providing a abdomen warming patch, which has the effects of promoting blood circulation to remove blood stasis, promoting qi circulation to relieve pain aiming at qi stagnation and blood stasis type dysmenorrhea, and has the advantages of quick treatment effect, small toxic and side effects and convenient use.

The invention also provides a preparation method of the abdomen warming patch, which is simple, high in production efficiency, easy in process parameter control and free of pollution in the production process.

In order to solve the technical problems, the technical scheme adopted by the invention is as follows:

the abdomen warming patch is prepared from the following raw material medicines, namely folium artemisiae argyi, prepared monkshood and cinnamon, in a mass ratio of 8-10:4-5:0.5-1.

The preparation method of the abdomen warming patch is characterized by comprising the following steps:

(1) Weighing the raw material medicines according to the parts by weight;

(2) Weighing each raw material medicine in the step (1), adding 10 times of water, performing combined extraction by using a double extraction method for 3 times with the extraction time of 2 hours, and collecting an extracting solution and volatile oil;

(3) Concentrating the extracting solution in the step (2) until the liquor ratio is 1.5, precipitating with 80% ethanol, standing for 24 hours, separating, recovering ethanol, dissolving the precipitate, and adjusting the liquor concentration to 0.47g/mL of crude drug;

(4) Enabling the precipitation liquid medicine obtained in the step (3) to pass through a D101 macroporous adsorption resin column at the flow rate of 2BV/h for dynamic adsorption, eluting with 2BV of purified water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, collecting the ethanol eluent, and recovering the ethanol to obtain medicine dry powder;

(5) Weighing the following raw materials in parts by weight based on the using amount of the pressure-sensitive adhesive: 80% of absolute ethyl alcohol, 12% of glycerol, 3% of zinc oxide, 3% of azone and 5% of peppermint oil, 12% of medicine extract and corresponding volatile oil), mixing the prescription uniformly in sequence, degassing for 5min by ultrasonic, uniformly coating on a back lining, and drying for 42h at 55 ℃;

wherein, the pressure-sensitive adhesive, absolute ethyl alcohol, glycerol, zinc oxide, azone and peppermint oil are auxiliary materials.

In the present invention, radix Aconiti lateralis Preparata and cortex Cinnamomi are a pair of partner, radix Aconiti lateralis is yang of yang, which is floating but not sinking in nature, and is used to walk but not keep on, and run the twelve main meridians. Rou Gui is used to supplement fire of Mingmen but not to keep it, so it is good at directing the fire of Tornalei downward to calm the kidney. Radix Aconiti lateralis Preparata can be regarded as the property of cortex Cinnamomi to insist the gate of life, but it cannot fly through the triple energizer; rou Gui can dispel the cold from zang-fu organs and dispel the cold from the triple energizer, warm and tonify without staying. The two can be matched, so they are put together and complement each other. The three medicines are compatible to achieve the effects of eliminating abdominal accumulated cold and dispelling cold accumulation in gynecology.

Advantageous effects

(1) The prepared monkshood, the cinnamon and the folium artemisiae argyi are mutually matched, the effects complement each other, and the traditional Chinese medicine can effectively treat the pain of waist and abdomen before and during menstruation caused by deficiency-cold of qi and blood and cold stagnation of uterus.

(2) Compared with traditional moxibustion, the preparation has the advantages of convenient carrying and use, no influence on work during use, no generation of a large amount of dense smoke pollution environment, no harm to patients caused by baking time and distance, long-time abdomen sticking, gradual warming, cold dispelling and meridian dredging, and pain relieving and eliminating.

(3) The preparation has the advantages of simple production process, high production efficiency, easily controlled process parameters and no pollution in the production process.

Detailed Description

The invention will be described in part in connection with specific embodiments thereof, and the advantages and features of the invention will become apparent from the description. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.

Example 1

Taking 10g of folium artemisiae argyi, 5g of prepared monkshood and 1g of cinnamon. Adding 10 times of water, carrying out combined extraction by using a double extraction method for 2 hours, extracting for 3 times, collecting an extracting solution and volatile oil, wherein the extracted volatile oil is 0.1mL for later use, concentrating the extracting solution until the liquid medicine ratio is 1.5, then precipitating with 80% ethanol, standing for 24 hours, separating, recovering ethanol from an ethanol precipitation solution until no alcohol smell exists, and adjusting the concentration of the concentrated solution to be equal to 0.47g/mL of crude drug; performing dynamic adsorption through a pretreated D101 macroporous adsorption resin column at the flow rate of 2BV/h, eluting with 2BV of purified water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, discarding water solution, collecting ethanol eluate, recovering ethanol, and continuously drying to obtain 0.92g of dry drug powder; mixing 5g of pressure sensitive adhesive, 4g of absolute ethyl alcohol, 0.6g of glycerol, 0.15g of zinc oxide, 0.15g of azone, 0.25g of peppermint oil, 0.54g of medicine extraction dry powder and 0.06ml of volatile oil in sequence, degassing for 5min by ultrasonic wave, uniformly coating on a back lining, and drying for 42h at 55 ℃.

The patch is a two-agent patch, has appropriate paste surface viscosity and appropriate adhesive force, can be pasted by lightly pressing, is convenient to remove, has no skin tearing feeling, and has no residue on the skin surface after being removed. The pain of the patient is gradually relieved after the plaster is applied, and the pain disappears after 12 hours. The patient moves as usual during application without interfering with any life or work.

Example 2

Taking 8g of folium artemisiae argyi, 4g of prepared monkshood and 0.5g of cinnamon, adding 10 times of water, carrying out combined extraction by using a double extraction method, wherein the extraction time is 2h, extracting for 3 times, collecting an extracting solution and volatile oil, wherein the extracted volatile oil is 0.1mL for later use, concentrating the extracting solution until the liquid medicine ratio is 1.5, then precipitating with 80% ethanol, standing for 24 hours, separating, recovering ethanol from an ethanol precipitation solution until no ethanol smell exists, and adjusting the concentration of the concentrated solution to be equal to 0.47g/mL of crude drug; performing dynamic adsorption through a pretreated D101 macroporous adsorption resin column at the flow rate of 2BV/h, eluting with 2BV of purified water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, discarding water solution, collecting ethanol eluate, recovering ethanol, and continuously drying to obtain 0.69g of dry drug powder; mixing 5g of pressure sensitive adhesive, 4g of absolute ethyl alcohol, 0.6g of glycerol, 0.15g of zinc oxide, 0.15g of azone, 0.25g of peppermint oil, 0.54g of medicine extraction dry powder and 0.06ml of volatile oil in sequence, degassing for 5min by ultrasonic wave, uniformly coating on a back lining, and drying for 42h at 55 ℃.

The patch is a two-agent patch, has proper paste surface viscosity and proper adhesive force, can be pasted by lightly pressing, is convenient to remove, has no skin tearing feeling, and has no residue on the surface of the skin after being removed. The patient takes a patch to remove the isolating membrane, and pastes the patch on the navel, so that the pain of the patient is gradually relieved after the patch is pasted, and the pain basically disappears after 12 hours. The patient moves as usual during application without interfering with any life or work.

Comparative example

Comparative example 1

Taking 10g of folium artemisiae argyi, 3g of prepared monkshood and 1g of cinnamon, adding 10 times of water, carrying out combined extraction by a double extraction method for 3 times with the extraction time of 2h, and collecting the extracting solution and the volatile oil. Wherein 0.1mL of extracted volatile oil is reserved, the extracting solution is concentrated until the liquid medicine ratio is 1.5, then 80% ethanol is used for precipitation, the mixture is kept stand for 24 hours, separation is carried out, ethanol is recovered from the ethanol precipitation solution until no alcohol smell exists, and the concentration of the concentrated solution is adjusted to be equal to 0.47g/mL of crude drug; performing dynamic adsorption through a pretreated D101 macroporous adsorption resin column at the flow rate of 2BV/h, eluting with 2BV of purified water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, discarding water solution, collecting ethanol eluate, recovering ethanol, and continuously drying to obtain 0.81g of dry drug powder; mixing 5g of pressure sensitive adhesive, 4g of absolute ethyl alcohol, 0.6g of glycerol, 0.15g of zinc oxide, 0.15g of azone, 0.25g of peppermint oil, 0.54 of dry powder of the drug extract and 0.06ml of volatile oil in sequence, degassing for 5min by ultrasonic waves, uniformly coating on a back lining, and drying for 42h at 55 ℃.

The patch is a two-agent patch, has appropriate paste surface viscosity and appropriate adhesive force, can be pasted by lightly pressing, is convenient to remove, has no skin tearing feeling, and has no residue on the skin surface after being removed. The patient takes a patch to remove the isolating membrane, the patch surface is pasted on the navel, the pain of the patient after the paste is pasted is gradually relieved after the patient takes the medicine for 6 hours, but the pain disappears slowly, and the pain basically disappears after more than 24 hours. The patient moves as usual during application without interfering with any life or work.

Comparative example 2

Taking 10g of folium artemisiae argyi, 5g of prepared monkshood and 1g of cinnamon. Adding 10 times of water, extracting for 3 times with 2 hr, and collecting extractive solution and volatile oil. Wherein the extracted volatile oil is 0.1ml for standby, after the extracting solution is concentrated until the liquid medicine ratio is 1.5; mixing 5g of pressure sensitive adhesive, 4g of absolute ethyl alcohol, 0.6g of glycerol, 0.15g of zinc oxide, 0.15g of azone, 0.25g of peppermint oil, 0.6g of dry powder of a drug extract and 0.06ml of volatile oil in sequence, degassing for 5min by ultrasonic waves, uniformly coating on a back lining, and drying for 42h at 55 ℃.

The patch is a two-agent patch, has good appearance and large stickiness of the surface of the patch, and has residual ointment on the surface of the skin after being taken off, so that the patch is inconvenient to take off. The patient takes a patch to remove the isolating membrane, the patch surface is pasted on the navel, the pain of the patient after the paste is pasted is gradually relieved within 12 hours after the drug is taken, and the pain basically disappears within 26 hours.

Comparative example 3

Taking 10g of folium Artemisiae Argyi, 10g of herba Leonuri, and 1g of cortex Cinnamomi

Extracting by a double extraction method for 3 times for 2 hours, collecting an extracting solution and volatile oil, wherein the extracted volatile oil is 0.1mL for later use, concentrating the extracting solution until the liquor ratio is 1.5; performing dynamic adsorption through a pretreated D101 macroporous adsorption resin column at the flow rate of 2BV/h, eluting with 2BV of purified water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, discarding water solution, collecting ethanol eluate, recovering ethanol, and continuously drying to obtain 1.24g of dry drug powder; mixing 5g of pressure sensitive adhesive, 4g of absolute ethyl alcohol, 0.6g of glycerol, 0.15g of zinc oxide, 0.15g of azone, 0.25g of peppermint oil, 0.54g of dry powder of a drug extract and 0.06ml of volatile oil in sequence, degassing for 5min by ultrasonic waves, uniformly coating on a back lining, and drying for 42h at 55 ℃.

The patch is a two-agent patch, has good appearance and large stickiness of the surface of the patch, and has no residual ointment on the surface of the skin after being taken off and no tearing feeling. The patient takes a patch to remove the isolating membrane, and the patch is pasted on the navel, so that the pain of the patient after the paste is pasted cannot be relieved after the patch is applied for 8 hours.

Comparative example 4

Collecting herba Leonuri 10g, carthami flos 5g, and semen Persicae 1g

Extracting for 3 times with 2 hr, and collecting extractive solution and volatile oil. Wherein the extracted volatile oil is 0.1mL for standby, the extracting solution is concentrated until the liquid medicine ratio is 1.5, then the extracting solution is precipitated by 80 percent ethanol, the standing is carried out for 24 hours, the separation is carried out, the ethanol is recovered from the ethanol precipitation solution until no alcohol smell exists, and the concentration of the concentrated solution is adjusted to be equivalent to 0.47g/mL of crude drug; performing dynamic adsorption through a pretreated D101 macroporous adsorption resin column at the flow rate of 2BV/h, eluting with 2BV of purified water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, discarding water solution, collecting ethanol eluate, recovering ethanol, and continuously drying to obtain 0.91g of dry drug powder; mixing 5g of pressure sensitive adhesive, 4g of absolute ethyl alcohol, 0.6g of glycerol, 0.15g of zinc oxide, 0.15g of azone, 0.25g of peppermint oil, 0.54g of dry powder of a drug extract and 0.06ml of volatile oil in sequence, degassing for 5min by ultrasonic waves, uniformly coating on a back lining, and drying for 42h at 55 ℃.

The patch has good appearance, large stickiness of the patch surface, no residual plaster on the skin surface after being taken off, and convenient taking off. The patient takes a patch to remove the isolating membrane, and the patch is applied to the navel, so that the pain of the patient is not relieved after the patch is applied, and the alleviation of the symptoms is independent of the application of the medicine. Several subjects had increased bleeding during the menstrual cycle.

1. Object and method

1.1 case selection and grouping

180 patients were selected and subjected to clinical trials of the formulation of the present invention, and the 180 patients were 18-25 years old and randomly divided into 6 groups, i.e., example 1 group, example 2 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, and comparative example 4 group.

1.2 diagnostic criteria

The diagnosis standard refers to the diagnosis standard in "Chinese medicine and gynecology". Dysmenorrhea refers to a patient with periodic lower abdominal pain or even syncope caused by severe pain during or before the menstrual period of women, and is accompanied by other discomforts such as breast swelling and cold hands and feet, so as to affect work and life. The gynecological examination of married women and B-type ultrasonic examination of unmarried women all give birth to genital organ organic lesions. According to the clinical research guiding principle of new traditional Chinese medicines, the dysmenorrhea course is divided into 3 grades of light, medium and heavy (Ministry of health of the people' S republic of China. Clinical research guiding principle of important new medicines: edition 1 [ S ]. 1993.

1.3 methods of treatment

The abdominal pain begins to be pasted on the navel part and is pasted with a belly warming patch. Changing the patch every two days

1.4 results are shown in Table 1

Clinical effects in typical cases

Case one: for women, 20 years old, the menstrual cycle is regular, abdominal cramps, pains, nausea, dizziness, lumbago on the first and second days of menstruation, patients need to lie in bed, and pain-relieving herbs are unavailable for self-purchase and can be dosed. The abdomen warming patch is applied on the first day of menstruation, and the pain is relieved on the same day.

Case two: for a woman in 22 years old, the abdomen fell down before menstruation, cold, pain and low back pain, the hot water bag can relieve the symptoms of massive menstrual blood and dark color. No other treatment was done. The abdominal pain before menstruation starts to be pasted on the abdomen warming patch, and the pain is relieved in the same day, so that the blood clots are reduced, and the color becomes red.

Case three: female, age 19, dizziness and vomiting in the early menstrual period, lower abdominal pain, cold hands and feet, lumbago. The bellyache in menstrual period starts to be pasted with the belly warming paste, so that the cold and cool hand and foot phenomena are improved, the bellyache is relieved, the lumbago is relieved, and the vomiting is relieved.

The foregoing is merely a preferred embodiment of this invention, which is intended to be illustrative, not limiting; those skilled in the art will appreciate that many variations, modifications, and even equivalent variations are possible within the spirit and scope of the invention as defined in the appended claims.

Claims

1. The abdomen warming patch is characterized in that the mass ratio of the folium artemisiae argyi to the radix aconiti lateralis preparata to the cinnamon is 8-10:4-5:0.5 to 1;

the preparation method of the abdomen warming patch comprises the following steps:

(1) Weighing the raw material medicines according to the parts by weight;

(3) Concentrating the extracting solution in the step (2) until the liquid medicine ratio is 1.5:1, precipitating with 80% ethanol, standing for 24 hr, separating, recovering ethanol, dissolving the precipitate, and adjusting the concentration of the medicinal liquid to 0.47g/mL;

(4) Enabling the precipitation liquid medicine obtained in the step (3) to pass through a D101 macroporous adsorption resin column at the flow rate of 2BV/h for dynamic adsorption, eluting with 2BV of pure water, eluting with 9BV of 60% ethanol at the elution speed of 2BV/h, collecting ethanol eluent, and recovering ethanol to obtain medicine dry powder;

(5) Weighing the following raw materials in parts by weight based on the using amount of the pressure-sensitive adhesive: mixing anhydrous ethanol 80%, glycerol 12%, zinc oxide 3%, azone 3%, oleum Menthae 5%, medicinal extract 12% and corresponding volatile oil, ultrasonic degassing for 5min, uniformly coating on backing, and drying at 55 deg.C for 42 hr;

wherein, the pressure-sensitive adhesive, the absolute ethyl alcohol, the glycerol, the zinc oxide, the azone and the peppermint oil are auxiliary materials.

2. A method of making the abdominal warming patch of claim 1, comprising the steps of:

(1) Weighing the raw material medicines according to the parts by weight;

wherein the pressure-sensitive adhesive, the absolute ethyl alcohol, the glycerol, the zinc oxide, the azone and the peppermint oil are auxiliary materials.