CN102805737A - Lansoprazole enteric oral disintegrating tablet and preparation method thereof - Google Patents

Lansoprazole enteric oral disintegrating tablet and preparation method thereof Download PDF

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CN102805737A
CN102805737A CN 201210318841 CN201210318841A CN102805737A CN 102805737 A CN102805737 A CN 102805737A CN 201210318841 CN201210318841 CN 201210318841 CN 201210318841 A CN201210318841 A CN 201210318841A CN 102805737 A CN102805737 A CN 102805737A
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enteric
lansoprazole
nanocapsules
orally disintegrating
disintegrating tablet
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CN 201210318841
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Chinese (zh)
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魏雪纹
李强
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海南中化联合制药工业股份有限公司
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Abstract

The invention relates to a nanometer lansoprazole enteric oral disintegrating tablet and a preparation method thereof. The lansoprazole enteric oral disintegrating tablet contains about 10-90 percent by weight of a nanocapsule. The lansoprazole enteric oral disintegrating tablet provided by the invention is not required to be taken with water, and can be used for quickly disintegrating an enteric nanocapsule in an oral cavity; the particle diameter of the nanocapsule is less than 1,000 nanometers, and does not cause sand feel in mouth; and compared with an ordinary enteric tablet or enteric capsule, the nanometer lansoprazole enteric oral disintegrating tablet has the characteristics of good treatment effect, high repeatability, high adaptability and the like, is suitable for patients suffering from mental diseases or dysphagia caused by peptic ulcer, and contributes to bringing greater flexibility to clinical administration.

Description

—种兰索拉唑肠溶口崩片及其制备方法 - Lansoprazole enteric species orally disintegrating tablets and preparation method

技术领域 FIELD

[0001] 本发明涉及一种用于治疗胃溃疡、十二指肠溃疡、反流性食管炎、卓-艾综合征、吻合口部溃疡的口服固体制剂,特别是涉及以兰索拉唑为活性成分的纳米化肠溶口崩片制剂。 [0001] The present invention relates to a method of treating gastric ulcer, duodenal ulcer, reflux esophagitis, for Zhuo - Ellison syndrome, oral solid preparations anastomotic ulcer, particularly as relates to Lansoprazole ODTs nano enteric formulation of the active ingredient.

背景技术 Background technique

[0002] 消化性溃疡主要指发生于胃和十二指肠的慢性溃疡,是一多发病、常见病。 [0002] The peptic ulcer occurs mainly refers to chronic ulcers of stomach and duodenum, is a disease, common diseases. 溃疡的形成有各种因素,其中酸性胃液对粘膜的消化作用是溃疡形成的基本因素。 There are various factors that the formation of ulcers, digestion wherein the acidic gastric mucosa is an essential factor for ulcer formation. 酸性胃液接触的任何部位,如食管下段、胃肠吻合术后吻合口、空肠以及具有异位胃粘膜的Meckel憩室。 Any portion of the acidic gastric fluid contact, such as the lower esophagus, gastrointestinal anastomosis anastomotic, ectopic gastric mucosa of the jejunum and a Meckel diverticulum. 绝大多数的溃疡发生于十二指肠和胃,因此又称胃、十二指肠溃疡。 The vast majority of ulcers in the duodenum and stomach, also known as gastric and duodenal ulcer.

[0003] 兰索拉唑为1992年由日本武田药品公司上市开发的H+/K+-ATP酶抑制剂,是继奥美拉唑之后开发的苯并咪唑取代物,为质子泵抑制剂。 [0003] Lansoprazole was in 1992 by Takeda Pharmaceutical developed listing H + / K + -ATP enzyme inhibitor, it is developed after omeprazole was substituted benzimidazole, is a proton pump inhibitor. 其作用机制为药物吸收后,转移到胃粘膜壁细胞的酸分泌管,在酸性条件下,转变为活性体结构,此种活性物与质子泵(H+、K+-ATP酶)的SH基结合,从而抑制该酶的活性,故能抑制胃酸的分泌,主要用于治疗胃溃疡、十二指肠溃瘍、反流性食管炎、卓-艾综合征(Zollinger-Ellison症候群)、吻合口部溃瘍。 The mechanism for the absorption of the drugs, the tube was transferred to the acid secretion of gastric parietal cells, under acidic conditions, to an active structure, such active proton pump (H +, K + -ATP enzyme) bound SH groups, thereby inhibiting the activity of the enzyme, it can inhibit gastric acid secretion, for the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, Zhuo - Ellison syndrome (Zollinger-Ellison syndrome), anastomotic ulcer.

[0004] 兰索拉唑化学名为(+ )-2[[[3_甲基-4- (2,2,2_三氟乙氧基)-2-吡啶基]甲基]亚硫酰基]苯并咪唑,由于其在吡啶环4位侧链引入氟原子,取代基为三氟乙氧基,亲脂性较强,可作用于H7K+-ATP酶的三个部位,生物利用率较奥美拉唑提高30倍。 [0004] lansoprazole chemical name is (+) - 2 [[[3_-methyl-4- (2,2,2_ trifluoroethoxy) -2-pyridinyl] methyl] sulfinyl ] benzimidazole, since the side chain of the ring 4 is introduced a fluorine atom, the substituent is trifluoroethoxy pyridine, lipophilic strong, may be applied to three H7K + -ATP enzyme site, bioavailability than olmesartan omeprazole 30 times.

[0005] 兰索拉唑,其性状为带褐色的白色结晶性粉末,易溶于二甲基甲酰胺,可溶于甲醇,难溶于乙醇、乙醚,几乎不溶于水。 [0005] lansoprazole, which is a trait of a brownish white crystalline powder, soluble in dimethylformamide, soluble in methanol, insoluble in alcohol, ether, almost insoluble in water. 其在酸性条件下不稳定,在胃酸环境中容易降解,需制成肠溶制剂在小肠和十二指肠吸收。 Which is unstable under acidic conditions, susceptible to degradation in the acid environment, the need to give enteric formulation absorbed in the small intestine and duodenum. 普通的肠溶片可以防止药物的降解,但崩解较慢,生物利用度较低,不利于及时缓解患者的痛苦;部分患者吞咽有困难。 Ordinary enteric tablets degradation of the drug can be prevented, but the slower disintegrating, low bioavailability, are not conducive to ease the suffering of patients in a timely manner; some patients have difficulty swallowing. 本发明涉及的肠溶口腔崩解片,在服用药物后,不需用水送服,能在口腔中迅速崩解出肠溶纳米囊,与普通的肠溶片或肠溶胶囊相比,具有治疗重现性好、病人顺应性高等特点,为临床用药带来更大的灵活性,适用于患有精神疾病或者吞咽困难的胃溃疡病人。 The present invention relates to an enteric orally disintegrating tablet, after taking the drug, without water delivery service, which rapidly disintegrates in the oral cavity enteric nanocapsules, compared with the conventional enteric-coated tablets or enteric capsules, having treatment good reproducibility, and high patient compliance, greater flexibility for clinical treatment for mentally ill patients with gastric ulcer or swallowing difficulties.

发明内容 SUMMARY

[0006] 为了解决现有技术的不足,本发明提供一种兰索拉唑肠溶口崩片及其制备方法。 [0006] In order to solve the deficiencies of the prior art, the present invention provides an orally disintegrating tablet and enteric lansoprazole preparation.

[0007] 本发明通过以下技术实现:一种兰索拉唑肠溶口腔崩解片,它由兰索拉唑肠溶纳米囊及适宜的压片辅料制成。 [0007] The present invention is achieved by the following technique: one kind of enteric lansoprazole orally disintegrating tablets, enteric lansoprazole which the azole and nanocapsules made of a suitable tabletting excipients.

[0008] 本发明涉及的一种兰索拉唑肠溶口腔崩解片,进一步包括肠溶纳米囊及口腔崩解层。 [0008] The present invention relates to an orally disintegrating tablets of enteric lansoprazole, and further comprising an enteric nanocapsule orally disintegrating layer.

[0009] 一种兰索拉唑肠溶口崩片的制备方法,包括下述步骤: [0009] A method for preparing an enteric lansoprazole orally disintegrating tablets, comprising the steps of:

(O将肠溶囊材、兰索拉唑、植物油溶于乙醇,制成质量浓度广10%的囊材溶液,搅拌O. 5〜2h ; (O enteric capsule material, lansoprazole, vegetable oil was dissolved in ethanol, 10% of the capsule material widely solution prepared mass concentration, stirring O. 5~2h;

(2)将制得的囊材溶液搅拌下缓慢加入到5〜20倍体积,含有表面活性剂O. Γΐ%体积浓度的水溶液中,搅拌f3h,过微孔滤膜,静置分层; (2) The resulting solution was stirred bladder material slowly added to 5~20 times volume, the volume concentration of an aqueous solution containing a surfactant O. Γΐ%, the F3H stirring, over the microporous membrane, standing layer;

(3)将沉淀物干燥,制得兰索拉唑肠溶纳米囊; (3) The precipitate was dried to obtain enteric lansoprazole nanocapsule;

(4)将纳米囊与适宜的压片辅料混合,压片,即得兰索拉唑肠溶纳米囊口崩片。 (4) The nanocapsules with suitable tabletting excipients mixing, tabletting, i.e. nanocapsules to obtain enteric lansoprazole orally disintegrating tablets.

[0010] 上述兰索拉唑原料经过纳米化处理。 [0010] The lansoprazole nano material after treatment.

[0011] 上述兰索拉唑肠溶口腔崩解片,含有兰索拉唑肠溶纳米囊约为109Γ90%重量百分比。 [0011] The enteric lansoprazole orally disintegrating tablet containing enteric lansoprazole nanocapsules about 109Γ90% by weight.

[0012] 上述所制得含药纳米囊粒径小于lOOOnm,口腔崩解后无沙粒感,肠溶纳米囊能保护药物免受外界环境影响,降低胃肠道刺激,吸收更好。 [0012] The prepared drug-containing nanocapsules size of less than lOOOnm, non-gritty mouth after disintegration, enteric-coated nanocapsules can protect the drug from the external environment, reducing gastrointestinal irritation, absorption and better.

[0013] 如步骤(I)所述肠溶囊材为丙烯酸树脂。 [0013] The step (I) an enteric capsule material is acrylic.

[0014] 如步骤(I)所述所述植物油为大豆油、花生油、玉米油、棕榈油中的一种或几种。 [0014] The step (I) the vegetable oil is one or more of soybean oil, peanut oil, corn oil, palm oil.

[0015] 如步骤(2)所述表面活性剂为泊洛沙姆。 [0015] The step (2) the surfactant is a poloxamer.

[0016] 所述的兰索拉唑肠溶口崩片,其口腔崩解层由适宜的压片用辅料组成,包括崩解齐U、润滑剂、矫味剂。 [0016] The enteric lansoprazole orally disintegrating tablets, orally disintegrating layer which is made with suitable tabletting excipients, including disintegration Qi U, lubricants, flavoring agents.

[0017] 上述崩解剂可以选用低取代羟丙基纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、微晶纤维素其中的一种或几种。 [0017] The disintegrant may be selected low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, one or more of microcrystalline cellulose therein.

[0018] 上述润滑剂为硬脂酸及其盐、微粉硅胶、滑石粉中的一种或几种。 [0018] The lubricant is stearic acid and its salts, silica powder, talc, one or several.

[0019] 上述矫味剂为果糖、蔗糖、苹果酸、柠檬酸、阿斯巴甜、甜菊甙中的一种或几种。 [0019] The flavoring agent is one or more of fructose, sucrose, malic acid, citric acid, aspartame, stevioside in.

[0020] 本发明的技术特点是:本发明所提供的兰索拉唑肠溶口崩片可在口腔崩解出纳米囊,易于吞咽,同时纳米囊粒径比普通肠溶微丸粒径要小,粒径小于lOOOnm,在口腔中崩解后无沙粒感,更利于吸收,减少药物对胃肠道的刺激,提高生物利用度,与胶囊剂相比,具有可分割性,更易于临床灵活应用,适用于精神疾病或者吞咽困难的病人。 [0020] Technical features of the present invention are: Lansoprazole enteric-coated orally disintegrating tablets according to the present invention may be provided in the nanocapsules disintegrate in the mouth, easy to swallow, while nanocapsules particle diameter than the average particle diameter of enteric-coated pellets small size of less than lOOOnm, non-gritty in the mouth after disintegration, is more conducive to absorption, the drug to reduce the irritation of the gastrointestinal tract to improve bioavailability, compared to the capsules, severable, easier clinical flexible application for mental illness or dysphagia patients.

具体实施方式 detailed description

[0021] 下面再以实施例方式对本发明作进一步说明,给出本发明得实施细节,但并不是旨在限定本发明的保护范围。 [0021] The following Example further embodiment of the present invention will be further described, have given details of the embodiment of the present invention, but not intended to limit the scope of the present invention.

[0022] 实施例I : [0022] Example I:

兰索拉唑 20. Og Lansoprazole 20. Og

大豆油 20g Soybean oil 20g

丙烯酸树脂 30g 30g acrylic resin

泊洛沙姆 IOg Poloxamer IOg

交联聚乙烯吡咯烷酮40g 硬脂酸镁 9g Cross-linked polyvinyl pyrrolidone, magnesium stearate 40g 9g

柠檬酸 I. 2g Citric acid I. 2g

制成 1000片。 1000 made.

[0023] 将丙烯酸树脂30g用乙醇270g配成囊材溶液,加入20g大豆油、20g纳米化兰索拉唑,搅拌0. 5h。 [0023] The acrylic resin with 30g ethanol and 270g formulated capsule material was added 20g of soybean oil, 20g nano lansoprazole, stirred for 0. 5h. 将上述溶液边搅拌缓慢加入到5倍体积(1500ml)含0. 1% (I. 5ml)泊洛沙姆的水溶液中,搅拌lh,过微孔滤膜,静置分层;沉淀物干燥,制得兰索拉唑肠溶纳米囊;将纳米囊与处方量PVPP,硬脂酸镁、柠檬酸混合压片,每片重约0. 12g。 The above solution was added slowly with stirring to 5 volumes (1500ml) containing 0. 1% (I. 5ml) an aqueous solution of poloxamer stirred LH, over the microporous membrane, standing layer; the precipitate was dried, lansoprazole enteric prepared nanocapsule; nanocapsules with the recipe quantity of PVPP, magnesium stearate, citrate tableting mixture, each weighing about 0. 12g.

[0024] 实施例2 : [0024] Example 2:

Figure CN102805737AD00051

[0025] 将丙烯酸树脂30g用乙醇270g配成囊材溶液,加入35g棕榈油、20g纳米化兰索拉唑,搅拌lh。 [0025] The acrylic resin with 30g ethanol and 270g formulated capsule material was added 35g palm oil, 20g nano lansoprazole, stirred for lh. 将上述溶液边搅拌缓慢加入到10倍体积(3000ml)含O. 5% (15ml)泊洛沙姆的水溶液中,搅拌2h,过微孔滤膜,静置分层;沉淀物干燥,制得兰索拉唑肠溶纳米囊;将纳米囊与处方量微晶纤维素,硬脂酸镁、阿斯巴甜混合压片,每片重约O. 12g。 The above solution was added slowly with stirring to 10 volumes (3000ml) containing an aqueous solution of 5% (15ml) O. poloxamer, stirred for 2h, through the microporous membrane, standing layer; the precipitate was dried to obtain lansoprazole enteric nanocapsule; nanocapsules with the prescribed amount of microcrystalline cellulose, magnesium stearate, aspartame tableting mixture, each weighing about O. 12g.

[0026] 制备好后,对以上不同处方脆碎度和崩解时间进行检测,与普通肠溶片相比,具体结果如下表: [0026] is prepared, for more different prescription friability and disintegration time were detected, compared with the conventional enteric-coated tablets, specific results in the following table:

Figure CN102805737AD00052

释放度测定结果显示,本发明兰索拉唑肠溶口崩片的释放度要好于市售品普托平的释放度。 Release determination results show that the present Minglansuola oxadiazol-enteric release of orally disintegrating tablets of better than commercially available products protopine release level.

Claims (10)

  1. 1. 一种兰索拉唑肠溶口崩片,其特征在于,它由兰索拉唑肠溶纳米囊及适宜的压片辅料制成口腔崩解片,适用于患有精神疾病或者吞咽困难的消化道溃疡病人。 An enteric lansoprazole orally disintegrating tablets, characterized in that it is oxazole by the enteric lansoprazole and nanocapsules Suitable tabletting excipients made orally disintegrating tablet suitable for swallowing or suffering from mental illness difficult of peptic ulcer patients.
  2. 2.本发明涉及的一种兰索拉唑肠溶口腔崩解片,进一步包括肠溶纳米囊、口腔崩解层。 2. The present invention relates to one kind of enteric lansoprazole orally disintegrating tablet further comprising an enteric nanocapsules, orally disintegrating layer.
  3. 3.如权利要求I所述的兰索拉唑肠溶口腔崩解片的制备方法,其特征在于,包括下述步骤: (O将肠溶囊材、兰索拉唑、植物油溶于乙醇,制成质量浓度广10%的囊材溶液,搅拌O. 5〜2h ; (2)将制得的囊材溶液搅拌下缓慢加入到5〜20倍体积,含有表面活性剂O. f 1%体积浓度的水溶液中,搅拌f3h,过微孔滤膜,静置分层; (3)将沉淀物干燥,制得兰索拉唑肠溶纳米囊; (4)将纳米囊与适宜的压片辅料混合,压片,即得兰索拉唑肠溶纳米囊口崩片。 3. I claim the oral preparation of enteric lansoprazole disintegrating tablets, characterized by comprising the steps of: (O enteric capsule material, lansoprazole, vegetable oil was dissolved in ethanol, wide made of 10% by mass concentration of capsule material was stirred O. 5~2h; (2) the resulting stirred solution was slowly added to the capsule material 5~20 times volume, containing a surfactant O. f 1% by volume aqueous solution concentration, stirring F3H, through microporous membrane, standing layer; (3) the precipitate was dried to obtain enteric lansoprazole nanocapsules; (4) the nanocapsules with suitable tabletting excipients mixing, tabletting, i.e. nanocapsules to obtain enteric lansoprazole orally disintegrating tablets.
  4. 4.如权利要求3所述兰索拉唑原料经纳米化处理。 4. A process as claimed in claim 3 nano lansoprazole raw materials requirements.
  5. 5.如权利要求3所制得的兰索拉唑肠溶口腔崩解片,含药纳米囊的特征在于,含有兰索拉唑肠溶纳米囊约为109Γ90%重量百分比。 5. The three resulting enteric lansoprazole orally disintegrating tablet as claimed in claim, wherein the drug containing nanocapsules comprising an enteric lansoprazole nanocapsules containing about 109Γ90% by weight.
  6. 6.如权利要求3所制得的兰索拉唑肠溶口腔崩解片,其特征在于,所制得含药纳米囊粒径小于lOOOnm,口腔崩解后无沙粒感,肠溶纳米囊能保护药物免受外界环境影响,降低胃肠道刺激,吸收更好。 6. The three resulting enteric lansoprazole orally disintegrating tablet as claimed in claim, characterized in that the prepared drug-containing nanocapsules size of less than lOOOnm, non-gritty mouth after disintegration, enteric nanocapsule to protect the drug from the external environment, to reduce gastrointestinal irritation, absorption better.
  7. 7.如权利要求3所述的兰索拉唑肠溶口腔崩解片,所述肠溶囊材为丙烯酸树脂。 Lansoprazole as claimed in claim 3 azole enteric orally disintegrating tablets, the enteric capsule material is acrylic.
  8. 8.如权利要求3所述的兰索拉唑肠溶口腔崩解片,所述植物油为大豆油、花生油、玉米油、棕榈油中的一种或几种。 Lansoprazole as claimed in claim 3 azole enteric orally disintegrating tablets, the vegetable oil is soybean oil, peanut oil, corn oil, palm oil, one or several.
  9. 9.如权利要求3所述的兰索拉唑肠溶口腔崩解片,所述表面活性剂为泊洛沙姆。 Lansoprazole enteric-coated oral cavity as claimed in claim 3 disintegrating tablet, the surfactant is a poloxamer.
  10. 10.如权利要求2所述的兰索拉唑肠溶口腔崩解片,其口腔崩解层的特征在于,其由适宜的压片用辅料组成,包括崩解剂、润滑剂、矫味剂,具体可选用以下辅料: (I)如权利要求10所述的崩解剂可以选用低取代羟丙基纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、微晶纤维素其中的一种或几种; (2)如权利要求10所述的润滑剂为硬脂酸及其盐、微粉硅胶、滑石粉中的一种或几种; (3)如权利要求10所述的矫味剂为果糖、蔗糖、苹果酸、柠檬酸、阿斯巴甜、甜菊甙中的一种或几种。 10. Lansoprazole enteric-coated oral claim 2 disintegrating tablet, orally disintegrating layer is characterized in that it is a suitable tableting excipients, including disintegrants, lubricants, flavoring agents specific use the following materials: (I) as a disintegrating agent according to claim 10 can use a low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, microcrystalline cellulose, one of which or more; (2) as claimed in claim 10, said lubricant is stearic acid and its salts, silica powder, talc, one or more of; (3) such as flavorings according to claim 10 fructose, sucrose, malic acid, citric acid, aspartame, stevioside of one or more.
CN 201210318841 2012-09-03 2012-09-03 Lansoprazole enteric oral disintegrating tablet and preparation method thereof CN102805737A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
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US9925148B2 (en) 2010-10-26 2018-03-27 Capsugel Belgium Nv Bulk enteric capsule shells
CN103169684A (en) * 2013-03-15 2013-06-26 丽珠集团丽珠制药厂 Ilaprazole enteric orally disintegrating tablet and preparation method thereof
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