CN102641236B - Expandable biological adhesive sustained and controlled release preparation for preventing and curing oral diseases and preparation method thereof - Google Patents
Expandable biological adhesive sustained and controlled release preparation for preventing and curing oral diseases and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an expandable biological adhesive sustained and controlled release preparation for preventing and curing oral diseases, which consists of a water phase, a surfactant and an oil phase. Active ingredients for preventing and curing the oral diseases exist in the water phase and/or the oil phase, wherein the water phase is an inner phase, the oil phase is an outer phase, the boundary of the water phase and the oil phase is constructed and maintained by the surfactant, and the water phase and the oil phase are in a uniform and fully osculatory state. The invention also discloses a preparation method of the biological adhesive sustained and controlled release preparation. Through the preparation, a drug sustained and controlled release mode is formed, a product is lasting and effective, the frequency of usage of the product is reduced, the compliance of the product is increased, and the use cost is reduced; and the release preparation exists at drug administration target positions in a plastic physical form, so that the active ingredients in the product effectively cover the drug administration target positions, even the drug administration target positions with complex physiological structures, such as teeth in an oral cavity and periodontal pocket between gingivae.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of bioadhesion sustained-release preparation, relate in particular to a kind of expansiveness bioadhesion sustained-release preparation of preventing and treating oral disease and preparation method thereof; The present invention can be applied to include but not limited to: the administration of topical, non local form, hole filling or tissue repairing and its surface-treated medical apparatus and instruments.
Background technology
Emulsion is generally by two immiscible phase compositions, and wherein one is scattered in another phase equably with trickle particle shape.According to which as decentralized photo (interior phase) or which as continuous phase (extroversion), can be divided into roughly two kinds of fundamental types of oil-in-water and Water-In-Oil.The constructed system of the present invention is the latter.At present, during industrial use Water-In-Oil system, the difficulty run into is mainly complex manufacturing, and product stability is poor.
Be used for the treatment of at present or the reducing human oral cavity in the method for symptom of tract relevant disease comprise physical method and chemical method.Physical method generally needs doctor or professional to be undertaken by instrument, and needs the patient by adhering to using toothbrush, dental floss or toothpick partner treatment.But this method usually can be because of the restriction of the anatomical structure of tooth and is difficult to touch the dead angle in some deeps, and especially in antibiotic means, chemical method is still the most effective way (as antibiotic use).Chemical method comprises available polytype preparation in the market, as solid preparation (patch, tablet, suppository etc.), and liquid preparation (as foam, lotion, liniment etc.) and semi-solid preparation (emulsifiable paste, gel, cream etc.).Generally, solid preparation, when medication, as buccal tablet, is on the one hand to be difficult to reach needed slow release effect (several hours or more of a specified duration), and a large amount of medicines does not contact with lesions position but along with saliva is ingested on the other hand; The second, the administration shape can not be satisfactory, and even some preparations can produce discomfort or make troubles to the patient when administration, for example mouth paster; The liquid form of medication may be more acceptant for the patient comparatively speaking, but be difficult to reach the purpose of slow release: because lotion generally is difficult at the enough medicines of the long-time reservation of lesions position; So all there are an identical defect in solid and liquid drug-supplying system, be exactly all to be difficult to reach the deep layer position of needs treatment and keep the sufficiently long time.
In order to overcome the above problems, someone has developed multiple topical therapeutic scheme; For example (patent No. is: US5599553) disclosed diformazan tetracycline hydrochloride and polycaprolactone are with the pharmaceutical preparation of strips composition, and said preparation can continue at the periodontal pocket position release 7 days for United States Patent (USP).But, in drug release process, still be difficult to preparation is filled up to periodontal pocket fully, and need pharmaceutical base is removed after seven days, because its decomposition in vivo is very difficult slowly.(patent No. is United States Patent (USP): US4913882) disclose the pharmaceutical preparation that a kind of polymer particle can be scattered in water-soluble decentralized photo, advantage is can independently discharge medicine patient is felt bad, but need frequent drug administration, because its release only has 6 hours.(number of patent application is: in fact 03116412.9) disclosed a kind of mouth paster applies it in periodontal medical science space and remains inconvenient Chinese patent application.Chinese patent application (number of patent application is: 91105673.4) disclosed chewing gum preparation method, and still undesirable on sustained release performance.
Summary of the invention
One of the technical problem to be solved in the present invention is to provide a kind of expansiveness bioadhesion sustained-release preparation of preventing and treating oral disease, and it forms slow controlled release medicine pattern, makes the lasting onset of product, reduces the frequency of usage of product, increases the product compliance, reduces use cost; Due to the release dosage form, be to occur with plastic physical aspect at the administration target position, therefore can make the active component in product effectively cover the administration target position, even comprise the administration target position with complex physiologic structure, such as the periodontal pocket between oral cavity inner teeth gear and gums etc.
Two of the technical problem to be solved in the present invention is to provide the preparation method of this bioadhesion sustained-release preparation.
The present invention relates to the expandable emulsifiable paste system of a class based on water and oil mixture or substrate.This system can be attached to biological mucosa or skin surface for a long time, and can discharge contained active component according to the mode of the slow release of predetermined design or controlled release and reach the purpose of long-acting.The key feature of this class preparation is that product form has plasticity because of expansiveness, thereby prepared formulation products can form the plastic shape be complementary with administration target position physiological make-up or can realize automatic filling at the administration target position in application.
A kind of expansiveness biologic adhesion preparation of realizing slow controlled release involved in the present invention, have good stability, is applicable to the slow release of bioactive substances in biological tract, and realizes automatic filling.This preparation is a kind of by oil phase, surfactant, water and the common water-in-oil emulsion built of auxiliary adjuvant, the controlled capability of its dilatancy, adhesiveness and active component is all relevant with the interface energy of water (also become the surface energy, both increased the needed energy of system surface area or merit) with constructed oil phase.And kind and the ratio of the influence factor of interface energy and decentralized photo, temperature, droplet size and particle size distribution, physical property and the oil-water interfaces characteristic of oil, water, the character of emulsifying agent and content, the factor analysis such as production technology.
In order to solve the problems of the technologies described above, the invention provides a kind of expansiveness bioadhesion sustained-release preparation of preventing and treating oral disease, said preparation is comprised of water, surfactant, oil phase; The active component of preventing and treating oral disease is present in water and/or oil phase; Wherein, water is interior phase, and oil phase is the foreign minister, and the interface of oil phase and water is built and maintained by surfactant, makes the biphase state that is in homogeneous and contacts fully.
Described bioadhesion sustained-release preparation can be the system of a kind of semisolid or liquid.This system has certain relatively long-term bioadhesive, depends on the interface energy in this system and stick the length of time.This system administering mode can local or non local administration.This system comprises in the topical mode route of administration is mainly oral cavity.Described topical mode is for periodontal pocket, gingiva, tissue, dental caries hole, tooth body, oral cavity wall at all, or medically acceptable hole.
Described active component can dissolve or be suspended in water and/or oil phase.
Preferably, when described active component was suspended in water and/or oil phase, it was micronized, was present in water and/or oil phase to guarantee its stable uniform ground.
Described active component can be used as surfactant or cosurfactant.
Described active component comprises antibacterial, antiinflammatory, hemorrhage, osteoporosis agent, tissue repair agent, nutrient, analgesic.
The viscosity of this bioadhesion sustained-release preparation should be greater than 1PaS, and preferred, the viscosity of this bioadhesion sustained-release preparation should be greater than 3PaS.
The release characteristic of the semisolid of described bioadhesion sustained-release preparation or the viscosity of liquid, stability, active component can be adjusted effectively by adding excipient.The excipient used comprises one or several of correctives, pH adjusting agent, stabilizing agent, solvent, osmotic pressure regulator, diluent, surfactant, thickening agent, delayed release agent, antiseptic and inhibiting bacteria function agent, chelating agen, adsorbent, softening agent, wetting agent, antioxidant, aromatic, coloring agent, lucifuge agent.Described excipient is selected from: any one or a few in mannitol, sorbitol, propylene glycol, sucrose, Mel, glycerol, maltose alcohol, xylitol, xanthan gum, carrageenin, carboxymethyl cellulose (sodium), polyvidone, hypromellose, boric acid, borate, carbomer, titanium dioxide, hydrophobic ultrafine silica powder, spermaceti, paraffin, vaseline, Cera Flava.
Described oil phase is selected from: any one in mineral oil, vegetable oil, fatty acid (alcohol, ester, ether) or several mixture; Be preferably: one or several mixture of mineral oil, olive oil, Oleum Ricini, Oleum sesami, soybean oil, almond oil, Oleum Gossypii semen, glyceryl monostearate, medium chain length fatty acid triglyceride, hexadecanol, silicone oil, IPIS, the poly-ring of stearic acid the third Ethylene Oxide-15 ether.
The surfactant used is one or several in nonionic surfactant, natural surfactant, part ion type surfactant.Be preferably: one or several in polysiloxane alcohols copolymer, polyglyceryl fatty acid ester, cithrol/alcohol ester, polyoxyethylene aliphatic alcohol ether, polyoxyethylene ether wax, Myrj 45, tristerin, polyethers organosilicon wax, succinic acid sulphonic acid ester salt, oxirane and expoxy propane copolymer, Span.
In described bioadhesion sustained-release preparation, the percentage by weight of oil phase is 1 ~ 40%; The percentage by weight of surfactant is 0.5 ~ 35%; The percentage by weight of water is 25 ~ 98.5%.
In addition, the present invention also provides the preparation process of above-mentioned bioadhesion sustained-release preparation.A kind of semisolid be comprised of water and oil phase of the present invention or the system of liquid, oil-water boundary is built and is maintained by surfactant (emulsifying agent), makes biphase homogeneous and the state of contact fully of being in.This system has certain relatively long-term bioadhesive, depends on the interface energy in system and stick the length of time.Active component can be distributed in a phase or biphase wherein, and can be according to release profiles, emission levels and the persistent period designed from formulation system, diffusing out.Its preparation method, comprise the steps:
A) select oil phase and surfactant, if solid, melting or add solvent auxiliary it, and stir;
B) prepare water;
C) under stirring, water is slowly added to oil phase until finish, make emulsifiable paste, according to the dosage packing and get final product;
Step a) and/or step b) in add the active component of preventing and treating oral disease, stir;
Step a) and step b) order interchangeable.
Step a) and/or step b) in can also add excipient.
Scheme 1:
At first the aqueous solution or the suspension that prepare the carrying active composition, the viscosity of the liquid that forms and dissolubility can be adjusted effectively by adding excipient; The excipient added includes but not limited to: glycerol, sorbitol, propylene glycol, sucrose, Mel, mannitol, maltose alcohol, xylitol, xanthan gum, carrageenin, carboxymethyl cellulose (sodium), polyvidone, hypromellose etc.Then use surfactant and needed excipient to be dissolved in mineral oil or vegetable oil and make oil phase, described excipient can be hydrophobic ultrafine silica powder, paraffin, vaseline etc.Water and the oil phase that finally will make at room temperature mix, and stir and make stable components and uniform Emulsion.
Scheme 1Concrete steps are as follows:
A) select oil phase and surfactant, if solid, melting or add solvent auxiliary it, add excipient (optional), and stir;
B) prepare water: active component is dispersed in water, and adds excipient (optional), stir;
C) under stirring, water is slowly added to oil phase until finish, make emulsifiable paste, according to the dosage packing and get final product;
Step a) and step b) order can exchange.
Scheme 2:
According to said method, prepare oil phase and water, active component is joined in oil phase.In emulsion process, different active component can be retained in respectively relatively independent biphase in, can also interpenetrate by oil-water interfaces.After product was used, each active component in mutually disengaged and plays a role.According to the pharmacokinetics drug release characteristic of active component self, release mode is controlled in design, to realize the needed effect of preparation.
Scheme 2Concrete steps are as follows:
A) select oil phase and surfactant, if solid, melting or add solvent auxiliary it, add active component and excipient (optional), and stir;
B) prepare water: this water is comprised of water and optional excipient;
C) under stirring, water is slowly added to oil phase until finish, make emulsifiable paste, according to the dosage packing and get final product;
Step a) and step b) order can exchange.
Scheme 3:
According to said method, prepare oil phase and water, some compositions of a plurality of active component in compound preparation are joined in oil phase, remaining active component is added to water.In emulsion process, different active component can be retained in respectively relatively independent biphase in, can also interpenetrate by oil-water interfaces.After product was used, each active component in mutually disengaged respectively, combined effect.According to the pharmacokinetics drug release characteristic of each active component self, release mode is controlled in design, to realize the needed synergism of compound preparation.
Scheme 3Concrete steps are as follows:
A) select oil phase and surfactant, if solid, melting or add solvent auxiliary it, add active component and excipient (optional), and stir;
B) prepare water: water-soluble active ingredient is dispersed in water, and adds excipient (optional), stir;
C) under stirring, water is slowly added to oil phase until finish, make emulsifiable paste, according to the dosage packing and get final product;
Step a) and step b) order can exchange.
In addition, also bioadhesion sustained-release preparation of the present invention is carried out to release property and dilatancy experiment:
A. the release of active component
Generally, medicine must can be brought into play necessary curative effect from preparation, discharging.By measuring the release conditions of medicine in external different time sections, with release conditions in the body of aids drug.
B. dilatancy experiment
When the Emulsion sample is placed in water, can keep a complete body; Along with the variation of time, its volume can obviously increase, and continues to expand to all directions.By the final volume of measuring samples initial sum, and calculate its ratio, can obtain this sample expansile evaluation index over a period to come: the coefficient of expansion, and then can obtain the quantitative criteria of this sample in the effective covering power of target position.
The present invention compared with prior art, following beneficial effect is arranged: the effect that the present invention reaches is that active component is delivered to lesions position effectively according to predetermined administering mode, and according to the speed release designed, preparation fully contacts with lesions position in expansion process, and the advantage of this improved drug delivery system comprises:
1. preparation of the present invention has good bioadhesive and slow release effect, can long term in part, release is slow, reduces the administration access times, reduces toxic and side effects; And administering mode is flexible, self-help is strong; Have certain viscosity, bioadhesive is good, can not produce water clock after medication, has long-term stability;
2. the dilatancy that has of preparation of the present invention can be filled up biological space automatically, with the lesions position surface, fully contact, during application, need only inject medicament in a small amount makes it be full of voluntarily the biological space that needs filling, with targeting moiety, more fully contact, its soft plasticity not only facilitates administration, and is easier to be accepted than solid preparation;
3. preparation of the present invention can be widely used in treating the exploitation of the novel product of dental disorder, personal healthcare.Related product can comprise single-activity composition or compound recipe (in containing, Western medicine), both can belong to pharmacy or medical instruments field, also can be used as hygienic article and uses;
4. prescription involved in the present invention and technique are simple, with low cost.
The accompanying drawing explanation
Fig. 1 is the sustained release performance experimental result schematic diagram of prepared emulsifiable paste in embodiment 1-4.
The specific embodiment
The present invention is further described for following example, but the present invention is not limited to following listed embodiment:
Embodiment 1-1
Preparation method:
A) oil phase is mixed homogeneously with surfactant;
B) each component of water is mixed with active component, continue to stir to guarantee that each composition is uniformly dispersed;
(200 ~ 600rpm) slowly add oil phase to the water that c) will prepare, and the limit edged stirs until finish, and then high-speed stirred (more than 1000rpm) 2min, obtain the cream preparation of the about 4PaS of viscosity, packing and get final product under stirring condition.
Embodiment 1-2
Preparation method is with embodiment 1-1, the about 68PaS of emulsifiable paste viscosity obtained.
Embodiment 1-3
Preparation method is with embodiment 1-1, the about 230PaS of emulsifiable paste viscosity obtained.
Embodiment 1-4
A) sustained release performance of prepared emulsifiable paste test:
Testing conditions: the 5g sample spreads upon in the surface plate that diameter is 6cm equably, the surface plate of coating is placed in 500ml water, adopt the slurry method of Chinese Pharmacopoeia standard digestion instrument, rotating speed 50rpm, 32 ℃ of water-baths, at different point in time sampling and measure the content (ultraviolet method) of pigment, the cumulative release effect is as shown in Figure 1, by Fig. 1, can be predicted significantly, can write out a prescription with rate of release and the level of regulating drug effectively by adjusting.
B) expansion performance experiment of prepared emulsifiable paste:
Method of testing: get about 1.0g sample and be placed in the graduated cylinder that 40ml water is housed under room temperature, the liquid volume of reading is sample volume V1, while measuring, original liquid is carefully poured out later at every turn, add again quantitative liquid, volume V2 after can obtaining sample after a period of time and expanding, sample, at the coefficient of expansion C=V2/V1 of this time period, the results are shown in Table 1:
The coefficient of expansion of sample in water of table 1 preparation
Embodiment 2
Preparation method is with embodiment 1-1, and the active component chlorhexidine acetate in this embodiment can be used as surfactant.
Expansion performance experiment: method is with embodiment 1-4, and the coefficient of expansion of three days (72h) is greater than 1.4.
The sustained release performance test: method is with embodiment 1-4, and active component discharges and is less than 40% in 72h.
Embodiment 3
Preparation method:
A) each component of oil phase (active component) is mixed with surfactant, and dispersed with stirring is even;
B) each component of water is mixed, continue to stir to guarantee that each composition is uniformly dispersed;
(200 ~ 600rpm) slowly add oil phase to the water that c) will prepare, and the limit edged stirs until finish, and then high-speed stirred (more than 1000rpm) 2min, obtain the cream preparation of the about 1700PaS of viscosity, packing and get final product under stirring condition.
Expansion performance experiment: method is with embodiment 1-4, and the coefficient of expansion of three days (72h) is greater than 1.5.
The sustained release performance test: method is with embodiment 1-4, and active component discharges and is less than 40% in 72h.
Embodiment 4
Preparation method:
A) oil phase is mixed with surfactant, and dispersed with stirring is even, after then adding Oleum Caryophylli, Borneolum Syntheticum, Fructus Piperis Longi extract isoreactivity composition, and fully is uniformly mixed;
B) each component of water is mixed with micronized metronidazole, chlorhexidine acetate, continue to stir to guarantee that each composition is uniformly dispersed;
(200 ~ 600rpm) slowly add oil phase to the water that c) will prepare, and the limit edged stirs until finish, and then high-speed stirred (more than 1000rpm) 2min, obtain the cream preparation of the about 810PaS of viscosity, packing and get final product under stirring condition.
Expansion performance experiment: method is with embodiment 1-4, and the coefficient of expansion of three days (72h) is greater than 1.7.
The sustained release performance test: method is with embodiment 1-4, and active component discharges and is less than 35% in 72h.
Claims (16)
1. an expansiveness bioadhesion sustained-release preparation of preventing and treating oral disease, is characterized in that, is comprised of water, surfactant, oil phase; The active component of preventing and treating oral disease is present in water and/or oil phase; Wherein, water is interior phase, and oil phase is the foreign minister, and the interface of oil phase and water is built and maintained by surfactant, makes the biphase state that is in homogeneous and contacts fully; Described oil phase is selected from: one or several mixture of mineral oil, olive oil, Oleum Ricini, Oleum sesami, soybean oil, almond oil, Oleum Gossypii semen, glyceryl monostearate, medium chain length fatty acid triglyceride, hexadecanol, silicone oil, IPIS, the poly-ring of stearic acid the third Ethylene Oxide-15 ether; Described surfactant is selected from one or several in polysiloxane alcohols copolymer, polyglyceryl fatty acid ester, cithrol/alcohol ester, polyoxyethylene aliphatic alcohol ether, polyoxyethylene ether wax, Myrj 45, tristerin, polyethers organosilicon wax, succinic acid sulphonic acid ester salt, oxirane and expoxy propane copolymer, Span; In described bioadhesion sustained-release preparation, the percentage by weight of oil phase is 1～40%; The percentage by weight of surfactant is 0.5～35%; The percentage by weight of water is 25～98.5%.
2. by bioadhesion sustained-release preparation claimed in claim 1, it is characterized in that, described bioadhesion sustained-release preparation is the system of a kind of semisolid or liquid.
3. by bioadhesion sustained-release preparation claimed in claim 1, it is characterized in that, described active component dissolves or is suspended in water and/or oil phase.
4. by bioadhesion sustained-release preparation claimed in claim 3, it is characterized in that, when described active component was suspended in water and/or oil phase, it was micronized, was present in water and/or oil phase to guarantee its stable uniform ground.
5. by bioadhesion sustained-release preparation claimed in claim 1, it is characterized in that, described active component is as surfactant or cosurfactant.
6. by bioadhesion sustained-release preparation claimed in claim 1, it is characterized in that, described active component is selected from antibacterial, antiinflammatory, hemorrhage, osteoporosis agent, tissue repair agent, nutrient, analgesic.
7. by bioadhesion sustained-release preparation claimed in claim 2, it is characterized in that, this system administering mode is local or non local administration.
8. by bioadhesion sustained-release preparation claimed in claim 7, it is characterized in that, described topical mode is oral administration.
9. by bioadhesion sustained-release preparation claimed in claim 8, it is characterized in that, described topical mode is for periodontal pocket, gingiva, root of the tooth tissue, dental caries hole, tooth body, oral cavity wall.
10. by bioadhesion sustained-release preparation claimed in claim 1, it is characterized in that, the viscosity of this bioadhesion sustained-release preparation is greater than 1PaS.
11. by bioadhesion sustained-release preparation claimed in claim 10, it is characterized in that, the viscosity of this bioadhesion sustained-release preparation is greater than 3PaS.
12. by bioadhesion sustained-release preparation claimed in claim 2, it is characterized in that, the release characteristic of the viscosity of described semisolid or liquid, stability, active component is adjusted effectively by adding excipient.
13. by the described bioadhesion sustained-release preparation of claim 12, it is characterized in that, the excipient used is selected from one or several of correctives, pH adjusting agent, stabilizing agent, solvent, osmotic pressure regulator, diluent, surfactant, thickening agent, delayed release agent, antiseptic and inhibiting bacteria function agent, chelating agen, adsorbent, softening agent, wetting agent, antioxidant, aromatic, coloring agent, lucifuge agent.
14. by the described bioadhesion sustained-release preparation of claim 13, it is characterized in that, described excipient is selected from: any one or a few in mannitol, sorbitol, propylene glycol, sucrose, Mel, glycerol, maltose alcohol, xylitol, xanthan gum, carrageenin, sodium carboxymethyl cellulose, polyvidone, hydroxypropyl emthylcellulose, boric acid, borate, carbomer, titanium dioxide, hydrophobic ultrafine silica powder, spermaceti, paraffin, vaseline, Cera Flava.
15. the preparation method by bioadhesion sustained-release preparation claimed in claim 1, is characterized in that, comprises the steps:
A) select oil phase and surfactant, if solid, melting or add solvent auxiliary it, and stir;
B) prepare water;
C) under stirring, water is slowly added to oil phase until finish, make emulsifiable paste, according to the dosage packing and get final product;
Step a) and/or step b) in add the active component of preventing and treating oral disease, stir;
Step a) and step b) order interchangeable.
16. by the preparation method of the described bioadhesion sustained-release preparation of claim 15, it is characterized in that, step a) and/or step b) in add excipient.
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| CN113546210A (en) * | 2021-07-23 | 2021-10-26 | 振德医疗用品股份有限公司 | Powder dressing for preventing dental caries in orthodontic process and preparation method thereof |
| CN113713113B (en) * | 2021-09-28 | 2023-09-19 | 四川护家卫士生物医药科技有限公司 | Composition for treating oral mucosa diseases and preparation method thereof |
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