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CN104623678A - Novel matrix formula and production method of bisacodyl suppository - Google Patents

Novel matrix formula and production method of bisacodyl suppository Download PDF

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CN104623678A
CN104623678A CN201510097876.7A CN201510097876A CN104623678A CN 104623678 A CN104623678 A CN 104623678A CN 201510097876 A CN201510097876 A CN 201510097876A CN 104623678 A CN104623678 A CN 104623678A
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bisacodyl
suppository
matrix
fatty acid
semi
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沈立
郝静梅
韩怡
鲁曼曼
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Pharmaceutical Co Ltd China Univ Of Pharmacy
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Pharmaceutical Co Ltd China Univ Of Pharmacy
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Abstract

本发明涉及一种关于比沙可啶栓的新基质处方和制备方法,属于医药技术领域。本发明采用的辅料为油脂性基质,基质以半合成脂肪酸甘油酯类为主。本发明的制备方法如下:称取处方量基质,水浴加热融化,再加入处方量比沙可啶,水浴加热搅拌溶解后,进行灌装。本发明解决了目前国内上市的比沙可啶产品存在的腹痛等不良反应,很多患者不能耐受的问题。大大提高了比沙可啶栓剂质量的稳定性。使用本发明的油脂性基质的产品色谱图无不明杂质峰出现。The invention relates to a new matrix prescription and preparation method of bisacodyl suppository, belonging to the technical field of medicine. The auxiliary material adopted in the present invention is an oily matrix, and the matrix is mainly semi-synthetic fatty acid glycerides. The preparation method of the present invention is as follows: take the substrate of the prescribed amount, heat and melt in a water bath, then add the prescribed amount of bisacodyl, heat and stir in a water bath to dissolve, and then carry out filling. The invention solves the problem that many patients cannot tolerate adverse reactions such as abdominal pain in the current domestic marketed bisacodyl products. The quality stability of the bisacodyl suppository is greatly improved. No unknown impurity peaks appear in the product chromatograms using the oily base of the present invention.

Description

一种比沙可啶栓的新基质处方及生产方法A kind of new matrix prescription and production method of bisacodyl suppository

技术领域technical field

本发明涉及一种关于比沙可啶栓的新基质处方和制备方法,属于医药技术领域。The invention relates to a new matrix prescription and preparation method of bisacodyl suppository, belonging to the technical field of medicine.

背景技术Background technique

比沙可啶是一种接触性缓泻药,直接作用于大肠,刺激其感觉神经末梢,引起直肠反射性蠕动增强而导致排便。临床上用于急、慢性便秘及习惯性便秘,比沙可啶已经收录到美国、欧洲及日本等多国药典,具有确切的临床疗效。Bisacodyl is a contact laxative that acts directly on the large intestine, stimulating its sensory nerve endings, causing increased rectal reflex peristalsis, leading to defecation. It is clinically used for acute and chronic constipation and habitual constipation. Bisacodyl has been included in the pharmacopoeias of the United States, Europe and Japan, and has definite clinical curative effect.

目前国内上市的比沙可啶产品有肠溶片剂和栓剂,肠溶片为口服剂型,存在腹痛等不良反应,很多患者不能耐受。而外用栓剂剂型通过直肠给药,无腹痛不良反应,对卧床病人和老年人便秘患者及不便于口服用药的患者使用更加方便。但是目前CFDA批准的比沙可啶栓的基质均为水溶性基质,市售栓剂基质水溶性基质一般采用如聚已二醇类、甘油明胶等。对使用该类水溶性基质的产品稳定性进行考察发现,其色谱图会产生不明杂质峰,分析其原因可能为水溶性基质,破坏了比沙可啶的化学结构,故水溶性基质对药物质量和稳定性造成一定的风险。Currently, bisacodyl products on the domestic market include enteric-coated tablets and suppositories. Enteric-coated tablets are oral dosage forms, which have adverse reactions such as abdominal pain, and many patients cannot tolerate them. The suppository dosage form for external use is administered rectally, without adverse reactions of abdominal pain, and is more convenient for bedridden patients, elderly patients with constipation and patients who are inconvenient to take medication orally. However, the bases of bisacodyl suppositories approved by the CFDA are all water-soluble bases, and commercially available suppository bases are generally water-soluble bases such as polyethylene glycols and glycerin gelatin. The stability of the product using this type of water-soluble matrix is investigated and found that its chromatogram will produce unknown impurity peaks. The reason for the analysis may be that the water-soluble matrix destroys the chemical structure of bisacodyl, so the water-soluble matrix has a great impact on the quality of the drug and Stability poses certain risks.

经过对比沙可啶相关专利的检索发现,例如:公开号CN1118571A,发明名称:《比沙可啶剂型》,申请(专利权)人:普罗克特和甘保尔公司,其申报内容为剂量单位形式的药物组合物,口服用于人或具有胃肠道(中间有腔,具有小肠和结肠并且之间连接起来)的低等动物。再例如:比沙可啶滴丸及其制备方法,公开号:CN1528299A6申请人:南昌弘益科技有限公司,申报内容通过应用超微粉碎和滴丸剂生产工艺技术制成的比沙可啶滴丸,可以达到提高崩解溶散速度,起效迅速,提高药物稳定性,减少辅料用量,降低生产成本,携带和服用方便的目的。它既可以含服也可以吞服,依从性好,特别适合于儿童、老年人、卧床病人和吞咽困难...。国内涉及比沙可啶的专利一般为口服肠溶剂型的相关技术专利,未涉及外用制剂的处方和方法。欧洲专利局和美国专利局未检索到相关专利。Through the retrieval of bisacodyl-related patents, it is found, for example: publication number CN1118571A, title of invention: "Bisacodyl dosage form", applicant (patent right): Proctor and Gambol Company, and the declared content is in the form of dosage units The pharmaceutical composition of the invention is orally used for humans or lower animals with a gastrointestinal tract (with a cavity in the middle, with a small intestine and a colon connected therebetween). Another example: Bisacodyl dripping pills and its preparation method, publication number: CN1528299A6 Applicant: Nanchang Hongyi Technology Co., Ltd., the content of the declaration is made by applying ultrafine pulverization and dropping pill production technology, can be To achieve the purpose of improving disintegration and dissolution speed, rapid onset of effect, improving drug stability, reducing the amount of auxiliary materials, reducing production costs, and being convenient to carry and take. It can be swallowed or swallowed with good compliance, especially suitable for children, the elderly, bedridden patients and dysphagia...  Domestic patents involving bisacodyl are generally related to oral enteric agent technology patents, and do not involve the prescription and method of external preparations. No related patents were found by the European Patent Office and the US Patent Office.

发明内容Contents of the invention

针对现有技术中存在的问题,本发明提供了一种新的比沙可啶栓的基质和制备方法,解决比沙可啶栓质量稳定性进一步提高的问题。Aiming at the problems existing in the prior art, the present invention provides a new bisacodyl suppository matrix and a preparation method to solve the problem of further improving the quality stability of the bisacodyl suppository.

本发明采用的辅料为油脂性基质,采用半合成脂肪酸甘油酯或氢化植物油类,包含半合成椰油酯、混合脂肪酸甘油酯(硬脂)、硬脂酸丙二醇酯、半合成脂肪酸酯,或氢化植物油类,以混合脂肪酸甘油酯(硬脂)为最优。The adjuvant used in the present invention is an oily base, using semi-synthetic fatty acid glycerides or hydrogenated vegetable oils, including semi-synthetic coconut oil esters, mixed fatty acid glycerides (stearin), propylene glycol stearate, semi-synthetic fatty acid esters, or Hydrogenated vegetable oils, preferably mixed fatty acid glycerides (stearin).

本发明采用的处方比例,主药成分含量0.2-1%:基质成分=1:149为99.8-99%;基质以半合成脂肪酸甘油酯为主。The formula ratio adopted in the present invention is that the main ingredient content is 0.2-1%: the matrix component=1:149 is 99.8-99%; the matrix is mainly semi-synthetic fatty acid glyceride.

基质组成比例包含:混合脂肪酸甘油酯、硬质或其他油脂类基质99.8-99%。The matrix composition ratio includes: 99.8-99% of mixed fatty acid glyceride, hard or other oily matrix.

本发明的制备方法如下:称取处方量基质,水浴45-85℃加热融化,再加入处方量比沙可啶,水浴45-85℃加热搅拌1-5小时溶解后,进行灌装。The preparation method of the present invention is as follows: weigh the matrix of the prescription amount, heat and melt in a water bath at 45-85°C, then add the prescription amount of bisacodyl, heat and stir in a water bath at 45-85°C for 1-5 hours to dissolve, and then fill it.

本发明采用的比沙可啶含量检测方法为高效液相色谱法,其检验步骤和条件如下:流动相:醋酸钠水溶和乙腈的混合溶液(30-55:30-55)以(55:45为优)。The bisacodyl content detection method that the present invention adopts is high performance liquid chromatography, and its inspection steps and conditions are as follows: mobile phase: sodium acetate water-soluble and the mixed solution (30-55:30-55) of acetonitrile with (55:45 as excellent).

供检定样品的制备:称大约含有100mg比沙可啶栓剂至500mL的分液漏斗中,加入150mL的正己烷后振摇至栓剂全部溶解。加入50mL的乙腈,振荡1分钟使溶液分层。排出下层溶液至200mL容量瓶中,两次分别用50mL乙腈萃取仍在分液漏斗中的正己烷层后,排出合并至含有下层溶液的容量瓶中。用乙腈稀释定容容量瓶中的混合萃取物,振匀,过滤。Preparation of test samples: Weigh approximately 100 mg bisacodyl suppository into a 500 mL separating funnel, add 150 mL of n-hexane and shake until the suppository is completely dissolved. Add 50 mL of acetonitrile and shake for 1 min to separate the layers. Drain the lower layer solution into a 200mL volumetric flask, extract the n-hexane layer still in the separatory funnel twice with 50mL acetonitrile respectively, then discharge and merge into the volumetric flask containing the lower layer solution. Dilute the mixed extracts in the volumetric flask with acetonitrile, shake well, and filter.

色谱系统:含有L1(十八烷基键合多孔硅胶或无机氧化物微粒固定相,简称C18或ODS)填料的3.9mm×30cm的色谱柱,流速为1-3mL/min。先分析标准品的色谱图,记录下步骤中所对应的:1.拖尾因子(对称因子)不大于2.0;2.重复进样的相对标准偏差不大于2.0%的峰。Chromatography system: a 3.9mm×30cm chromatographic column containing L1 (octadecyl bonded porous silica gel or inorganic oxide particulate stationary phase, referred to as C18 or ODS) packing, with a flow rate of 1-3mL/min. First analyze the chromatogram of the standard, and record the corresponding peaks in the steps: 1. The tailing factor (symmetry factor) is not greater than 2.0; 2. The relative standard deviation of repeated injections is not greater than 2.0%.

步骤:分别将相同体积(约10μL)制备好的标准品和供检定样品注射入色谱仪中,记录下色谱图、测出主峰的峰值响应,通过下列公式计算出栓剂中含有C22H19NO4的量(mg):200C(ru/rs),其中C为比沙可啶标准品浓度(mg/mL),ru和rs分别为制备好的供检定样品和标准品的峰值响应。Steps: inject the same volume (about 10 μL) of the prepared standard and the test sample into the chromatograph, record the chromatogram, measure the peak response of the main peak, and calculate the amount of C 22 H 19 NO contained in the suppository by the following formula The amount of 4 (mg): 200C (ru/rs), wherein C is the bisacodyl standard concentration (mg/mL), ru and rs are the peak response of the prepared sample and standard for verification respectively.

本发明具有以下有益效果:本发明大大提高了产品的稳定性,解决了目前国内上市的比沙可啶产品存在的腹痛等不良反应,很多患者不能耐受的问题,对卧床病人和老年人便秘患者及不便于口服用药的患者使用更加方便。通过对储存0,6,12个月的使用本发明油脂性基质和市售水溶性基质稳定性对比考察试验发现,使用本发明的油脂性基质的产品无不明斑点出现。The present invention has the following beneficial effects: the present invention greatly improves the stability of the product, solves the adverse reactions such as abdominal pain in the current domestic marketed bisacodyl products, and the problem that many patients cannot tolerate it, and is suitable for bedridden patients and elderly patients with constipation. It is more convenient for patients who are not convenient for oral medication. By comparing the stability of the oily base of the present invention with that of the commercially available water-soluble base after storage for 0, 6, and 12 months, it was found that the product using the oily base of the present invention has no unidentified spots.

附图说明Description of drawings

图1:脂溶性基质与水溶性基质放置9月后产品图谱。Figure 1: Product map of fat-soluble matrix and water-soluble matrix after 9 months.

具体实施方式Detailed ways

实施例1:通过对储存0,6,12个月的使用本发明油脂性基质和市售水溶性基质稳定性对比考察试验发现,使用本发明的油脂性基质的产品无不明斑点出现。Example 1: Through the comparative investigation of the stability of the oily base of the present invention and the commercially available water-soluble base stored for 0, 6, and 12 months, it was found that the product using the oily base of the present invention has no unidentified spots.

实施例2:比沙可啶栓制备处方组成及制备方法。Embodiment 2: Bisacodyl suppository preparation prescription composition and preparation method.

比沙可啶0.01g*1000粒=10g;Bisacodyl 0.01g*1000 grains=10g;

混合脂肪酸甘油酯1.49g*1000粒=1490g;Mixed fatty acid glycerides 1.49g*1000 grains=1490g;

称量1490g混合脂肪酸甘油酯在50-85℃水浴加热融化;Weigh 1490g of mixed fatty acid glycerides and melt in a water bath at 50-85°C;

加入处方量的比沙可啶;Add the prescribed amount of bisacodyl;

50-85℃水浴加热搅拌1-5小时,使主药混合均匀;Heat and stir in a water bath at 50-85°C for 1-5 hours to mix the main ingredients evenly;

40-50℃灌装。Filling at 40-50°C.

实例3:比沙可啶栓制备处方组成及制备方法。Example 3: Bisacodyl suppository preparation prescription composition and preparation method.

比沙可啶:0.01g*1000粒=10gBisacodyl: 0.01g*1000 grains=10g

硬酯:0.99g*1000粒=990gStearic ester: 0.99g*1000 grains=990g

称量990g硬酯在50-85℃水浴加热融化;Weigh 990g of stearate and melt in a water bath at 50-85°C;

加入处方量的比沙可啶;Add the prescribed amount of bisacodyl;

50-85℃水浴加热搅拌1-5小时,使主药混合均匀;Heat and stir in a water bath at 50-85°C for 1-5 hours to mix the main ingredients evenly;

40-50℃灌装。Filling at 40-50°C.

实施例4:本发明采用的比沙可啶含量检测方法为高效液相色谱法,其检验步骤和条件如下:流动相:醋酸钠水溶和乙腈的混合溶液(30-55:30-55)以(55:45为优)。Embodiment 4: the bisacodyl content detection method that the present invention adopts is high performance liquid chromatography, and its inspection steps and conditions are as follows: Mobile phase: the mixed solution (30-55:30-55) of sodium acetate water-soluble and acetonitrile with ( 55:45 is excellent).

供检定样品的制备:称大约含有100mg比沙可啶栓剂至500mL的分液漏斗中,加入150mL的正己烷后振摇至栓剂全部溶解。加入50mL的乙腈,振荡1分钟使溶液分层。排出下层溶液至200mL容量瓶中,两次分别用50mL乙腈萃取仍在分液漏斗中的正己烷层后,排出合并至含有下层溶液的容量瓶中。用乙腈稀释定容容量瓶中的混合萃取物,振匀,过滤。Preparation of test samples: Weigh approximately 100 mg bisacodyl suppository into a 500 mL separating funnel, add 150 mL of n-hexane and shake until the suppository is completely dissolved. Add 50 mL of acetonitrile and shake for 1 min to separate the layers. Drain the lower layer solution into a 200mL volumetric flask, extract the n-hexane layer still in the separatory funnel twice with 50mL acetonitrile respectively, then drain and merge into the volumetric flask containing the lower layer solution. Dilute the mixed extracts in the volumetric flask with acetonitrile, shake well, and filter.

色谱系统:含有L1(十八烷基键合多孔硅胶或无机氧化物微粒固定相,简称C18或ODS)填料的3.9mm×30cm的色谱柱,流速为1-3mL/min。先分析标准品的色谱图,记录下步骤中所对应的:1.拖尾因子(对称因子)不大于2.0;2.重复进样的相对标准偏差不大于2.0%的峰。Chromatography system: a 3.9mm×30cm chromatographic column containing L1 (octadecyl bonded porous silica gel or inorganic oxide particulate stationary phase, referred to as C18 or ODS) packing, with a flow rate of 1-3mL/min. First analyze the chromatogram of the standard, and record the corresponding peaks in the steps: 1. The tailing factor (symmetry factor) is not greater than 2.0; 2. The relative standard deviation of repeated injections is not greater than 2.0%.

步骤:分别将相同体积(约10μL)制备好的标准品和供检定样品注射入色谱仪中,记录下色谱图、测出主峰的峰值响应,通过下列公式计算出栓剂中含有C22H19NO4的量(mg):200C(ru/rs),其中C为比沙可啶标准品浓度(mg/mL),ru和rs分别为制备好的供检定样品和标准品的峰值响应。Steps: inject the same volume (about 10 μL) of the prepared standard and the test sample into the chromatograph, record the chromatogram, measure the peak response of the main peak, and calculate the amount of C 22 H 19 NO contained in the suppository by the following formula The amount of 4 (mg): 200C (ru/rs), wherein C is the bisacodyl standard concentration (mg/mL), ru and rs are the peak response of the prepared sample and standard for verification respectively.

上述实施例虽以具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。Although the above examples have described the present invention in detail with specific implementation methods and tests, it is obvious to those skilled in the art that some modifications or improvements can be made on the basis of the present invention. Therefore, the modifications or improvements made on the basis of not departing from the spirit of the present invention all belong to the protection scope of the present invention.

Claims (5)

1.一种采用新基质的比沙可啶栓的处方,其特征在于:重量百分比,主药含量0.2-1%:基质成分为99.8-99%;所述基质为油脂性基质,栓剂重量为0.5g-2g;所述主药为比沙可啶。1. A prescription for the bisacodyl suppository that adopts a new matrix, is characterized in that: percentage by weight, main ingredient content 0.2-1%: matrix composition is 99.8-99%; Described matrix is oily matrix, suppository weight is 0.5% g-2g; the main drug is bisacodyl. 2.根据权利要求1所述的比沙可啶栓的处方,其特征在于:所述油脂性基质为半合成脂肪酸甘油酯类包含半合成椰油酯、混合脂肪酸甘油酯(硬脂)、硬脂酸丙二醇酯、半合成脂肪酸酯及氢化植物油类。2. the prescription of bisacodyl suppository according to claim 1 is characterized in that: described oily matrix is that semi-synthetic fatty acid glycerides comprise semi-synthetic coconut oil ester, mixed fatty acid glyceride (stearin), stearin propylene glycol esters, semi-synthetic fatty acid esters and hydrogenated vegetable oils. 3.根据权利要求1所述的比沙可啶栓的处方,其特征在于:所述基质采用油脂性基质,半合成脂肪酸甘油酯类或氢化植物油类的一种或几种;其中半合成混合脂肪酸甘油酯类或氢化植物油类占比50-99.9%。3. The prescription of bisacodyl suppository according to claim 1 is characterized in that: the base adopts oily base, one or more of semi-synthetic fatty acid glycerides or hydrogenated vegetable oils; wherein the semi-synthetic mixed fatty acid Glycerides or hydrogenated vegetable oils account for 50-99.9%. 4.一种权利要求1至3之一所述的比沙可啶栓的生产方法,其特征在于,包括以下步骤:4. A production method of the bisacodyl suppository described in one of claims 1 to 3, characterized in that, comprising the following steps: 步骤一、称取处方量基质,水浴45-85℃加热融化;Step 1. Weigh the prescription amount matrix, heat and melt in a water bath at 45-85°C; 步骤二、加入处方量比沙可啶栓,水浴45-85℃加热Step 2: Add the prescribed amount of bisacodyl suppository and heat in a water bath at 45-85°C 步骤三、搅拌1-5小时;Step 3, stirring for 1-5 hours; 步骤四、比沙可啶溶解后,进行灌装。Step 4, after the bisacodyl is dissolved, it is filled. 5.一种权利要求4所述的比沙可啶含量检测方法,其特征在于:5. a method for detecting bisacodyl content as claimed in claim 4, characterized in that: 采用高效液相色谱法:流动相:醋酸钠水溶和乙腈的混合溶液(30-55:30-55);Adopt high-performance liquid chromatography: mobile phase: a mixed solution of sodium acetate water-soluble and acetonitrile (30-55:30-55); 供检定样品的制备:称大约含有100mg比沙可啶栓剂至500mL的分液漏斗中,加入150mL的正己烷后振摇至栓剂全部溶解;加入50mL的乙腈,振荡1分钟使溶液分层。排出下层溶液至200mL容量瓶中,两次分别用50mL乙腈萃取仍在分液漏斗中的正己烷层后,排出合并至含有下层溶液的容量瓶中;用乙腈稀释定容容量瓶中的混合萃取物,振匀,过滤;Preparation of test samples: Weigh approximately 100 mg of bisacodyl suppository into a 500 mL separating funnel, add 150 mL of n-hexane and shake until the suppository is completely dissolved; add 50 mL of acetonitrile and shake for 1 minute to separate the solution. Drain the lower layer solution into a 200mL volumetric flask, use 50mL acetonitrile to extract the n-hexane layer still in the separatory funnel twice, then discharge and merge into the volumetric flask containing the lower layer solution; dilute the mixed extraction in the constant volume volumetric flask with acetonitrile matter, vibrate, filter; 色谱系统:含有L1(十八烷基键合多孔硅胶或无机氧化物微粒固定相)填料的3.9mm×30cm的色谱柱,流速为1-3mL/min;先分析标准品的色谱图,记录下步骤中所对应的:1.拖尾因子(对称因子)不大于2.0;2.重复进样的相对标准偏差不大于2.0%的峰;Chromatography system: a 3.9mm×30cm chromatographic column containing L1 (octadecyl bonded porous silica gel or inorganic oxide particle stationary phase) packing, with a flow rate of 1-3mL/min; analyze the chromatogram of the standard first, and record Corresponding in the steps: 1. The tailing factor (symmetry factor) is not greater than 2.0; 2. The relative standard deviation of repeated injections is not greater than 2.0% of the peak; 分别将相同体积(约10μL)制备好的标准品和供检定样品注射入色谱仪中,记录下色谱图、测出主峰的峰值响应,通过下列公式计算出栓剂中含有C22H19NO4的量(mg):200C(ru/rs),其中C为比沙可啶标准品浓度(mg/mL),ru和rs分别为制备好的供检定样品和标准品的峰值响应。Inject the same volume (about 10 μL) of the prepared standard and the test sample into the chromatograph, record the chromatogram, measure the peak response of the main peak, and calculate the amount of C 22 H 19 NO 4 contained in the suppository by the following formula: Quantity (mg): 200C (ru/rs), where C is the concentration of the bisacodyl standard (mg/mL), ru and rs are the peak responses of the prepared sample and standard for verification, respectively.
CN201510097876.7A 2015-03-05 2015-03-05 Novel matrix formula and production method of bisacodyl suppository Pending CN104623678A (en)

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CN104856942A (en) * 2015-06-04 2015-08-26 烟台荣昌制药股份有限公司 Ciclopirox pessary and preparation method thereof
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