CN1650989A - Chinese medicine oral cavity adherent emplastrum and its preparation method - Google Patents

Chinese medicine oral cavity adherent emplastrum and its preparation method Download PDF

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Publication number
CN1650989A
CN1650989A CN 200410098630 CN200410098630A CN1650989A CN 1650989 A CN1650989 A CN 1650989A CN 200410098630 CN200410098630 CN 200410098630 CN 200410098630 A CN200410098630 A CN 200410098630A CN 1650989 A CN1650989 A CN 1650989A
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China
Prior art keywords
oral cavity
chinese medicine
medicine oral
sticking tablet
sanguis draxonis
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CN 200410098630
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Chinese (zh)
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CN100384407C (en
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胡少勇
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Abstract

A Chinese medicine in the form of oral picking for treating oral ulcer (aphtha) is prepared from Dragon's blood and adhesive biologic material.

Description

A kind of Chinese medicine oral cavity sticking tablet and preparation thereof
Technical field
This invention relates to a kind of Chinese medicine oral cavity sticking tablet and preparation thereof, is specifically related to contain the sticking tablet and the preparation thereof of Sanguis Draxonis or Sanguis Draxonis.
Background technology:
Stomatocace is that common diseases of oral mucosa decreases, and often betides non-keratosis, oral cavity, locates as lip, cheek, oral mucosa etc.Oral ulcer also claims aphtha, is common in the adolescence crowd, and the female patient ratio is higher, recurrent aphtha particularly, but prevalence intelligent group 20%.The pathogenic factor complexity of stomatocace may be relevant with crucial immunological abnormality, Nervous and Mental Factors, heredity, infection, nutrition, digestive system disease and dysfunction thereof, endocrine, local wound and microcirculation disturbance etc.The marked feature of oral ulcer is to show effect repeatedly, the ulcer number from less to more, the position is from front to back, be mainly in oral mucosa, gingiva, tongue body up and down with side and bottleneck throat, the face that festers is big as Semen Glycines, little of the grain of rice, the surface attachment white rotten film that festers, but the lighter's several months take place once, weight person shortens the intermission gradually, increase the weight of year by year, even fester, rise one after another the several years, many decades is not healed, and has a strong impact on normal work and animation.
Pathogenic factor complexity in view of oral ulcer, still there is not comparatively ideal treatment way at present, in recent years often use dexamethasone, metronidazole oral sticking tablets treatment oral ulcer clinically, but because oral ulcer cause of disease complexity, dexamethasone, metronidazole indication are clear and definite, be of limited application, and these 2 kinds of poisonous side effect of medicine are bigger, can not life-time service.
Summary of the invention:
Sanguis Draxonis be plant be subjected to that pathogenic bacterium are infected or external irritant and injury after, produce defense response and form a kind of plant defense element in ground.Sanguis Draxonis is just used in the middle of the traditional Chinese medical science very early, and literature record the earliest is for can trace back to " South Uietnam will " (sixties 5th century of Christian era) that the Shen Huai of the Northern and Southern Dynasties writes, and this book is referred to as " Sanguis Draxonis ".The traditional Chinese medical science thinks that the Sanguis Draxonis nature and flavor are sweet, warm, salty, flat, and GUIXIN, Liver Channel have that blood circulation promoting and blood stasis dispelling, hemostasis are enriched blood, the effect of promoting tissue regeneration and ulcer healing; Be mainly used in traumatic hemorrhage, ulcer being unable to heal, traumatic injury, the stasis of blood disease such as have a pain that stagnates.
Sanguis Draxonis relies on import in the past always, from the seventies in last century successively in Yunnan, ground such as Guangxi, Hainan find the Sanguis Draxonis resource, along with the going deep into of basic research, domestic Dragon Blood substitutes the import medical material gradually afterwards, domestic Dragon Blood is called Sanguis Draxonis again, to be different from the import kind.Modern study shows that Sanguis Draxonis has tangible antiinflammatory, the antibiotic and effect that promotes wound healing.
The correlational study data show Sanguis Draxonis to oral ulcer have the good curing effect (Bu Xianghong, etc. West China stomatology magazine, 2000; 18:115), the preparations carrier of using the dragon blood for treating oral ulcer at present has membrane and powder, but because special physicochemical property and the dosage form technology of Sanguis Draxonis is limit, these dosage forms all exist in various degree contact with ulcer surface bad, drug release is limited, time of contact is short, or problem such as zest is strong.
Discover through us Sanguis Draxonis is made oral cavity sticking tablet, can effectively solve the contact performance of medicine and wound surface, the holdup time in prolong drug and affected part, significantly improve the therapeutic effect of Sanguis Draxonis to oral ulcer, the zest of Sanguis Draxonis sticking tablet obviously reduces simultaneously, and sticking tablet is the ideal preparations carrier of dragon blood for treating stomatocace.
In the middle of Sanguis Draxonis oral cavity pasting tablet recipe, add bioadhesive macromolecular material with solubility, make oral cavity sticking tablet according to the conventional formulation method, through the research data of prerun in conjunction with relevant sticking tablet, find that having the excellent compatibility polymeric biomaterial with Sanguis Draxonis has hydroxypropyl emthylcellulose (HPMC), carbopol (Carbopol), sodium carboxymethyl cellulose, hydroxypropyl cellulose, in the middle of some prescription, use the above-mentioned material of different proportion can obtain best adhesion time.
The preparation of Sanguis Draxonis sticking tablet:
According to following preparation prescription:
Sanguis Draxonis 20g
HPMC???????????????????????????????5g
Carbopol 934P 15g
Make 1000
Method for making: get the Sanguis Draxonis micronize and handle, cross 300 mesh sieves, with principal agent fine powder and adjuvant mix homogeneously, direct compression promptly gets oral cavity sticking tablet.
With reference to pertinent literature prepare the Sanguis Draxonis membrane (Bu Xianghong, etc. West China stomatology magazine, 2000; 18:115), relatively Sanguis Draxonis membrane and the difference of sticking tablet on bioadhesion power and adhesion time.
Adhesion (g/cm 2) Adhesion time (min)
Sticking tablet 1 (embodiment 1) 145.1 ?78.6
Sticking tablet 2 (embodiment 2) 78.9 ?33.4
Sticking tablet 3 (embodiment 3) 100.7 ?65.8
Sticking tablet 4 (embodiment 4) 86.9 ?39.4
Membrane 26.8 ?5.2
Sanguis Draxonis oral cavity sticking tablet treatment effectiveness evaluation:
The Sanguis Draxonis sticking tablet is applied to clinical, control drug is respectively dexamethasone acetate plaster and Sanguis Draxonis film, the index of ulcer doing well,improving, ulcer healing time length, zest aspect relatively, and concrete outcome such as following table:
Group Doing well,improving Recovery from illness in 4 days Invalid Total effective rate (%)
Dexamethasone acetate plaster 17 ?6 ?7 ?76.6
The Sanguis Draxonis membrane 12 ?7 ?11 ?63.3
The Sanguis Draxonis sticking tablet 10 ?18 ?2 ?93.3
Can see that from above-mentioned clinical data cure rates on the 3rd of Sanguis Draxonis oral cavity sticking tablet are compared with membrane has significant raising, this and oral cavity sticking tablet and ulcer surface are long closely related time of contact; In addition, can see that from above-mentioned test data the therapeutic effect of Sanguis Draxonis oral cavity sticking tablet is better than the dexamethasone sticking tablet.
The zest aspect: serious adverse reaction does not all appear in all cases, but the medication compliance of Sanguis Draxonis sticking tablet obviously is better than other drug, and tablet contacts with wound surface and do not occur zest substantially, and the zest of Sanguis Draxonis membrane is the strongest relatively.
Chinese patent (number of accepting is 2004100463673), we disclose a kind of phosphatide complexes of Sanguis Draxonis, in the middle of this invention research, we find to have absorption characteristic preferably after Sanguis Draxonis is made phosphatide complexes, with reference to this invention, make the Sanguis Draxonis phosphatide complexes, make sticking tablet again.
This disclosed oral cavity sticking tablet of research also comprises double-layer tablet, and being specially one deck is medicated layer, and one deck is a protective layer in addition, discharges to the offside of oral mucosa to avoid medicine, and increases the time of staying of medicine at ulcer surface.Protective layer is selected water-fast material, makes as acrylic resin, titanium dioxide etc., and it is promptly one-sided to be applied to tablet.
We find in the middle of the development of Sanguis Draxonis oral cavity sticking tablet, in tablet formulation, add the symptom that an amount of freshener can be alleviated oral ulcer, as ease the pain, and eliminate the halitosis that ulcer causes, freshener can be selected natural Broneolum Syntheticum, borneol, menthol or Mentholum.
Embodiment 1
Preparation prescription:
Sanguis Draxonis 20g
HPMC?????????????????????????????????????5g
Carbopol 15g
Make 1000
Method for making: get the Sanguis Draxonis micronize and handle, cross 300 mesh sieves, with principal agent fine powder and adjuvant mix homogeneously, direct compression promptly gets oral cavity sticking tablet.
Embodiment 2
Preparation prescription:
Sanguis Draxonis phosphatide complexes 300g
HPMC?????????????????????????????????????35g
Carbopol 55g
Magnesium stearate 1.5g
Make 1000
Method for making: get Sanguis Draxonis, make phosphatide complexes, pulverize, cross 300 mesh sieves, with principal agent fine powder and adjuvant mix homogeneously, granulate, oven dry adds magnesium stearate in the middle of dried granule, and direct compression promptly gets oral cavity sticking tablet.
Embodiment 3
Preparation prescription:
Sanguis Draxonis 50g
HPMC?????????????????????????????????????100g
Carbopol 155g
Lactose 45g
Pulvis Talci 3.0g
Make 1000
Method for making: get Sanguis Draxonis, carry out micronize and handle, other gets other adjuvant mix homogeneously, and direct compression promptly.
Embodiment 4
Preparation prescription:
Sanguis Draxonis 5.0g
Natural Broneolum Syntheticum 1.0g
Hydroxypropyl cellulose 15g
Carbopol 23g
Make 1000
Method for making: get Sanguis Draxonis and Borneolum Syntheticum mix homogeneously; With adjuvant HPMC and carbopol mix homogeneously, with coubling dilution principal agent is mixed with adjuvant, tabletting, promptly.
Embodiment 5
Preparation prescription (double-layer tablet):
Sanguis Draxonis 50.0g
Mentholum 50.0g
Sodium lauryl sulphate 1.0g
HPMC?????????????????????????????????????10g
Carbopol 934P 20g
Mannitol 10g
Micropowder silica gel 1.0g
Make 1000
Method for making: get Sanguis Draxonis, Mentholum, add sodium lauryl sulphate, carry out micronize and handle; In the middle of the micronize principal agent, add other adjuvants, mix homogeneously, direct compression obtains medicated layer; Get acrylic resin 4.0g, add titanium dioxide 0.8g, dioctyl phthalate, pigment are an amount of, and with 95% dissolve with ethanol, mixing is coated the medicated layer surface with Membrane jetter with protective layer, and drying promptly gets double-layer tablet.
Embodiment 6
Preparation prescription:
Sanguis Draxonis 20.0g
Tween 80 1.0g
Sodium carboxymethyl cellulose 5g
Carbopol 934P 20g
Microcrystalline Cellulose 5.0g
Micropowder silica gel 1.0g
Make 1000
Method for making: get Sanguis Draxonis,, spray into tween 80 solution with sodium carboxymethyl cellulose and microcrystalline Cellulose mix homogeneously, wet granulation, drying obtains dried granule; With above-mentioned dried granule and carbopol mix homogeneously, add micropowder silica gel, tabletting, promptly.

Claims (11)

1, a kind of Chinese medicine oral cavity sticking tablet is characterized in that containing in the middle of every dosage unit sticking tablet 5~300 milligrams of principal agent Sanguis Draxonis or Sanguis Draxonis, has 5~300 milligrams of the biomaterials of adhesive attraction.
2, Chinese medicine oral cavity sticking tablet according to claim 1 is characterized in that including in the middle of the preparation of every dosage unit other pharmaceutically 3~200 milligrams of acceptable excipient.
3, Chinese medicine oral cavity sticking tablet according to claim 1 and 2 is characterized in that described sticking tablet can adhere to the oral ulcer wound surface, and adhesion time was not less than 30 minutes.
4, Chinese medicine oral cavity sticking tablet according to claim 1 is characterized in that described described Sanguis Draxonis or Sanguis Draxonis can pass through micronize and handle, or makes complex.
5, Chinese medicine oral cavity sticking tablet according to claim 1 is characterized in that described biomaterial with adhesive attraction can be selected from a kind of in the middle of the hydroxypropyl emthylcellulose, carbopol, sodium carboxymethyl cellulose, hydroxypropyl cellulose or several mixture.
6, Chinese medicine oral cavity sticking tablet according to claim 1 and 2, it is characterized in that described other pharmaceutically the acceptable excipient comprise filler, fluidizer, filler can be selected from a kind of in the middle of the microcrystalline Cellulose, mannitol, lactose or several mixture; Fluidizer is selected from magnesium stearate, micropowder silica gel.
7, according to claim 1 or 2 or 6 described Chinese medicine oral cavity sticking tablets, it is characterized in that described other pharmaceutically the acceptable excipient comprise cosolvent, cosolvent is selected from sodium lauryl sulphate, dodecyl sodium sulfate, tween 80.
8, Chinese medicine oral cavity sticking tablet according to claim 1 is characterized in that described sticking tablet comprises common single-layer sheet, or double-layer tablet.
9,, it is characterized in that described double-layer tablet comprises the adhesion layer and the water-fast protective layer of pastille according to claim 1 or 8 described Chinese medicine oral cavity sticking tablets.
10, Chinese medicine oral cavity sticking tablet according to claim 1 is characterized in that containing in the preparation a certain proportion of freshener, and every dosage unit tablet contains 1~50 milligram of freshener; Freshener can be selected from a kind of in the middle of the Borneolum Syntheticum, menthol, Mentholum or several mixture.
11, the application of Chinese medicine oral cavity sticking tablet according to claim 1 in the middle of the oral ulcer control.
CNB2004100986303A 2004-12-15 2004-12-15 Chinese medicine oral cavity adherent emplastrum and its preparation method Expired - Fee Related CN100384407C (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100345542C (en) * 2005-09-29 2007-10-31 北京紫辰宣医药经营有限公司 Tinizadole dental plaster for treating buccal inflammation
CN101647768B (en) * 2009-09-08 2011-06-08 上海大学 Process for preparing Chinese herbal medicine toothpaste containing dragon's blood extract
CN102727756A (en) * 2012-07-05 2012-10-17 杨发祥 Compound powder for treating aphtha and method for preparing compound powder
CN113018365A (en) * 2021-02-19 2021-06-25 昆明市中医医院 Compound dragon's blood dental ulcer medicine composition and preparation method thereof
CN114886791A (en) * 2022-05-09 2022-08-12 广州市白云区大荣精细化工有限公司 Bubble type sterilization and bacteriostasis mouth wash and preparation method thereof

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100345542C (en) * 2005-09-29 2007-10-31 北京紫辰宣医药经营有限公司 Tinizadole dental plaster for treating buccal inflammation
CN101647768B (en) * 2009-09-08 2011-06-08 上海大学 Process for preparing Chinese herbal medicine toothpaste containing dragon's blood extract
CN102727756A (en) * 2012-07-05 2012-10-17 杨发祥 Compound powder for treating aphtha and method for preparing compound powder
CN102727756B (en) * 2012-07-05 2013-07-31 杨发祥 Compound powder for treating aphtha and method for preparing compound powder
CN113018365A (en) * 2021-02-19 2021-06-25 昆明市中医医院 Compound dragon's blood dental ulcer medicine composition and preparation method thereof
CN114886791A (en) * 2022-05-09 2022-08-12 广州市白云区大荣精细化工有限公司 Bubble type sterilization and bacteriostasis mouth wash and preparation method thereof

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