CN103908535A - Enteric capsule containing andrographolide - Google Patents
Enteric capsule containing andrographolide Download PDFInfo
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- CN103908535A CN103908535A CN201410100621.7A CN201410100621A CN103908535A CN 103908535 A CN103908535 A CN 103908535A CN 201410100621 A CN201410100621 A CN 201410100621A CN 103908535 A CN103908535 A CN 103908535A
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- acrylic resin
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Abstract
The invention relates to a traditional Chinese medicine colon location preparation, which comprises an effective region group extracted from herba andrographitis and cattail pollen, and acrylic resin L, acrylic resin S and polyvinyl alcohol 4000 taken as auxiliary materials. The provided auxiliary materials employed by the colon location preparation of the effective region of herba andrographitis and cattail pollen enable disintegration and medicine release only under colon pH environment, and the purposes of colon location and medicine release can be reached.
Description
Technical field
The present invention relates to a kind of enteric coated capsule that contains andrographolide and preparation method thereof, relate to especially ー kind colon location preparation and preparation method thereof.
Background technology
Colitis comprises two independently diseases: ulcerative colitis (Ulcerative colitis, UC) and Crohn disease (Crohns disease).Wherein, UC is the non-specific chronic inflammatory disease of intestinal, and pathological changes is mainly confined to the mucosa of colon, taking ulcer and erosion as main, involves lower distal colon more, but can spread to near-end, and spread all over whole colon.Clinical manifestation is diarrhoea, stomachache, mucosanguineous feces and tenesmus etc., and part shows outward with intestinal, and side does repeatedly, is chronic process.After this disease First-episode, approximately 10% patient can be eased, and can maintain 15 years.Separately there is 10% patient can continue for a long time to suffer from mobile colon inflammation.Other Most patients are alleviated with outbreak and are replaced, and do not heal for a long time.Ill more than 10 years person, the dangerous type of concurrent colon cancer increases, and patient is subject to the torment of spirit and body.
At present, also mainly rely on medicine for the treatment of this disease.The Western medicine often having comprises aminosalicylic acids, corticosteroid hormone class, immunosuppressant, anti-infective etc.Although aminosalicylic acids medicine is the choice drug for the treatment of ulcerative colitis, after but it is oral,, under the effect of intestinal bacteria azo reductase, the sulfadiazine of pyrolysis product can cause allergic reaction, gastrointestinal reaction and the untoward reaction such as hepatic and renal function injure and sperm power abnormality.Corticosteroid hormone class Western medicine is the choice drug of severe refractory ulcerative colitis in treating clinically, but long-term, high-dose uses this medicine can cause untoward reaction such as osteoporosis, hypertension, diabetes.The onset of immune formulation class is slow, and the most serious untoward reaction meeting causes tumor.Anti-infective is mainly for the patient who has accompanying infection, but consumption is large, the used time is more of a specified duration, and gastrointestinal reaction easily occurs.
Due to the easy compound recipe of primary disease, need long-term prescription, therefore the untoward reaction of Western medicine affects patient's compliance.The advantages such as Chinese medicine uses tcm treatment according to syndrome differentiation principle and the flexible compatibility feature of Chinese medicine, has good effect aspect treatment ulcerative colitis, and side effect is little.In clinical treatment, doctor and needs of patients are effectively treated the Chinese medicine preparation of ulcerative colitis and irritable bowel syndrome.
Summary of the invention
The enteric coated capsule that the present invention is made up of Herba Andrographis, Pollen Typhae, has blood circulation promoting and blood stasis dispelling, the effect of bowel relieving antidiarrheal, and fixed point discharges, the feature that local drug concentration is higher.It is suffered from diarrhoea (chronic bacillary dysentery, chronic colitis, ulcerative colitis) for chronic colitis, shows through clinical trial and late result tracking, and said preparation is evident in efficacy, and relapse rate is low, has no adverse reaction.
The enema treatment of the more clinical use of the present invention, lessly makes troubles to patient, and patient dependence is improved, and required expense also reduces.In addition, common oral formulations is after first pass effect, and the valid density of medicine declines, and colon spots localization discharges, and can effectively bring into play drug effect, reaches better therapeutic purposes.
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, and a kind of colon location preparation of the effective part group with Pollen Typhae and Herba Andrographis composition is provided.
This invention Ling ー object is to provide the preparation method of such colon location preparation.
Object of the present invention can realize by the following technical solutions:
An enteric coated capsule that contains andrographolide, containing the compound effective site group extracting from Herba Andrographis, Pollen Typhae and the pharmaceutic adjuvant of effective dose.
The preparation method of wherein said compound effective site group is: Herba Andrographis and Pollen Typhae mix, and add alcohol reflux, filters concentrated, the dry compound effective site group that is of filtrate.
Wherein compound effective site group is granulated or is made micropill, coating, and filled capsules is made.
Described coating solution is the mixed liquor of acrylic resin L, acrylic resin S, polyvinyl alcohol 4000 and alcoholic solution composition, the weight ratio of acrylic resin L and acrylic resin S is 1:1 1:7, and the total amount of polyvinyl alcohol 4000 accounts for 10 30% of acrylic resin L and acrylic resin S gross weight.
The preparation method of the enteric coated capsule of andrographolide of the present invention, preparation comprises the steps:
1) Herba Andrographis and Pollen Typhae mix, and add alcohol reflux, filter concentrated, the dry compound effective site group that is of filtrate; 2) compound effective site group and starch mix, and with wetting agent soft material processed, granulate, and dry, for subsequent use; Or it is for subsequent use to be crushed to micropill;
3) separately get acrylic resin L, acrylic resin S, polyvinyl alcohol 4000 is dissolved in ethanol, makes coating solution.
4) by step 2) granule or the coating of pellets made, filled capsules.
Described coating solution method for making is: get acrylic resin L, acrylic resin S, polyvinyl alcohol 4000 is dissolved in ethanol, wherein the weight ratio of acrylic resin L and acrylic resin S is 1:1 1:7,10 30% polyvinyl alcohol 4000 of acrylic resin L and acrylic resin S gross weight is as plasticizer, and the weight ratio of acrylic resin and alcoholic solution is 1:10 1:20;
The preparation method of Chinese medicine colon site-specific drug of the present invention agent, is characterized in that, prepares capsule and comprises the steps: 1) Herba Andrographis, Pollen Typhae and mixing, add alcohol reflux, filter concentrated, the dry compound effective site group that is of filtrate; 2) compound effective site group making is mixed to soft material processed, granulation, dry, granulate, product in the middle made from starch; 3) pack middle product into conventional capsule, outer spray one deck is by olefin(e) acid resin L, acrylic resin S, polyvinyl alcohol 4000 is dissolved in the coating membrane making in ethanol, obtain the colon site-specific drug of compound effective site group, wherein the weight ratio of acrylic resin L and acrylic resin S is 1:1 1:7, accounts for 20% polyvinyl alcohol 4000 of acrylic resin L and acrylic resin S gross weight as plasticizer, and the weight ratio of acrylic resin and alcoholic solution is 1:10 1: 20.
Compared with prior art, Herba Andrographis provided by the invention, Pollen Typhae effective site colon location preparation, all adopt elite adjuvant, according to the difference of the each position of human stomach, small intestinal and colon pH value, make only disintegrate under colon pH environment of medicine, discharge medicine, reach the object of conlon targeting release medicine.Its accurate positioning, evident in efficacy, to light, in, severe refractory ulcerative colitis is all effective in cure.
Obviously,, according to foregoing of the present invention, those skilled in the art, not departing under the above-mentioned basic fundamental thought of the present invention prerequisite, can also make other forms of amendment, replacement or change.
Detailed description of the invention by the following examples, remakes into the detailed description of ー step foregoing of the present invention, and Dan Buying is interpreted as that by this scope of the above-mentioned theme of the present invention only limits to following example.All technology realizing based on foregoing of the present invention all belong to scope of the present invention.Detailed description of the invention
The invention provides a kind of enteric coated capsule that contains andrographolide, the preparation method of this Chinese medicine colon location preparation is provided simultaneously, form is by the following examples further described foregoing of the present invention.
Embodiment 1
Prepare Herba Andrographis, Pollen Typhae effective part group
By Herba Andrographis, Pollen Typhae, with 2000g water soaking 40min, decoct lh, pour out decoction liquor.Rejoin 2000g water, then decoct lh.Merge twice decoction liquor and concentrate, until concentrated decoction liquor is 800g.By cooling concentrated decoction liquor placement, then add while stirring 75% ethanol with concentrated decoction liquor same volume; Mixed liquor, 2 ° of C cold preservations 24 hours, is filtered, and filtrate decompression concentrates to obtain extractum 300g, is compound effective component.
Embodiment 2
The conlon targeting tablet of preparing compound effective site group of the present invention, this prescription is:
Compound effective site group 300 weight portions
Starch 75 weight portions
Magnesium stearate 7. 5 weight portions
Acrylic resin L 37. 5 weight portions
Acrylic resin S 37. 5 weight portions
Polyvinyl alcohol 4,000 7. 5 weight portions
95% ethanol 750 weight portions
The compound effective site group 300g making and starch 75g are mixed, with 95% ethanol be wetting agent soft material processed, mistake 16 mesh sieves granulations, dry, granulate, is crushed to micropill, for subsequent use.Separately get acrylic resin L 37. 5g, acrylic resin S 37. 5g, polyvinyl alcohol 40007. 5g are dissolved in 95% ethanol 750g, make coating solution.Then the above-mentioned micropill of preparing is carried out to coating, filled capsules, makes the colon site-specific drug of 1000 compound effective site groups.
Embodiment 3
The conlon targeting tablet of preparing compound effective site group of the present invention, this prescription is:
Compound effective site group 1000 weight portions
Starch 100 weight portions
Magnesium stearate 10 weight portions
Acrylic resin L 10 weight portions
Acrylic resin S 70 weight portions
Polyvinyl alcohol 4,000 24 weight portions
95% ethanol 800 weight portions
The compound effective site group 1000g making and starch 100g are mixed, with 95% ethanol be wetting agent soft material processed, mistake 16 mesh sieves granulations, dry, granulate, for subsequent use, separately get acrylic resin L 10g, acrylic resin S 70g, polyvinyl alcohol 4000 24g are dissolved in 95% ethanol 800g, make coating solution.Then by the granule coating of above-mentioned preparation, make appropriate weightening finish, make coated granule dry, 2500 of filled capsules.Obtain the colon site-specific drug of compound effective site group.
Embodiment 4
Prepare the colon site-specific drug of compound effective site group of the present invention, this prescription is:
Compound effective site group 500 weight portions
Starch 75 weight portions
Acrylic resin L 17 weight portions
Acrylic resin S 58 weight portions
Polyvinyl alcohol 4,000 11 weight portions
95% ethanol 1125 weight portions
The compound effective site group 500g making is mixed with starch 75g, soft material processed, be crushed to micropill, Wai Pen ー layer coating membrane, filled capsules, obtains the colon site-specific drug of compound effective site group of the present invention; Wherein coating solution formula is acrylic resin L 17g, acrylic resin S 58g, and polyvinyl alcohol 4000 Ilg are dissolved in 95% ethanol 1125g, make coating solution.
Embodiment 5
Prepare the colon site-specific drug of compound effective site group of the present invention, this prescription is:
Compound effective site group 800 weight portions
Starch 80 weight portions
Acrylic resin L 20 weight portions
Acrylic resin S 60 weight portions
Polyvinyl alcohol 4,000 16 weight portions
95% ethanol 1500 weight portions
The compound effective site group 800g making is mixed with starch 80g, soft material processed, granulate, be crushed to micropill, Wai Pen ー layer coating membrane, dry filled capsules, obtains the colon site-specific drug of compound effective site group of the present invention; Wherein coating solution formula is acrylic resin L 20g, acrylic resin S 60g, and polyvinyl alcohol 4000 16g are dissolved in 95% ethanol 1500g, make coating solution.
Embodiment 7
Adopt Chinese Pharmacopoeia version annex in 2005 to carry out Shi Fang Du Measuring and determine,
The results are shown in Table 1.
The release (embodiment 2,3) of the compound enteric-coated capsule of table 1
Experimental condition is as follows:
Dissolution medium: hydrochloric acid solution;
PH6. 8 phosphate buffers; PH 7.8 phosphate buffers
Medium volume: 900ml; Temperature: 37 ± 0. 5 ° of C
100 revs/min of rotating speeds.
Make colon-positioning enteric tablet or capsule with embodiment.All, first taking dilute hydrochloric acid as dissolution medium, within 2 hours, planted agent is intact, not disintegrate; Then be transferred in PH6. 8 phosphate buffers, within four hours, planted agent is intact, not disintegrate; Then be transferred in PH7. 8 phosphate buffers, within 60 minutes, measure dissolution and be greater than 90%.
Experimental example:
Medicine: prepare by the embodiment of the present invention 3.
MethodsThe cases enrolled: 35 examples, age 35-62 year; Man's 25 examples, female's 10 examples.Clinical manifestation: have the diarrhoea, mucopurulent bloody stool companion stomachache, tenesmus and the General Symptoms in various degree that continue or repeatedly show effect.The course of disease is many at 4 – more than 6 weeks.5 times/day of diarrhoea <, have blood in stool light or nothing, accelerate or anemia without heating, pulse, and erythrocyte sedimentation rate is normal.
Colonoscopy: pathological changes is many from rectum, is seriality, diffusivity distribution, shows as:
(1) fuzzy, disorderly or disappearance, hyperemia, edema of mucosa vascular lake, easily crisp, hemorrhage and purulent secretion adheres to, also common mucosa is coarse, is fine particulate;
(2) pathological changes is obviously located visible diffusivity, multiple erosion or ulcer;
(3) the visible colon bag of chronic disease person shoal, rust or disappearance, pseudopolyp and bridge shape mucosa etc.
Medication: (preparing by the embodiment of the present invention 3): can select sulfasalazine (SASP) preparation, every day 2 times, each 2-3 grain, oral; The 1-2 week course for the treatment of.Part no longer gives relevant drug suppository and receives anus or enema treatment.
Curative effect: diarrhoea number of times reduces by 32 examples; 3 times/day of 18 example of diarrhoea <, 2 times/day of 11 example of diarrhoea <, mucopurulent bloody stool companion stomachache, tenesmus and General Symptoms in various degree alleviate 34 examples.In low-residue diet situation, just time nothing obviously increases by 18 examples.
Safety: healthy volunteer, take medicine continuously 3 weeks, hepatic and renal function, electrolyte, coagulation function, erythrocyte sedimentation rate, c reactive protein; Non Apparent Abnormality.
Claims (7)
1. contain an enteric coated capsule for andrographolide, it is characterized in that by the compound effective site group extracting from Herba Andrographis, Pollen Typhae and pharmaceutic adjuvant containing effective dose.
2. a kind of enteric coated capsule that contains andrographolide according to claim 1, the preparation method of wherein said compound effective site group is: Herba Andrographis and Pollen Typhae mix, and add alcohol reflux, filters concentrated, the dry compound effective site group that is of filtrate.
3. a kind of enteric coated capsule that contains andrographolide according to claim 1, wherein compound effective site group is granulated or is made micropill, coating, filled capsules is made.
4. a kind of enteric coated capsule that contains andrographolide according to claim 1, described coating solution is the mixed liquor of acrylic resin L, acrylic resin S, polyvinyl alcohol 4000 and alcoholic solution composition, the weight ratio of acrylic resin L and acrylic resin S is 1:1 1:7, and the total amount of polyvinyl alcohol 4000 accounts for 10 30% of acrylic resin L and acrylic resin S gross weight.
5. a preparation method that contains the enteric coated capsule of andrographolide, is characterized in that, preparation comprises the steps:
1) Herba Andrographis and Pollen Typhae mix, and add alcohol reflux, filter concentrated, the dry compound effective site group that is of filtrate; 2) compound effective site group and starch mix, and with wetting agent soft material processed, granulate, and dry, for subsequent use; Or it is for subsequent use to be crushed to micropill;
3) separately get acrylic resin L, acrylic resin S, polyvinyl alcohol 4000 is dissolved in ethanol, makes coating solution;
4) by step 2) granule or the coating of pellets made, filled capsules.
6. a kind of enteric coated capsule that contains andrographolide according to claim 5, described coating solution method for making is: get acrylic resin L, acrylic resin S, polyvinyl alcohol 4000 is dissolved in ethanol, wherein the weight ratio of acrylic resin L and acrylic resin S is 1:1 1:7,10 30% polyvinyl alcohol 4000 of acrylic resin L and acrylic resin S gross weight is as plasticizer, and the weight ratio of acrylic resin and alcoholic solution is 1:10 1:20.
7. a preparation method that contains the enteric coated capsule of andrographolide, is characterized in that, prepares capsule and comprises the steps: 1) Herba Andrographis, Pollen Typhae and mixing, add alcohol reflux, filter concentrated, the dry compound effective site group that is of filtrate; 2) compound effective site group making is mixed to soft material processed, granulation, dry, granulate, product in the middle made from starch; 3) pack middle product into conventional capsule, outer spray one deck is by olefin(e) acid resin L, acrylic resin S, polyvinyl alcohol 4000 is dissolved in the coating membrane making in ethanol, obtain the colon site-specific drug of compound effective site group, wherein the weight ratio of acrylic resin L and acrylic resin S is 1:1 1:7, accounts for 20% polyvinyl alcohol 4000 of acrylic resin L and acrylic resin S gross weight as plasticizer, and the weight ratio of acrylic resin and alcoholic solution is 1:10 1:20.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410100621.7A CN103908535A (en) | 2014-03-19 | 2014-03-19 | Enteric capsule containing andrographolide |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410100621.7A CN103908535A (en) | 2014-03-19 | 2014-03-19 | Enteric capsule containing andrographolide |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168171A (en) * | 2015-10-23 | 2015-12-23 | 成都乾坤动物药业有限公司 | Andrographolide enteric-coated tablet as well as preparation method and application thereof |
| CN105451734A (en) * | 2013-08-06 | 2016-03-30 | 天士力制药集团股份有限公司 | Application of andrographolide in the preparation of a pharmaceutical for treatment of inflammatory bowel disease, andrographolide enteric targeting micropellet, and method for preparation thereof |
| CN106176619A (en) * | 2014-08-06 | 2016-12-07 | 天士力制药集团股份有限公司 | A kind of andrographolide enteric coated micropill location preparation |
| CN111297825A (en) * | 2020-03-30 | 2020-06-19 | 黄山中皇制药有限公司 | Preparation method of andrographolide enteric dry suspension |
-
2014
- 2014-03-19 CN CN201410100621.7A patent/CN103908535A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105451734A (en) * | 2013-08-06 | 2016-03-30 | 天士力制药集团股份有限公司 | Application of andrographolide in the preparation of a pharmaceutical for treatment of inflammatory bowel disease, andrographolide enteric targeting micropellet, and method for preparation thereof |
| EP3031456A4 (en) * | 2013-08-06 | 2016-12-28 | Tasly Pharmaceutical Group Co | Application of andrographolide in the preparation of a pharmaceutical for treatment of inflammatory bowel disease, andrographolide enteric targeting micropellet, and method for preparation thereof |
| CN106176619A (en) * | 2014-08-06 | 2016-12-07 | 天士力制药集团股份有限公司 | A kind of andrographolide enteric coated micropill location preparation |
| CN106176619B (en) * | 2014-08-06 | 2020-10-16 | 天士力医药集团股份有限公司 | Andrographolide enteric-coated pellet positioning preparation |
| CN105168171A (en) * | 2015-10-23 | 2015-12-23 | 成都乾坤动物药业有限公司 | Andrographolide enteric-coated tablet as well as preparation method and application thereof |
| CN111297825A (en) * | 2020-03-30 | 2020-06-19 | 黄山中皇制药有限公司 | Preparation method of andrographolide enteric dry suspension |
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Application publication date: 20140709 |
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