CN103520226A - PH dependent type colon positioning hard capsule - Google Patents
PH dependent type colon positioning hard capsule Download PDFInfo
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- CN103520226A CN103520226A CN201310470800.5A CN201310470800A CN103520226A CN 103520226 A CN103520226 A CN 103520226A CN 201310470800 A CN201310470800 A CN 201310470800A CN 103520226 A CN103520226 A CN 103520226A
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Abstract
The invention belongs to the field of pharmaceutical preparation, relates to an alimentary canal drug preparation, and particularly relates to a pH dependent type colon positioning capsule. The pH dependent colon positioning hard capsule includes a hard capsule injected with drug ingredients and a coating film; a coating liquid for forming the coating film has the use amount which is 1-N times that of the following prescription: 2 g of a coating material comprising acrylic resin No.III, EudragitRL100 and/or EudragitRS100; the weight of EudragitRL100 and/or EudragitRS100 accounts for 18-25% of the total weight of the coating material; the coating liquid also comprises 2-3 ml of a plasticizer and 92-98 ml of a solvent of the coating material. An outermost layer of the hard capsule is coated with the polymer coating film, so that injected drugs are ensured not to leak, and the colon positioning drug release requirements can be met.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of digestive tract medication preparation, particularly a kind of pH dependent form colon site-specific drug.
Background technology
Colonic diseases (as colitis, colon cancer etc.) there is no specific medicament at present, and its reason is that after drug oral or injection, arrival colon position concentration is very low.Its bioavailability is low, and main cause is that such medicine has been absorbed or has decomposed before entering lesions position colon.Oral colon-specific drug release system (Oral colon-specific drug delivery system, OCDDS) refer to by suitable method, make medicine avoid discharging at Stomach duodenum, jejunum and ileum front end, discharge and a kind of drug-supplying system of performance part or whole body therapeutic effect after being directly transported to human body ileocecus.Colon locating administrated advantage has: improve the bioavailability of macromolecular drug after as protein, polypeptide oral administration; Colon drug delivery can some special diseases of locating therapy, as colonic ulcer, Ke Luoshi sick (segmental colon disease), colon cancer, some infectious diseases and constipation etc.; After oral colon-target medicine, need certain movement time could arrive colon, can be used for regular disease round the clock.Therefore, the important clinical meaning of OCDDS has become the Hot Contents of current oral positioning release medicine research.Colon locating administrated system can be divided into 5 kinds according to the mechanism of action: 1) pressure control medicine-releasing system; 2) pH dependent form medicine-releasing system; 3) time lag type medicine-releasing system; 4) Bacterialtriggered medicine-releasing system or enzyme controlled release durg delivery system; 5) compound medicine-releasing system.
Wherein, pH dependent form medicine-releasing system is according to increasing gradually to anus pH from mouth, and the pH of colon is the highest in whole intestinal segment, uses the knot enteric material dissolving under corresponding pH condition, makes preparation within the scope of the pH of colon, just start to discharge medicine.At present, occurred the preparation of many principle design according to this on domestic and international market, research comparatively successfully product has 5-aminosalicylic acid conlon targeting sheet, sulfasalazine enteric coatel tablets, budesonide colon-specific pellets.
Oleum Fructus Bruceae (
brucea javanicaseed oil) be dry mature fruit resulting fatty oil after Petroleum ether extraction of quassia Fructus Bruceae.Oleum Fructus Bruceae is yellow supernatant liquid, and gas is special, and bitter in the mouth mainly consists of Palmic acid, stearic acid, oleic acid, linoleic acid plus linolenic acid, and wherein oleic acid content reaches 63. 3%.Pharmacological research shows, Oleum Fructus Bruceae has anti-tumor activity widely, as gastric cancer, the esophageal carcinoma, primary hepatocarcinoma, colorectal cancer, cancer of pancreas etc., can suppress multiple cancer cell multiplication, and have the effects such as hypertension and hyperlipemia.
In current existing 'Brucea fruit oil ', oral solid formulation only has oleum fructus bruceae soft capsule (for example disclosed colon targeting drug delivery soft capsule of Chinese invention patent ZL200710031234.2).But the making of soft capsule is more complicated, rubber is processed with content parcel and must be carried out simultaneously, compares with hard capsule, and the moisture of soft capsule and oxygen permeability are obviously higher, are unfavorable for the storage of medicine, and the easy dehydration of rubber is aging, cause product disintegrate defective.Liquid-tilled hard capsule is as newer a kind of preparation technique, and its advantage also has stability to improve except preparation is relatively convenient, improves bioavailability or reaches slow release object, improves patient's compliance etc.Liquid-tilled hard capsule preparation technology is simple, and occupation area of equipment is less, eliminates dust, has many advantages with traditional powder packing and soft capsule filling contrast.The common soft capsule implant such as oily liquid, solution, suspension or pastel all can fill in hard capsule, but be prone to Seepage, can solve by the method for sealing.Sealing can effectively shield bad smell and oxygen infiltration, greatly reduces the probability of leakage.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of pH dependent form conlon targeting hard capsule, and this hard capsule outermost layer is surrounded by macromolecule coating membrane, guarantees that the medicine of injection is not revealed, and can reach the requirement of colon positioning release.
Technical problem to be solved by this invention is achieved by the following technical programs:
A kind of pH dependent form conlon targeting hard capsule, the hard capsule and the coating membrane thereof that comprise injection of medicine composition, the described coating solution of coating membrane and the 1 ~ N that consumption is following prescription doubly (concrete multiple needs the quantity of the hard capsule of coating as required to determine, and quantity at most multiple increases) of being used to form:
Coating material 1.5 ~ 2.5g, described coating material is,
Eudragit Ⅲ,
Eudragit RL100 and/or Eudragit RS 100;
Described Eudragit RL100 and/or Eudragit RS 100 account for 18 ~ 25% of coating material gross weight;
Solvent 92 ~ the 98ml that also contains plasticizer 2 ~ 3ml, coating material.
Described coating membrane weight account for the injection of medicine composition before coating not hard capsule weight 3.5 ~ 4.5%.
Described plasticizer is at least one and the mixture of Oleum Ricini in diethyl phthalate or triethyl citrate.
Described solvent is the mixture of dehydrated alcohol and acetone.
When described coating material is selected Eudragit Ⅲ, Eudragit RL100,100 3 kinds of components of Eudragit RS, the weight ratio of Eudragit RL100 and Eudragit RS 100 is 1:1.
As the preferred version of technique scheme, described in be used to form the coating solution of coating membrane and 1 ~ N that consumption is following prescription thereof doubly:
Eudragit Ⅲ 1.6g,
Eudragit RL100 0.2g，
Eudragit RS100 0.2g，
Diethyl phthalate or triethyl citrate 1.5ml,
Oleum Ricini 1ml,
Dehydrated alcohol 47.5ml,
Acetone 47.5ml,
Described coating membrane weight account for the injection of medicine composition before coating not hard capsule weight 3.8%.
The ingredient of described injection hard capsule is Oleum Fructus Bruceae.
The present invention has following beneficial effect:
The present invention compares existing Oleum Fructus Bruceae colon targeting drug delivery soft capsule, and processing technology is simpler, and it is aging that rubber is difficult for dehydration, and stability improves, and improves bioavailability or reaches slow release object, improves patient's compliance.
Inventor learns in prescription, to only have Eudragit Ⅲ as the prescription of coating material through overtesting, when coating weightening finish is 3.5%, in PH6.8,55min has oil to discharge, and visible solution is muddy, and 3h disintegrate is complete.Increase coating and increase weight 5.0%, the time lengthening of disintegrate, but still in PH6.8 buffer solution the visible solution of 59min muddy, only surplus a small amount of capsule shells after 3h, the complete disintegrate of 32min in PH7.8 buffer solution.Therefore two kinds of coating capsules all can not reach the requirement of colon positioning release.And the present invention on the basis as main coating material, has added the Eudragit RL100(RL of osmosis type at Eudragit Ⅲ) and Eudragit RS 100 (RS), and through formulation optimization, reach colon positioning release requirement.
The present invention with coating weightening finish, the percent of RL, the percent that the percent of RS and RL mix with 1:1 with RS carries out single factor investigation, the impact of the variation of understanding these factors on the disintegration time of coating capsule, and pass through orthogonal test, determined best coating fluid prescription, use this coating solution to carry out the hard capsule that coating obtains, the disintegration time on average needing in the buffer solution of pH7.8 is 52min, is better than all results of orthogonal test.
The specific embodiment
Self-control Oleum Fructus Bruceae hard capsule, only puts into Oleum Fructus Bruceae in hard capsule and there will be very soon leakage of oil, so will seal after hard capsule charge of oil.According to the record of prior art (Chinese invention patent ZL200710031234.2), and the proof of process preliminary experiment, Eudragit Ⅲ has disintegrate in the buffer solution of PH6.8, in the buffer solution of PH7.8, very fast disintegrate is complete, but the Eudragit Ⅲ of usining seals as coating material, hard capsule is intact oil-proof, so the main coating material of coating solution of the present invention still adopts Eudragit Ⅲ.Eudragit Ⅲ is by methacrylic acid, to be reacted with the ratio of 1:2 the copolymer forming with methyl methacrylate.In prescription, Eudragit Ⅲ originates from Lianyun Harbour Wan Tai medical material company limited.
Eudragit RL100(is hereinafter to be referred as RL) and Eudragit RS 100 (hereinafter to be referred as RS) be the acrylic resin (originate from German Degussa company) of two kinds of osmosis types.
Oleum Fructus Bruceae pH dependent form conlon targeting hard capsule preparation method is:
Oleum Fructus Bruceae is packed in hard capsule, and each fills 0.6ml, lock capsule.Lock carries out coating after capsule in coating pan by coating fluid prescription of the present invention, the evaporating solvent that ventilates under room temperature, and the hard capsule after coating carries out aging more than 12 hours at the baking oven of 40 ℃, then carry out slaking test.Require coating membrane even, smooth.
External disintegrate experiment: according to the regulation in 2010 editions Chinese Pharmacopoeias, coating hard capsule after aging is placed in to Intelligent disintegration tester, allow capsule slaking test 2 hours in 9 → 1000 hydrochloric acid solution respectively, in PH6.8 phosphate buffer solution, slaking test is 3 hours, and in PH7.8 phosphate buffer solution, disintegrate is 1 hour.Require the not disintegrates or do not discharge in hydrochloric acid solution and PH6.8 phosphate buffer solution of hard capsule after coating, and disintegrate is completely or discharge completely in 1 hour in PH7.8 phosphate buffer solution.
1. coating fluid prescription optimization experiment:
9 prescriptions of this experiment of table 1
| Prescription numbering |
 |
 |
 |
 |
 |
 |
 |
 |
 |
| Eudragit Ⅲ (g) | 1.80 | 1.64 | 1.50 | 1.80 | 1.64 | 1.50 | 1.80 | 1.64 | 1.50 |
| Eudragit RL100（g） | 0.2 | 0.36 | 0.50 | / | / | / | 0.1 | 0.18 | 0.25 |
| Eudragit RS100（g） | / | / | / | 0.2 | 0.36 | 0.50 | 0.1 | 0.18 | 0.25 |
| Diethyl phthalate (ml) | 1.5 | 1.5 | 1.5 | 1.5 | 1.5 | 1.5 | 1.5 | 1.5 | 1.5 |
| Oleum Ricini (ml) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Dehydrated alcohol (ml) | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 |
| Acetone (ml) | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 | 47.5 |
The external disintegrate situation of the Oleum Fructus Bruceae pH dependent form conlon targeting hard capsule after each coating fluid prescription coating of table 1 is in Table 2:
the external disintegrate experimental result of table 2
| Prescription numbering |
 |
 |
 |
 |
 |
 |
 |
||
| PH1 | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h | Not disintegrate of 2h |
| PH6.8 | 109min has disintegrate | Not disintegrate of 3h | Not disintegrate of 3h | 82min has disintegrate | Not disintegrate of 3h | Not disintegrate of 3h | 136min has and collapses | Not disintegrate of 3h | Not disintegrate of 3h |
| PH7.8 | 50min collapses entirely | 64min collapses entirely | 57min collapses entirely | 36min collapses entirely | 52min collapses entirely | 58min collapses entirely | 45min collapses entirely | 56min collapses entirely | 67min collapses entirely |
| Remarks | Film is intact | Pericarpium Citri Reticulatae | Film is intact | Film is intact | Film is intact | Film is intact | Film is intact | Film is intact | Film is intact |
As shown in Table 2, the coating material of prescription 1-3 is Eudragit Ⅲ and Eudragit RL100, wherein, the percentage by weight of Eudragit RL100 accounts for respectively 10%, 18%, 25% of coating material, the external disintegrate result of prescription 1-3 shows, when the ratio of Eudragit RL100 is 10%, can not reach conlon targeting requirement, may be that 18% and 25% reaches conlon targeting requirement substantially because the amount of Eudragit Ⅲ is larger in prescription.
The coating material of prescription 4-6 is Eudragit Ⅲ and Eudragit RS100, the percentage by weight of Eudragit RS100 accounts for respectively 10%, 18%, 25% of coating material, the external disintegrate result of prescription 4-6 shows, when being 10%, the ratio of Eudragit RS100 can not reach conlon targeting requirement, may be that 18% and 25% reaches conlon targeting requirement substantially because the amount of Eudragit Ⅲ is larger in prescription.
The coating material of prescription 7-9 is tri-kinds of Eudragit Ⅲ, Eudragit RL100 and Eudragit RS100, the percentage by weight of the mixture of Eudragit RL100 and Eudragit RS100 accounts for respectively 10%, 18%, 25% of coating material, and both weight ratios are 1:1.The external disintegrate result of prescription 7-9 shows, the ratio that Eudragit RL100 mixes with Eudragit RS100 can not reach conlon targeting requirement 10% time.18% and 25% coating capsule can reach requirement substantially.
2. the impact experiment of coating weightening finish on disintegration:
Coating weightening finish is important influence factor in film coating.The thickness of coating increase heavy influence coatings increase weight large to the protecting of medicine, but disintegration time is long, and the little disintegration time that increases weight is short, but easily there is disintegrate in the protection poor effect to medicine in pH6.8 buffer solution or even in hydrochloric acid solution.Three levels of selected coating weightening finish are: 2%; 4%; 6%.
The coating fluid prescription of coating weightening finish experiment: Eudragit Ⅲ 1.6g; Eudragit RL100 0.6g; Diethyl phthalate 1.5ml; Oleum Ricini 1ml; Dehydrated alcohol 47.5ml, acetone 47.5ml.It the results are shown in following table 1:
the impact of table 3 coating weightening finish on disintegrate situation
| Level | PH1 | PH6.8 | PH7.8 | Remarks |
| 2% | 45min has disintegrate | There is disintegrate | 22min | Film is intact |
| 4% | Not disintegrate of 2h | Not disintegrate of 3h | 60min | Film is intact |
| 6% | Not disintegrate of 2h | Not disintegrate of 3h | 102min | Film is intact |
Result shows, weightening finish coating membrane 2% time can not be protected capsule substantially, may be because coating membrane is imperfect or due to the osmosis of the Eudragit RL100 in prescription; Weightening finish more than 4% can reach requirement substantially, but disintegration time is partially long.
3. orthogonal experiment screening:
According to monofactorial experimental result, coating weightening finish should be greater than 2%, and the amount of the RL adding and RS should be greater than 10%.Determine investigation factor A(coating weightening finish), factor B(RL accounts for the percent of coating material after mixing with RS) and the mixed proportion of factor C(RL and RS) these 3 mixed proportions.Three factors are divided into 3 levels separately, list in table 4.
table 4 factor level table
Adopt L9 (3
3) orthogonal array, according to L9 (3
3) use table, each level of each factor of correspondence is inserted in table to testing program and the results are shown in Table 5.
table 5 L9 (3
3
) positive quadraturing design test scheme and result
From result, to the factor having the greatest impact disintegration, be coating weightening finish, be secondly the ratio of RL and RS, be finally the ratio that RL and RS mixture account for coating material.In orthogonal experiment, the best prescription of result is A
3b
1c
3.According to the requirement of disintegrate experiment, choose disintegration time shorter be excellent scheme, i.e. A
3b
3c
1, this scheme is that mix the ratio that accounts for coating material with RS be that ratio between 20%, RL and RS is 1:1 to coating weightening finish 3.8%, RL.
4. the checking of optimum coating prescription
With this (A that writes out a prescription
3b
3c
1) carrying out coating three times, the coating hard capsule obtaining carries out respectively disintegrate experiment, obtains result as table 6:
the checking of table 6 prescription
| PH1 | PH6.8 | PH7.8（min） | Remarks | |
| 1 | 2h is without disintegrate | 3h is without disintegrate | 50 | Film is intact |
| 2 | 2h is without disintegrate | 3h is without disintegrate | 52 | Film is intact |
| 3 | 2h is without disintegrate | 3h is without disintegrate | 54 | Film is intact |
The disintegration time that this optimum prescription capsule on average needs is 52min, reaches conlon targeting requirement and is better than all results of orthogonal experiment.
Claims (7)
1. a pH dependent form conlon targeting hard capsule, comprises and it is characterized in that hard capsule and the coating membrane thereof of injection of medicine composition, described in be used to form the coating solution of coating membrane and 1 ~ N that consumption is following prescription thereof doubly:
Coating material 2g, described coating material is,
Eudragit Ⅲ,
Eudragit RL100 and/or Eudragit RS 100;
Described Eudragit RL100 and/or Eudragit RS 100 account for 18 ~ 25% of coating material gross weight;
Solvent 92 ~ the 98ml that also contains plasticizer 2 ~ 3ml, coating material.
2. pH dependent form conlon targeting hard capsule according to claim 1, is characterized in that: described coating membrane weight account for the injection of medicine composition before coating not hard capsule weight 3.5 ~ 4.5%.
3. pH dependent form conlon targeting hard capsule according to claim 1, is characterized in that: described plasticizer is at least one and the mixture of Oleum Ricini in diethyl phthalate or triethyl citrate.
4. pH dependent form conlon targeting hard capsule according to claim 1, is characterized in that: described solvent is the mixture of dehydrated alcohol and acetone.
5. according to the pH dependent form conlon targeting hard capsule described in claim 1 ~ 4 any one, it is characterized in that: when described coating material is selected Eudragit Ⅲ, Eudragit RL100,100 3 kinds of components of Eudragit RS, the weight ratio of Eudragit RL100 and Eudragit RS 100 is 1:1.
6. according to the pH dependent form conlon targeting hard capsule described in claim 1 ~ 4 any one, it is characterized in that, described in be used to form the coating solution of coating membrane and 1 ~ N that consumption is following prescription thereof doubly:
Eudragit Ⅲ 1.6g,
Eudragit RL100 0.2g，
Eudragit RS100 0.2g，
Diethyl phthalate or triethyl citrate 1.5ml,
Oleum Ricini 1ml,
Dehydrated alcohol 47.5ml,
Acetone 47.5ml.
7. pH dependent form conlon targeting hard capsule according to claim 1, is characterized in that: the ingredient of described injection hard capsule is Oleum Fructus Bruceae.
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Cited By (2)
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| CN105287427A (en) * | 2015-10-20 | 2016-02-03 | 沈阳红旗制药有限公司 | Semi-solid rifampicin capsule and preparation method thereof |
| CN112022828A (en) * | 2019-06-04 | 2020-12-04 | 绍兴康可胶囊有限公司 | Colon capsule and its preparing process |
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Effective date of registration: 20210830 Address after: 516000 office building of Henan an Dalang Du Jiuhui Pharmaceutical Co., Ltd., Huizhou City, Guangdong Province Patentee after: Huizhou Jiuhui Pharmaceutical Co.,Ltd. Address before: 516007 No. 199 Nan'an Road, Huizhou City, Guangdong Province Patentee before: JIUHUI PHARMACEUTICAL Co.,Ltd. |