CN102755396A - Preparation process and matrix for gel cream for treating coronary heart disease - Google Patents
Preparation process and matrix for gel cream for treating coronary heart disease Download PDFInfo
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- CN102755396A CN102755396A CN 201110108364 CN201110108364A CN102755396A CN 102755396 A CN102755396 A CN 102755396A CN 201110108364 CN201110108364 CN 201110108364 CN 201110108364 A CN201110108364 A CN 201110108364A CN 102755396 A CN102755396 A CN 102755396A
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Abstract
The invention discloses gel cream for treating a coronary heart disease and a preparation process and a matrix accessory formula for the gel cream for treating the coronary heart disease. Salvia miltiorrhiza, radix paeoniae rubra, rhizoma chuanxiong, safflower carthamus and dalbergia wood in a prescription are extracted and refined to obtain an extract, and the extract and a proper matrix are prepared into the gel cream, the gel cream is used for treating thoracic obstruction, chest stuffiness and precordial pain which are caused by internal blockage of static blood and cardiovascular diseases such as angina pectoris with the above symptoms. The preparation method comprises extracting essential oil from the dalbergia wood by a water vapor distilling method; extracting the salvia miltiorrhiza, the rhizoma chuanxiong and dregs of the dalvergia wood by 90% of ethanol, and extracting the dregs of the salvia miltiorrhiza, the rhizoma chuanxiong and the dalvergia wood, the radix paeoniae rubra and the safflower carthamus by water; purifying filtrate by macroreticular resin; concentrating the purified liquid medicine into liquid medicine with the relative density of 1.15-1.25 (measured at the temperature of 50 DEG C ), combining the liquid medicine with an ethanol extracted cream, mixing the mixture with the matrix and finally adding the essential oil; and stirring for 20-120 minutes, and coating, pressing and cutting to obtain the refined gel cream for treating the coronary heart disease. Eluent is equal to 40% of ethanol and is four times of the resin, and the elution speed is 3BV/H.
Description
Technical field
The present invention relates to a kind of thoracic obstruction that can be used for treating due to stopping in the blood stasis, uncomfortable in chest, pareordia twinge that disease is seen: angina pectoris is seen the gel ointment of the percutaneous dosing exterior-applied formulation of the cardiovascular disease of above-mentioned symptom-made into by Jingzhi Guanxin tablet.The present invention be more particularly directed to the preparation technology and the matrix formulations of this medicine.
Background technology
Prescriptions of Chinese medicine of the present invention derives from 2010 editions first one of Pharmacopoeia of People's Republic of China, and former dosage form is a tablet.Jingzhi Guanxin tablet is mainly used in coronary heart disease treatment and prevention clinically.The present invention changes Jingzhi Guanxin tablet into the hydrogel plaster unguentum according to the traditional Chinese medical science " inner disease outer treat " theory, the diseases such as " " thoracic obstruction ", " cardiopalmus " " of the percutaneous dosing treatment traditional Chinese medical science.
The external use plaster that Chinese medicine hydrogel plaster unguentum is made up of water-soluble high-molecular material.At first occur the seventies in Japan.Cataplasma is claimed in Japan's name.Early stage is mud shape cataplasma, because the medication chemistry Development of Materials provides selectable high molecular polymer; Develop into the typing cataplasma, that is: medicine is mixed with the substrate of water-soluble high-molecular substance, coat on the backing of non-woven fabrics; Surface coverage polyethylene or polypropylene film; Be cut into different size by instructions for use, in the plastic bag of packing into, sealing is preserved.The typing cataplasma is because easy to use, ixoderm skin not, and the skin allergy of no rubber plaster, and moisture retention is preferably arranged, be prone to make keratodermatitis to soften, thereby help the Transdermal absorption of medicine.
2010 editions pharmacopeia change cataplasma into gel ointment, and gel ointment has plurality of advantages, compare with peroral dosage form, and no liver first-pass effect does not receive the influence of gastrointestinal tract degraded, and bioavailability is high; Compare with injection, easy to use, no pain; Compare with ointment, dosage is accurate, and absorption area is fixed, so blood drug level is stable; Compare with rubber-emplastrum, the sensitization that viscosifier such as no Colophonium possibly cause is little to skin irritation.Product development at present is used for the pain that treatment of arthritis, soft tissue injury, hyperosteogeny diseases cause more; Compare with the traditional Chinese medicines emplastrum, the polymer-based material in the gel ointment can absorb and carry the Chinese medicine extract that comprises multiple water solublity and liposoluble constituent better and give " gelation " molding.Therefore, have advantages such as the medicine carrying capacity is big, the transdermal performance is good, dosage is accurate, absorption area is little, blood drug level is stable, the comfortable convenience of use.
Present Chinese medicine gel ointment has been limited to the patch of local therapeutic effects basically, and the transdermal delivery system of inner disease outer treat is not also seen has launch.Meanwhile, Chinese medicine gel ointment also ubiquity viscosity deficiency, poor stability, long shortcoming of production cycle, therefore, and " inner disease outer treat " emplastrum kind that the present invention provides a kind of topical to play general action.
Summary of the invention
The objective of the invention is to application skins based upon bidding drug treatment " thoracic obstruction due to stopping in the blood stasis; disease is seen uncomfortable in chest, pareordia twinge ": angina pectoris is seen the diseases such as cardiovascular disease of above-mentioned symptom; The gastrointestinal of avoiding long-term oral administration to bring does not accommodate the destruction to medicine, and medicine of a kind of safe, effective, nonirritant, hypersensitive percutaneous dosing treatment cardiovascular system diseases and preparation method thereof is provided.
The function of its prescription of treating coronary heart disease hydrogel plaster unguentum of the present invention cures mainly: the thoracic obstruction due to stopping in the blood stasis, disease are seen uncomfortable in chest, pareordia twinge: angina pectoris is seen above-mentioned symptom.Monarch drug in the Radix Salviae Miltiorrhizae side of being has effects such as blood circulation promoting and blood stasis dispelling, nourishing blood to tranquillize the mind, removing heat from blood eliminating carbuncle, evacuation of pus granulation promoting for the Labiatae herbaceos perennial.Modern pharmacological research proves; Effective component in red sage is fat-soluble diterpene-kind compound and water-soluble phenolic acid compounds; Comprise number of chemical compositions such as salviol, danshensu, TANSHINONES; Wherein fat-soluble tanshinone with improve blood circulation, antibiotic and antiinflammatory is main, and the antioxidation of the red phenols of water solublity, anticoagulation, antithrombotic forms and cytoprotection is obvious.Ministerial drug in the Rhizoma Chuanxiong side of being: the dry rhizome of samphire Rhizoma Chuanxiong, mainly contain ligustrazine, be traditional Chinese medical science drug for invigorating blood circulation and eliminating stasis commonly used
[10]Modern medicine study shows that Rhizoma Chuanxiong has tangible blood vessel dilating effect, can obviously improve cardiovascular function and antioxidation, clinical treatment cardiovascular and cerebrovascular disease and the ischemic injuries etc. of being widely used in.Full side forms Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra blood-supplementing blood-nourishing, Flos Carthami promoting blood circulation by removing blood stasis by Radix Salviae Miltiorrhizae, Flos Carthami, Lignum Dalbergiae Odoriferae, Rhizoma Chuanxiong, Radix Paeoniae Rubra 5 flavor Chinese medicines; The Lignum Dalbergiae Odoriferae vital energy regualting and blood circulation-promoting; Rhizoma Chuanxiong is a gas medicine in the blood, and full side has blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain function, cures mainly " thoracic obstruction "; Being applicable to coronary heart disease, is the active drug of treatment angina pectoris.For reducing oral administration gastrointestinal tract is produced stimulation.Extract and the suitable substrate adjuvant of medicine of respectively distinguishing the flavor of during the present invention will write out a prescription processed the hydrogel plaster unguentum of percutaneous dosing.
The present invention is through following scheme implementation:
Treating coronary heart disease hydrogel plaster unguentum of the present invention, be with Radix Salviae Miltiorrhizae, Flos Carthami, Lignum Dalbergiae Odoriferae, Rhizoma Chuanxiong, Radix Paeoniae Rubra in the prescription through extract, refining, process extractum, mix with suitable substrate adjuvant again, process the hydrogel plaster unguentum.
The method for preparing of coronary disease hydrogel plaster of the present invention, concrete steps are following:
1, steam distillation extracted volatile oil 8h after Lignum Dalbergiae Odoriferae steeped 2h with 6 times of water loggings, collected the device storage in addition of volatile oil, filtrating and medicinal residues;
2, together, with 5 times of amount 90% ethanol extractions three times, each 0.5h reclaims ethanol to relative density 1.15-1.25 (50 ℃ of surveys) with Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Lignum Dalbergiae Odoriferae medicinal residues;
3, Radix Paeoniae Rubra is with above-mentioned medicinal residues, with the water extraction of 10 times of amounts 3 times, and each 0.5h; When extracting for the third time, add the Flos Carthami that steeps 30min with 10 times of water loggings; Filtering and concentrating is used purification with macroreticular resin to the medicinal liquid of 0.2g crude drug/ml concentration: process conditions are: blade diameter length ratio is 1: 7, the sample solution of 8 times of amount of resin; The washing amount is 1 times a amount of resin; Eluent is 4 times of amount of resin of 40% ethanol, and elution rate is 3BV/H, and it is subsequent use that the medicinal liquid behind the purification is concentrated into relative density 1.15-1.25 (50 ℃ of surveys);
4, the water extracted immersing paste and alcohol-extracted extract merge, and get the treating coronary heart disease Chinese medical concrete;
5, Chinese medical concrete is added the transdermal penetrating agent, presses 1 with substrate again:: 3-1: 12 mixed adds volatile oil at last.Stirred 20-120 minute, and promptly got treating coronary heart disease hydrogel plaster through coating, press mold, cutting.
Substrate of the present invention can be by following natural and synthetic high molecular polymer by weight mixing:
Preparation technology of the present invention is:
A. carbomer, gelatin, magnificent glue, arabic gum are used 15-120g G & W 20-150g respectively, heat 40-80 ℃ of swelling, mix homogeneously.
B. polyvinyl alcohol, sodium carboxymethyl cellulose add 5-15g water dissolution and swelling, mixing.
C. sodium polyacrylate adds the dispersion of 5-20g glycerol.
D. aluminum glycinate or aluminium potassium sulfate, tartaric acid, EDTA-2Na add water 2-10g dissolving
The E.A component is mixed with the B component, adds the D component again, and mix with the C component back that stirs, and processed gel cream base matter in 20-120 minute.
The present invention has significant curative effect through pharmacodynamic experiment research:
1, coronary disease gel emplastrum is to the effect of hemorheology index.
The ointment for treating coronary disease various dose is to the influence of packed cell volume, plasma viscosity:
The result shows that model group animal blood slurry viscosity obviously raises, and with the blank group significant differences (P＜0.001) is arranged relatively; See that from the improvement situation of plasma viscosity positive drug group, heavy dose of group attenuating plasma viscosity and model group relatively have the significance difference opposite sex (P＜0.05).
2, the ointment for treating coronary disease various dose is to the influence of the former content of PF fibroin, platelet aggregation rate
The result shows that the former content of model group animal blood slurry cellulose protein, platelet aggregation rate obviously raise, and relatively have significant differences (P＜0.001) with blank control group; The platelet aggregation rate and the apparent in view reduction of model group of positive drug and heavy dose of group have significant difference (P＜0.05).
3, the ointment for treating coronary disease various dose is to 10s
-1, 200s
-1The influence of the WBV under the shear rate
The result representes, model group animal 10s
-1, 200s
-1WBV under the shear rate obviously raises, and relatively has significant differences (P＜0.001) with blank control group; Compare with model group, DIAOXINXUE KANG group, ointment for treating coronary disease small dose group can reduce high blood viscosity animal pattern 10s
-1, 200s
-1WBV under the shear rate has significant difference (P＜0.05, P＜0.01); Heavy dose of group can reduce 200s
-1WBV under the shear rate.
4, ointment for treating coronary disease causes the ARR influence of rat anti to medicine
The result shows: two kinds of technology samples of coronary disease gel emplastrum all have certain mitigation to rat by the arrhythmia that pituitrin causes, but do not see notable difference between two kinds of samples.
5, drug effect conclusion
Heavy dose of plasma viscosity, platelet aggregation rate and the WBV that reduces the syndrome of blood stasis animal pattern of ointment for treating coronary disease preparation; Results suggest, the external of ointment for treating coronary disease preparation can improve the hemorheology index of syndrome of blood stasis, and rat is all had certain mitigation by the arrhythmia that pituitrin causes, the prevention and the treatment of coronary heart disease had certain effect.
Coronary disease gel cream nonirritant of the present invention and anaphylaxis:
Adopt the coronary disease gel to give rabbit intact skin and damaged skin single and multiple dosing, dosage is 7 * 10cm
2/ only/inferior.The result shows, single-dose, and IRs such as erythema, edema all do not appear in intact skin and damaged skin group, and the average product score value is 0; Successive administration, intact skin treated animal and damaged skin group be not show speckle or edema all, and the average product score value is 0;
Therefore, the coronary disease gel is to rabbit intact skin, the equal nonirritant of damaged skin.
The coronary disease gel is pressed 17.5cm
2/ only, the guinea pig skin sensitization contact is contacted administration with exciting.After the administration, body weight gain of Cavia porcellus and matched group be no significant difference relatively.Overview index Non Apparent Abnormality, anaphylaxis does not appear in skin.And positive control drug 2,4 one dinitro-chloro-benzenes obviously cause the guinea pig skin anaphylaxis.The experiment proof: the coronary disease gel can not cause the anaphylaxis of guinea pig skin.
The specific embodiment
Embodiment:
Press following prepared coronary disease extractum:
1, steam distillation extracted volatile oil 8h after Lignum Dalbergiae Odoriferae steeped 2h with 6 times of water loggings, collected the device storage in addition of volatile oil, filtrating and medicinal residues;
2, together, with 5 times of amount 90% ethanol extractions three times, each 0.5h reclaims ethanol to relative density 1.15-1.25 (50 ℃ of surveys) with Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Lignum Dalbergiae Odoriferae medicinal residues;
3, Radix Paeoniae Rubra is with above-mentioned medicinal residues, with the water extraction of 10 times of amounts 3 times, and each 0.5h; Add the Flos Carthami that steeps 30min with 10 times of water loggings when extracting the last time, filter, will be concentrated into the medicinal liquid of 0.2g crude drug/ml concentration; Use purification with macroreticular resin: process conditions are: blade diameter length ratio is 1: 7; The sample solution of 8 times of amount of resin, washing amount are 1 times amount of resin, and eluent is 4 times of amount of resin of 40% ethanol; Elution rate is 3BV/H, and it is subsequent use that the medicinal liquid behind the purification is concentrated into relative density 1.15-1.25 (50 ℃ of surveys).
4, the water extracted immersing paste and alcohol-extracted extract merge, and get the treating coronary heart disease Chinese medical concrete.
The substrate preparation:
A. carbomer, gelatin, use 40g G & W 60g respectively, heat 50 ℃ of swellings, mix homogeneously.
B. polyvinyl alcohol, sodium carboxymethyl cellulose add 10g water dissolution and swelling, mixing.
C. sodium polyacrylate adds the dispersion of 5g glycerol.
D. aluminum glycinate, tartaric acid, EDTA-2Na add water 10g dissolving
The E.A component is mixed with the B component, adds the D component again, and mix with the C component back that stirs, and processed gel cream base matter in 60 minutes.
The preparation of coronary disease gel emplastrum:
Chinese medical concrete is added the transdermal penetrating agent, with the mixed of substrate, add volatile oil at last again by 1: 5.Stirred 60 minutes, and promptly got treating coronary heart disease hydrogel plaster through coating, press mold, cutting.
Claims (3)
1. thoracic obstruction that can be used for treating due to stopping in the blood stasis, that disease is seen is uncomfortable in chest, the middle medicinal gel emplastrum of the cardiovascular disease of above-mentioned symptom is seen in pareordia twinge, angina pectoris.It is characterized in that it is to be processed by the extract and the substrate of Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Flos Carthami, Lignum Dalbergiae Odoriferae five kinds of Chinese medicine, is characterized in that: this substrate is to be made up of by weight mixing following natural or synthetic high molecular polymer:
2. 1 described coronary disease gel cream according to claim is to process as follows:
A. carbomer, gelatin, magnificent glue, arabic gum are used 15-120g G & W 20-150g respectively, heat 40-80 ℃ of swelling, mix homogeneously.
B. polyvinyl alcohol, sodium carboxymethyl cellulose add 5-15g water dissolution and swelling, mixing.
C. sodium polyacrylate adds the dispersion of 5-20g glycerol.
D. aluminum glycinate or aluminium potassium sulfate, tartaric acid, EDTA-2Na add water 2-10g dissolving
The E.A component is mixed with the B component, adds the D component again, and mix with the C component back that stirs, and processed gel cream base matter in 20-120 minute.
3. coronary disease gel cream according to claim 1 is processed by Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Flos Carthami four flavor extracts and above-mentioned substrate; It is characterized in that: steam distillation extracted volatile oil 8h after Lignum Dalbergiae Odoriferae steeped 2h with 6 times of water loggings; Filter the device storage in addition of filtrating and medicinal residues; With Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Lignum Dalbergiae Odoriferae medicinal residues together, with 5 times of amount 90% ethanol extractions three times, each 0.5h reclaims ethanol to relative density 1.15-1.25 (50 ℃ of surveys); Radix Paeoniae Rubra is with the alcohol extraction medicinal residues, with the water extraction of 10 times of amounts 3 times, and each 0.5h; When extracting for the third time, add the Flos Carthami that steeps 30min with 10 times of water loggings, filtering and concentrating is used purification with macroreticular resin to the medicinal liquid of 0.2g crude drug/ml concentration: process conditions are: blade diameter length ratio is 1: 7; The sample solution of 8 times of amount of resin; The washing amount is 1 times a amount of resin, and eluent is 4 times of amount of resin of 40% ethanol, and elution rate is 3BV/H; Medicinal liquid behind the purification is concentrated into relative density 1.15-1.25 (50 ℃ of surveys) to be merged with alcohol-extracted extract.Again above-mentioned extractum is mixed with substrate, add volatile oil at last.Stirred 20-120 minute, and promptly got treating coronary heart disease hydrogel plaster unguentum through coating, press mold, cutting.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103816237A (en) * | 2013-11-15 | 2014-05-28 | 广东利泰制药股份有限公司 | Oral liquid for coronary heart disease, and preparation method thereof |
| CN111000903A (en) * | 2020-01-07 | 2020-04-14 | 吉林修正药业新药开发有限公司 | Traditional Chinese medicine composition for treating blood stasis type coronary heart disease angina and preparation method thereof |
-
2011
- 2011-04-28 CN CN 201110108364 patent/CN102755396A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103816237A (en) * | 2013-11-15 | 2014-05-28 | 广东利泰制药股份有限公司 | Oral liquid for coronary heart disease, and preparation method thereof |
| CN103816237B (en) * | 2013-11-15 | 2015-01-21 | 广东利泰制药股份有限公司 | Oral liquid for coronary heart disease, and preparation method thereof |
| CN111000903A (en) * | 2020-01-07 | 2020-04-14 | 吉林修正药业新药开发有限公司 | Traditional Chinese medicine composition for treating blood stasis type coronary heart disease angina and preparation method thereof |
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Application publication date: 20121031 |