CN104523717A - Simethicone otilonium bromide chewable tablets and preparing method thereof - Google Patents

Simethicone otilonium bromide chewable tablets and preparing method thereof Download PDF

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CN104523717A
CN104523717A CN 201510004527 CN201510004527A CN104523717A CN 104523717 A CN104523717 A CN 104523717A CN 201510004527 CN201510004527 CN 201510004527 CN 201510004527 A CN201510004527 A CN 201510004527A CN 104523717 A CN104523717 A CN 104523717A
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simethicone
parts
bromide
chewable
otilonium bromide
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CN 201510004527
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Chinese (zh)
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罗雷
曾海春
罗永煌
王小红
王兰周
骆晓宏
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西南大学
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Abstract

The invention discloses simethicone otilonium bromide chewable tablets and a preparing method of the simethicone otilonium bromide chewable tablets. The simethicone otilonium bromide chewable tablets comprise, by mass, 12.5 parts of simethicone, 4 parts of otilonium bromide, 10-40 parts of adsorbent, 25-75 parts of filler, 0.2-10 parts of adhesive, 0.2-5.0 parts of lubricant, 0.5-10 parts of corrigent, 0.05-0.5 part of aromatic and 1.5-7.5 parts of moisture sealer coating materials. According to the simethicone otilonium bromide chewable tablets, the formula is reasonable, the cost is low, and the preparing method is simple and suitable for industrial production. The prepared tablets are good in taste, the surfaces of the tablets are smooth and attractive, the tablets are even in color, appropriate in hardness, stable in quality, convenient to take and carry, and particularly suitable for the elderly, children and patients who cannot swallow solid preparations, the compliance of the patients is improved, and the simethicone otilonium bromide chewable tablets have good application prospects to treatment of the irritable bowel syndrome due to various reasons, especially the irritable bowel syndrome accompanied with abdominal distension and stomachache.

Description

西甲硅油奥替溴铵咀嚼片及其制备方法 Simethicone Chewable otilonium bromide and preparation method

技术领域 FIELD

[0001] 本发明属于制药领域,具体涉及西甲硅油奥替溴铵咀嚼片,还涉及该咀嚼片的制备方法。 [0001] The present invention belongs to the pharmaceutical field, particularly relates to simethicone chewable otilonium bromide, also relates to methods of the chewable tablet.

背景技术 Background technique

[0002]胃肠功能紊乱(WSN),是一组胃肠综合征的总称。 [0002] gastrointestinal disorders (WSN), is a general term for a group of gastrointestinal syndrome. 临床上不仅有上腹部不适、厌食、腹胀、腹痛、腹泻、嗳气、反酸、恶心、呕吐、便秘等消化道表现,还常伴有全身性的神经官能症表现,如失眠、多梦、健忘、身体疲倦、注意力不集中、心悸、胸闷、头痛、头晕、自汗、盗汗等,是临床常见的慢性、顽固性疾病。 Clinically not only have upper abdominal discomfort, anorexia, abdominal distension, abdominal pain, diarrhea, belching, acid reflux, nausea, vomiting, constipation and other gastrointestinal manifestations, but also often accompanied by systemic manifestations of neurosis, such as insomnia, dreams, forgetfulness , physical fatigue, lack of concentration, heart palpitations, chest tightness, headache, dizziness, spontaneous perspiration, night sweats, etc., is a common clinical chronic, intractable disease. WSN的发生常与精神因素有关,情志失调、思虑劳疲可引起WSN的发生。 WSN often associated with the occurrence of mental factors, emotional disorders, thinking labor fatigue can cause the occurrence of WSN. WSN的显著特点是有一系列WSN的临床表现,但在病理、解剖等方面却无器质性病变。 The distinctive feature of WSN WSN is a series of clinical manifestations, but but no organic disease in pathology, anatomy and so on. 因此,现代医学无法确诊WSN,也无疗效确切的治疗药物,只能作对症处理或辅助性治疗。 Therefore, modern medicine can not be confirmed WSN, have no therapeutic value exact drugs, only symptomatic treatment or for adjuvant therapy. 实际上,胃肠胀气与消化道疼痛也是WSN的常见表现。 In fact, flatulence and gastrointestinal pain is also a common manifestation of WSN. 胃肠胀气是病因作用胃肠使气体产生过多引起的腹部膨胀,消化道疼痛则是病因作用胃肠平滑肌使其过度收缩或强烈收缩引起的腹部疼痛。 Flatulence gas is the cause of the gastrointestinal abdominal swelling due to excessive, cause gastrointestinal pain is so excessive smooth muscle contraction of the gastrointestinal or abdominal pain due to strong contraction. WSN虽然对人的生命无致死性危害,也不会影响人的寿命,但会造成生活质量下降,影响人们正常的生活、工作。 WSN Although no fatal harm to human life, it will not affect the person's life, but will result in reduced quality of life, affecting people's normal life and work.

[0003] 肠易激综合征(irritablebowelsyndrome,IBS),是最常见的胃肠功能紊乱(WSN)中的一种症候群,以慢性或复发性腹痛、腹胀伴排便/便意频繁、粪便性状异常和排便后症状改善为主要症状。 [0003] Irritable bowel syndrome (irritablebowelsyndrome, IBS), a syndrome of the most common gastrointestinal disorders (WSN) in order to chronic or recurrent abdominal pain, bloating associated with bowel movements / it intended to frequent bowel movements and stool abnormalities symptoms improved after the main symptoms. IBS的发病机制目前尚未明确,可能与精神心理因素、内脏高敏感性、胃肠道动力异常、免疫异常、感染等多方面因素有关,但大量研宄表明胃肠动力异常可能是IBS的发生的主要原因,特别与痉挛性收缩活动频繁有关。 IBS pathogenesis is not yet clear, may be related to psychological factors, visceral hypersensitivity, gastrointestinal motility disorders, immune disorders, infection, and many other factors, but a large study based on gastrointestinal motility abnormalities may indicate the occurrence of IBS the main reason, in particular, frequently associated with spasmodic contraction. 因此,改善胃肠动力异常是当前治疗IBS的重要手段,目前针对胃肠运动异常(胃肠平滑肌过度收缩所致腹痛)的治疗药物,主要有美贝维林、匹维溴铵、曲美布汀、奥替溴铵等,缓解腹痛的疗效较好,但对IBS伴有的腹胀几乎无效。 Therefore, to improve gastrointestinal motility disorders is currently an important means of treating IBS, is currently for gastrointestinal motility abnormalities (excessive gastrointestinal smooth muscle contraction caused by abdominal pain) of drugs, mainly mebeverine, horse-dimensional bromide, Qu Mei cloth Ting, Austria for the bromide, etc., ease the pain of good effect, but the bloating associated with IBS are almost ineffective.

[0004] 西甲硅油为聚二甲基硅氧烷和二氧化硅组成的复合物,是一种稳定的非离子型表面活性剂,主要作用于消化道中存在于食糜和粘液内的气泡表面,降低气泡表面张力,促使气泡破裂释放气体,释出的气体可部分被肠壁吸收,也可随肠道蠕动而排出,因而西甲硅油具有消泡、消胀作用。 [0004] Simethicone is a composite of polydimethylsiloxane and silica, is a stable nonionic surfactant, present in a major role in the bubble surface chyme and mucus in the digestive tract, reduce the surface tension of the bubbles, the bubbles cause burst release gas, the gas may be partially released intestinal absorption, it may also be discharged with the intestinal peristalsis, thus having a simethicone antifoam Xiaozhang effect. 西甲硅油属于药理学和生理学惰性物质,消泡作用为纯粹的物理性作用,不涉及化学反应。 Simethicone belonging pharmacological and physiological inert material, a defoaming effect is purely physical action, does not involve a chemical reaction. 西甲硅油口服给药后,经过胃肠道转运后又以原型排出,而且大鼠的亚急性毒性实验表明西甲硅油没有毒性作用,迄今尚未观察到与服用西甲硅油有关的不良反应。 After simethicone oral administration, transit through the gastrointestinal tract and then excreted, and sub-acute toxicity test in rats showed no toxic effects simethicone, simethicone has not yet been observed adverse effects associated with the administration. 西甲硅油基于其良好的安全性,可广泛应用于婴幼儿、儿童、成人、孕妇、手术患者、 老年患者等;基于其良好的消泡性,临床上主要用于因气体聚集腹部而引起的腹胀、腹部不适、消化不良、术后肠梗阻以及腹部影像学检查的辅助用药等。 Simethicone based on their favorable safety profile, can be widely used in infants, children, adults, pregnant women, surgical patients, elderly patients and so on; based on their good defoaming, mainly for abdominal distension due to accumulation of gas caused by the clinical , abdominal discomfort, indigestion, postoperative ileus and abdominal imaging studies of adjuvant and the like.

[0005] 奥替溴铵,化学名为N,N-二乙基-N-甲基-2- [ [4 [ [2-(辛基)苯甲酰]氨基]苯甲酰]氧基]乙烷铵溴化物,是一种胆碱能受体拮抗剂,也是一种钙拮抗剂。 [0005] otilonium bromide, chemical name N, N- diethyl--N- methyl-2- [[4 [[2- (octyl) benzoyl] amino] benzoyl] oxy] ethane bromide, a cholinergic receptor antagonist, is also a calcium antagonist. 进入胃肠的奥替溴铵可抑制Ca2+通过L型Ca2+通道进入肠平滑肌细胞,从而降低肠平滑肌细胞的收缩性。 Into the gastrointestinal otilonium bromide inhibit Ca2 + into the intestinal smooth muscle cells via the L-type Ca2 + channels, thereby reducing the contractility of intestinal smooth muscle cells. 在药物治疗学上,奥替溴铵属于抗胆碱类解痉药,对于消化道平滑肌具有选择性解痉挛作用,因此适用于所有的胃肠运动功能亢进,不同原因和不同部位以及由于平滑肌病理性萎缩引起的痉挛反应。 In drug therapy, otilonium bromide belonging anticholinergic spasmolytics, gastrointestinal smooth muscle selective for antispasmodic action, and therefore to all of gastrointestinal motility hyperthyroidism, and different parts of different reasons and due to smooth muscle pathology atrophy caused by spasm reaction. 此外,动物实验结果表明,奥替溴铵无毒性反应,对人类来说几乎不可能出现由于药物过量引起的问题。 In addition, animal experiments show that non-toxic otilonium bromide reaction, is almost impossible due to the problems caused by an excess of drug to humans. 所以,奥替溴铵作为一种解痉药已被广泛应用,有效且安全,临床上用于胃肠道痉挛和胃肠运动障碍引起的腹痛、肠易激综合征、胃炎、十二指肠炎、 肠炎、食管病变等,也可用于内窥镜检查前用药(如食管-胃-十二指肠镜,结肠镜,直肠镜等)。 Therefore, otilonium bromide as an antispasmodic drug has been widely used, effective and safe for abdominal cramps and gastrointestinal disorders caused by gastrointestinal motility clinically, irritable bowel syndrome, gastritis, duodenitis , enteritis, esophagus lesions, endoscopy can be used before treatment (e.g., esophagus - stomach - duodenum, colonoscopy, proctoscope, etc.).

[0006] 但迄今为止,国内外均未见西甲硅油与奥替溴铵组合制备成咀嚼片的研宄报道, 也无相关产品上市。 [0006] But so far, at home and abroad were no simethicone chewable tablets and Austria prepared for bromide combination study based on reports, and no related products on the market. 因此,研制西甲硅油奥替溴铵咀嚼片具有良好的市场前景。 Therefore, the development simethicone Austria for the bromide chewable tablets have good market prospects.

发明内容 SUMMARY

[0007] 有鉴于此,本发明的目的之一在于提供西甲硅油奥替溴铵咀嚼片,配方合理,成本低廉;本发明的目的之二在于提供西甲硅油奥替溴铵咀嚼片的制备方法,制备方法简单,便于工业化生产。 [0007] It is therefore one object of the present invention to provide a simethicone otilonium bromide chewable tablet, a reasonable formula, low cost; object of the present invention is to provide two methods for preparing simethicone Austria bromide chewable tablets, preparation method is simple, convenient for industrial production.

[0008] 为解决上述发明目的,本发明提供如下技术方案: [0008] In order to solve the above object, the present invention provides the following technical solutions:

[0009] 1、西甲硅油奥替溴铵咀嚼片,按质量份计由以下组分组成:西甲硅油12. 5份、奥替溴铵4份、吸附剂10-40份、填充剂25-75份、黏合剂0. 2-10份、润滑剂0. 2-5. 0份、矫味剂0. 5-10份、芳香剂0. 05-0. 5份和防潮膜包衣剂1. 5-7. 5份。 [0009] 1, simethicone otilonium bromide chewable tablets, by parts by mass of the following components: 12.5 parts of simethicone, otilonium bromide 4 parts, 10-40 parts adsorbents, fillers 25-75 parts, 0. 2-10 parts by adhesives, lubricants 0. 2-5. 0 parts, 0.5 to 10 parts flavoring, perfuming 0. 05-0. 5 parts of a film-coating agent and moisture. 5-7. 5 parts.

[0010] 优选的,按质量份计由以下组分组成:西甲硅油12.5份、奥替溴铵4份、吸附剂16-32份、填充剂42-57. 64份、黏合剂2-2. 6份、润滑剂0. 5-0. 6份、矫味剂5. 2-5. 5份、芳香剂0. 14-0. 15份和防潮膜包衣剂3. 3-3. 6份。 [0010] Preferably, parts by mass of the following components: 12.5 parts of simethicone, otilonium bromide 4 parts, 16-32 parts of an adsorbent, 42-5764 parts of filler, binder 2-2. 6 parts of lubricant 0. 5-0. 6 parts, 5. 2-5. 5 parts flavoring, perfuming 0. 14-0. 15 parts of moisture-proof film-coating agent and 3. 3-3. 6 parts .

[0011] 优选的,所述吸附剂为玉米淀粉、微晶纤维素、糊精、磷酸氢钙中的一种或几种。 [0011] Preferably, the sorbent is one or more of corn starch, microcrystalline cellulose, dextrin, dibasic calcium phosphate.

[0012] 优选的,所述填充剂为玉米淀粉、蔗糖、微晶纤维素、预胶化淀粉、葡萄糖、乳糖、甘露醇、木糖醇、麦芽糖醇中的一种或几种。 [0012] Preferably, the filler is corn starch, sucrose, microcrystalline cellulose, one or more of pregelatinized starch, glucose, lactose, mannitol, xylitol, maltitol.

[0013] 优选的,所述润滑剂为硬脂酸镁、滑石粉、微粉硅胶中的一种或几种。 [0013] Preferably, the lubricant is magnesium stearate, talc, silica powder is one or several.

[0014] 优选的,所述黏合剂为PVP-K30、淀粉浆、低取代羟丙基纤维中的一种或几种。 [0014] Preferably, the binder one or more substituted hydroxypropyl cellulose is from PVP-K30, starch, low.

[0015] 本发明中制备咀嚼片,与普通片剂相比,其口感要更好。 [0015] Preparation of chewable tablets of the present invention, compared with ordinary tablets, which to taste better. 因此,在配方中加入合适的矫味剂以改善口感,提高患者的服药依从性。 Thus, addition of suitable flavoring agents in the formulations to improve taste, to improve the medication compliance of patients. 本发明中矫味剂优选为阿司巴坦、甜菊素、 糖精钠、香兰素中的一种或几种,同时加入带有甜味的填充剂来更好地改善口感,使病人乐于接受。 In the present invention flavoring agent is preferably astemizole tazobactam, steviosin, sodium saccharin, vanillin of one or several of the filler was added simultaneously with a sweet taste to better improve the patient willing to accept . 此外,出于改善咀嚼片香味的目的,本发明处方中加入了药学上可接受的香精。 Further, the purpose of improving flavor chewable tablets, prescription according to the present invention is added to a pharmaceutically acceptable flavors.

[0016] 本发明处方中奥替溴铵在室温条件下遇水不稳定,易水解生成4_(2_辛氧基苯甲酰胺基)苯甲酸和N-甲基-N,N_二乙基-N_(2-羟乙基)溴化铵。 [0016] The formulation of the present invention, water otilonium bromide is unstable at room temperature, easily hydrolyzed 4_ (benzoylamino 2_ octyloxy) benzoic acid and N- methyl -N, N_ diethyl -N_ (2- hydroxyethyl) ammonium bromide. 为了保证咀嚼片在贮存过程中不受吸潮的影响,提高片剂的稳定性,延长储存期,本发明对压制的咀嚼片片芯进行防潮薄膜包衣。 In order to ensure impact chewable tablets during storage from moisture absorption, to improve tablet stability, prolonged storage, the present invention is compressed to a chewable tablet cores were film-coated moisture. 优选的防潮薄膜包衣剂为羟丙基甲基纤维素、甲基纤维素、羟乙基纤维素、 羟丙基纤维素。 Preferred moisture-proof film coating agent is hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose.

[0017] 2、所述西甲硅油奥替溴铵咀嚼片的制备方法,包括以下步骤: [0017] 2, the method for preparing simethicone otilonium bromide chewable tablet, comprising the steps of:

[0018] a.粉碎:将处方中的固态组分分别粉碎成粒度为80目以上的细粉; . [0018] a pulverization: the solid component in the formulation were crushed to a particle size less than 80 mesh powder;

[0019] b.制粒:取配方量的西甲硅油与吸附剂混合均匀,再加入填充剂、奥替溴铵和矫味剂混合均匀,混匀后加入黏合剂制成软材,将软材过20目筛制粒,接着在40〜60°C下干燥,最后过20目筛整粒; [0019] b granulation: the amount of simethicone formulation mixed with the adsorbent takes a uniform, then add filler, otilonium bromide, and flavoring agent are mixed uniformly, added after mixing a binder made of soft material, the soft material granulated through a 20 mesh sieve, then dried at 40~60 ° C, and finally through a 20 mesh sieve;

[0020] C.压片:将芳香剂均匀喷入步骤b整粒的干颗粒中混合均匀,再加入处方量的润滑剂,混匀,压片,即得西甲硅油奥替溴铵咀嚼片片芯; [0020] C. Tablet: The fragrance is sprayed into uniform particles of step b sieved dry mixed evenly, then add prescribed amount of lubricant, mixing, tabletting, simethicone obtain chewable tablets otilonium bromide core;

[0021] d.包衣:将防潮薄膜包衣剂用乙醇溶解制成质量分数为6-18%的溶液,对步骤c 所得西甲硅油奥替溴铵咀嚼片片芯进行包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 [0021] d Coating: The moisture-proof film coating agent made with ethanol was dissolved fraction of 6-18 mass% solution obtained in step c simethicone for Austria coated chewable tablet core bromide, sulfate, i.e., prepared simethicone chewable otilonium bromide.

[0022] 本发明处方中西甲硅油为粘稠的油状液体,流动性差,不宜使用粉末直接压片法压片。 [0022] Prescription of simethicone in the present invention as a viscous oily liquid, poor fluidity, the powder should not be used direct compression tabletting method. 因此本发明选择湿法制粒压片法制备咀嚼片。 Thus, the present invention selects a chewable tablet prepared wet granulation compression method. 在制粒时,本发明先选用常见油状药物吸附填充剂(如微晶纤维素、淀粉、糊精等)来吸附西甲硅油,以便其分散均匀,然后再与奥替溴铵、填充剂及其他固体辅料混合均匀后进行制粒。 When granulating, the present invention is commonly selected to adsorb oily pharmaceutical filler (such as microcrystalline cellulose, starch, dextrin, etc.) to adsorb simethicone, so that a uniform dispersion, then the otilonium bromide, and other fillers the solid was granulated materials mixed uniformly.

[0023] 本发明的有益效果在于:本发明提供了一种西甲硅油奥替溴铵咀嚼片,选用药学上可接受的辅料并对辅料组分及其配比进行了筛选和优化,处方设计合理;同时,本发明对西甲硅油奥替溴铵咀嚼片的制备方法也进行了设计和优化,操作简便,成本低廉,适用于工业化生产,所得片剂质量稳定可控,口感良好,表面光滑美观、色泽均匀,硬度适中,在治疗因各种原因所致的肠易激综合征特别伴有腹胀、腹痛方面具有良好的应用前景。 [0023] Advantageous effects of the present invention: The present invention provides a simethicone otilonium bromide chewable pharmaceutically acceptable excipient selection and auxiliary components and their ratio were screened and optimized prescription rational design ; Meanwhile, the present invention method for preparing simethicone otilonium bromide chewable also been designed and optimized, simple operation, low cost, suitable for industrial production, stable and controllable quality of the resulting tablets, taste good, smooth surface appearance, color uniformity, hardness, particularly in the treatment due to abdominal distension with various causes of irritable bowel syndrome, abdominal pain aspect has a good prospect.

具体实施方式 Detailed ways

[0024] 下面将结合优选实施例对本发明进行详细的描述。 [0024] The following embodiments in conjunction with preferred embodiments of the present invention will be described in detail. 实施例中未注明具体条件的实验方法,通常按照常规条件或按照制造厂商所建议的条件。 Experimental methods without specific conditions in the examples are performed under routine conditions, or according to conditions recommended by the manufacturer.

[0025] 实施例1 [0025] Example 1

[0026] 西甲硅油奥替溴铵咀嚼片,具体配方如下: [0026] Simethicone otilonium bromide chewable tablet, the following specific formulations:

[0027] 西甲硅油125.0g; 奥替溴铵40.0g; 玉米淀粉275.0g; 葡萄糖463.6g; PVP-K30 20.9g; 硬脂酸镁5.0g; 糖精钠55.0g; 香精1.4g; 羟丙基甲基纤维素35g; [0027] Simethicone 125.0 g; 40.0 g of otilonium bromide; Corn starch 275.0g; glucose 463.6g; PVP-K30 20.9g; magnesium stearate 5.0 g; 55.0 g sodium saccharin; 1.4 g of flavor; hydroxypropyl methylcellulose cellulose 35g;

[0028] 将上述配方制成1000片西甲硅油奥替溴铵咀嚼片,制备方法包括如下步骤: [0028] The above formulation was prepared simethicone 1000 otilonium bromide chewable tablet, the method comprising the steps of preparing:

[0029] a.将配方中的固态组分(奥替溴按、玉米淀粉、葡萄糖、硬脂酸镁、糖精钠)分别粉碎成粒度为80目以上的细粉;将配方量的PVP-K30配制成10%的PVP-K30乙醇(50% ) 溶液; . [0029] a solid component of the formula (otilonium Press, corn starch, glucose, magnesium stearate, sodium saccharin) were pulverized to a particle size less than 80 mesh powder; the formula amount of PVP-K30 formulated as a 10% PVP-K30 in ethanol (50%) solution;

[0030] b.取配方量的西甲硅油与玉米淀粉混合均匀;再与配方量的奥替溴铵、葡萄糖、 糖精钠混合均匀;加入10%PVP-K30乙醇溶液制成软材,过20目筛制粒,40°C干燥,然后过20目筛整粒; [0030] b simethicone and corn starch are mixed uniformly taken formula amount of;. Mixed with the formula amount of otilonium bromide, glucose, saccharin sodium uniform; was added 10% PVP-K30 in ethanol obtain a soft material, 20 mesh sieve granulator, 40 ° C and dried, then passed through a 20 mesh sieve;

[0031]c.将配方量的香精均匀喷在步骤b整粒后的干颗粒表面,用密封袋密封片刻,再加入配方量的硬脂酸镁,混匀,压片,即得西甲硅油奥替溴铵咀嚼片片芯; [0031] c. The formula amount of flavor in the spray dried particles of uniform surface after step b whole, the bag sealed with a sealing moment, then add formula amount of magnesium stearate, mixing, tabletting, simethicone obtain Austrian Alternatively bromide chewable tablet core;

[0032]d.将防潮薄膜包衣剂羟丙基甲基纤维素用乙醇溶解制成质量分数为13%的溶液,然后对西甲硅油奥替溴铵咀嚼片片芯包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 [0032] d. The moisture-proof film coating agent is hydroxypropyl methyl cellulose dissolved in ethanol was prepared mass fraction of 13% solution, then otilonium bromide Simethicone Chewable tablet cores were coated, dried, i.e., Ltd. We have simethicone chewable otilonium bromide.

[0033] 质量检查: [0033] Quality inspection:

[0034] 本实施例制得的西甲硅油奥替溴铵咀嚼片表面光洁、色泽均匀;口感良好,有香味;硬度为6. 5〜7. 5kg;溶出度检查:30分钟时,西甲硅油的溶出度为77. 2%,奥替溴铵的溶出度为79. 5%。 [0034] The present embodiment is obtained simethicone otilonium bromide chewable surface must be smooth; good taste, flavor; hardness 6. 5~7 5kg; dissolution test: 30 minutes, simethicone dissolution was 77.2%, otilonium bromide dissolution was 79.5%.

[0035] 实施例2 [0035] Example 2

[0036] 西甲硅油奥替溴铵咀嚼片,具体配方如下: [0036] Simethicone otilonium bromide chewable tablet, the following specific formulations:

[0037] 西甲硅油125.0g; 奥替溴铵40.0g; 玉米淀粉287.0g; 鹿糖200.0g; 甘露醇255.0g; PVP-K30 23,5g; 硬脂酸镁5.3g; 阿司巴坦53.2g; 香精1.5g; 羟丙基甲基纤维素33g; [0037] Simethicone 125.0 g; 40.0 g of otilonium bromide; Corn starch 287.0g; deer sugar 200.0 g; mannitol 255.0g; PVP-K30 23,5g; 5.3 g of magnesium stearate; Aspirin 53.2g tazobactam ; flavor 1.5 g; 33g hydroxypropyl methylcellulose;

[0038] 将上述配方制成1000片西甲硅油奥替溴铵咀嚼片,制备方法包括如下步骤: [0038] The above formulation was prepared simethicone 1000 otilonium bromide chewable tablet, the method comprising the steps of preparing:

[0039]a.将配方中的固态组分(奥替溴铵、玉米淀粉、蔗糖、甘露醇、硬脂酸镁、阿司巴坦)分别粉碎成粒度为80目以上的细粉;将配方量的PVP-K30配制成10%的PVP-K30乙醇(50% )溶液; . [0039] a solid component of the formula (otilonium bromide, corn starch, sucrose, mannitol, magnesium stearate, astemizole TAZ) were crushed to a particle size less than 80 mesh powder; recipe the amount of PVP-K30 formulated as a 10% PVP-K30 in ethanol (50%) solution;

[0040] b.取配方量的西甲硅油与玉米淀粉混合均匀;再与配方量的奥替溴铵、甘露醇、 蔗糖、阿司巴坦混合均匀;加入10%PVP-K30乙醇溶液制成软材,过20目筛制粒,40°C干燥,然后过20目筛整粒; [0040] b simethicone and corn starch are mixed uniformly taken formula amount; again to the formula amount of otilonium bromide, mannitol, sucrose, astemizole TAZ mixed; was added 10% PVP-K30 in ethanol as soft material, granulated through a 20 mesh sieve, 40 ° C and dried, then passed through a 20 mesh sieve;

[0041] C.将处方量的香精均匀喷在步骤b整理的干颗粒表面,用密封袋密封片刻,再加入配方量的硬脂酸镁,混匀,压片,即得西甲硅油奥替溴铵咀嚼片片芯; [0041] C. The formulation amounts of the dry flavor particles uniformly sprayed surface finishing step b, the bag sealed with a sealing moment, then add formula amount of magnesium stearate, mixing, tabletting, to obtain simethicone otilonium ammonium chewable tablet core;

[0042] d.将防潮薄膜包衣剂羟丙基甲基纤维素用乙醇溶解制成质量分数为13%的溶液,然后对西甲硅油奥替溴铵咀嚼片片芯包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 [0042] d. The moisture-proof film coating agent is hydroxypropyl methyl cellulose dissolved in ethanol was prepared mass fraction of 13% solution, then otilonium bromide Simethicone Chewable tablet cores were coated, dried, i.e., Ltd. We have simethicone chewable otilonium bromide.

[0043] 质量检查:本实施例制得的西甲硅油奥替溴铵咀嚼片表面光洁、色泽均匀;口感良好,有香味;硬度为6. 0-8. 0kg;溶出度检查:30分钟时,西甲硅油的溶出度为76. 7%,奥替溴铵的溶出度为78. 6%。 [0043] QA: Auburn simethicone alternative embodiment bromide prepared chewable surface must be smooth; good taste, flavor; hardness 6. 0-8 0kg; dissolution test: 30 minutes, dissolution of simethicone was 76.7%, otilonium bromide dissolution was 78.6%.

[0044] 实施例3 [0044] Example 3

[0045] 西甲硅油奥替溴铵咀嚼片,具体配方如下: [0045] Simethicone otilonium bromide chewable tablet, the following specific formulations:

[0046] 西甲娃油125.0g; 奥替溴铵40.0g; 微晶纤维素290.0g; 甘露醇450.0g; PVP-K30 21.8g; 硬脂酸镁3.02g; 微粉娃胶2.0g; 糖精钠53.5g; 香精1.48g; 甲基纤维素35g; [0046] Spanish baby oil 125.0 g; 40.0 g of otilonium bromide; Microcrystalline cellulose 290.0 g; mannitol 450.0g; PVP-K30 21.8g; Magnesium stearate 3.02 g; 2.0 g of plastic baby powder; 53.5 Sodium Saccharin G; flavor 1.48 g; 35g methyl cellulose;

[0047] 将上述配方制成1000片西甲硅油奥替溴铵咀嚼片,制备方法包括如下步骤: [0047] The above formulation was prepared simethicone 1000 otilonium bromide chewable tablet, the method comprising the steps of preparing:

[0048]a.将配方中的固态组分(奥替溴按、微晶纤维素、甘露醇、硬脂酸镁、微粉硅胶、糖精钠)分别粉碎成细度为80目以上的细粉;将配方量的PVP-K30配制成10%的PVP-K30乙醇(50% )溶液; . [0048] a solid component of the formula (otilonium Press, microcrystalline cellulose, mannitol, magnesium stearate, aerosil, sodium saccharin) were pulverized to a fineness of 80 mesh or finer powder; the amount of PVP-K30 formulation formulated as a 10% PVP-K30 in ethanol (50%) solution;

[0049] b.取配方量的西甲硅油与微晶纤维素混合均匀;再与处方量奥替溴铵、甘露醇、 糖精钠混合均匀;加入10%PVP-K30乙醇溶液制成软材,过20目筛制粒,50°C干燥,然后过20目筛整粒; [0049] b taken formula amount of simethicone mixed with microcrystalline cellulose; again to the prescription amount otilonium bromide, mannitol, sodium saccharin mixed; was added 10% PVP-K30 in ethanol obtain a soft material, through 20 mesh sieve granulator, 50 ° C and dried, then passed through a 20 mesh sieve;

[0050] C.将配方量的香精均匀喷在步骤b整粒的干颗粒表面,用密封袋密封片刻,再加入配方量的硬脂酸镁、微粉硅胶,混匀,压片,得西甲硅油奥替溴铵咀嚼片片芯; [0050] C. The formula amount of perfume was sprayed uniformly dry particles of step b whole surface of the bag sealed with a sealing moment, then add formula amount of magnesium stearate, aerosil, mixing, tabletting to give simethicone otilonium bromide chewable tablet core;

[0051]d.将防潮薄膜包衣剂甲基纤维素用乙醇溶解制成质量分数为13%的溶液,然后对西甲硅油奥替溴铵咀嚼片片芯进行包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 [0051] d. The moisture-proof film coating agent made of methyl cellulose dissolved in ethanol content of 13% solution, and then coated on the simethicone for Austria bromide chewable tablet core and dried to obtain Spanish i.e. silicone otilonium bromide chewable tablets.

[0052] 质量检查:本实施例制得的西甲硅油奥替溴铵咀嚼片表面光洁、色泽均匀;口感良好,有香味;硬度为6. 3-7. 8kg;溶出度检查:30分钟时,西甲硅油的溶出度为76. 9%,奥替溴铵的溶出度为80.0%。 [0052] QA: Auburn simethicone alternative embodiment bromide prepared chewable surface must be smooth; good taste, flavor; hardness 6. 3-7 8kg; dissolution test: 30 minutes, dissolution of simethicone was 76.9%, otilonium bromide dissolution of 80.0%.

[0053] 实施例4 [0053] Example 4

[0054] 西甲硅油奥替溴铵咀嚼片,具体配方如下: [0054] Simethicone otilonium bromide chewable tablet, the following specific formulations:

[0055] 西甲娃油125.0g; [0055] 125.0 g Spanish baby oil;

[0056] 奥替溴铵40.0g; 磷酸氢钙125.0g; 玉米淀粉192.0g: 葡萄糖420.0g; 10 (wt) %淀粉楽(以淀粉计)25.7g; 硬脂酸镁5.6g; 阿司巴坦55.0g; 香精1.4g; 羟丙基甲基纤维素36g; [0056] 40.0 g of otilonium bromide; calcium hydrogen phosphate 125.0 g; Corn starch 192.0g: glucose 420.0g; 10 (wt)% yue starch (starch basis) 25.7 g; 5.6 g magnesium stearate; astemizole bar Tan 55.0 g; 1.4 g of flavor; 36g hydroxypropyl methylcellulose;

[0057] 将上述配方制成1000片西甲硅油奥替溴铵咀嚼片,制备方法包括如下步骤: [0057] The above formulation was prepared simethicone 1000 otilonium bromide chewable tablet, the method comprising the steps of preparing:

[0058]a.将配方中的固态组分(奥替溴铵、磷酸氢钙、玉米淀粉、葡萄糖、硬脂酸镁、阿司巴坦)分别粉碎成细度为80目以上的细粉; . [0058] a solid component of the formula (otilonium bromide, calcium hydrogen phosphate, corn starch, glucose, magnesium stearate, astemizole TAZ) were pulverized into a fineness of 80 mesh or finer powder;

[0059] b.取配方量的西甲硅油与磷酸氢钙混合均匀;再与配方量的奥替溴铵、玉米淀粉、葡萄糖、阿司巴坦混合均匀;加入10%淀粉浆制成软材,过20目筛制粒,40°C干燥,然后过20目筛整粒; [0059] b taken formula amount of simethicone mixed with dicalcium phosphate; again to the formula amount of otilonium bromide, corn starch, glucose, astemizole TAZ mixed; 10% starch paste made of soft material, granulated through a 20 mesh sieve, 40 ° C and dried, then passed through a 20 mesh sieve;

[0060] C.将配方量的香精均匀喷在步骤b整粒的干颗粒表面,用密封袋密封片刻,再加入配方量的硬脂酸镁,混匀,压片,即得西甲硅油奥替溴铵咀嚼片片芯; [0060] C. The formula amount of perfume was sprayed uniformly dry particles of step b whole surface of the bag sealed with a sealing moment, then add formula amount of magnesium stearate, mixing, tabletting, simethicone obtain otilonium bromide chewable tablet core;

[0061] d.将防潮薄膜包衣剂羟丙基甲基纤维素用乙醇溶解制成质量分数为13%的溶液,然后对西甲硅油奥替溴铵咀嚼片片芯包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 [0061] d. The moisture-proof film coating agent is hydroxypropyl methyl cellulose dissolved in ethanol was prepared mass fraction of 13% solution, then otilonium bromide Simethicone Chewable tablet cores were coated, dried, i.e., Ltd. We have simethicone chewable otilonium bromide.

[0062] 质量检查:本实施例制得的西甲硅油奥替溴铵咀嚼片表面光洁、色泽均匀;口感良好,有香味;硬度为6.5-8. 0kg ;溶出度检查:30分钟时,西甲硅油的溶出度为77.4%,奥替溴铵的溶出度为79. 8%。 [0062] QA: Auburn simethicone alternative embodiment bromide prepared chewable surface must be smooth; good taste, flavor; hardness 6.5-8 0kg; dissolution test: 30 minutes, simethicone the dissolution rate was 77.4%, otilonium bromide dissolution was 79.8%.

[0063] 实施例5 [0063] Example 5

[0064] 西甲硅油奥替溴铵咀嚼片,具体配方如下: [0064] Simethicone otilonium bromide chewable tablet, the following specific formulations:

[0065] 西甲硅油125.0g; 奥替溴铵40.0g; 微晶纤维素165.0g; 预胶化淀粉150.0g; 鹿糖226.4g; [0065] Simethicone 125.0 g; 40.0 g of otilonium bromide; 165.0 g microcrystalline cellulose; pregelatinized starch 150.0 g; 226.4 g sugar deer;

[0066] 葡萄糖200.0g; 10 (wt) %淀粉浆(以淀粉计)24.3g; 硬脂酸镁5.4g; 糖精钠52.7g; 香精L5g; 甲基纤维素34g; [0066] Glucose 200.0g; 10 (wt)% starch slurry (starch basis) 24.3 g of; 5.4 g of magnesium stearate; 52.7 g of sodium saccharin; L5G flavor; methylcellulose 34g;

[0067]将上述配方制成1000片西甲硅油奥替溴铵咀嚼片,制备方法包括如下步骤: [0067] The above formulation was prepared simethicone 1000 otilonium bromide chewable tablet, the method comprising the steps of preparing:

[0068] a.将配方中固态组分(奥替溴按、微晶纤维素、预胶化淀粉、鹿糖、葡萄糖、硬脂酸镁、糖精钠)分别粉碎成细度为80目以上的细粉; [0068] a. The solid component formulation (otilonium Press, microcrystalline cellulose, pregelatinized starch, deer, glucose, magnesium stearate, sodium saccharin) were pulverized into a fineness of 80 mesh or more powder;

[0069] b.取配方量的西甲硅油与微晶纤维素混合均匀;再与配方量的奥替溴铵、预胶化淀粉、蔗糖、葡萄糖、糖精钠混合均匀;加入10%淀粉浆制成软材,过20目筛制粒,60°C干燥,然后过20目筛整粒; [0069] b taken formula amount of simethicone uniformly mixed with microcrystalline cellulose; again to the formula amount of otilonium bromide, pregelatinized starch, sucrose, glucose, saccharin were also mixed uniformly; 10% starch paste prepared soft material, granulated through a 20 mesh sieve, 60 ° C and dried, then passed through a 20 mesh sieve;

[0070] c.将配方量的香精均匀喷在步骤b整粒的干颗粒表面,用密封袋密封片刻,再加入配方量的硬脂酸镁,混匀,压片,即得西甲硅油奥替溴铵咀嚼片片芯; [0070] c. The formula amount of perfume was sprayed uniformly dry particles of step b whole surface of the bag sealed with a sealing moment, then add formula amount of magnesium stearate, mixing, tabletting, simethicone obtain otilonium bromide chewable tablet core;

[0071] d.将防潮薄膜包衣剂甲基纤维素用乙醇溶解制成质量分数为13%的溶液,然后对西甲硅油奥替溴铵咀嚼片片芯进行包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 [0071] d. The moisture-proof film coating agent made of methyl cellulose dissolved in ethanol content of 13% solution, and then coated on the simethicone for Austria bromide chewable tablet core and dried to obtain Spanish i.e. silicone otilonium bromide chewable tablets.

[0072]质量检查:本实施例制得的西甲硅油奥替溴铵咀嚼片表面光洁、色泽均匀;口感良好,有香味;硬度为6.0-7. 9kg ;溶出度检查:30分钟时,西甲硅油的溶出度为78. 5%,奥替溴铵的溶出度为80. 3%。 [0072] QA: Auburn simethicone alternative embodiment bromide prepared chewable surface must be smooth; good taste, flavor; hardness 6.0-7 9kg; dissolution test: 30 minutes, simethicone dissolution of 78.5%, otilonium bromide dissolution was 80.3%.

[0073]上述实施例中,吸附剂除了可以使用玉米淀粉、微晶纤维素和磷酸氢钙外,还可以使用糊精;填充剂除了使用玉米淀粉、蔗糖、微晶纤维素、预胶化淀粉、葡萄糖和甘露醇外, 还可以使用乳糖、木糖醇、麦芽糖醇;润滑剂除了使用硬脂酸镁和微粉硅胶外,还可以使用滑石粉;粘合剂除了使用PVP-K30和淀粉浆外,还可以使用低取代羟丙基纤维;矫味剂除了使用阿司巴坦和糖精钠外,还可以使用甜菊素和香兰素。 [0073] In the above embodiment, the adsorbent may be used in addition to corn starch, microcrystalline cellulose and dibasic calcium phosphate external, may be used dextrin; fillers except that corn starch, sucrose, microcrystalline cellulose, pregelatinized starch , than glucose and mannitol, may also be used lactose, xylitol, maltitol; except the lubricant magnesium stearate and micronized silica gel, the talc may be used; outer adhesive except starch and PVP-K30 , may also be used a low-substituted hydroxypropyl cellulose; flavoring agents except that astemizole and tazobactam sodium saccharin, but may also be used steviosin and vanillin.

[0074]最后说明的是,以上优选实施例仅用以说明本发明的技术方案而非限制,尽管通过上述优选实施例已经对本发明进行了详细的描述,但本领域技术人员应当理解,可以在形式上和细节上对其作出各种各样的改变,而不偏离本发明权利要求书所限定的范围。 [0074] Finally is noted that the foregoing preferred embodiments are intended to illustrate and not limit the present invention, although the invention has been described in detail by the above preferred embodiments, those skilled in the art will appreciate, it may be It is made various changes in form and detail without departing from the scope of the claims of the invention as defined.

Claims (9)

1. 西甲硅油奥替溴铵咀嚼片,其特征在于,按质量份计由以下组分组成:西甲硅油12. 5份、奥替溴铵4份、吸附剂10-40份、填充剂25-75份、黏合剂0. 2-10份、润滑剂0. 2-5. 0份、矫味剂0. 5-10份、芳香剂0. 05-0. 5份和防潮膜包衣剂1. 5-7. 5份。 1. Simethicone Chewable otilonium bromide, wherein parts by mass of the following components: 12.5 parts of simethicone, otilonium bromide 4 parts, 10-40 parts adsorbent, a filler 25 75 parts, 0. 2-10 parts by adhesives, lubricants 0. 2-5. 0 parts, 0.5 to 10 parts flavoring, perfuming 0. 05-0. 5 parts of a film-coating agent and moisture 5-7. 5 parts.
2. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于,按质量份计由以下组分组成:西甲硅油12. 5份、奥替溴铵4份、吸附剂16-32份、填充剂42-57. 64份、黏合剂2-2. 6份、润滑剂0. 5-0. 6份、矫味剂5. 2-5. 5份、芳香剂0. 14-0. 15份和防潮膜包衣剂3. 3-3. 6 份。 According to the claim 1 for Austria simethicone chewable bromide, wherein parts by mass of the following components: 12.5 parts of simethicone, 4 parts of otilonium bromide, adsorbents 16-32 parts filler 42-57. 64 parts of a binder 2-2. 6 parts, lubricants 0. 5-0. 6 parts, 5. 2-5. 5 parts flavoring, perfuming 0. 14-0 15 parts of moisture-proof film-coating agent and 3. 3-3. 6 parts.
3. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于:所述吸附剂为玉米淀粉、微晶纤维素、糊精、磷酸氢钙中的一种或几种。 According to the claim 1 for Austria simethicone chewable bromide, wherein: said one or more adsorbent corn starch, microcrystalline cellulose, dextrin, calcium hydrogen phosphate is from.
4. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于:所述填充剂为玉米淀粉、蔗糖、微晶纤维素、预胶化淀粉、葡萄糖、乳糖、甘露醇、木糖醇、麦芽糖醇中的一种或几种。 According to the claim 1 for Austria simethicone bromide chewable, characterized in that: the filler is corn starch, sucrose, microcrystalline cellulose, pregelatinized starch, glucose, lactose, mannitol, xylose maltitol one or several.
5. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于:所述润滑剂为硬脂酸镁、滑石粉、微粉硅胶中的一种或几种。 According to the claim 1 for Austria simethicone chewable bromide, wherein: said lubricant is magnesium stearate, talc, silica powder is one or several.
6. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于:所述黏合剂为PVP-K30、淀粉浆、低取代羟丙基纤维中的一种或几种。 According to the claim 1 for Austria simethicone bromide chewable, characterized in that: said binder one or more substituted hydroxypropyl cellulose is from PVP-K30, starch, low.
7. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于:所述矫味剂为阿司巴坦、甜菊素、糖精钠、香兰素中的一种或几种。 According to the claim 1 for Austria simethicone bromide chewable, characterized in that: the flavoring agent is astemizole tazobactam, steviosin, sodium saccharin, one or more of vanillin.
8. 根据权利要求1所述西甲硅油奥替溴铵咀嚼片,其特征在于:所述防潮膜包衣剂为羟丙基甲基纤维素、甲基纤维素、羟乙基纤维素、羟丙基纤维素中的一种。 8. Alternatively chewable bromide, according to claim 1 wherein simethicone Austrian wherein: said moistureproof film-coating agent is hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl a cellulose group of.
9. 权利要求1〜8任一项所述西甲硅油奥替溴铵咀嚼片的制备方法,其特征在于,包括以下步骤: a. 粉碎:将处方中的固态组分分别粉碎成粒度为80目以上的细粉; b. 制粒:取配方量的西甲硅油与吸附剂混合均匀,再加入填充剂、奥替溴铵和矫味剂混合均匀,混匀后加入黏合剂制成软材,将软材过20目筛制粒,接着在40〜60°C下干燥,最后过20目筛整粒; c. 压片:将芳香剂均匀喷入步骤b整粒的干颗粒中混合均匀,再加入处方量的润滑剂, 混匀,压片,即得西甲硅油奥替溴铵咀嚼片片芯; d. 包衣:将防潮薄膜包衣剂用乙醇溶解制成质量分数为6-18%的溶液,对步骤c所得西甲硅油奥替溴铵咀嚼片片芯进行包衣,干燥,即制得西甲硅油奥替溴铵咀嚼片。 9. The Austrian simethicone to any one of claims 1~8 bromide for preparing a chewable tablet, characterized in that it comprises the steps of: a pulverization: The formulation of the solid components are pulverized into a particle size of 80 mesh more fines; B granulation: simethicone to adsorbent is uniformly mixed to take the formulation amount, then add filler, otilonium bromide, and flavoring agent were uniformly mixed, added after mixing a binder made of soft material, will soft material granulated with 20 mesh sieve, then dried at 40~60 ° C, and finally through a 20 mesh sieve; tabletting C: the fragrance is sprayed into a uniform dry particles of step b sieved uniformly mixed, prescribed amount of lubricant is added, mixing, tabletting, to obtain otilonium bromide simethicone chewable tablet core; D coating: the moisture resistant film coating agents dissolved in ethanol was made 6-18% of the mass fraction of solution, obtained in step c simethicone chewable bromide for Austria for tablet cores were coated, dried, i.e. to obtain simethicone chewable otilonium bromide.
CN 201510004527 2015-01-06 2015-01-06 Simethicone otilonium bromide chewable tablets and preparing method thereof CN104523717A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3173076A1 (en) * 2015-05-14 2017-05-31 Abdi Ibrahim Ilac Sanayi ve Ticaret A.S. A pharmaceutical composition comprising simethicone and otilonium

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000076478A1 (en) * 1999-06-14 2000-12-21 Cosmo S.P.A. Controlled release and taste masking oral pharmaceutical compositions
WO2010092436A1 (en) * 2009-02-12 2010-08-19 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical combinations of simethicone and otilonium
CN102018721A (en) * 2009-09-23 2011-04-20 黄石李时珍药业集团武汉李时珍药业有限公司 Chewable tablet of calcium carbonate dimeticone and preparation process

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000076478A1 (en) * 1999-06-14 2000-12-21 Cosmo S.P.A. Controlled release and taste masking oral pharmaceutical compositions
WO2010092436A1 (en) * 2009-02-12 2010-08-19 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical combinations of simethicone and otilonium
CN102018721A (en) * 2009-09-23 2011-04-20 黄石李时珍药业集团武汉李时珍药业有限公司 Chewable tablet of calcium carbonate dimeticone and preparation process

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
吕作培等: "结肠镜检查术前应用奥替溴铵的效果观察", 《浙江实用医学》 *
周志宏等: "奥替溴铵治疗肠易激综合征的疗效观察", 《胃肠病学》 *
张宏博等: "奥替溴铵、比特诺尔和复方地芬诺酯治疗肠易激综合征的双盲随机对照研究", 《中国临床药理学杂志》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3173076A1 (en) * 2015-05-14 2017-05-31 Abdi Ibrahim Ilac Sanayi ve Ticaret A.S. A pharmaceutical composition comprising simethicone and otilonium

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