CN104706621B - One kind of marbofloxacin microcapsule and preparation method - Google Patents

One kind of marbofloxacin microcapsule and preparation method Download PDF

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CN104706621B
CN104706621B CN 201510120102 CN201510120102A CN104706621B CN 104706621 B CN104706621 B CN 104706621B CN 201510120102 CN201510120102 CN 201510120102 CN 201510120102 A CN201510120102 A CN 201510120102A CN 104706621 B CN104706621 B CN 104706621B
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marbofloxacin
solution
reduced pressure
under reduced
microcapsule
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CN104706621A (en )
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姜应新
侯仲轲
郑立斌
邱家军
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国邦医药化工集团有限公司
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Abstract

本发明涉及一种麻保沙星微囊及其制备方法,包括以下步骤:(1)制备壁材溶液(2)制备芯材溶液(3)乳化及减压蒸馏:在高速剪切条件下,向步骤(1)制得的壁材溶液中缓慢滴加步骤(2)制得的芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度10‑40℃,真空度0.01‑0.07Mpa,滴加时间在0.5‑2小时,剪切速度为5000‑10000r/min,滴加完毕后继续减压蒸馏2小时;(4)喷雾干燥。 The present invention relates to a microcapsule marbofloxacin and its preparation method, comprising the steps of: (1) preparing a solution of wall material (2) Preparation of a solution of the core (3) and evaporated under reduced pressure emulsification: under high shear conditions, step (1) a wall member was slowly added dropwise obtained in step (2) was obtained in the core, while the distillation under reduced pressure, recovered with dichloromethane / ethanol mixed solution, system temperature 10-40 deg.] C, the degree of vacuum 0.01-0.07Mpa, the dropping time of 0.5-2 hours at a shear rate of 5000-10000r / min, after completion of the dropwise addition continues distilled for 2 hours under reduced pressure; (4) spray-drying. 本发明可以降低麻保沙星对光的敏感,延长药效,掩盖不良气味,增加溶解度,并且可以很方便地制备各种制剂,如散剂、片剂、胶囊剂、缓控释剂等,有利于动物的用药。 The present invention can reduce marbofloxacin light sensitivity, extend the efficacy, masking unpleasant odor, increased solubility, and can be conveniently prepared in various formulations, such as powders, tablets, capsules, slow release agent, there conducive to drug the animals.

Description

一种麻保沙星微囊及其制备方法 One kind of marbofloxacin microcapsule and preparation method

技术领域 FIELD

[0001] 本发明涉及一种麻保沙星微囊及其制备方法,属于兽药制剂领域。 [0001] The present invention relates to a microcapsule marbofloxacin and its preparation method, belonging to the field of veterinary medicine preparation.

背景技术 Background technique

[0002] 麻保沙星是继恩诺沙星、达氟沙星、沙拉沙星、二氟沙星之后的又一个第三代喹诺酮类动物专用抗菌药物。 [0002] marbofloxacin is the second enrofloxacin, danofloxacin, sarafloxacin, difloxacin yet a third generation quinolone animal-specific antibiotics. 主要通过抑制细菌拓扑异构酶活性而抗菌。 Mainly the antibacterial activity by inhibiting bacterial topoisomerase. 麻保沙星最早由瑞士罗氏公司创制,Vetoquinol公司进一步开发,并于1995年首次在英国上市,随后相继在法国、美国和欧洲上市。 Marbofloxacin was first created by the Swiss company Roche, Vetoquinol further developed and first launched in the UK in 1995 and was subsequently listed in France, the United States and Europe. 麻保沙星抗菌谱广,杀菌力强,对革兰氏阴性和阳性菌均有较强的活性,甚至对某些霉菌和厌氧菌有效。 Marbofloxacin broad spectrum antimicrobial, bactericidal strong, have strong activity against gram-negative and positive bacteria, fungi and even effective for some anaerobic bacteria. 组织渗透力强,其体内吸收迅速完全而且分布广泛,消除半衰期长,生物利用度接近100%;安全剂量范围宽,与其他抗菌无交叉耐药性,无明显生殖和遗传毒性。 Tissue infiltration, rapid and complete absorption in vivo and is widely distributed, long elimination half-life, bioavailability close to 100%; broad safe dose range, with no cross-resistance to other antimicrobial, no obvious reproductive and genetic toxicity. 这些都决定了其在防治畜禽呼吸系统感染、泌尿系统感染、消化系统感染、 浅表或深层皮肤组织感染、眼睛和耳道感染等方面的巨大潜力,是新一代动物专用氟喹诺酮类抗菌药。 All decisions of its prevention and treatment of respiratory infections in poultry, urinary tract infections, digestive infections, superficial or deep skin tissue infections, the huge potential of the eye and ear infections, a new generation of animal-specific fluoroquinolone antibiotics . 目前,美国和欧盟可批准用于宠物,欧盟批准可用于家畜,日本可用于家禽。 Currently, the United States and the European Union can be approved for pets, the EU approved for use in livestock, Japan can be used for poultry.

Figure CN104706621BD00031

[0004] 麻保沙星结构式 [0004] marbofloxacin structural formula

[0005] 麻保沙星属氟喹诺酮类药物,对光较为敏感、溶解性较差、并存在一定的气味,不利于动物的用药。 [0005] marbofloxacin belong to fluoroquinolones, are more sensitive to light, poor solubility, and there is a certain smell, is not conducive to treatment of animals. 但目前该药制剂品种单一,主要为其乳酸或盐酸盐的注射剂和溶液口服剂,且应用领域窄,主要应用于宠物。 But drug formulations single species, mainly lactic acid or its hydrochloride injection solutions and oral preparation, and a narrow field of application, mainly used in pet. 同时还存在成本高、质量控制难的技术难题。 Also there is a high cost, quality control difficult technical problems.

[0006] 辛烯基琥珀酸淀粉钠作为一种新型壁材,已经广泛应用于脂溶性维生素包埋,辛烯基琥珀酸淀粉钠作为壁材包埋油脂时,包埋原理是辛烯基琥珀酸钠的疏水基团插入油相,羧酸钠基团插入水相,淀粉基团在油水界面形成一层强度很大的薄膜,达到包埋效果。 [0006] starch sodium octenyl succinate as a new wall material, has been widely used embedding fat-soluble vitamins, starch sodium octenyl succinate as a wall material embedding grease, embedded principle is octenyl succinate sodium hydrophobic group is inserted into the oil phase, aqueous sodium carboxylate groups insertion phase, the starch group formed large oil-water interface in the strength of the film layer, to achieve the effect of embedding. 但是因为麻保沙星的溶解性能极其特殊,其状态为固体,并且麻保沙星在油脂中溶解度较低。 However, dissolution performance because marbofloxacin is very special, it is a solid state, and marbofloxacin low solubility in oil. 限制了麻保沙星制剂开发及应用。 Limiting the development and application of marbofloxacin preparation. 本发明应用溶剂将麻保沙星溶解,高速剪切下将溶剂相加入水相,在蒸发溶剂同时,使麻保沙星微粒析出,同时辛烯基琥珀酸淀粉钠将麻保沙星微粒包埋形成微囊,可以降低麻保沙星对光的敏感,延长药效,掩盖不良气味,增加溶解度, 并且可以很方便地制备各种制剂,如散剂、片剂、胶囊剂、缓控释剂等,有利于动物的用药。 The solvent of the present invention applied to marbofloxacin dissolved under high shear aqueous phase is added to the solvent phase, the solvent is evaporated while the precipitated particles marbofloxacin, and starch sodium octenyl succinate marbofloxacin the microparticles package forming microencapsule buried, marbofloxacin can be reduced sensitivity to light, extend the efficacy, masking unpleasant odor, increased solubility, and can be conveniently prepared in various formulations, such as powders, tablets, capsules, slow release agent etc., is conducive to drug use animals.

发明内容 SUMMARY

[0007] 为了解决麻保沙星包埋问题,本发明提供了一种以辛烯基琥珀酸淀粉钠为壁材的麻保沙星微囊及其制备方法,通过将壁材、芯材进行乳化,喷干,制成水溶性微囊粉末,可以降低麻保沙星对光的敏感,延长药效,掩盖不良气味,增加溶解度,并且可以很方便地制备各种制剂,如散剂、片剂、胶囊剂、缓控释剂等,有利于动物的用药。 [0007] In order to solve the problem marbofloxacin embedding, the present invention provides a microcapsule marbofloxacin to a preparation method thereof, sodium octenyl succinate starch as wall material, by the wall material, the core material emulsified, spray-dried, a powder made of a water-soluble microcapsule, marbofloxacin can be reduced sensitivity to light, extend the efficacy, masking unpleasant odor, increased solubility, and can be conveniently prepared in various formulations, such as powders, tablets , capsules, sustained and controlled release agent, beneficial treatment of animals.

[0008] 为达到上述目的,本发明是通过以下技术方案实现的: [0008] To achieve the above object, the present invention is achieved by the following technical solution:

[0009] —种麻保沙星微囊,由以下质量百分比的组分组成:作为壁材的辛烯基琥珀酸淀粉钠40-99%和作为芯材的麻保沙星I -60%。 [0009] - species marbofloxacin microcapsules, percentage by mass of the following components: a wall material octenyl succinate starch sodium as 40-99% of the core material and marbofloxacin I -60%.

[0010] —种麻保沙星微囊的制备方法,包括以下步骤: [0010] - The method of producing microcapsules marbofloxacin, comprising the steps of:

[0011] (1)制备壁材溶液:将辛烯基琥珀酸淀粉钠溶解于纯化水中,配制成浓度为10-30% 的溶液; [0011] (1) Preparation of a solution of wall material: the starch sodium octenyl succinate were dissolved in purified water to prepare a solution of a concentration of 10-30%;

[0012] (2)制备芯材溶液:将麻保沙星溶解于二氯甲烷/无水乙醇混合溶液中,配制成浓度为20%-50%的溶液; [0012] (2) Preparation of core material solution: marbofloxacin was dissolved in methylene chloride / ethanol mixed solution to prepare a solution of 20% -50% to a concentration of;

[0013] (3)乳化及减压蒸馏:在高速剪切条件下,向步骤(1)制得的壁材溶液中缓慢滴加步骤(2)制得的芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度10-40°C,真空度0.01-0.07Mpa,滴加时间在0.5-2小时,剪切速度为5000-10000r/min,滴加完毕后继续减压蒸馏2小时; [0013] (3) and evaporated under reduced pressure emulsification: under high shear conditions of step (1) a wall member was slowly added dropwise obtained in step (2) was obtained in the core, while the distillation under reduced pressure after collecting dichloromethane / ethanol mixed solution, a system temperature of 10-40 ° C, vacuum degree 0.01-0.07Mpa, the dropping time of 0.5-2 hours at a shear rate of 5000-10000r / min, dropwise addition continued distilled for 2 hours under reduced pressure;

[0014] ⑷喷雾干燥:在进风温度180-220 °C、出风温度80-120 °C下进行喷雾干燥。 [0014] ⑷ spray drying: spray-dried at an inlet air temperature of 180-220 ° C, outlet temperature 80-120 ° C.

[0015] 所述步骤(2)中的二氯甲烷与无水乙醇的体积比为6:4-19:1。 [0015] The volume ratio of the step (2) with ethanol in dichloromethane to 6: 4-19: 1.

[0016] 本发明的有益效果如下: [0016] Advantageous effects of the present invention are as follows:

[0017] 本发明采用微囊化技术将非水溶性的麻保沙星包埋制成微囊,包埋所用壁材为辛烯基琥珀酸淀粉钠,通过助剂二氯甲烷/无水乙醇的加入,使麻保沙星可以被包埋,将药物包埋于壁材之后喷雾干燥,形成速溶微囊粉末。 [0017] The present invention utilizes microencapsulation of water-insoluble marbofloxacin embedded in micro-encapsulated, embedded in the wall material used is starch sodium octenyl succinate, through the aid of methylene chloride / ethanol the addition of the marbofloxacin can be entrapped, then the drug is embedded in the wall material spray dried to form an instant microcapsule powder.

[0018] 本发明工艺简单,成本低廉,所得麻保沙星微囊粉末可以降低麻保沙星对光的敏感,延长药效,掩盖不良气味,增加溶解度,并且可以方便地制备各种制剂,如散剂、片剂、胶囊剂、缓控释剂等,有利于动物的用药。 [0018] The present process is simple, low cost, resulting microcapsule powder marbofloxacin marbofloxacin can be reduced sensitivity to light, extend the efficacy, masking unpleasant odor, increased solubility, and can be conveniently prepared in various formulations, such as powders, tablets, capsules, slow release agents, animal drugs beneficial.

具体实施方式 detailed description

[0019] 下面结合具体实施例对本发明作进一步的说明,但本发明的保护范围并不限于此。 [0019] The following embodiments in conjunction with specific embodiments of the present invention will be further described, although the scope of the present invention is not limited thereto.

[0020] 本发明中所涉及的所有原料及助剂均可以采用本领域公知的方式合成,也可以采用市售产品。 [0020] All raw materials and additives involved in the present invention are known in the art may be employed in the synthesized, may be used commercially available products.

[0021] 实施例1 [0021] Example 1

[0022] 辛烯基琥珀酸淀粉钠40% [0022] sodium starch octenyl succinate 40%

[0023] 麻保沙星60% [0023] marbofloxacin 60%

[0024]制备方法: [0024] Preparation:

[0025] 将辛烯基琥珀酸淀粉钠溶解于纯化水中,配制浓度10%的壁材溶液。 [0025] A starch sodium octenyl succinate were dissolved in purified water to prepare a 10% concentration solution of wall material. 将麻保沙星溶解于二氯甲烷/无水乙醇(比例为9:1)混合溶液中,配制成浓度为20%的芯材溶液。 The marbofloxacin was dissolved in methylene chloride / ethanol (ratio 9: 1) mixed solution to prepare a 20% strength solution of the core material. 在5000r/ min剪切速度下,向壁材溶液中缓慢滴加芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度10°C,真空度0.07Mpa,滴加时间在2小时,滴加完毕后继续减压蒸馏2小时。 At 5000r / min shear rate, the solution was slowly added dropwise to the wall of the core material solution while distillation under reduced pressure, recovered with dichloromethane / ethanol mixed solution, system temperature 10 ° C, the degree of vacuum 0.07Mpa, dropwise time plus 2 hours. after addition was complete the distillation continued under reduced pressure for 2 hours. 乳液喷雾干燥,进风温度180°C,出风温度80°C。 Emulsion spray drying, inlet temperature 180 ° C, outlet temperature 80 ° C.

[0026] 制得粉末油脂外观为淡黄色,流动性好,遇水溶解。 [0026] The powdered fat was obtained as a pale yellow appearance, good fluidity, water dissolution.

[0027] 实施例2 [0027] Example 2

[0028] 辛烯基琥珀酸淀粉钠90% [0028] sodium starch octenyl succinate 90%

[0029] 麻保沙星10% [0029] marbofloxacin 10%

[0030] 制备方法: [0030] Preparation:

[0031] 将辛烯基琥珀酸淀粉钠溶解于纯化水中,配制浓度30%的壁材溶液。 [0031] A starch sodium octenyl succinate were dissolved in purified water to prepare a 30% concentration solution of wall material. 将麻保沙星溶解于二氯甲烷/无水乙醇(比例为3: 2)混合溶液中,配制成浓度为50%的芯材溶液。 The marbofloxacin was dissolved in methylene chloride / ethanol (ratio 3: 2) mixed solution to prepare a core solution concentration of 50%. 在lOOOOr/min剪切速度下,向壁材溶液中缓慢滴加芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度40°C,真空度0.0IMpa,滴加时间在0.5小时,滴加完毕后继续减压蒸馏2小时。 In lOOOOr / min shear rate, the solution was slowly added dropwise to the wall of the core material solution while distillation under reduced pressure, recovered with dichloromethane / ethanol mixed solution, system temperature of 40 ° C, vacuum degree 0.0IMpa, dropwise plus time 0.5 hour. after addition was complete the distillation continued under reduced pressure for 2 hours. 乳液喷雾干燥,进风温度220°C,出风温度120°C。 Spray drying the emulsion, inlet air temperature 220 ° C, outlet temperature 120 ° C.

[0032] 制得粉末油脂外观为淡黄色,流动性好,遇水溶解。 [0032] The powdered fat was obtained as a pale yellow appearance, good fluidity, water dissolution.

[0033] 实施例3 [0033] Example 3

[0034] 辛烯基琥珀酸淀粉钠70% [0034] sodium starch octenyl succinate 70%

[0035] 麻保沙星30% [0035] marbofloxacin 30%

[0036] 制备方法: [0036] Preparation:

[0037] 将辛烯基琥珀酸淀粉钠溶解于纯化水中,配制浓度20%的壁材溶液。 [0037] A starch sodium octenyl succinate were dissolved in purified water to prepare a concentration of 20% solution of wall material. 将麻保沙星溶解于二氯甲烷/无水乙醇(比例为19: 3)混合溶液中,配制成浓度为35%的芯材溶液。 The marbofloxacin was dissolved in methylene chloride / ethanol (ratio 19: 3) mixed solution to prepare a core material solution of a concentration of 35%. 在7500r/min剪切速度下,向壁材溶液中缓慢滴加芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度25°C,真空度0.04Mpa,滴加时间在1.25小时,滴加完毕后继续减压蒸馏2小时。 At 7500r / min shear rate, the solution was slowly added dropwise to the wall of the core material solution while distillation under reduced pressure, recovered with dichloromethane / ethanol mixed solution, a system temperature of 25 ° C, the degree of vacuum 0.04Mpa, dropwise plus time for 1.25 hours after the addition was complete the distillation continued under reduced pressure for 2 hours. 乳液喷雾干燥,进风温度200°C,出风温度100°C。 Spray drying the emulsion, inlet air temperature 200 ° C, outlet temperature 100 ° C.

[0038] 制得粉末油脂外观为淡黄色,流动性好,遇水溶解。 [0038] The powdered fat was obtained as a pale yellow appearance, good fluidity, water dissolution.

[0039] 实施例4 [0039] Example 4

[0040] 辛烯基琥珀酸淀粉钠50% [0040] sodium starch octenyl succinate 50%

[0041] 麻保沙星50% [0041] marbofloxacin 50%

[0042] 制备方法: [0042] Preparation:

[0043] 将辛烯基琥珀酸淀粉钠溶解于纯化水中,配制浓度25%的壁材溶液。 [0043] A starch sodium octenyl succinate were dissolved in purified water to prepare a 25% concentration solution of wall material. 将麻保沙星溶解于二氯甲烷/无水乙醇(比例为7:2)混合溶液中,配制成浓度为45%的芯材溶液。 The marbofloxacin was dissolved in methylene chloride / ethanol (ratio of 7: 2) mixed solution to prepare a concentration of 45% solution of the core material. 在9000r/ min剪切速度下,向壁材溶液中缓慢滴加芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度15°C,真空度0.05Mpa,滴加时间在1.5小时,滴加完毕后继续减压蒸馏2小时。 At 9000r / min shear rate, the solution was slowly added dropwise to the wall of the core material solution while distillation under reduced pressure, recovered with dichloromethane / ethanol mixed solution, the system temperature 15 ° C, the degree of vacuum 0.05Mpa, dropwise plus the time 1.5 hours after the addition was complete the distillation continued under reduced pressure for 2 hours. 乳液喷雾干燥,进风温度190°C,出风温度90°C。 Spray drying the emulsion, inlet air temperature 190 ° C, outlet temperature 90 ° C.

[0044] 制得粉末油脂外观为淡黄色,流动性好,遇水溶解。 [0044] The powdered fat was obtained as a pale yellow appearance, good fluidity, water dissolution.

[0045] 本发明以辛烯基琥珀酸淀粉钠为壁材的麻保沙星微囊及其制备方法,通过将壁材、芯材进行乳化,喷干,制成水溶性微囊粉末,可以降低麻保沙星对光的敏感,延长药效, 掩盖不良气味,增加溶解度,并且可以很方便地制备各种制剂,如散剂、片剂、胶囊剂、缓控释剂等,有利于动物的用药。 [0045] In the present invention, sodium octenyl succinate starch marbofloxacin microcapsule wall material and its preparation method, through the wall material, the core material emulsification, spray drying, made of a water-soluble microcapsule powder, marbofloxacin reduced sensitivity to light, extend the efficacy, masking unpleasant odor, increased solubility, and can be conveniently prepared in various formulations, such as powders, tablets, capsules, slow release agent, beneficial animals medication.

[0046] 上述实施例仅用于解释说明本发明的发明构思,而非对本发明权利保护的限定, 凡利用此构思对本发明进行非实质性的改动,均应落入本发明的保护范围。 [0046] The above-described embodiments are merely for illustrative concepts of the present invention, not to limit the claimed invention to protect, where the use of this concept of the present invention without substantive changes, shall fall within the scope of the present invention.

Claims (2)

  1. 1. 一种麻保沙星微囊,其特征在于由以下质量百分比的组分组成:作为壁材的辛烯基琥珀酸淀粉钠40-99%和作为芯材的麻保沙星1 -60%; 所述麻保沙星微囊的制备方法包括以下步骤: (1) 制备壁材溶液:将辛烯基琥珀酸淀粉钠溶解于纯化水中,配制成浓度为10-30%的溶液; (2) 制备芯材溶液:将麻保沙星溶解于二氯甲烷/无水乙醇混合溶液中,配制成浓度为20%-50%的溶液; (3) 乳化及减压蒸馏:在高速剪切条件下,向步骤(1)制得的壁材溶液中缓慢滴加步骤(2)制得的芯材溶液,同时进行减压蒸馏,回收二氯甲烷/无水乙醇混合溶液,体系温度10-40°C,真空度0.01-0.07Mpa,滴加时间在0.5-2小时,剪切速度为5000-10000r/min,滴加完毕后继续减压蒸馏2小时; (4) 喷雾干燥:在进风温度180-220 °C、出风温度80-120 °C下进行喷雾干燥。 A microcapsule marbofloxacin, characterized in that the percentage by mass of the following components: a starch sodium octenyl succinate 40 to 99% wall material and core material as marbofloxacin 1-60 %; the preparation method marbofloxacin microcapsules comprising the steps of: (1) preparing a wall material solution: starch sodium octenyl succinate were dissolved in purified water to prepare a concentration of 10-30% solution; ( 2) preparation of core material solution: marbofloxacin dissolved in methylene chloride / ethanol mixed solution, to prepare a solution of 20% -50% to a concentration of; (3) and evaporated under reduced pressure emulsification: high shear under conditions of step (1) a wall member was slowly added dropwise obtained in step (2) was obtained in the core, while the distillation under reduced pressure, recovered with dichloromethane / ethanol mixed solution, temperature of the system 10- 40 ° C, vacuum degree 0.01-0.07Mpa, the dropping time of 0.5-2 hours at a shear rate of 5000-10000r / min, after completion of the dropwise addition continues distilled for 2 hours under reduced pressure; (4) spray-drying: inlet air a temperature of 180-220 ° C, outlet temperature at 80-120 ° C for spray drying.
  2. 2. 如权利要求1所述麻保沙星微囊,其特征在于:所述步骤(2)中的二氯甲烷与无水乙醇的体积比为6:4-19:1。 2. The microcapsule 1 marbofloxacin claim, wherein: said step volume ratio (2) with ethanol in dichloromethane to 6: 4-19: 1.
CN 201510120102 2015-03-19 2015-03-19 One kind of marbofloxacin microcapsule and preparation method CN104706621B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101019838A (en) * 2007-02-12 2007-08-22 清华大学 Linseed oil microcapsule powder and its prepn
CN103271875A (en) * 2013-07-01 2013-09-04 浙江华尔成生物药业股份有限公司 Marbofloxacin freeze-dried powder for injection and preparation method and application thereof

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EP2440165A4 (en) * 2009-06-08 2014-01-22 Otic Pharma Ltd Otic foam formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101019838A (en) * 2007-02-12 2007-08-22 清华大学 Linseed oil microcapsule powder and its prepn
CN103271875A (en) * 2013-07-01 2013-09-04 浙江华尔成生物药业股份有限公司 Marbofloxacin freeze-dried powder for injection and preparation method and application thereof

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