CN1186015C - Traditional Chinese medicine compound oral sticking film for coronary heart disease and angina pectoris - Google Patents
Traditional Chinese medicine compound oral sticking film for coronary heart disease and angina pectoris Download PDFInfo
- Publication number
- CN1186015C CN1186015C CNB011019298A CN01101929A CN1186015C CN 1186015 C CN1186015 C CN 1186015C CN B011019298 A CNB011019298 A CN B011019298A CN 01101929 A CN01101929 A CN 01101929A CN 1186015 C CN1186015 C CN 1186015C
- Authority
- CN
- China
- Prior art keywords
- rete
- rhizoma chuanxiong
- film
- parts
- medicine carrying
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Images
Abstract
The present invention relates to a membrane agent using the oral mucosa for medical absorption. A medical carrying membrane layer and an antistick isolating membrane layer are arranged between a surface layer and a basal layer, wherein the medical carrying membrane layer is prepared from 1.5 to 3 weight parts of chuanxiong rhizome extract, 30 to 50 weight parts of borneol which is HP-beta-cyclodextrin inclusion compound, 50 to 70 weight parts of membrane forming agent and 8 to 15 weight parts of plasticiser, the antistick isolating layer is prepared from 18 to 22 weight parts of membrane forming agent and 2 to 3 weight parts of plasticiser, and the grain sizes of the chuanxiong rhizome extract and the borneol are from 1 to 500 nm. The present invention has the outstanding advantages that the effect-starting time is equal to that of glonoin which is a western medicine, the medical ingredients can be sufficiently used, and the side effect on the digestive system does not exist.
Description
The present invention relates to a kind of membrane that absorbs the drug by oral mucosa.
Be that the cardiopathic patent medicine of treatment of main component is a lot of with Chinese medicine Rhizoma Chuanxiong and Borneolum Syntheticum at present, wherein " SUXIAO JIUXIN WAN " is to be mainly used in quick alleviation or treatment coronary heart disease, anginal medicine commonly used.Show that according to clinical statistics the average onset time of this pill is about 5 minutes, be lower than the average onset time of nitroglycerin of Western medicine.
SUXIAO JIUXIN WAN and other are used for cardiopathic Chinese patent medicine and are the oral administration mode, the gi system of medicine through comprising liver absorbed, often take except that stomach, intestinal etc. are caused discomfort and exist the effect of paying, also inevitably be subjected to the influence of liver " first pass effect ", cause the part effective ingredient of medicine to be degraded and lose, obviously the effective ingredient of oral administration mode utilizes degree to be lower than the membrane administering mode.
Yet the version of existing membrane is not suitable for again directly being attached at the oral cavity, because the medicine that is dissolved in the oral cavity removes by the mucosa absorption, quite a few will enter digestive system with swallowing of saliva in addition.Therefore the existing membrane that is made of antiseized silicon paper top layer, middle medicine carrying rete and medical PVC basic unit especially is not suitable for being used for coronary heart disease, anginal Chinese medicine compound to what the digestive system internal organs had an effect of paying.
It is suitable with the Western medicine nitroglycerin that purpose of the present invention is intended to disclose a kind of onset time, and effective medicinal components can make full use of and digestive system is not had the Chinese medicine compound oral film that is used for angina pectoris of the effect of paying.
Oral film of the present invention is the gentle molten separating film layer of medicine carrying rete that sets gradually mutual applying between antiseized silicon paper top layer and medical PVC basic unit from top to bottom, the medicine carrying rete is the compositions that is made of following component and parts by weight, Rhizoma Chuanxiong extract 1.5-3 part, Borneolum Syntheticum-HP-Benexate Hydrochloride 30-50 part, film former 50-70 branch, plasticizer 8-15 part: slow molten separating film layer is the compositions that is made of following component and parts by weight, film former 18-22 part, plasticizer 2-3 part; Its granularity of the Rhizoma Chuanxiong extract of described medicine carrying rete and Borneolum Syntheticum is 1-500nm.
Paste rapidly for making medicine carrying rete and oral cavity, oral film of the present invention is provided with between antiseized silicon paper top layer and medicine carrying rete with the pastille of medicine carrying membrane laminating platform pastes rete, its thickness is between 0.03-0.06mm, the component and the parts by weight that constitute this rete are Rhizoma Chuanxiong extract 0.3-0.6 parts, Borneolum Syntheticum-HP-Benexate Hydrochloride 8-12 part, film former 18-22 part, plasticizer 2-3 part, the granularity of Rhizoma Chuanxiong extract and Borneolum Syntheticum is 1-500nm.
Said Rhizoma Chuanxiong extract is that yield is the Rhizoma Chuanxiong biology total alkali of 0.4-1.5%.
The film former that said medicine carrying rete, slow molten separating film layer and pastille are pasted in the rete component is a polyvinyl alcohol, and plasticizer is a glycerol.
Said slow molten separating film layer is mixed with the tender flavor agent as cyclamate in its component, its parts by weight are 0.3-1 part.
Rhizoma Chuanxiong and Borneolum Syntheticum its drug effect in the cardiopathic Chinese patent medicine of treatment is known, Rhizoma Chuanxiong uses with its extractum usually, and yield is the Rhizoma Chuanxiong biology total alkali of 0.4-1.5% among the present invention, its kind of main compound surplus principal component has comprised 10, as 2,3,5, the 6-tetramethylpyazine promptly is commonly called as ligustrazine, pharmacological experiment shows, the salt of this chemical compound can suppress rabbit that epinephrine or potassium chloride the causes large artery trunks that exsomatizes and shrink, and the coronary flow that increases the anesthesia Canis familiaris L., reduce arteria coronaria and press and the arteria coronaria resistance, therefore have the effect that increases blood supply of cardiac muscle, oxygen supply.As 3,1-(5-methylol-2-furyl)-B-carboline, pharmacological evaluation shows, the salt of this chemical compound has and brings high blood pressure down coronary blood flow increasing, effects such as spasmolytic, analgesia, arrhythmia.3-isopropyl-6-sec-butyl-2 for another example, 5-piperazinedione, 1-acetyl-3-carboline and cyclic peptide chemical compound isoleucyl-valine acid anhydride of being made up of L-valine and L-isoleucine etc. all have the effect of obvious coronary artery dilator and coronary blood flow increasing, and the clinical practice result shows that the present invention utilizes its effect of biology total alkali of Rhizoma Chuanxiong to be better than Rhizoma Chuanxiong extractum.
As monarch drug, Borneolum Syntheticum then is a messenger drug to Rhizoma Chuanxiong extract in the compound recipe of this membrane, and itself has the analgesic effect, also auxiliary drug action and the absorption that promotes monarch drug.Borneolum Syntheticum among the present invention-HP-Benexate Hydrochloride not only can be avoided the volatilization loss of Borneolum Syntheticum component in making storage process, thereby guarantee the stability of compound medicines, also utilized the solid dispersion principle and be of value to the rate of release of Borneolum Syntheticum microgranule from rete with composition proportion.
Medicinal composition mean particle dia easily is absorbed less than the blood capillary of the about 4 μ m of the thinnest blood vessel diameter of human body below 500nm among the present invention.This membrane makes full use of the thin good physiological characteristics of permeability of oral mucosa simultaneously, and pad pasting is that large tracts of land contacts with oral mucosa, therefore the medicinal ingredient in the rete absorbs a large amount of blood capillaries under the direct tunicle and imports the internal jugular vein blood vessel and through heart, quick-acting heart pill thing onset time than oral administration route obviously shortens, suitable with the Western medicine nitroglycerin, clinical comparison statistical result sees Table 1.
Table 1:
| Grouping N=50 | Produce effects (%) | Effectively (%) | Total effective rate (%) | Average onset time (branch) |
| This oral film | 62 | 34 | 96 | 2.89(±1.89) |
| Nitroglycerin | 56 | 36 | 92 | 3.15(±1.98) |
| SUXIAO JIUXIN WAN | 38 | 58 | 96 | 5.73(±2.15) |
Grouping case in the table 1 is according to the clinical symptoms and the impartial distribution of various check result of angina pectoris." produce effects " is defined as after the medication 3 minutes and alleviates with interior cardinal symptom, " effectively " be 3-8 minute with interior cardinal symptom alleviation.
Effective medicinal components of the present invention can make full use of except that having the characteristics of " first pass effect " that general membrane can avoid liver, the main slow molten separating film layer that fits in the medicine carrying rete outside that relies on, it has prevented medicine carrying rete direct containing in the oral cavity effectively, and its ingredient is only had by the mucosa absorption single channel.Be not difficult to find out that simultaneously slow molten separating film layer stops the dissolution of saliva to the medicine carrying rete, making not contain in the saliva digestive system produced stimulates and the uncomfortable ingredient of paying effect Borneolum Syntheticum particularly.Therefore this oral film also can often use to be used for control not only as the first aid pad pasting of angina pectoris acute attack.
Each rete of oral film of the present invention is the colloid situation, and the affinity that each laminating closes by the film former polyvinyl alcohol forms naturally.The micro state of rete is be cross-linked with each other random netted, nm level medicinal ingredient microgranule uniform distribution therebetween, after medicine carrying rete or pastille stickup rete and oral mucosa applying, at first the medicinal ingredient microgranule of deep layer is separated out from reticulate body and by mucosa absorption behind its top layer, and power and speed derive from the particle concentration gradient that constantly changes in the rete.
Among the present invention the medicine carrying rete actual be nm level Drug Storage, the content adjustment of medicinal ingredient can make this pad pasting be suitable for the angina pectoris of different symptoms, is controlled at effective acting time in 1 hour to 24 hours scope.This pad pasting can be made into strip, removes antiseized silicon paper top layer during use, removes medical PVC basic unit after the attaching again and gets final product, and is very easy to use.This pad pasting can be attached at oral cavity, gingiva and Sublingual, is first-selected position with the Sublingual generally, and this position makes and avoids foreign body sensation in the oral cavity, and the cyclamate in the slow molten separating film layer can improve mouthfeel.
Pad pasting of the present invention is made by following method: the Rhizoma Chuanxiong CO through selecting
2Supercritical fluid extraction obtains its extract, and yield all can in the 0.4-1.5% scope.Borneolum Syntheticum is dissolved in ethanol earlier, under stirring state, splash in the HP-beta-schardinger dextrin-, under 50 ℃ of constant temperatures, continue to stir and became Borneolum Syntheticum-HP-beta cyclodextrin clathrate serosity in 1-2 hour, in nanometer (nm) level particle diameter microemulsified common apparatus, make each rete slurry respectively by each rete component and parts by weight, and separate application drying and forming-film, compound successively each rete and antiseized silicon paper top layer in medical PVC basic unit are through hemisection with the packing of cutting into slices entirely.
Below in conjunction with embodiment and description of drawings the present invention thereof.
Accompanying drawing 1 embodiment 1 structural representation.
Accompanying drawing 2 embodiment 2 structural representations.
Shown in Figure 1, set gradually the medicine carrying rete 2 gentle molten separating film layers 3 of mutual applying in the example 1 between antiseized silicon paper top layer 1 and the medical PVC basic unit 4 from top to bottom, Rhizoma Chuanxiong extract parts by weight in the medicine carrying rete are 2 parts, Borneolum Syntheticum-HP-Benexate Hydrochloride parts by weight are 40 parts, film former polyvinyl alcohol parts by weight are 60 parts, and the glycerol parts by weight are 10 parts.The polyvinyl alcohol parts by weight are 20 parts in the slow molten separating film layer, and the glycerol parts by weight are 2.5 parts, and the cyclamate parts by weight are 0.5 part.This routine pad pasting can be used for angina cordis emergency aid and treatment and general coronary heart disease treatment.
Be provided with between antiseized silicon paper top layer 1 and the medicine carrying rete 2 in the example 2 shown in Figure 2 and benefit this membrane and the rapid pastille stickup rete of pasting 5 of oral mucosa, thickness is 0.03mm, the Rhizoma Chuanxiong extract parts by weight are 0.5 part in this rete, Borneolum Syntheticum-HP-Benexate Hydrochloride is 10 parts, polyvinyl alcohol is 20 parts, and plasticizer is 2 parts.The Rhizoma Chuanxiong extract parts by weight of medicine carrying rete are 1 part, and Borneolum Syntheticum-HP-Benexate Hydrochloride is 20 parts, 30 parts of film former polyvinyl alcohol, 8 parts of glycerol.The viscosity that pastille stickup rete in the present embodiment utilizes polyvinyl alcohol to produce through the dissolving of oral cavity liquid is rapid and the oral mucosa realization is bonding, and pharmaceutical compositions wherein can play basic drug action, dissolution velocity is about 10 seconds when being 0.03mm according to this thicknesses of layers of test, does not influence the normal effect of medicine carrying rete.Other structure of present embodiment is same as embodiment 1.The medicinal ingredient of this routine medicine carrying rete is lower than example 1, and the people who is mainly used in existing angina pectoris medical history is in sleep or be easy to excited occasion and may cause acute attack and do prevention and use.
Claims (5)
1, the Chinese medicine compound oral film that is used for angina pectoris, it is characterized in that it is made up of the antiseized silicon paper top layer that sets gradually mutual applying from top to bottom, medicine carrying rete, slow molten separating film layer and medical PVC basic unit, wherein the medicine carrying rete is that component by following parts by weight constitutes: Rhizoma Chuanxiong extract 1.5-3 part, Borneolum Syntheticum-HP-Benexate Hydrochloride 30-50 part, film former 50-70 part, plasticizer 8-15 part; Slow molten separating film layer is that the component by following parts by weight constitutes: film former 18-22 part, plasticizer 2-3 part; The Rhizoma Chuanxiong extract in the described medicine carrying rete and the granularity of Borneolum Syntheticum are 1-500nm.
2, oral film as claimed in claim 1, it is characterized in that: the pastille that closes with the medicine carrying membrane laminating is set between antiseized silicon paper top layer and medicine carrying rete pastes rete, its thickness is between 0.03-0.06mm, the component and the parts by weight that constitute this rete are Rhizoma Chuanxiong extract 0.3-0.6 parts, Borneolum Syntheticum-HP-Benexate Hydrochloride 8-12 part, film former 18-22 part, plasticizer 2-3 part, the granularity of Rhizoma Chuanxiong extract and Borneolum Syntheticum is 1-500nm.
3, oral film as claimed in claim 1 is characterized in that: said Rhizoma Chuanxiong extract is that yield is the Rhizoma Chuanxiong biology total alkali of 0.4-1.5%.
4, oral film as claimed in claim 1 or 2 is characterized in that: the film former that said medicine carrying rete, slow molten separating film layer and pastille are pasted in the rete component is a polyvinyl alcohol, and plasticizer is a glycerol.
5, oral film as claimed in claim 1 is characterized in that: said slow molten separating film layer, be mixed with correctives in its component as cyclamate, and its parts by weight are 0.3-1 part.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011019298A CN1186015C (en) | 2001-01-18 | 2001-01-18 | Traditional Chinese medicine compound oral sticking film for coronary heart disease and angina pectoris |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011019298A CN1186015C (en) | 2001-01-18 | 2001-01-18 | Traditional Chinese medicine compound oral sticking film for coronary heart disease and angina pectoris |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1364586A CN1364586A (en) | 2002-08-21 |
| CN1186015C true CN1186015C (en) | 2005-01-26 |
Family
ID=4652320
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB011019298A Expired - Fee Related CN1186015C (en) | 2001-01-18 | 2001-01-18 | Traditional Chinese medicine compound oral sticking film for coronary heart disease and angina pectoris |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1186015C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1883492B (en) | 2006-05-22 | 2010-07-28 | 富力 | Water solution of 20(R)-ginsenoside Rg3 pharmaceutical composition and preparation method thereof |
| CN105232598A (en) * | 2015-11-04 | 2016-01-13 | 天津市中宝制药有限公司 | Chinese herbal compound quick-acting nasal cavity clip film for relieving heart attack and preparation method thereof |
| CN105343892A (en) * | 2015-12-15 | 2016-02-24 | 天津市中宝制药有限公司 | Traditional Chinese medicine compound oral mucoadhesive film for angina pectoris and preparation method |
-
2001
- 2001-01-18 CN CNB011019298A patent/CN1186015C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1364586A (en) | 2002-08-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Nagaraju et al. | Comprehensive review on oral disintegrating films | |
| CA1328621C (en) | Galenic forms of beta-2-mimetics for per- and sublingual administration | |
| WO2020051122A2 (en) | Cannabinoid, menthol and caffeine dissolvable film compositions, devices and methods | |
| US11185526B2 (en) | Cannabinoid, menthol and caffeine dissolvable film compositions, devices and methods | |
| DE102006027794A1 (en) | Antihypertensive combination wafer | |
| Lade Milind et al. | Polymer based wafer technology: A Review | |
| CN113509454A (en) | Novel one-way drug release oral ulcer double-layer film and preparation method thereof | |
| CN1186015C (en) | Traditional Chinese medicine compound oral sticking film for coronary heart disease and angina pectoris | |
| Rana et al. | A REVIEW ON FAST DISSOLVING SUBLINGUAL FILM FOR SYSTEMIC DRUG DELIVERY. | |
| EP1549326A1 (en) | Dry oral phlebotonic and vasculoprotective formulation for the treatment of venous insufficiency, capillary fragility and haemorrhoids, in the pharmaceutical form of a chewable tablet containing diosmin | |
| US20220040115A1 (en) | Pharmaceutical compositions and delivery systems for prevention and treatment of candidiasis | |
| EP1638521A1 (en) | Transmucosal form of administration with reduced mucosal irritation | |
| CN100386071C (en) | Medicine for treating cough and chronic bronchitis | |
| JPH07242536A (en) | Gelatin capsule agent containing essential oil component in skin | |
| Thosar | Intra oral sprays-An overview. | |
| JP5284070B2 (en) | Oral mucosa patch preparation | |
| US11235013B2 (en) | Cannabinoid, menthol and caffeine dissolvable film compositions, devices and methods | |
| DE102006027792A1 (en) | Antidepressants Combination wafer | |
| CN106727272A (en) | A kind of mouthwash formulation and method of gargling | |
| CN1954843B (en) | Traditional Chinese medicine plaster for treating tunica mucosa oris ulcer and its preparation method | |
| US20190125660A1 (en) | Orally dissolving mucoadhesive films utilizing menthol and l-arginine to enhance the bioavailability of cannabinoids | |
| US20110280941A1 (en) | Compositions of proton pump inhibitors and insulin secretagogues, and methods of their use to treat diabetes | |
| KR20230058452A (en) | mucosal perforation | |
| CN106421137A (en) | Compound preparation for treating chronic pharyngitis | |
| CN111743936A (en) | Functional hemp chewing gum for improving memory and reducing pressure and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C57 | Notification of unclear or unknown address | ||
| DD01 | Delivery of document by public notice |
Addressee: Gao Huiming Document name: Notice of first review |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: TIANJIN ZHONGBAO TECHNOLOGY CO., LTD. Free format text: FORMER OWNER: TIANYIN TEST ANIMAL CENTRE Effective date: 20050318 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20050318 Address after: 300300 No. 73 Yuejin Road, Dongli District, Tianjin, China Patentee after: Tianjin Zhongbao Technology Co., Ltd. Address before: A village of 300301 Tianjin city Dongli District Junliangcheng side Patentee before: Tianyin Test Animal Centre |
|
| C56 | Change in the name or address of the patentee |
Owner name: TIANJIN ZHONGBAO PHARM. CO., LTD. Free format text: FORMER NAME OR ADDRESS: TIANJIN ZHONGBAO TECHNOLOGY CO., LTD. |
|
| CP03 | Change of name, title or address |
Address after: 300300 No. 29, Jing Lu, Dongli Economic Development Zone, Tianjin, China Patentee after: Zhongbao Pharmaceutical Co., Ltd., Tianjin Address before: 300300 No. 73 Yuejin Road, Dongli District, Tianjin, China Patentee before: Tianjin Zhongbao Technology Co., Ltd. |
|
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20050126 Termination date: 20110118 |