CN115919928B - Quick-acting dripping pills of three ginseng for dredging collaterals, its preparation method and application - Google Patents
Quick-acting dripping pills of three ginseng for dredging collaterals, its preparation method and application Download PDFInfo
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention belongs to the field of pharmaceutical preparations, and in particular relates to a quick-acting dripping pill of three ginseng and dredging collaterals, and a preparation method and application thereof. The dripping pill of the invention comprises a traditional Chinese medicine extract and a water-soluble matrix, wherein the traditional Chinese medicine extract is prepared from red sage root, ginkgo leaf and pseudo-ginseng, and the water-soluble matrix consists of polyethylene glycol 4000, polyoxyethylene (40) stearate and poloxamer 188. The preparation method of the invention comprises the following steps: heating water-soluble matrix to melt state, adding Chinese medicinal extract, and mixing to obtain mixed material; introducing the mixed materials into a pill dropping machine, and condensing the materials dropped out of the pill dropping machine by adopting condensate; collecting dripping pill, cooling, washing, drying, selecting, and packaging. The dripping pill has the characteristics of good roundness, small pill weight difference and short dissolving time, and can effectively improve or treat the symptoms of patients after coronary heart disease or coronary intervention.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, and in particular relates to a quick-acting dripping pill of three ginseng and dredging collaterals, and a preparation method and application thereof.
Background
Coronary atherosclerotic heart disease (abbreviated as CHD) is a heart disease that is caused by a lumen occlusion of a coronary artery or by stenosis or ischemia. The coronary heart disease is characterized in that the typical angina pectoris can be induced due to the increase of the burden of the heart during the severe activity, the chest distress, dyspnea or chest pain can be manifested, the duration can be about several minutes to one hour, the coronary heart disease can be relieved by self through rest, or the symptoms can be relieved by taking the medicine for dilating the coronary artery.
With the continuous improvement of living standard, CHD has increasingly increased incidence rate, and has become one of important diseases seriously threatening human health. In 2004 alone, coronary heart disease led to 1700 thousands of deaths worldwide, 1 million 5 thousands of disabilities; by 2008, 1730 ten thousand people die from coronary heart disease worldwide, accounting for 30% of the total deaths worldwide. According to the statistical annual authentication of national sanitation and family planning in 2016, the death rate of coronary heart diseases of residents in China and rural areas in 2012 has a continuous rising trend, and particularly in rural areas, the death rate is obviously increased. Research on CHD control has also become a common focus of attention at home and abroad with increasing CHD incidence.
At present, the treatment of coronary heart disease mainly comprises several modes of drug treatment, coronary bypass operation, percutaneous coronary intervention treatment and the like. However, the therapeutic effect of the drug is limited, and the plaque stenosis which is formed can not be eliminated, and the drug is relatively conservative; although the coronary bypass (CAGB) can effectively open the blocked blood vessel, the coronary bypass is difficult to accept by patients due to large surgical trauma, high cost and high risk. Percutaneous Transluminal Coronary Angioplasty (PTCA) is rapidly accepted by a wide range of patients, as it is characterized by small trauma and rapid and effective resolution of stenosis and occlusion of the coronary arteries. PCI technology based on PTCA and coronary stent implantation has been rapidly developed thereafter, and PCI has become an important means for treating coronary heart disease and reconstructing blood flow at present.
However, intervention does not solve all the problems of coronary heart disease patients, and the risks of acute, subacute and late intrastent thrombosis present in drug stents also act as barriers to the development of PCI surgery. PCI surgery focuses on local interventions, and overall lack of focus is a disadvantage. The whole treatment and the whole regulation are one of the advantages of the traditional Chinese medicine, and the traditional Chinese medicine is used for regulating yin and yang and regulating qi and blood after PCI operation, so that 'yin and yang secret' and 'qi and blood harmonizing' can just make up the deficiency of interventional treatment. Therefore, the research of the traditional Chinese medicine after the PCI of the coronary heart disease is actively developed, and the method has great feasibility and practical significance. Domestic scholars have conducted a great deal of effective research around the intervention of traditional Chinese medicine for coronary heart disease and PCI postoperative diseases, and more effective treatment methods are provided for patients after the coronary heart disease and PCI.
The present technology discloses a compound gingko and red sage tablet for treating cardiovascular and cerebrovascular diseases and a preparation method thereof, which is a tablet prepared from Chinese herbal medicines such as gingko leaf extract, red sage extract, pseudo-ginseng and the like as raw materials and is used for treating cardiovascular and cerebrovascular diseases.
The prior art also discloses a traditional Chinese medicine preparation for coronary stent postoperative blood stasis, which mainly comprises the following components of red sage root, notoginseng, ginkgo leaf and the preparation method thereof: crushing 166.5g of pseudo-ginseng, adding water, decocting twice, adding 13320g of water each time, decocting for 1.5 hours each time, combining the decoctions obtained by the two times, filtering the combined decoctions to obtain filtrate, concentrating the filtrate under reduced pressure to a relative density of 1.20-1.25 and obtaining thick paste at 60 ℃, drying the thick paste under reduced pressure, and crushing the thick paste into fine powder; and secondly, adding 666g of red sage root and 499.5g of ginkgo leaf into the fine powder obtained in the first step, adding dextrin and corn starch, uniformly mixing, granulating, drying and preparing 1000 g.
However, the tablets and granules in the prior art have slow onset of action and are inconvenient to carry about and take. The dripping pill is quick-acting preparation formed by melting and mixing liquid or solid medicine and matrix together, condensing and shrinking, and has the advantages of simple preparation, low cost, quick effect, high curative effect and bioavailability, convenient storage, convenient carrying and administration, and accurate dosage. The preparation of the Chinese medicinal active ingredients into the dripping pill has great advantages for treating the CHD, and can quickly relieve the symptoms of patients. However, the drop pills have poor heat resistance, the drop pills made of water-soluble matrix are easy to absorb moisture and deteriorate, and the medicines with large dosage are difficult to prepare into drop pills.
Accordingly, there remains a need for further research and improvement of the dosage forms based on the prior art.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a quick-acting dripping pill for dredging collaterals, a preparation method and application thereof.
The invention is realized by the following technical scheme.
In one aspect, the invention provides a three-ginseng vein-relaxing quick-acting dripping pill for improving or treating symptoms of patients after coronary heart disease or coronary intervention, which comprises a traditional Chinese medicine extract and a water-soluble matrix, wherein the traditional Chinese medicine extract is prepared from red sage root, ginkgo leaf and pseudo-ginseng, and the water-soluble matrix consists of polyethylene glycol 4000, polyoxyethylene (40) stearate and poloxamer 188.
The preparation method of the traditional Chinese medicine extract comprises the following steps: (a) Weighing 500-750g of red sage root, 400-500g of ginkgo leaf and 150-450g of pseudo-ginseng, crushing, mixing, adding 8-12 times of water, decocting for 1-3 times, each time for 1-3 hours, and merging the decoctions; (b) Filtering the decoction, concentrating the filtrate at 60-80deg.C to relative density of 1.20-1.25, passing through treated macroporous adsorbent resin, eluting with water, 30-50% ethanol solution and 50-80% ethanol solution respectively; (c) Collecting eluate, recovering ethanol, concentrating to relative density of 1.20-1.35, spray drying, pulverizing, and sieving with 80-100 mesh sieve.
For a drop pill, whether or not a suitable matrix can be selected for a specific pharmaceutically active ingredient is an important factor affecting the pill's sphericity, dissolution and release rate of the drug. Aiming at the defects that the traditional Chinese medicine granules of the red sage root, the ginkgo leaf and the pseudo-ginseng in the prior art have large dosage and the extract is not suitable to be prepared into a preparation which is dissolved or dissolved quickly, the invention improves the preparation process of the traditional Chinese medicine extract and researches the matrix of the dripping pill on the basis. The inventor of the present invention has unexpectedly found that the obtained dripping pill has more remarkable improvement in terms of roundness, dissolution property, drug effect, etc. by adopting a water-soluble matrix composed of polyethylene glycol 4000, polyoxyethylene (40) stearate and poloxamer 188 as the matrix of the specific Chinese medicinal extract of the present invention.
In the preparation process of the traditional Chinese medicine extract, based on conventional water decoction extraction, the invention further uses macroporous adsorption resin to carry out adsorption and gradient elution treatment on the traditional Chinese medicine decoction, and researches show that the extraction process can reduce the content of medicines in the preparation and improve the medicine effect.
Preferably, the macroporous adsorbent resin is of the D101, AB-8 or DM301 type.
Preferably, the mass ratio of polyethylene glycol 4000, polyoxyethylene (40) stearate and poloxamer 188 is (3-5): (0.8-1.5): (1-2).
Preferably, the mass ratio of the traditional Chinese medicine extract to the water-soluble matrix is (1-1.5): (5.0-8.5).
The invention also adopts spray drying to dry the traditional Chinese medicine extract, and the obtained medicine particles are more uniform and have higher efficiency. The spray drying process parameters are as follows: the air inlet temperature is 180-250 ℃, the flow is 50-90mL/min, and the air outlet temperature is 60-100 ℃.
In another aspect of the present invention, there is provided a method for preparing the dripping pill of the present invention, comprising the steps of:
(1) Heating water-soluble matrix to molten state at 45-80deg.C, adding Chinese medicinal extract, and mixing to obtain mixed material;
(2) Introducing the mixed material in the step (1) into a pill dropping machine, and condensing the material dropped out of the pill dropping machine by adopting condensate, wherein the temperature of a material tank of the pill dropping machine is 60-80 ℃, the diameter of a dripping head is 2-6mm, the temperature of the dripping head is 50-75 ℃, the vacuum degree is-0.05 to-0.08 MPa, the speed of the dripping head is 42-55 drops/min, and the height of the dripping head is 8.0-9.0;
(3) Collecting dripping pill, cooling, washing, drying, selecting, and packaging.
Wherein the condensate is liquid paraffin, vegetable oil or dimethyl silicone oil.
In a third aspect of the invention, there is provided the use of the dripping pill of the invention in the manufacture of a medicament for ameliorating or treating clinical symptoms in patients with coronary heart disease or post-coronary intervention.
Further, the medicament has the effect of improving chest pain, weakness, shortness of breath, anorexia and/or limb weakness by inhibiting inflammatory factors, protecting endothelial cells, regulating platelets and/or reducing blood lipid.
Compared with the prior art, the invention has the following advantages: (1) The invention adopts ethanol solutions with different concentrations to carry out gradient elution after adsorption by macroporous adsorption resin, thus obtaining the extract with rich active ingredients and reducing the content of the extract in the dosage form. (2) Through researches, it is unexpectedly found that when polyethylene glycol 4000, polyoxyethylene (40) stearate and poloxamer 188 are combined in a specific ratio to be used as a dripping pill matrix, dripping pills with good roundness and small pill weight difference can be obtained, and the dripping pill has short dissolution time and quick release. (3) Animal model researches show that the dripping pill can quickly relieve symptoms such as chest pain and the like caused by coronary heart disease after oral administration.
Detailed Description
The technical scheme of the present invention will be further explained and illustrated with reference to examples. It should be understood that the described embodiments are only a part of the present invention and are not to be considered as all implementations. All other embodiments obtained by the usual substitution by those skilled in the art based on the specific embodiments described in the present invention will fall within the scope of the present invention
Example 1:
the preparation process of the traditional Chinese medicine extract comprises the following steps: (a) Weighing 500g of red sage root, 450g of ginkgo leaf and 150g of pseudo-ginseng, crushing, mixing, adding 10 times of water, decocting for 3 times, each time for 1.5 hours, and merging the decoctions; (b) Filtering the decoction, concentrating the filtrate at 70deg.C to relative density of 1.22, passing through treated D101 macroporous adsorbent resin, eluting with water, 40% ethanol solution and 70% ethanol solution respectively; (c) Collecting eluate, recovering ethanol, concentrating to relative density of 1.22, spray drying, pulverizing, and sieving with 100 mesh sieve.
Wherein the spray drying process parameters are as follows: the air inlet temperature is 180 ℃, the flow is 60mL/min, and the air outlet temperature is 80 ℃.
Example 2:
the preparation process of the traditional Chinese medicine extract comprises the following steps: (a) Weighing 750g of red sage root, 500g of ginkgo leaf and 400g of pseudo-ginseng, crushing, mixing, adding 12 times of water, decocting for 2 times, each time for 2 hours, and merging the decoctions; (b) Filtering the decoction, concentrating the filtrate at 80deg.C to relative density of 1.25, passing through AB-8 type macroporous adsorbent resin, eluting with water, 50% ethanol solution and 60% ethanol solution respectively; (c) Collecting eluate, recovering ethanol, concentrating to relative density of 1.25, spray drying, pulverizing, and sieving with 80 mesh sieve.
Wherein the spray drying process parameters are as follows: the air inlet temperature is 200 ℃, the flow is 55mL/min, and the air outlet temperature is 70 ℃.
Example 3:
the formula of the dripping pill comprises the following components: 500g of the traditional Chinese medicine extract of example 1, 4000 g of polyethylene glycol (PEG) 4000 g, 600g of polyoxyethylene (40) stearate and 188 g of poloxamer 600g.
The preparation process comprises the following steps: heating all matrixes to a molten state at 75 ℃, then adding the traditional Chinese medicine extract, and uniformly mixing to obtain a mixed material for standby; introducing the mixed material into a pill machine, and condensing the material dropped out of the pill machine by adopting liquid paraffin, wherein the temperature of a charging bucket of the pill machine is 75 ℃, the diameter of a dripping head is 3mm, the temperature of the dripping head is 55 ℃, the vacuum degree is-0.06 MPa, the speed of the dripping head is 50 drops/min, and the height of the dripping head is 8.0cm; collecting dripping pill, cooling, washing, drying, selecting, and packaging to obtain dripping pill with particle diameter of 3.2 mm.
Example 4:
the formula of the dripping pill comprises the following components: 500g of the traditional Chinese medicine extract of example 1, 4000 g of polyethylene glycol, 600g of polyoxyethylene (40) stearate and 188 g 1200g of poloxamer.
The preparation process comprises the following steps: heating all matrixes at 60 ℃ to a molten state, then adding the traditional Chinese medicine extract, and uniformly mixing to obtain a mixed material for standby; introducing the mixed materials into a pill dripping machine, and condensing the materials dripped from the pill dripping machine by adopting condensate, wherein the temperature of a charging bucket of the pill dripping machine is 60 ℃, the diameter of a dripper is 3mm, the temperature of the dripper is 55 ℃, the vacuum degree is-0.08 MPa, the speed of the dripper is 45 drops/min, and the height of the dripper is 9.0cm; (3) Collecting dripping pill, cooling, washing, drying, selecting, and packaging to obtain dripping pill with particle diameter of 3.1 mm. Comparative example 1:
the formulation and preparation method of the dripping pill are the same as those of example 3, except that the dripping pill substrate is 40003000g of polyethylene glycol.
Comparative example 2:
the formulation and preparation method of the dripping pill were the same as in example 3, except that the dripping pill base consisted of 40002400g of polyethylene glycol and 600g of poloxamer 188.
Comparative example 3:
the drop pill formulation and preparation method are the same as in example 3, except that the providing process of the traditional Chinese medicine extract is as follows: mixing the above materials, adding 10 times of water, decocting for 2 times each for 1.5 hr, mixing decoctions, filtering, concentrating the filtrate at 60deg.C to obtain soft extract with relative density of 1.22, drying under reduced pressure for 20min, and pulverizing into fine powder.
Test example 1:
the test examined the quality inspection items of the dripping pills prepared in examples 3-4 and comparative examples 1-3 in terms of weight difference, roundness, dissolution time limit and the like.
(1) Weight difference and roundness investigation: taking 6 pills of each group, weighing and calculating the pill weight difference variation coefficient, and visually checking the roundness, wherein the roundness is respectively recorded as 1-5 minutes from poor to good.
(2) And (3) measuring the dissolution time limit: the dissolution time limit was measured by taking 6 pills of each group of test substances using a disintegration tester (manufactured by Seiko Instrument and technology Co., ltd.).
Table 1 comparative results of the quality inspection tests of the groups
The results in Table 1 show that the weight difference coefficient of variation of the pellets prepared in examples 3 and 4 of the present invention is smaller, indicating that the weight of the pellets prepared by the formulation and method is more uniform. In addition, compared with comparative examples 1-3, the dripping pills of examples 3-4 have significantly faster dissolution rate, probably because the invention uses polyethylene glycol 4000, polyoxyethylene (40) stearate 600g and poloxamer 188 with similar physicochemical properties, and the composite matrix has better uniformity and fluidity when in melting, thus not only being beneficial to the formation of the dripping pills, but also improving the dissolution rate of the medicine.
Test example 2:
the test uses high-fat feed to model atherosclerosis of rabbits so as to simulate the symptoms of angina pectoris of coronary heart disease. The method comprises the steps of taking 20 healthy rabbits with weight of 1.8-2.4kg, and dividing the healthy rabbits into a blank group, a model group, a test group (the dripping pill of the embodiment 3 of the invention) and a positive control group (the compound red-rooted salvia dripping pill), wherein each group comprises 5 healthy rabbits. After successful molding, each group was dosed in parallel for 4 weeks, and the drug was dispersed in distilled water to prepare 150mg/10mL of purified water in the same amount as the blank group and the model group.
Table 2 comparison of blood lipid changes of the groups
The results in table 2 show that the dripping pills of the invention and the positive control group can effectively regulate blood fat, thereby improving the symptoms of coronary heart disease, wherein each index of the test group has obvious difference compared with the model group and has no obvious difference compared with the positive control group.
TABLE 3 comparative results of Electrocardiogram changes for each group
The results in Table 3 show that the T wave value of the test group is obviously lower than that of the model group at each time, and meanwhile, the T wave value of the test group is not obviously different from that of the positive control group, so that the dripping pill has obvious improvement effect on coronary functions and the like.
Claims (9)
1. The quick-acting dripping pill for treating the common cold with the three ginseng and the vein relaxing is characterized by comprising a traditional Chinese medicine extract and a water-soluble matrix, wherein the traditional Chinese medicine extract is prepared from red sage root, ginkgo leaf and pseudo-ginseng, and the water-soluble matrix is composed of polyethylene glycol 4000, polyoxyethylene (40) stearate and poloxamer 188;
the quality of the red sage root is 500-750g, the quality of the ginkgo leaf is 400-500g, and the quality of the pseudo-ginseng is 150-450g;
the mass ratio of the polyethylene glycol 4000, the polyoxyethylene (40) stearate and the poloxamer 188 is (3-5): (0.8-1.5): (1-2).
2. The dripping pill as set forth in claim 1, wherein the preparation step of the Chinese medicinal extract comprises: (a) Weighing 500-750g of red sage root, 400-500g of ginkgo leaf and 150-450g of pseudo-ginseng, crushing, mixing, adding 8-12 times of water, decocting for 1-3 times, each time for 1-3 hours, and merging the decoctions; (b) Filtering the decoction, concentrating the filtrate at 60-80deg.C to relative density of 1.20-1.25, passing through treated macroporous adsorbent resin, eluting with water, 30-50% ethanol solution and 50-80% ethanol solution respectively; (c) Collecting eluate, recovering ethanol, concentrating to relative density of 1.20-1.35, spray drying, pulverizing, and sieving with 80-100 mesh sieve.
3. The drop pill of claim 2, wherein the macroporous adsorbent resin is of the D101, AB-8 or DM301 type.
4. The dripping pill according to claim 1, wherein the mass ratio of the traditional Chinese medicine extract to the water-soluble matrix is (1-1.5): (5.0-8.5).
5. The drop pill of claim 2, wherein the spray drying process parameters are: the air inlet temperature is 180-250 ℃, the flow is 50-90mL/min, and the air outlet temperature is 60-100 ℃.
6. The method for preparing the dripping pill according to one of claims 1 to 5, comprising the following steps: (1) Heating water-soluble matrix to molten state at 45-80deg.C, adding Chinese medicinal extract, and mixing to obtain mixed material; (2) Introducing the mixed material in the step (1) into a pill dropping machine, and condensing the material dropped out of the pill dropping machine by adopting condensate, wherein the temperature of a material tank of the pill dropping machine is 60-80 ℃, the diameter of a dripping head is 2-6mm, the temperature of the dripping head is 50-75 ℃, the vacuum degree is-0.05 to-0.08 MPa, the speed of the dripping head is 42-55 drops/min, and the height of the dripping head is 8.0-9.0cm; (3) Collecting dripping pill, cooling, washing, drying, selecting, and packaging.
7. The method according to claim 6, wherein the condensate is liquid paraffin, vegetable oil or simethicone.
8. Use of a drop pill according to one of claims 1-5 for the preparation of a medicament for improving or treating clinical symptoms in patients with coronary heart disease.
9. The use according to claim 8, wherein the medicament acts to ameliorate the clinical symptoms of patients with coronary heart disease by reducing blood lipid.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686384A (en) * | 2005-04-11 | 2005-10-26 | 北京正大绿洲医药科技有限公司 | Guanxinning drip pill for treating heart disease and its preparation method |
| CN104434825A (en) * | 2014-11-04 | 2015-03-25 | 中国药科大学 | Tanshinone II A dropping pill and preparation method thereof |
| CN113143993A (en) * | 2021-04-26 | 2021-07-23 | 吉林大学第一医院 | Traditional Chinese medicine preparation for coronary stent postoperative blood stasis and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686384A (en) * | 2005-04-11 | 2005-10-26 | 北京正大绿洲医药科技有限公司 | Guanxinning drip pill for treating heart disease and its preparation method |
| CN104434825A (en) * | 2014-11-04 | 2015-03-25 | 中国药科大学 | Tanshinone II A dropping pill and preparation method thereof |
| CN113143993A (en) * | 2021-04-26 | 2021-07-23 | 吉林大学第一医院 | Traditional Chinese medicine preparation for coronary stent postoperative blood stasis and preparation method thereof |
Non-Patent Citations (2)
| Title |
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| Preparation of tea polyphenols-loaded solid lipid nanoparticles based on the phase behaviors of hot microemulsions;QuanHong Ma et al.;《Nanoscience and Technology》;第705-708页 * |
| 鹅冰舒冠滴丸对动脉脂质斑块影响的实验研究;程丑夫等;《中国中西医结合急救杂志》;第10卷(第3期);第170-173页 * |
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