CN102961250B - Multi-component container and external preparation for treating acne - Google Patents

Multi-component container and external preparation for treating acne Download PDF

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CN102961250B
CN102961250B CN 201210381893 CN201210381893A CN102961250B CN 102961250 B CN102961250 B CN 102961250B CN 201210381893 CN201210381893 CN 201210381893 CN 201210381893 A CN201210381893 A CN 201210381893A CN 102961250 B CN102961250 B CN 102961250B
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parts
component
propylene glycol
ph
mixing
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CN 201210381893
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CN102961250A (en )
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林山
季玉华
何达
王松
何宇新
孙小伟
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江苏山信药业有限公司
成都山信药业有限公司
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Abstract

本发明提供了一种带混合装置的多组份容器。 The present invention provides a container with a multi-component mixing device. 本发明还提供了基于上述多组分容器的痤疮用外用制剂。 The present invention further provides a preparation for external use of acne based on the multi-component container. 本发明提供的外用制剂,能够有效避免Acanya复方制剂中有效成分的降解,显著提高各成分稳定性,无需冷藏即可延长制剂存放时间,降低了产品的贮藏成本,大大增加了产品的便携性和使用舒适度;同时,本发明提供的多组分容器,可以使药物混合挤出步骤在装置内部完成,不仅节省了时间,而且避免人为混合造成的产品不一致和浪费。 The external preparation provided by the present invention can effectively prevent the degradation of compound preparations Acanya active ingredient, significantly improve the stability of the components, the formulation without refrigeration storage time can be extended, reducing the cost of storage products, greatly increasing the portability of the product and the use of comfort; Meanwhile, the present invention provides a multi-component container, it is possible to complete the drug mixing the extrusion step within the device not only saves time, but also to avoid the waste of human inconsistency and mixing products caused.

Description

一种多组份容器及治疗痤疮的外用制剂 A multi-component container and the external preparation for treating acne

技术领域 FIELD

[0001] 本发明涉及一种多组份容器及治疗痤疮的外用制剂。 [0001] The present invention relates to a multi-component container and the external preparation for the treatment of acne.

背景技术 Background technique

[0002] 痤疮是一种常见的皮肤病,多发生于青春期,又叫青春痘,粉刺。 [0002] Acne is a common skin disease, occurs in puberty, also known as acne, acne. 痤疮发生的因素多种多样,但最直接的因素是毛孔堵塞,毛孔堵塞以后,毛囊里面的油脂排不出来,由于毛囊口被堵塞,毛囊管腔狭窄,形成缺氧状态,使毛囊内的厌氧菌大量增生,导致微生物失衡, 人体启动炎症介质,粉刺变红,就形成了痤疮。 Factors variety of acne, but the most direct factor is clogged pores after pore blockage, the grease inside follicles did not break out, since the port is blocked follicles, follicles stenosis, anoxic state, the hair follicles in the repulsive aerobic bacteria proliferated, leading to microbial imbalance, the body starts mediators of inflammation, acne red, on the formation of acne.

[0003] 现已有多种治疗痤疮的制剂,大部分为过氧化苯甲酰的单独制剂或是其与一些抗生素的组合物,但是单独使用过氧化苯甲酰存在刺激性问题,会引起皮肤的泛红而影响患者对初期痤疮改善的观察。 [0003] There are now a variety of preparations for treatment of acne, most of the benzoyl peroxide through separate formulations or compositions with antibiotics, but using benzoyl peroxide alone had irritating problems exist, it can cause skin redness and acne improved observation of the early patients affected. 因此,由于刺激物的问题,过氧化苯甲酰治疗对某些患者是无效的,而且过氧化苯甲酰用于治疗痤疮时,还会造成皮肤干燥、起皮等问题。 Accordingly, since the problem stimulus, benzoyl peroxide treatment is ineffective for some patients, but when benzoyl peroxide for treating acne, but also cause dry skin, peeling and other problems.

[0004] 由于过氧化苯甲酰存在的问题,医药工作者将过氧化苯甲酰与某些药物组合使用治疗痤疮,如美国专利4497794, 一种含过氧化苯甲酰和红霉素的组合物,该制剂的商品名为Benzamycin,被广泛用来治疗痤疮,在某些情况下被认为比单独使用过氧化苯甲酰更有效。 [0004] Because of the presence of benzoyl peroxide had problems, medical workers benzoyl peroxide certain drugs used in combination with the treatment of acne, as described in U.S. Patent No. 4,497,794, a combination of benzoyl peroxide and erythromycin containing too was tradename Benzamycin the formulation, is widely used to treat acne, in some cases is considered more efficient than benzoyl peroxide alone. 在此之后,美国Valeant制药公司生产上市含有克林霉素磷酸酯和过氧化苯甲酰这两种活性药物的凝胶复方制剂,是最新一代的抗痤疮凝胶复方制剂,商品名为Acanya,该产品出现不良反应的几率低于〇. 2%。 After that, the US pharmaceutical company Valeant listed contains clindamycin phosphate and benzoyl peroxide had a gel compound preparation of two active drugs, is the latest generation of anti-acne gel compound, trade name Acanya, the probability of adverse reactions product is lower than the square. 2%.

[0005] 但是,发明人研究发现,混合包装的Acanya复方凝胶剂中,克林霉素磷酸酯和过氧化苯甲酰的含量会快速降低,即表明该凝胶剂的稳定性存在缺陷。 [0005] However, the inventors found that mixed packaging Acanya gel compound, the amount of clindamycin phosphate and benzoyl peroxide will quickly decrease, i.e., is defective in the stability of the gel.

发明内容 SUMMARY

[0006] 为了解决上述问题,本发明的目的在于提供一种多组份容器。 [0006] In order to solve the above problems, an object of the present invention is to provide a multi-component container. 本发明的另一目的在于提供一种稳定性良好的痤疮外用制剂。 Another object of the present invention is to provide a good stable external preparation acne.

[0007] 本发明提供了一种带混合装置的多组份容器,包括至少两个单独的储料室,推进器,混合装置,其中所述推进器设置在底部外壳内,所述储料室设置在上部外壳内,所述储料室的上部设置有加料口和封盖,所述上部外壳滑动的嵌套在底部外壳内,所述储料室的底盖紧压在所述推进器上,所述混合装置设置在上部外壳的顶部,所述混合装置顶部侧面设置有出料口,所述混合装置的进料口与所述储料室的出料口连通。 [0007] The present invention provides a container with a multi-component mixing device, comprising at least two separate storage compartments, the pusher, a mixing device, wherein the pusher is provided in the bottom of the housing, the storage compartments disposed within the upper housing, the upper material storage chamber provided with a feed opening and closure, the upper housing is slidably nested within the bottom housing, the bottom cover of the storage compartment of the pusher is pressed against the top, the mixing means provided at the top of the upper housing, the mixing device is provided with a side discharge port, discharge port and said inlet of said storage compartment in communication with the mixing device.

[0008] 所述混合装置由圆筒外壳和内部的螺旋通道构成。 [0008] The mixing device is constituted by a cylindrical casing and a helical path inside.

[0009] 所述容器上部外壳的外侧面设置有刻度。 [0009] The outer side of the container upper portion of the housing is provided with a scale.

[0010] 更进一步的,所述推进器嵌套在所述混合装置的上部,设置在所述推进器的上部侧面的出料口通过管道与所述混合装置的出料口连通,所述推进器与所述混合装置之间设置有弹簧,所述弹簧是压簧,储料室内增设吸管,所述吸管的上端口与所述混合装置的进料口连通,所述吸管的下端口达所述储料室的底部。 [0010] Still further, the nesting of the upper portion of the pusher mixing means is provided at an upper side of the pusher through the discharge port in communication with the discharge opening of the mixing duct means, the propulsion between the mixing device is provided with a spring, the spring is a compression spring, an additional material storage chamber a straw port in communication with the inlet of the mixing device, the port of the straw the bottom of said storage compartment.

[0011] 进一步地,各储料室尺寸相同;各储料室的出料口尺寸相同。 [0011] Further, each storage compartment of the same size; the same discharge opening dimensions of each of the storage compartment.

[0012] 本发明还提供了一种治疗痤疮的外用制剂,所述外用制剂的有效成分为氧化苯甲酰和克林霉素磷酸酯,两种有效成分分别单独置于上述多组份容器的不同储料室内。 [0012] The present invention further provides a topical formulation for the treatment of acne, the topical formulation of the active ingredient is benzoyl peroxide and clindamycin phosphate, two active ingredients separately placed on said plurality of component containers different material storage room.

[0013] 其中,所述外用制剂为凝胶剂。 [0013] wherein said formulation is a topical gel.

[0014] 进一步地,所述凝胶剂是由如下重量配比的原辅料制备而成的: [0014] Further, the gel is prepared by the following ratio by weight of raw materials obtained by:

[0015] 组分A: [0015] Component A:

[0016] 过氧化苯甲酰5-10份,水性凝胶基质10-20份、防腐剂0· 1-0. 5份,水70-85份; pH调节剂调节pH至5. 0 7· 0 ; [0016] 5-10 parts of benzoyl peroxide, 10-20 parts of an aqueous gel base, 1-05 parts of a preservative 0.5, 70-85 parts of water;. PH adjusting agent is adjusted to pH 5.0 7.1 0;

[0017] 组分B : [0017] Component B:

[0018] 克林霉素磷酸酯2-5份、水性凝胶基质10_2〇份、防腐剂0· 1-0. 5份,水75-88份; pH调节剂调节pH至5· (Γ7. 0。 [0018] Clindamycin phosphate 2-5 parts of an aqueous gel matrix 10_2〇 parts, 1-05 parts of a preservative 0.5, 75-88 parts of water;. PH adjusting agent to adjust the pH 5 · (Γ7. 0.

[0019] 其中,所述水性凝胶基质为甘油、丙二醇、卡波姆、纤维素衍生物、海藻酸盐、西黄蓍胶、明胶中的一种或两种以上的组合; [0019] wherein the aqueous gel matrix is ​​glycerol, propylene glycol, carbomer, cellulose derivatives, alginates, tragacanth, gelatin, one kind or a combination of two or more;

[0020] 所述防腐剂为尼泊金甲酯、尼泊金乙酯、尼泊金丙酯、山梨酸、苯甲酸钠中的一种或两种以上的组合; [0020] The preservative is methyl paraben, ethyl paraben, propyl paraben, sorbic acid, sodium benzoate, one kind or a combination of two or more;

[0021] 所述pH调节剂为氢氧化钠、氢氧化钾中的一种或两种以上的组合。 [0021] The pH adjusting agent is sodium hydroxide, potassium hydroxide, one kind or a combination of two or more.

[0022] 更进一步地,所述凝胶剂是由如下重量百分比的原辅料制备而成的: [0022] Still further, the gel is prepared by the following percentages by weight of raw materials obtained by:

[0023] 组分A : [0023] Component A:

[0024] 过氧化苯甲酰5-10份,卡波姆1. 25份、丙二醇10份、尼泊金甲酯0. 2份、尼泊金丙酯0. 05份,水78. 5-83. 5份;氢氧化钾调节pH至5. 0~7· 0 ; [0024] 5-10 parts of benzoyl peroxide, 1.25 parts of Carbopol, 10 parts of propylene glycol, methyl paraben 0.2 parts propyl paraben 0.05 parts water 78. 5- 83.5 parts; potassium hydroxide to adjust the pH to 7. 5.0 1.0;

[0025] 组分B : [0025] Component B:

[0026] 克林霉素磷酸酯2. 4份、卡波姆1. 2δ份、丙二醇10份、尼泊金甲酯0· 2份、尼泊金丙酯0. 05份,水86. 1份;氢氧化钾调节pH至5· (Γ7. 0。 [0026] Clindamycin phosphate 2.4 parts, carbomer 1. 2δ parts, 10 parts of propylene glycol, methyl paraben 0.5 parts 2, propylparaben 0.05 parts of water, 86.1 parts; potassium hydroxide to adjust the pH 5 · (Γ7 0..

[0027] 本发明还提供了上述外用制剂的制备方法,它包括如下操作步骤: [0027] The present invention further provides a method for preparing the external preparation, which comprises the following steps:

[0028] ( 1)按配比称取原辅料; [0028] (a) weighing raw materials according to the ratio;

[0029] (2)取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的卡波姆充分搅拌溶胀,再加入处方量的过氧化苯甲酰以及尼泊金甲酯、尼泊金丙酯, 搅拌使其分散均匀,氢氧化钾调PH到5. (Γ7. 0,加剩余丙二醇水溶液至全量,得组分A ; [0029] (2) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol, carbomer is added prescriptions swollen sufficiently stirred, then added prescribed amount of benzoyl peroxide and paraben Kap ester, propyl paraben, stirring uniformly dispersed, potassium hydroxide, adjusted to PH 5. (Γ7 0, the remaining aqueous propylene glycol was added to the total amount, to obtain component A.;

[0030] (3)取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的克林霉素磷酸酯使其溶解完全,再加入处方量的卡波姆,搅拌使其充分溶胀,加入尼泊金甲酯、尼泊金丙酯后,用氢氧化钾调节pH到5. (Γ7.0,加剩余丙二醇水溶液至全量,得组分B ; [0030] (3) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol were added prescribed amount of clindamycin phosphate to dissolve completely, then add prescribed amount of carbomer, stirring its fully swollen, Jia Runi methyl paraben, propyl paraben after pH was adjusted with potassium hydroxide to 5. (Γ7.0, add the remaining aqueous propylene glycol to the total amount, to obtain the component B;

[0031] (4)将组分A和组分B分别单独置于上述多组份容器的不同储料室内,封装。 [0031] (4) The component A and component B are placed individually in the plurality of different components of the container stocker chamber package.

[0032] 本发明处方中,组分A、B的粘度相当,加之多组分容器中各储料室尺寸和各出料口尺寸相同,保证了患者使用的两个成分剂量一致。 [0032] The formulation of the present invention, the components A, B considerable viscosity, combined with multi-component container size of each storage compartment and each of the discharge openings of the same size, ensures a consistent two component dose the patient.

[0033] 本发明提供的凝胶剂,能够有效避免Acanya复方制剂中有效成分的降解,显著提高各成分稳定性,无需冷藏即可延长制剂存放时间,降低了产品的贮藏成本,大大增加了产品的便携性和使用舒适度;同时,本发明提供的多组分容器,可以使药物混合挤出步骤在装置内部完成,不仅节省了时间,而且避免人为混合造成的产品不一致和浪费。 [0033] The present invention provides a gelling agent, can effectively avoid degradation Acanya compound preparation of the active ingredients, significantly improve the stability of the components, the formulation without refrigeration storage time can be extended, reducing the cost of storage products, greatly increasing the product portability and comfort of use; the same time, the present invention provides a multi-component container, it is possible to complete the drug mixing the extrusion step within the device not only saves time, but also to avoid the waste of human inconsistency and mixing products caused.

附图说明 BRIEF DESCRIPTION

[0034]图1本发明多组分容器的推进器设在底部结构示意图; [0034] FIG thruster 1 of the present invention provided a multi-component container bottom schematic structure;

[0035]图2本发明多组分容器的推进器设在上部结构示意图; [0035] FIG thruster 2 multicomponent container of the present invention in a schematic view of the upper structure is provided;

[0036]图3本发明多组分容器的推进器融与混合装置内的结构示意图; [0036] FIG. 3 propulsion container of the present invention into a multi-component structure diagram of the mixing apparatus;

[0037]图中:1-底部外壳,2-上部外壳,3-储料室B,4-螺旋通道,5-混合装置, [0037] FIG: 1 - the bottom of the housing, the upper housing 2-, 3- storage compartments B, 4- spiral channels, 5-mixing device,

[0038] 6-加料口和封盖,7-储料室A,8-推进器,9-弹簧,1〇-储料室b吸管,11-储料室A吸管。 [0038] 6- feed opening and closure, storage compartments A 7-, 8- pusher, 9 spring, b pipette 1〇- storage compartments, storage compartments 11- A pipette.

具体实施方式 detailed description

[0039] 实施例1本发明带混合装置的多组份容器 [0039] Multi-component container with a mixing apparatus of the present invention Example 1

[0040] 下面结合附图对本发明作进一步详细说明。 [0040] The following figures of the present invention will be further described in detail in conjunction.

[0041] 如图1,本发明提供的一种带混合装置的多组份容器,包括至少两个单独的储料室3、7,推进器8,混合装置5,其中所述推进器8设置在底部外壳丨内,所述储料室3、7设置在上部外壳2内,所述储料室3、7的上部设置有加料口和封盖6,所述上部外壳2滑动的嵌套在底部外壳1内,所述储料室3、7的底盖在所述推进器8的作用下向上滑动,所述混合装置5设置在上部外壳1的顶部,所述混合装置5顶部侧面设置有出料口,所述混合装置5的进料口与所述储料室3、7的出料口连通。 [0041] As shown in FIG 1, with a container for multi-component mixing apparatus provided by the invention, it comprises at least two separate storage compartments 3,7, 8 advance, the mixing device 5, wherein the pusher 8 is provided Shu in the bottom of the housing, the storage compartments 3,7 arranged in the upper housing 2, the upper material storage chamber provided with a charging port 3,7 and cover 6, the upper housing 2 slidably nested 1, the bottom cover of the storage compartment of the bottom of the slide housing 3 and 7 under the action of the pusher 8 upwards, the top of the upper housing 1, the top side of said mixing means 5 provided the mixing means 5 is provided with discharge opening, said mixing means inlet chamber with the reservoir material discharge port 5 communicates 3,7. 不同的组份物质盛装在不同的储料室内,在使用时向下按压混合装置5即可。 Substances containing different ingredients at different stocker chamber, when using a mixing device 5 can be pressed down. 当然本领域的技术员也可把底部推进器8通过简单的变形,将其移至顶部位置,如图2所示。 Of course the technician in the art may also be the bottom of the pusher 8 by a simple modification, to move to the top position, as shown in FIG.

[0042] 优选的,所述混合装置5主要由圆筒外壳和内部的螺旋通道4构成。 [0042] Preferably, the mixing device 5 mainly composed of a cylindrical shell and the interior of the spiral passage 4. 螺旋通道延长了组份的混合时间,使组份混合的更加均匀、充分。 Spiral channel extending the mixing time component, so that more uniform ingredients were mixed sufficiently.

[0043] 优选的,所述容器上部外壳2的外侧面设置有刻度。 [0043] Preferably, the outer side surface of the upper housing container 2 is provided with a scale. 可以更加精确的控制每次的用量,提高组份的利用率。 It can be more accurately control the amount of each, to improve the utilization of the components.

[0044] 更进一步的,如图3,所述推进器8嵌套在所述混合装置5的上部,所述推进器8的上部侧面的出料口通过管道与所述混合装置5的出料口连通,所述推进器8与所述混合装置5之间设置有弹簧9,所述弹簧9是压簧。 [0044] Further, as shown in the upper portion in advance of the mixing device 5, the upper side 8 of the propulsion of the nested discharge port 8 through a pipe with the mixing means of discharge 5 communication port, the propeller 8 is provided between the mixing means 9 with a spring 5, the spring 9 is a compression spring. 在使用时向下按压推进器8,混合装置5内混合好的组份就从推进器8的上部侧面的出料口排出,松开推进器8后,在弹簧9的作用下, 使推进器8复位,同时不同的组份A、B分别通过储料室A吸管11、储料室B吸管10又进入到混合装置5内进行混合为下次使用做好准备。 When using the pusher 8 is pressed down, good mixing within the mixing apparatus 5 is discharged from the component discharge port side of the upper portion of the pusher 8 after loosening propulsion 8, under the action of the spring 9, the pusher 8 is reset, the different parts of groups a, B, respectively, by pipette a storage compartment 11, the stocker 10 and into the pipette chamber B into the mixing device 5 are mixed to prepare for the next use. 这种结构变形,减小了容器的整体体积,便于储存和运输。 Such structural deformation, reduces the overall volume of the container, easy storage and transportation.

[0045] 本发明使用时,首先打开储料室的加料口的封盖,灌装不同的组份,灌装完成,盖好封盖。 When [0045] the present invention, the closure is first opened the feed opening of the storage compartment, the different ingredients of the filling, the filling is completed, the closure cover. 此时容器将相互作用的物质通过物理隔离的方法,阻隔其相互之间的反应;临用前再通过挤压容器的顶部,使组份混合后排出,即可使得混合挤出步骤在装置内部完成,节省时间,而且避免人为混合造成的产品不一致和浪费;且产品为现用现混,能达到提高其各自稳定性、延长保质期的目的。 In this case the container material by physical interaction method of isolating barrier which mutual reaction; then immediately prior to use by squeezing the container at the top of the mixed components after discharging, to the extrusion step such that the inside mixing means complete, saving time and avoiding inconsistencies and waste products resulting from human hybrid; and now with the current product mix, each of which can be to improve stability, the purpose of extending shelf life.

[0046] 进一步地,各储料室尺寸相同,这也保证了从不同储料室挤压出的物质体积也相同。 [0046] Further, each of the storage compartments of the same size, which also ensures the extruded out from different storage compartments is the same volume of material.

[0047] 进一步地,各储料室的出料口尺寸均相同,这就能保证被挤压出的物质所受的压力相同,保证混合的均匀性。 [0047] Further, the discharge opening dimensions of each storage compartment of the same, which can ensure the same the pressure on the material being extruded, to ensure uniformity of mixing.

[0048] 在由多种药物组成的复方制剂中,有很大一部分会因为其中成分的相互作用而造成产品不会在较长时间内稳定,保质期短等问题。 [0048] In the preparation of a compound consisting of a variety of drugs, a large part be due to the interaction caused by the product component wherein not stable over an extended period, problems such as short shelf life. 为解决此类问题,常规做法是在产品中添加各种各样的添加剂,这样又带来新的问题,使产品的生产成本提高,严重的可能会影响产品的性能,特别是可能引起的副作用。 To solve such problems, it is common practice to add various additives in the product, which in turn create new problems, the production costs of products, may seriously affect the performance of the product, in particular, may cause side effects . 为了避免此类问题,多组份构成的制剂,通常采用分开的多个包装,在使用前再进行混合,这样虽然可以延长产品的保质期,但使用上不方便。 To avoid such problems, multi-component formulations consisting of, usually a plurality of separate packaging, and then mixed prior to use, although this can extend the shelf life of the product, but the use is not convenient. 本发明结构简单可靠,采用该结构的容器,通过物理隔离的方法,用于将两种或更多种组份刚好在使用前加以混合,操作方便,能有效降低药物之间的相互反应,达到产品在较长时间内保持稳定,不用或少用添加剂,提高了产品的质量,降低了生产成本,同时使用操作方便。 Simple and reliable structure of the present invention, the use of the container structure through physical separation method, for two or more ingredients mixed just prior to use, easy to operate, can effectively reduce the interaction between the drug, to achieve products remained stable in a long time, no or little use additives to improve product quality, reduce production costs, while easy to use and operate.

[0049] 实施例2本发明治疗痤疮的凝胶剂的制备 Preparation of gels [0049] Example 2 of the present invention for treating acne

[0050] 处方: [0050] Prescription:

[0051]_ [0051] _

[0052] 制备方法: ' [0052] Preparation: '

Figure CN102961250BD00071

' '

[0053] (1)按配比称取原辅料; [0053] (a) weighing raw materials according to the ratio;

[0054] (2)取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的卡波姆充分搅拌溶胀,再加入处方量的过氧化苯甲酰以及尼泊金甲酯、尼泊金丙酯, 搅拌使其分散均匀,氢氧化钾调pH到5. 0,加剩余丙二醇水溶液至全量,得组分A ; [0054] (2) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol, carbomer is added prescriptions swollen sufficiently stirred, then added prescribed amount of benzoyl peroxide and paraben Kap ester, propyl paraben, stirring uniformly dispersed, potassium hydroxide adjusted to pH 5.0, was added to the remaining aqueous propylene glycol total amount, to obtain the component A;

[0055] (3)取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的克林霉素磷酸酯使其溶解完全,再加入处方量的卡波姆,搅拌使其充分溶胀,加入尼泊金甲酯、尼泊金丙酯后,用氢氧化钾调节pH到5. 0,加剩余丙二醇水溶液至全量,得组分B ; [0055] (3) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol were added prescribed amount of clindamycin phosphate to dissolve completely, then add prescribed amount of carbomer, stirring its fully swollen, Jia Runi methyl paraben, propyl paraben after adjusted with potassium hydroxide to pH 5.0, was added to the remaining aqueous propylene glycol total amount, to obtain the component B;

[0056] (4)将组分A和组分B分别单独置于实施例1所述多组份容器的不同储料室内,封装。 [0056] (4) The component A and component B are separately placed in different material storage chamber, a package according to the embodiment of the multi-component container.

[0057] 实施例3本发明治疗痤疮凝胶剂的制备 [0057] Preparation Example 3 of the present invention is the treatment of acne gel

[0058] 处方: [0058] Prescription:

[0059] _ [0059] _

Figure CN102961250BD00081

____ ____

[0060] 制备方法: [0060] Preparation:

[0061] (1)按配比称取原辅料; [0061] (a) weighing raw materials according to the ratio;

[0062] (2)取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的卡波姆充分搅拌溶胀,再加入处方量的过氧化苯甲酰以及尼泊金甲酯、尼泊金丙酯, 搅拌使其分散均匀,氢氧化钾调PH到7. 0,加剩余丙二醇水溶液至全量,得组分A ; [0062] (2) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol, carbomer is added prescriptions swollen sufficiently stirred, then added prescribed amount of benzoyl peroxide and paraben Kap ester, propyl paraben, stirring uniformly dispersed, potassium PH adjusted to 7.0, was added to the remaining aqueous propylene glycol total amount, to obtain the component A;

[0063] (3)取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的克林霉素磷酸酯使其溶解完全,再加入处方量的卡波姆,搅拌使其充分溶胀,加入尼泊金甲酯、尼泊金丙酯后,用氢氧化钾调节pH到7. 0,加剩余丙二醇水溶液至全量,得组分B ; [0063] (3) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol were added prescribed amount of clindamycin phosphate to dissolve completely, then add prescribed amount of carbomer, stirring its fully swollen, Jia Runi methyl paraben, propyl paraben after adjusted with potassium hydroxide to pH 7.0, was added to the remaining aqueous propylene glycol total amount, to obtain the component B;

[0064] (4)将组分A和组分B分别单独置于实施例1所述多组份容器的不同储料室内,封装。 [0064] (4) The component A and component B are separately placed in different material storage chamber, a package according to the embodiment of the multi-component container.

[0065] 本发明实施例2、3的处方中,组分A、B的粘度相当,加之多组分容器中各储料室尺寸和各出料口尺寸相同,保证了患者使用的两个成分剂量一致。 [0065] Formulation Example 2 and 3 embodiment of the present invention, the components A, B considerable viscosity, combined with multi-component container size of each storage compartment and each of the discharge openings of the same size to ensure that the two components used in patients uniformity of dosage. 以下通过试验例来具体说明本发明的有益效果。 The following advantageous effects will be specifically described by test examples of the present invention.

[0066] 试验例1本发明凝胶剂与现有产品的稳定性对比实验 [0066] Test Example 1 Stability of Comparative Experiment invention with the conventional gel products

[0067] (1)药物: [0067] (1) Drug:

[0068] 本发明组:实施例2、3制备的将活性成分分开包装的凝胶剂; [0068] The set of the present invention: gelling agent packaged separately from the active ingredient prepared in Example 3 of the embodiment;

[0069] 对照组:按实施例2的处方制备凝胶剂,将组分A、B混合后,包装; [0069] Control group: gel formulation prepared as Example 2, the components A, B after mixing, packing;

[0070] Acanya 组:即Acanya 产品。 [0070] Acanya groups: Acanya products.

[0071] (2)实验方法 [0071] (2) Experimental method

[0072] 取本发明组、对照组、Acanya组,一同置于40°C、RH75%条件下进行加速稳定性考察,并同步增加参比制剂平行考察。 [0072] The group of the present invention takes the control group, group Acanya, disposed with 40 ° C, subjected to accelerated stability conditions investigated at RH75% and simultaneous increase in parallel with the reference formulation were investigated. 其中本发明分开包装的两个凝胶组分在各取样点以1:1 混匀后取样,进行各主成分含量检测,各产品稳定性考察结果如下: Gel component of the present invention wherein two separately packed in each of the sampling points 1: After mixing the sample 1, the main component for the respective detected content, stability of each product was as follows:

[0073] 表1 [0073] TABLE 1

[0074] [0074]

Figure CN102961250BD00091

[0075] 注:ΒΡ0--过氧化苯甲酰;CP--克林霉素磷酸酯-............. [0075] Note: ΒΡ0-- benzoyl peroxide; CP-- clindamycin phosphate -.............

[0076]由上述结果可知,在加速稳定性考察实验中,本发明实施例2、3制备的凝胶剂中过氧化苯甲酰、克林霉素磷酸酯含量显著高于对照组(混合包装)和Acanya产品。 [0076] From these results, in the accelerated stability of experiments, benzoyl peroxide gels prepared in Examples 2 and 3 had, clindamycin phosphate content was significantly higher (mixing package embodiment of the present invention ) and Acanya products.

[0077] 实验表明,本发明凝胶剂能有效避免Acanya复方制剂中有效成分的降解,显著提高各成分稳定性,无需冷藏即可延长制剂存放时间,降低了产品的贮藏成本,大大增加了产品的便携性和使用舒适度。 [0077] The experiment shows that gels of the present invention can effectively avoid degradation Acanya compound preparation of the active ingredient, significantly improve the stability of the components, the formulation is stored without refrigeration for extended time to reduce the storage cost of the product, greatly increasing the product portability and comfort of use.

[0078] 试验例2本发明各装置制备的凝胶剂的稳定性考察 [0078] The stability of each gel prepared in Test Example 2 of the present invention means

[0079] 取图1-3的三个装置,按实施例2的方法制备凝胶剂,轻压装置顶部得到混合后产品,每个装置选取三份样品,比较其外观及其药物含量,结果如下: [0079] FIG three taking apparatus 1-3, according to the method of Example 2 for preparing gels, soft reduction means to obtain a top product after mixing, triplicate samples of each selected device, and comparing the appearance of drug content, the results as follows:

[0080] 表2 [0080] TABLE 2

[0081] [0081]

Figure CN102961250BD00092

[0082] 注:ΒΡ0-过氧化苯甲酰;CP--克林霉素磷酸酯 [0082] Note: ΒΡ0- benzoyl peroxide; CP-- clindamycin phosphate

[0083]由上述结果可知,本发明各种装置制备得到的凝胶剂,挤出药物外观和药物含量均一,无明显批间差别,表明本发明提供的各种装置效果相当。 [0083] From these results, preparation of various gels obtained by means of the present invention, extrusion of drug appearance and drug content uniformity, no obvious differences between batches, show that the effect of the present invention provides various devices quite.

[0084] 综上所述,本发明提供的外用制剂,能够有效避免Acanya复方制剂中有效成分的降解,显著提高各成分稳定性,无需冷藏即可延长制剂存放时间,降低了产品的贮藏成本, 大大增加了产品的便携性和使用舒适度;同时,本发明提供的多组分容器,可以使药物混合挤出步骤在装置内部完成,不仅节省了时间,而且避免人为混合造成的产品不一致和浪费。 [0084] In summary, the present invention provides an external preparation, it is possible to effectively avoid degradation Acanya compound preparation of the active ingredients, significantly improve the stability of the components, the formulation without refrigeration storage time can be extended, reducing the cost of storage of the product, greatly increases the comfort of use and portability of the product; the same time, the present invention provides a multi-component container, it is possible to complete the drug mixing the extrusion step within the device not only saves time, but also to avoid the waste of human inconsistency and mixing products caused by .

Claims (8)

  1. 1. 一种治疗痤疮的外用制剂,其特征在于:所述外用制剂的有效成分为过氧化苯甲酰和克林霉素磷酸酯,两种有效成分分别单独置于带混合装置的多组份容器的不同储料室内; 所述带混合装置的多组份容器,包括至少两个单独的储料室(3, 7),推进器(8),混合装置(5),其特征在于:推进器(8)设置在底部外壳(1)内,储料室(3, 7)设置在上部外壳(2)内,储料室(3, 7)的上部设置有加料口和封盖(6),上部外壳(2)滑动的嵌套在底部外壳⑴内,储料室(3,7)的底盖紧压在推进器⑶上,混合装置(5)设置在上部外壳⑵的顶部,混合装置(5)顶部侧面设置有出料口,混合装置(5)的进料口与储料室(3, 7)的出料口连通; 所述外用制剂为凝胶剂,所述凝胶剂是由如下重量配比的原辅料制备而成的: 组分A : 过氧化苯甲酰5-10份,水性凝胶基质10-20份、防腐剂〇· 1-0 1. An external preparation for the treatment of acne, characterized in that: said active ingredient for external preparation of benzoyl peroxide and clindamycin phosphate, two active ingredients separately disposed with multi-component mixing apparatus different material storage chamber of the container; the container with a multi-component mixing device comprising at least two separate storage compartments (3, 7), the pusher (8), mixing means (5), characterized in that: promoting (8) disposed in the bottom of the housing (1), storage compartments (3, 7) disposed in an upper portion of the housing (2), the upper material storage chamber (3, 7) is provided with a feed opening and the closure (6) the upper housing (2) is slidably nested within the bottom housing ⑴, storage compartments (3,7) pressed against the pusher bottom cover ⑶, mixing means (5) provided at the top of the upper housing ⑵ mixing device (5) is provided with a top side discharge port, a mixing device (5) with a feed inlet of storage compartments (3, 7) of the discharge opening communicate; the topical formulation is a gel, the gel is weight ratio was prepared by the following raw materials obtained by: component a: 5-10 parts of benzoyl peroxide, 10-20 parts of an aqueous gel matrix, a preservative square-1-0 . 5份,水70-85份;pH调节剂调节pH至5. 0 7. 0 ; 组分B : 克林霉素磷酸酯2-5份、水性凝胶基质10-2〇份、防腐剂0· 1-0. 5份,水75_88份;pH调节剂调节pH至5. 0 7· 0。 5 parts, 70-85 parts of water; pH adjusting agent to adjust the pH 5.0 7.0; Component B: 2-5 parts of clindamycin phosphate, an aqueous gel matrix 10-2〇 parts, preservative 0 · 1-05 parts, 75_88 parts of water; pH adjusting agent to adjust the pH 7. 0 5.0.
  2. 2. 根据权利要求1所述的外用制剂,其特征在于:所述水性凝胶基质为甘油、丙二醇、 卡波姆、纤维素衍生物、海藻酸盐、西黄蓍胶、明胶中的一种或两种以上的组合; 所述防腐剂为尼泊金甲酯、尼泊金乙酯、尼泊金丙酯、山梨酸、苯甲酸钠中的一种或两种以上的组合; 所述pH调节剂为氢氧化钠、氢氧化钾中的一种或两种以上的组合。 The external preparation according to claim 1, wherein: said aqueous gel matrix as a glycerol, propylene glycol, carbomer, cellulose derivatives, alginates, tragacanth, gelatin or a combination of two or more; the preservative is methyl paraben, ethyl paraben, propyl paraben, sorbic acid, sodium benzoate, one kind of or a combination of two or more; the pH adjuster agent is sodium hydroxide, potassium hydroxide or a combination of two or more.
  3. 3. 根据权利要求1或2所述的外用制剂,其特征在于:所述凝胶剂是由如下重量百分比的原辅料制备而成的: 组分A : 过氧化苯甲酰5-10份,卡波姆1.25份、丙二醇10份、尼泊金甲酯0.2份、尼泊金丙酯〇· 05份,水78. 5-83. 5份;氢氧化钾调节pH至5. 0〜7· 0 ; 组分B : 克林霉素磷酸酯2· 4份、卡波姆L 25份、丙二醇10份、尼泊金甲酯0· 2份、尼泊金丙酯0. 05份,水86. 1份;氢氧化钾调节pH至5. 0〜7· 0。 The external preparation according to claim 1 or claim 2, characterized in that: said gel is prepared by the following percentages by weight of raw materials obtained by: Component A: 5-10 parts of benzoyl peroxide, carbomer 1.25 parts, 10 parts of propylene glycol, 0.2 parts of methyl paraben, propyl paraben 0.05 billion parts, 78. 5-835 parts of water;. potassium hydroxide to adjust to pH 5. 0 to 7 · 0; component B: 2.4 clindamycin phosphate 2 parts, carbomer L 25 parts, 10 parts of propylene glycol, methyl paraben 0.5 parts 2, propylparaben 0.05 parts of water, 86 . 1; potassium hydroxide to adjust to pH 5. 0 to 7 · 0.
  4. 4. 根据权利要求1所述的外用制剂,其特征在于:所述混合装置(5)由圆筒外壳和内部的螺旋通道(4)构成。 4. The external preparation as claimed in claim 1, wherein: said mixing means (5) (4) comprises a cylindrical housing and the interior of the spiral channel.
  5. 5. 根据权利要求1所述的外用制剂,其特征在于:所述上部外壳(2)的外侧面设置有刻度。 The external preparation according to claim 1, wherein: an outer side surface of the upper housing (2) is provided with a scale.
  6. 6. 根据权利要求1所述的外用制剂,其特征在于:所述推进器(8)嵌套在混合装置(5) 的上部,设置在推进器(8)的上部侧面的出料口通过管道与混合装置(5)的出料口连通,推进器(8)与混合装置(5)之间设置有弹簧(9),弹簧(9)是压簧,储料室(3, 7)内增设吸管(10, 11),吸管(10, 11)的上端口与混合装置(5)的进料口连通,吸管(1〇, 11)的下端口达储料室(3, 7)的底部。 6. The external preparation according to claim 1, wherein: said upper propulsion device (8) is nested in the mixing means (5) is provided at the discharge port side of the upper portion of the pusher (8) through a pipe communication with the mixing device (5) of the discharge port, is provided with a spring (9) between the pusher (8) and the mixing means (5), a spring (9) is a spring, the storage compartments (3, 7) additional straw (10, 11), suction tube (10, 11) on the port and the mixing device (5) of the feed inlet in communication, straw bottom (1〇, 11) of the lower port of storage compartments (3, 7).
  7. 7. 根据权利要求1所述的外用制剂,其特征在于:各储料室尺寸相同;各储料室的出料口尺寸相同。 7. The external preparation according to claim 1, wherein: each storage compartment the same size; the same dimensions of each discharge opening of the storage compartment.
  8. 8.权利要求1所述外用制剂的制备方法,其特征在于:它包括如下操作步骤: (1) 按配比称取原辅料; (2) 取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的卡波姆充分搅拌溶胀,再加入处方量的过氧化苯甲酰以及尼泊金甲酯、尼泊金丙酯,搅拌使其分散均匀,氢氧化钾调PH到5. (Γ7. 0,加剩余丙二醇水溶液至全量,得组分A ; (3) 取丙二醇加水溶解配制成丙二醇水溶液;取丙二醇水溶液总量的90%,加入处方量的克林霉素磷酸酯使其溶解完全,再加入处方量的卡波姆,搅拌使其充分溶胀,加入尼泊金甲酯、尼泊金丙酯后,用氢氧化钾调节pH到5· (Γ7. 0,加剩余丙二醇水溶液至全量,得组分B ; (4) 将组分A和组分B分别单独置于多组份容器的不同储料室内,封装。 The method of preparing a topical formulation of claim 1, characterized in that: it comprises the following steps: (1) weighing raw materials according to the ratio; (2) take-propanediol dissolved in water formulated in aqueous propylene glycol; propylene glycol solution in a total amount 90% of the amount of carbomer added prescriptions swollen sufficiently stirred, then added prescribed amount of benzoyl peroxide and methyl paraben, propyl paraben, stirring uniformly dispersed, potassium hydroxide to adjust PH . 5. (Γ7 0, the remaining aqueous propylene glycol was added to the total amount, to obtain the component a; (3) take-propanediol dissolved in water formulated in aqueous propylene glycol; taken for 90% aqueous propylene glycol were added prescribed amount of clindamycin phosphate completely dissolved, then add prescribed amount of carbomer mixture was stirred and fully swollen, Jia Runi methyl paraben, propyl paraben after pH was adjusted with potassium hydroxide to 5 · (Γ7. 0, add the remaining aqueous propylene glycol to the total amount, to obtain component B; (. 4) the component a and component B are placed in individual containers of different multi-component material storage chamber package.
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