CN101732237A - Baicalin thermosensitive gelatin and preparation method and use thereof - Google Patents
Baicalin thermosensitive gelatin and preparation method and use thereof Download PDFInfo
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- CN101732237A CN101732237A CN201010031339A CN201010031339A CN101732237A CN 101732237 A CN101732237 A CN 101732237A CN 201010031339 A CN201010031339 A CN 201010031339A CN 201010031339 A CN201010031339 A CN 201010031339A CN 101732237 A CN101732237 A CN 101732237A
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Abstract
The invention discloses a baicalin thermosensitive gelatin and a preparation method and use thereof. The baicalin thermosensitive gelatin is prepared by the following steps: (1) taking the following components in percentage by weight: 0.6 to 15 percent of baicalin, 10 to 24 percent of poloxamer 407, 1 to 10 percent of poloxamer 188, 55.8 to 81.17 percent of solvent, 0 to 5 percent of viscosity modifier, and 0 to 0.2 percent of preservative; and (2) dissolving the baicalin and the preservative into the solvent, slowly adding the poloxamer 407 and the poloxamer 188 with stirring, mixing uniformly, adding the viscosity modifier, mixing uniformly, and placing the mixture into freely flowable semitransparent solution to prepare the baicalin thermosensitive gelatin. The baicalin thermosensitive gelatin is flowable liquid at normal temperature, which generates reversible phase change if affected by the body temperature after contacting with a mucous membrane or body fluid. Therefore, the medicament is tightly attached to the mucosal tissue, which is hard to leak. After the phase change is generated in the body fluid, the release rate of the medicament can be controlled.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of baicalin thermosensitive gelatin and preparation method and purposes.
Background technology
Baicalin (Baicalin) has another name called baicalin, is flavone compound, is mainly derived from the labiate Radix Scutellariae.Molecular formula is C
21H
18O
11, carboxyl is arranged in the molecule, acidity is stronger, is insoluble in water, is insoluble in methanol, ethanol, acetone, dissolves in hot acetic acid, is slightly soluble in 50% ethanol.Baicalin has many-sided effect such as heat-clearing and toxic substances removing, anti-inflammation, function of gallbladder promoting protect the liver, antihypertensive diuretic, antiallergic action, chelated metal ions.The baicalin antibacterial range is wider, and in vitro tests proves that it has inhibitory action to Gram-positive and negative bacteria, is used for diseases such as respiratory tract infection, acute tonsillitis, acute pharyngitis, pneumonia and dysentery clinically.In recent years along with in the world to the persistently overheating of baicalin research and understanding progressively deeply, think baicalin remove free radical, alleviate tissue ischemical reperfusion injury, regulate immunity, promote apoptosis and aspects such as antitumor and HIV all to have potential development and application values.But baicalin is after intravenous administration, and it is very fast to distribute in the body, and the half-life is short, and blood drug level descends rapidly, and bioavailability is low; Oral baicalin absorbs slower, to gastrointestinal tract mucous zest is arranged, and liver first-pass effect is obvious.So the improvement dosage form is very necessary to avoid above many side effect.
Thermosensitive hydrogel is meant a class viscous liquid, with the solution state administration, after being exposed to body physiological state, takes place to change mutually at agents area immediately, becomes semisolid gel state.Have good coupling and hydration effect with mucosa, better biocompatibility is arranged, no greasy feeling.But long period and site of action tight adhesion, thus prolong drug helped medicine and fully absorbs in the holdup time of body medicine-feeding part, thus improve bioavailability of medicament.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art, and a kind of baicalin thermosensitive gelatin is provided.
Second purpose of the present invention provides a kind of preparation method of baicalin thermosensitive gelatin.
The 3rd purpose of the present invention provides a kind of purposes of baicalin thermosensitive gelatin.
Technical scheme of the present invention is summarized as follows:
A kind of baicalin thermosensitive gelatin, make with following method:
(1) takes by weighing by weight percentage: baicalin 0.6%～15%, poloxamer 407 10%～24%, poloxamer 1881%～10%, solvent 55.8～81.17%, viscosity modifier 0%～5%, antiseptic 0%～0.2%;
(2) described baicalin, antiseptic are dissolved in the described solvent, slowly add described poloxamer 407 and poloxamer 188 while stirring, mix homogeneously; Add described viscosity modifier again, be placed to free flowable translucent solution in 4 ℃ behind the mixing, promptly make baicalin thermosensitive gelatin.
Described solvent is any one mixed solvent or any one a mixed solvent of phosphate buffer or phosphate buffer and glycerol, propylene glycol, Liquid Macrogol～400 of water or water and glycerol, propylene glycol, Liquid Macrogol～400.
Described viscosity modifier is that polyvinylpyrrolidone, hydroxypropyl emthylcellulose, methylcellulose, sodium alginate and sodium carboxymethyl cellulose are at least a.
Described antiseptic is methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, sorbic acid or potassium sorbate.
A kind of preparation method of baicalin thermosensitive gelatin comprises the steps:
(1) takes by weighing by weight percentage: baicalin 0.6%～15%, poloxamer 407 10%～24%, poloxamer 1881%～10%, solvent 55.8～81.17%, viscosity modifier 0%～5%, antiseptic 0%～0.2%;
(2) described baicalin, antiseptic are dissolved in the described solvent, slowly add described poloxamer 407 and poloxamer 188 while stirring, mix homogeneously; Add described viscosity modifier again, be placed to free flowable translucent solution in 4 ℃ behind the mixing, promptly make baicalin thermosensitive gelatin.
Described solvent is any one mixed solvent or any one a mixed solvent of phosphate buffer or phosphate buffer and glycerol, propylene glycol, Liquid Macrogol～400 of water or water and glycerol, propylene glycol, Liquid Macrogol～400.
Described viscosity modifier is that polyvinylpyrrolidone, hydroxypropyl emthylcellulose, methylcellulose, sodium alginate and sodium carboxymethyl cellulose are at least a.
Described antiseptic is methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, sorbic acid or potassium sorbate.
A kind of baicalin thermosensitive gelatin is used the purposes of gel with gel or skin at preparation oral gel, injection gel, vaginal gel, rectum.
The present invention has improved the temperature-sensitive of thermosensitive hydrogel preparation, and resulting thermosensitive hydrogel preparation to responsive to temperature liquid and the reversible co-conversionization of gel can take place under preference temperature.Thermosensitive hydrogel preparation of the present invention liquid in a flowable at normal temperatures and is subjected to body temperature (32～37 ℃) influence after mucosa or body fluid contact the reversibility phase transformation takes place, and medicine and mucosal tissue are fitted tightly, and is difficult for leakage.After in body fluid, taking place to change mutually, adjustable drug releasing rate.
After the present invention added baicalin phosphate buffer or contains the mixed solvent of phosphate buffer, the dissolubility that makes baicalin changed from original 0.3% situation, and the dissolubility of baicalin is increased to more than 7%, have until reaching 15%.
Poloxamer 407 that the present invention is selected and poloxamer 188.It is little that the two has toxicity, and skin irritation is little, and baicalin is had solubilization.
The thermosensitive hydrogel Drug Manufacturing Room relaxing the bowels with purgatives of warm nature of the present invention's preparation is better mobile, uniform and smooth, steady quality.Exquisiteness is soft and smooth when reaching gelation temperature, is easy to be coated with exhibition, and viscosity is suitable.
Description of drawings
Fig. 1 is baicalin thermosensitive gelatin and baicalin crude drug release in vitro curve.
Fig. 2 is the blood drug level-time graph of baicalin thermosensitive gelatin and baicalin ordinary suppository.
The specific embodiment
The present invention is described further below in conjunction with specific embodiment.
Embodiment 1-embodiment 9 each component different proportion are to the influence of gelation temperature
Baicalin, antiseptic are dissolved in the solvent, add poloxamer 407 and poloxamer 188 while stirring, mix homogeneously; Add viscosity modifier again, be placed to free flowable translucent solution in 4 ℃ behind the mixing, promptly make baicalin thermosensitive gelatin.
The gelation temperature assay method: adopt the stirrer method, that gets same amount is stored in variable concentrations medicine-containing gel liquid in the refrigerator in beaker, and thermometer is inserted in the gel solution.Beaker is placed on the heatable magnetic stirring apparatus, slowly heat up, heating rate is 1 ℃/min, and the temperature that magnetic stir bar stops operating fully is Tgel, parallel assay 3 times.The result shows: along with the increase of poloxamer P407 concentration, gelation temperature reduces; Along with the increase of poloxamer P188 concentration, gelation temperature raises.Test result is as shown in table 1.
The gelation temperature of table 1 different proportion gel-type vehicle baicalin thermosensitive gelatin
Embodiment 10-embodiment 18
The preparation method and the gelation temperature assay method of the baicalin thermosensitive in situ gel of different content of dispersion are the same.The results are shown in Table 2.
The gelation temperature of table 2 different proportion gel-type vehicle baicalin thermosensitive gelatin
Embodiment 19-embodiment 30
The preparation method and the gelation temperature assay method of baicalin thermosensitive in situ gel that contains viscosity modifier is the same.The results are shown in Table 3.Viscosity modifier can change gelation temperature.
The gelation temperature of table 3 different proportion gel-type vehicle baicalin thermosensitive gelatin
Embodiment 31-embodiment 35
The preparation method of baicalin thermosensitive in situ gel is the same.The comparative approach of baicalin thermosensitive gelatin and crude drug in-vitro release rate: adopt 2005 editions oar methods of the Pharmacopoeia of the People's Republic of China to measure, rotating speed is 100r/min, and temperature is (37 ± 0.5) ℃, is dissolution medium with the 500ml distilled water.Take by weighing 10mg baicalin raw material medicated powder and baicalin thermosensitive gelatin 0.5ml (being equivalent to baicalin 10mg) and put in the bag filter for each three parts, seal with plastic clip.5,10,15,20,30,60,120,240,360, the 420min 5ml that takes a sample respectively uses 0.45 μ m filtering with microporous membrane immediately, and it is to be measured to get subsequent filtrate 4ml, replenishes the fresh medium 5ml that uniform temp is preserved down simultaneously.Under the 275nm wavelength, measure content of baicalin.Calculate the cumulative release amount of baicalin.The result shows that the rate of releasing drug that thermosensitive hydrogel can obviously improve baicalin the results are shown in Table 4.(the cumulative release percentage rate has only 42.3% during the 100min of baicalin crude drug).
The release in vitro of table 4 baicalin thermosensitive gelatin
Water in table 3, the table 4 (pH8.0) is to be 8.0 with sodium hydroxide (NaOH) with the pH regulator of water.
Baicalin thermosensitive gelatin and baicalin crude drug release in vitro are relatively seen Fig. 1.
Embodiment 36
A kind of baicalin thermosensitive gelatin prepares oral gel according to a conventional method.
Embodiment 37
A kind of baicalin thermosensitive gelatin prepares the injection gel according to a conventional method.
Embodiment 38
A kind of baicalin thermosensitive gelatin prepares vaginal gel according to a conventional method.
Embodiment 39
A kind of baicalin thermosensitive gelatin prepares the skin gel according to a conventional method.
A kind of baicalin thermosensitive gelatin prepares the rectum gel according to a conventional method.
Embodiment 41
The baicalin thermosensitive rectum with pharmacokinetics in the rabbit body of gel and ordinary suppository relatively
Method: the dosage that gives rabbit 25mg/kg according to baicalin prepares water-soluble base suppository, and is standby.Prepare baicalin thermosensitive gelatin by method of the present invention.6 of healthy rabbits, water 24h is can't help in fasting, and three rabbit per rectums of random choose give ordinary suppository, and remaining three per rectums give thermosensitive hydrogel.Respectively at 5,10,15,30,45,60,90,120,180,300, the 480min auricular vein is got blood 0.8～1ml.The capable HPLC of sample measures content of baicalin in the serum.The result shows that thermosensitive hydrogel reaches peak concentration and is higher than ordinary suppository, and the persistent period of blood drug level more than 3 μ g/ml approximately is 2 times of ordinary suppository.As shown in Figure 2.
Claims (9)
1. baicalin thermosensitive gelatin is characterized in that making with following method:
(1) takes by weighing by weight percentage: baicalin 0.6%～15%, poloxamer 40710%～24%, poloxamer 1881%～10%, solvent 55.8～81.17%, viscosity modifier 0%～5%, antiseptic 0%～0.2%;
(2) described baicalin, antiseptic are dissolved in the described solvent, slowly add described poloxamer 407 and poloxamer 188 while stirring, mix homogeneously; Add described viscosity modifier again, be placed to free flowable translucent solution in 4 ℃ behind the mixing, promptly make baicalin thermosensitive gelatin.
2. a kind of baicalin thermosensitive gelatin according to claim 1 is characterized in that described solvent is any one mixed solvent or any one a mixed solvent of phosphate buffer or phosphate buffer and glycerol, propylene glycol, Liquid Macrogol～400 of water or water and glycerol, propylene glycol, Liquid Macrogol～400.
3. a kind of baicalin thermosensitive gelatin according to claim 1 is characterized in that described viscosity modifier is that polyvinylpyrrolidone, hydroxypropyl emthylcellulose, methylcellulose, sodium alginate and sodium carboxymethyl cellulose are at least a.
4. a kind of baicalin thermosensitive gelatin according to claim 1 is characterized in that described antiseptic is methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, sorbic acid or potassium sorbate.
5. the preparation method of a baicalin thermosensitive gelatin is characterized in that comprising the steps:
(1) takes by weighing by weight percentage: baicalin 0.6%～15%, poloxamer 40710%～24%, poloxamer 1881%～10%, solvent 55.8～81.17%, viscosity modifier 0%～5%, antiseptic 0%～0.2%;
(2) described baicalin, antiseptic are dissolved in the described solvent, slowly add described poloxamer 407 and poloxamer 188 while stirring, mix homogeneously; Add described viscosity modifier again, be placed to free flowable translucent solution in 4 ℃ behind the mixing, promptly make baicalin thermosensitive gelatin.
6. the preparation method of a kind of baicalin thermosensitive gelatin according to claim 5 is characterized in that described solvent is any one mixed solvent or any one a mixed solvent of phosphate buffer or phosphate buffer and glycerol, propylene glycol, Liquid Macrogol～400 of water or water and glycerol, propylene glycol, Liquid Macrogol～400.
7. the preparation method of a kind of baicalin thermosensitive gelatin according to claim 5 is characterized in that described viscosity modifier is that polyvinylpyrrolidone, hydroxypropyl emthylcellulose, methylcellulose, sodium alginate and sodium carboxymethyl cellulose are at least a.
8. the preparation method of a kind of baicalin thermosensitive gelatin according to claim 5 is characterized in that described antiseptic is methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, sorbic acid or potassium sorbate.
9. a kind of baicalin thermosensitive gelatin of one of claim 1-4 is used the purposes of gel with gel or skin at preparation oral gel, injection gel, vaginal gel, rectum.
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Cited By (18)
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|---|---|---|---|---|
| CN102335449A (en) * | 2011-10-11 | 2012-02-01 | 天津工业大学 | Nanometer composite gel dressing containing baicalin and soapstone and preparation method for nanometer composite gel dressing |
| CN102648894A (en) * | 2011-02-25 | 2012-08-29 | 天津中医药大学 | Eye-purposed in-vivo gel preparation prepared from pH (Potential Of Hydrogen) sensitive type baicalin |
| CN103520091A (en) * | 2013-10-15 | 2014-01-22 | 山东赛克赛斯药业科技有限公司 | Acidic buffer temperature-sensitive gel preparation for vagina as well as preparation method and application thereof |
| CN104138350A (en) * | 2013-05-06 | 2014-11-12 | 上海中医药大学 | Baicalein temperature-sensitive gel, preparing method thereof and applications of the gel |
| CN104888224A (en) * | 2015-03-25 | 2015-09-09 | 中山大学 | Amphipathic polysaccharide derivative/poloxamer thermo-sensitive type in-situ hydrogel and preparation method thereof |
| CN106031756A (en) * | 2015-03-12 | 2016-10-19 | 山东汉方制药有限公司 | Compound amur cork-tree temperature-sensitive gel for treating sore and ulcer and traumatic infection and preparing method thereof |
| CN106176580A (en) * | 2016-08-15 | 2016-12-07 | 成都医学院 | A kind of heat-sensitive gel containing matrine alkaloid and preparation method thereof |
| CN106994117A (en) * | 2016-01-25 | 2017-08-01 | 上海市肿瘤研究所 | A kind of medicament nano compound temperature-sensitive gel for treating biliary tract neoplasms |
| CN107349178A (en) * | 2017-07-27 | 2017-11-17 | 滨州医学院附属医院 | A kind of thermo-sensitive gel for treating radiation dermatitis and preparation method thereof |
| CN107375193A (en) * | 2017-06-23 | 2017-11-24 | 江西医学高等专科学校 | A kind of Chinese medicine compound prescription rectally thermo-sensitive gel agent and preparation method thereof |
| CN109316634A (en) * | 2018-10-23 | 2019-02-12 | 江苏耐雀生物工程技术有限公司 | A kind of natural bacteriostatic midwifery gel and preparation method thereof |
| CN110538140A (en) * | 2019-10-17 | 2019-12-06 | 中国人民解放军军事科学院军事医学研究院 | Nasal temperature-sensitive type puerarin in-situ gel, preparation method and application |
| CN112754989A (en) * | 2019-11-01 | 2021-05-07 | 四川大学 | Novel bidirectional temperature-sensitive in-situ gel composition |
| CN113082064A (en) * | 2021-04-23 | 2021-07-09 | 青岛科技大学 | Folium Platycladi gel absorbent for treating alopecia areata, preparation method thereof and external patch for treating alopecia areata |
| CN113144033A (en) * | 2021-04-07 | 2021-07-23 | 宫念樵 | Antibacterial temperature-sensitive gel and preparation method and application thereof |
| CN113521089A (en) * | 2021-07-21 | 2021-10-22 | 河南中医药大学 | Baicalin hydrogel and preparation method thereof |
| CN113750039A (en) * | 2021-10-26 | 2021-12-07 | 浙江中医药大学 | Baicalin-calcium alginate temperature-sensitive nanogel, preparation method and application thereof |
| CN114948795A (en) * | 2022-07-08 | 2022-08-30 | 上海信悉智能技术有限公司 | Temperature-sensitive gel mask liquid and preparation method thereof |
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2010
- 2010-01-12 CN CN201010031339A patent/CN101732237A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102648894A (en) * | 2011-02-25 | 2012-08-29 | 天津中医药大学 | Eye-purposed in-vivo gel preparation prepared from pH (Potential Of Hydrogen) sensitive type baicalin |
| CN102335449A (en) * | 2011-10-11 | 2012-02-01 | 天津工业大学 | Nanometer composite gel dressing containing baicalin and soapstone and preparation method for nanometer composite gel dressing |
| CN104138350A (en) * | 2013-05-06 | 2014-11-12 | 上海中医药大学 | Baicalein temperature-sensitive gel, preparing method thereof and applications of the gel |
| CN103520091A (en) * | 2013-10-15 | 2014-01-22 | 山东赛克赛斯药业科技有限公司 | Acidic buffer temperature-sensitive gel preparation for vagina as well as preparation method and application thereof |
| CN106031756A (en) * | 2015-03-12 | 2016-10-19 | 山东汉方制药有限公司 | Compound amur cork-tree temperature-sensitive gel for treating sore and ulcer and traumatic infection and preparing method thereof |
| CN104888224B (en) * | 2015-03-25 | 2019-02-01 | 中山大学 | A kind of amphiphilic polysaccharide derivative/poloxamer temperature sensitive type in-situ hydrogel and preparation method thereof |
| CN104888224A (en) * | 2015-03-25 | 2015-09-09 | 中山大学 | Amphipathic polysaccharide derivative/poloxamer thermo-sensitive type in-situ hydrogel and preparation method thereof |
| CN106994117B (en) * | 2016-01-25 | 2020-05-05 | 上海市肿瘤研究所 | A nanometer composite temperature-sensitive gel for treating biliary tumor |
| CN106994117A (en) * | 2016-01-25 | 2017-08-01 | 上海市肿瘤研究所 | A kind of medicament nano compound temperature-sensitive gel for treating biliary tract neoplasms |
| CN106176580B (en) * | 2016-08-15 | 2019-04-23 | 成都医学院 | A kind of heat-sensitive gel and preparation method thereof containing matrine alkaloid |
| CN106176580A (en) * | 2016-08-15 | 2016-12-07 | 成都医学院 | A kind of heat-sensitive gel containing matrine alkaloid and preparation method thereof |
| CN107375193A (en) * | 2017-06-23 | 2017-11-24 | 江西医学高等专科学校 | A kind of Chinese medicine compound prescription rectally thermo-sensitive gel agent and preparation method thereof |
| CN107349178A (en) * | 2017-07-27 | 2017-11-17 | 滨州医学院附属医院 | A kind of thermo-sensitive gel for treating radiation dermatitis and preparation method thereof |
| CN109316634A (en) * | 2018-10-23 | 2019-02-12 | 江苏耐雀生物工程技术有限公司 | A kind of natural bacteriostatic midwifery gel and preparation method thereof |
| CN110538140A (en) * | 2019-10-17 | 2019-12-06 | 中国人民解放军军事科学院军事医学研究院 | Nasal temperature-sensitive type puerarin in-situ gel, preparation method and application |
| CN112754989A (en) * | 2019-11-01 | 2021-05-07 | 四川大学 | Novel bidirectional temperature-sensitive in-situ gel composition |
| CN113144033A (en) * | 2021-04-07 | 2021-07-23 | 宫念樵 | Antibacterial temperature-sensitive gel and preparation method and application thereof |
| CN113082064A (en) * | 2021-04-23 | 2021-07-09 | 青岛科技大学 | Folium Platycladi gel absorbent for treating alopecia areata, preparation method thereof and external patch for treating alopecia areata |
| CN113082064B (en) * | 2021-04-23 | 2022-04-29 | 青岛科技大学 | Folium Platycladi gel absorbent for treating alopecia areata, preparation method thereof and external patch for treating alopecia areata |
| CN113521089A (en) * | 2021-07-21 | 2021-10-22 | 河南中医药大学 | Baicalin hydrogel and preparation method thereof |
| CN113750039A (en) * | 2021-10-26 | 2021-12-07 | 浙江中医药大学 | Baicalin-calcium alginate temperature-sensitive nanogel, preparation method and application thereof |
| CN113750039B (en) * | 2021-10-26 | 2023-08-18 | 浙江中医药大学 | Baicalin-calcium alginate temperature-sensitive nanogel, preparation method and application thereof |
| CN114948795A (en) * | 2022-07-08 | 2022-08-30 | 上海信悉智能技术有限公司 | Temperature-sensitive gel mask liquid and preparation method thereof |
| CN114948795B (en) * | 2022-07-08 | 2023-09-08 | 上海信悉智能技术有限公司 | Temperature-sensitive gel mask liquid and preparation method thereof |
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