WO2016086557A1 - 一种维d钙组合物咀嚼片及其制备方法 - Google Patents

一种维d钙组合物咀嚼片及其制备方法 Download PDF

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WO2016086557A1
WO2016086557A1 PCT/CN2015/075385 CN2015075385W WO2016086557A1 WO 2016086557 A1 WO2016086557 A1 WO 2016086557A1 CN 2015075385 W CN2015075385 W CN 2015075385W WO 2016086557 A1 WO2016086557 A1 WO 2016086557A1
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vitamin
calcium
solution
hours
keep
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吴函峰
汪宁卿
李珠珠
饶经纬
李彪
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海南卫康制药(潜山)有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10—Carbonates; Bicarbonates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

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  • the invention relates to the technical field of medicine and medicine production, in particular to a vitamin D calcium composition chewable tablet and a preparation method thereof.
  • the tablet is stable in quality and convenient to take, and is the most basic and most commonly used form of preparation.
  • ordinary tablets are often difficult to take, and long-term medication may even cause psychological refusal, and chewable tablets can make up for this deficiency.
  • Chewable tablets are a type of tablets that can be swallowed after being chewed in the oral cavity.
  • the size is generally the same as that of ordinary tablets, and shaped tablets of different shapes can be made as needed.
  • the tablets are easily swallowed after being chewed, and the surface area of the tablets is increased to promote the dissolution and absorption of the drug in the body.
  • making chewable tablets can accelerate their disintegration and improve drug efficacy.
  • Chewable tablets are convenient to take, even in the absence of water, can be used on time, especially for children, the elderly, patients with dysphagia or poor gastrointestinal function, can reduce the burden of drugs on the gastrointestinal tract. Therefore, chewing tablet applications are becoming more widespread.
  • Vitamin D calcium is a combination of calcium carbonate and vitamin D 3 for calcium supplementation in pregnant and lactating women, menopausal women, the elderly, children, etc., and helps prevent osteoporosis.
  • vitamin D calcium which have been marketed are only vitamin D calcium chewable tablets, and the auxiliary materials are: sorbitol, magnesium stearate, fruit flavor, coloring agent, and the types and quantities are large. More and more studies have shown that the side effects of the excipient itself, the incompatibility of the excipients with the main drug, the impurities in the excipients, etc. all have an impact on the safety of the drug.
  • Starch is made up of glucose molecules. It is a basic excipient for oral solid preparations. It is commonly used as a binder, diluent and disintegrant in chewable tablets, and the starch is from natural substances such as corn and cassava. Extraction, safe, reliable, cheap and easy to obtain, but the use of starch alone as an excipient for the production of chewable tablets has not been reported.
  • the technical problem to be solved by the present invention is to overcome the defects of the prior art, and further to provide a vitamin D calcium composition chewable tablet and a preparation method thereof, which have less auxiliary materials, good stability and high bioavailability.
  • a vitamin D calcium composition chewable tablet comprising vitamin D calcium, starch and sucrose
  • the tablet overcomes the disadvantages of the above ordinary chewable tablet, and reduces the kind and amount of excipients in the vitamin D calcium chewable tablet, and the pharmaceutical preparation has excellent performance. High bioavailability, good stability, high patient acceptance, no gritty, and important clinical application value.
  • a vitamin D calcium composition chewable tablet prepared from the following materials:
  • a preparation method of a vitamin D calcium composition chewable tablet comprising the following steps:
  • step C mixing the liquid obtained in step A with the solution obtained in step B, stirring well for 30 minutes, and then reducing the liquid to normal temperature to obtain a gelatinized corn-sucrose system liquid;
  • step E sampling the liquid medicine obtained in step D to measure the calcium carbonate content
  • the liquid medicine is divided into the medicinal herbs according to the loading amount, and each medicinal dish is filled with about 1.0 ml, and then the medicinal dish is covered with the unfilled state of the medicinal dish cover.
  • the medicinal dish is a cylindrical drug-loading package made of plastic or other materials;
  • the preparation method of the vitamin D calcium composition chewable tablet of the present invention wherein the pH adjusting agent in the step A is sodium hydroxide or hydrochloric acid, preferably the pH value of the solution is controlled to 6.5; the stirring time in the step C is preferably 30 minutes; In step F, it is preferred to gradually increase the temperature to 0 ° C for 3 hours, and then gradually increase the temperature to 30 ° C for 5 hours; the starch is selected from corn starch.
  • the preparation method of the vitamin D calcium composition chewable tablet of the invention adopts a unique process step, and special treatment of the common corn starch can improve the adhesion and disintegration effect of the starch in the chewable tablet and improve chewing.
  • the amount of sucrose in the vitamin D calcium composition chewable tablet is 8.5% (W/V), which is a hardness enhancer of the tablet and plays a flavoring effect.
  • Vitamin D calcium composition chewable tablets only need two kinds of excipients, starch and sucrose, to reduce the types of excipients needed; because the freeze-drying process uses two drops of two liters, two cooling and two warming can make the chewable sheet more formable. Good, and improve the stability of the product and improve the quality of the product. Therefore, the preparation method of the vitamin D calcium composition chewable tablet provided by the invention has the characteristics of convenient operation, simple prescription, unique process and stable product.
  • A weigh 100g of corn starch, add 900ml of purified water to stir, adjust the pH of the solution to 6.5 with pH adjuster, then heat to 72 ° C, hold for 120 minutes, make about 10% (W / V) Paste corn starch solution.
  • the drug solution obtained in the step A is mixed with the solution obtained in the step B, stirred well for 30 minutes, and then the drug solution is lowered to normal temperature to obtain a gelatinized corn-sucrose system drug solution.
  • step E Sampling the liquid obtained in step D to measure the calcium carbonate content.
  • the liquid medicine is divided into the medicinal herbs according to the loading amount, and each medicinal dish is filled with about 1.0 ml, and then the medicinal dish is covered with the unfilled state of the medicinal dish cover.
  • the medicinal dish is a cylindrical drug-loaded package made of plastic or other materials.
  • A weigh 150g of corn starch, add 900ml of purified water to stir, adjust the pH of the solution to 6.5 with pH adjuster, then heat to 72 ° C, hold for 120 minutes, make about 5 to 15% (W / V a gelatinized corn starch solution.
  • the drug solution obtained in the step A is mixed with the solution obtained in the step B, stirred well for 30 minutes, and then the drug solution is lowered to normal temperature to obtain a gelatinized corn-sucrose system drug solution.
  • step E Sampling the liquid obtained in step D to measure the calcium carbonate content.
  • the liquid medicine is divided into the medicinal herbs according to the loading amount, and each medicinal dish is filled with about 1.0 ml, and then the medicinal dish is covered with the unfilled state of the medicinal dish cover.
  • the medicinal dish is a cylindrical drug-loaded package made of plastic or other materials.
  • the vitamin D calcium composition chewable tablet prepared according to the above examples and the commercially available vitamin D calcium chewable tablet (commercially available) were tested for friability and hardness according to the Chinese Pharmacopoeia 2010 edition two appendix X G inspection method. The results are as follows:
  • the experimental data showed that the vitamin D calcium composition chewable tablets had no significant difference in hardness and friability compared with the commercially available vitamin D calcium chewable tablets, which met the requirements of the Chinese Pharmacopoeia 2010 edition for chewing tablets, and the taste was very large. Improve to make it more in line with the needs of patients.

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Abstract

一种维D钙咀嚼片及其制备方法，所述咀嚼片由碳酸钙、维生素D 3、淀粉、蔗糖和纯化水制成，其制备方法包括将淀粉与蔗糖分别加水制成溶液，将二者混合，加入碳酸钙和维生素D 3，然后将该药液放到圆柱状盛药皿中，冻干。

Description

一种维D钙组合物咀嚼片及其制备方法 技术领域
本发明涉及医药及医药生产技术领域，具体涉及一种维D钙组合物咀嚼片及其制备方法。
背景技术
片剂质量稳定、服用方便，是一种最基本、最常用的制剂形式。然而，对于儿童、老人以及吞咽困难的患者，普通片剂往往服用困难，长期服药甚至会使其产生心理上的拒药现象，咀嚼片则可弥补这种不足。咀嚼片是一类可在口腔内嚼碎后咽下的片剂，大小一般与普通片剂相同，可根据需要制成不同形状的异形片。药片经嚼碎后便于吞服，药片表面积增大，可促进药物在体内的溶解、吸收。对于难崩解的药物，制成咀嚼片可加速其崩解，提高药效。咀嚼片服用方便，即使在缺水的条件下也可以按时用药，特别适用于小儿、老人、吞咽困难或胃肠功能较差的患者，可减少药物对胃肠道的负担。因此，咀嚼片剂应用逐渐广泛起来。
维D钙为含碳酸钙和维生素D3的复方制剂，用于妊娠和哺乳期妇女、更年期妇女、老年人、儿童等的钙补充，并帮助防治骨质疏松症。
已上市的维D钙的药物制剂仅有维D钙咀嚼片，其辅料为：山梨糖醇、硬脂酸镁、水果香料、着色剂，种类及数量较多。越来越多的研究表明辅料本身的毒副作用、辅料与主药的配伍禁忌、辅料中的杂质等等都会对药品的安全性产生影响，
因此，选择合适的辅料和工艺，减少维D钙咀嚼片的辅料种类和用量，提高维D钙咀嚼片的生物利用度和稳定性，对于保证临床用药的安全性有积极意义。
淀粉是由葡萄糖分子聚合而成，它是口服固体制剂的基本辅料，常用于咀嚼片中作黏合剂、稀释剂及崩解剂，且淀粉均从玉米、木薯等天然物质中 提取，安全可靠、廉价易得，但是单独使用淀粉作为辅料用于咀嚼片的生产未见报道。
发明内容
本发明所要解决的技术问题在于克服现有技术的缺陷，进一步提出一种维D钙组合物咀嚼片及其制备方法，该制剂辅料少，稳定性好，生物利用度高。
本发明所要解决的技术问题采用以下技术方案来实现：
一种维D钙组合物咀嚼片，包含维D钙、淀粉、蔗糖，该片剂克服了上述普通咀嚼片的缺点，减少了维D钙咀嚼片中辅料种类和用量，该药物制剂性能优良，生物利用度高，稳定性良好，患者接受度高，无砂砾感，具有重要的临床应用价值。
一种维D钙组合物咀嚼片，由如下原料制备而成：
Figure PCTCN2015075385-appb-000001
一种维D钙组合物咀嚼片的制备方法，包括步骤如下：
A、称取组份量的淀粉，加入一定量的纯化水搅拌，用pH调节剂将溶液的pH值控制在4～9之间,然后加热至72℃，保温120分钟，制成5～15％(W/V)的糊化玉米淀粉溶液；
B、量取纯化水45ml，煮沸，加85g蔗糖，搅拌，溶解后，继续加热至100℃，用精制棉滤过，滤器用适量的热蒸馏水洗净，洗液与滤液合并，放冷，加适量的蒸馏水，使全量成100mL，搅匀，即得B溶液；
C、将步骤A得到的药液与步骤B得到的溶液混合，充分搅拌30分钟，后将药液降至常温得到糊化玉米-蔗糖体系药液；
D、称取碳酸钙750g，维生素D3 2.5mg，加入1L糊化玉米-蔗糖体系药液，搅拌25～35分钟；
E、对步骤D得到的药液取样测量碳酸钙含量；
F、药液测量碳酸钙含量后，按装量将药液分装于盛药皿中，每个盛药皿装约1.0ml，然后利用盛药皿盖未压紧状态盖住盛药皿，盛药皿为塑料或其他材料制成的圆柱状载药包装；
G、将装有药液的盛药皿放入冷冻干燥箱，降温至零下45℃，保持2小时，抽真空，然后逐渐升温至0℃，保持2小时，再降温至零下45℃，保持2小时，再逐渐升温至0℃，保持2～4小时，再逐渐升温至28～32℃干燥4～6小时，整个过程真空度保持在10帕以下；最后将装药的盛药皿盖盖紧，并装入铝箔袋进行密封得到维D钙组合物咀嚼片。
本发明的一种维D钙组合物咀嚼片的制备方法，所述步骤A中pH调节剂为氢氧化钠或盐酸，优选将溶液的pH值控制在6.5；步骤C中搅拌时间优选30分钟；步骤F中优选再逐渐升温至0℃，保持3小时，再逐渐升温至30℃干燥5小时；所述淀粉选用玉米淀粉。
本发明的有益效果为：
本发明的一种维D钙组合物咀嚼片的制备方法，其采用独特的工艺步骤，对普通玉米淀粉进行特殊工艺处理，可以提高淀粉在咀嚼片剂中的粘合、崩解作用，提高咀嚼片剂的成型。且维D钙组合物咀嚼片中蔗糖用量为8.5％(W/V)，它是此片剂的硬度增强剂，并起到矫味作用。维D钙组合物咀嚼片只需淀粉和蔗糖两种辅料，减少所需用辅料的种类；由于冻干工艺采用两降两升的工艺，两次降温、两次升温能够使咀嚼片成型性更好，并提高产品的稳定性，提高产品的质量。因此本发明提供的一种维D钙组合物咀嚼片的制备方法具有操作方便，处方简单，工艺独特，产品稳定性的特点。
具体实施方式
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体实施例，进一步阐述本发明，但下述实施例仅仅为本发明的优选实施例，并非全部。基于实施方式中的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得其它实施例，都属于本专利的保护范围。
实施例1
处方：1000片量
Figure PCTCN2015075385-appb-000002
A、称取100g的玉米淀粉，加入900ml的纯化水搅拌，用pH调节剂将溶液的pH值控制在6.5,然后加热至72℃，保持120分钟，制成约10％(W/V)的糊化玉米淀粉溶液。
B、量取纯化水45ml，煮沸，加85g蔗糖，搅拌，溶解后，继续加热至100℃，用精制棉滤过，滤器用适量的热蒸馏水洗净，洗液与滤液合并，放冷，加适量的蒸馏水，使全量成100mL，搅匀，即得B溶液。
C、将步骤A得到的药液与步骤B得到的溶液混合，充分搅拌30分钟，后将药液降至常温得到糊化玉米-蔗糖体系药液。
D、称取碳酸钙750g，维生素D3 2.5mg(按1000片算)，加入1L糊化玉米-蔗糖体系药液，搅拌30分钟。
E、对步骤D得到的药液取样测量碳酸钙含量。
F、药液测量碳酸钙含量后，按装量将药液分装于盛药皿中，每个盛药皿装约1.0ml，然后利用盛药皿盖未压紧状态盖住盛药皿，盛药皿为塑料或其他材料制成的圆柱状载药包装。
G、将装有药液的盛药皿放入冷冻干燥箱，降温至零下45℃，保持2小时，抽真空，然后逐渐升温至0℃，保持2小时，降温至零下45℃，保持2小时，再逐渐升温至0℃，保持3小时，再逐渐升温至30℃干燥5小时，整个过程真空度保持在10帕以下。最后将装药的盛药皿盖盖紧，并装入铝箔袋进行密封得到一种维D钙组合物咀嚼片。
实施例2
处方：1000片量
Figure PCTCN2015075385-appb-000003
Figure PCTCN2015075385-appb-000004
A、称取150g的玉米淀粉，加入900ml的纯化水搅拌，用pH调节剂将溶液的pH值控制在6.5,然后加热至72℃，保持120分钟，制成约5～15％(W/V)的糊化玉米淀粉溶液。
B、量取纯化水45ml，煮沸，加85g蔗糖，搅拌，溶解后，继续加热至100℃，用精制棉滤过，滤器用适量的热蒸馏水洗净，洗液与滤液合并，放冷，加适量的蒸馏水，使全量成100ml，搅匀，即得B溶液。
C、将步骤A得到的药液与步骤B得到的溶液混合，充分搅拌30分钟，后将药液降至常温得到糊化玉米-蔗糖体系药液。
D、称取碳酸钙750g，维生素D3 2.5mg(按1000片算)，加入1L糊化玉米-蔗糖体系药液，搅拌30分钟。
E、对步骤D得到的药液取样测量碳酸钙含量。
F、药液测量碳酸钙含量后，按装量将药液分装于盛药皿中，每个盛药皿装约1.0ml，然后利用盛药皿盖未压紧状态盖住盛药皿，盛药皿为塑料或其他材料制成的圆柱状载药包装。
G、将装有药液的盛药皿放入冷冻干燥箱，降温至零下45℃，保持2小时，抽真空，然后逐渐升温至0℃，保持2小时，降温至零下45℃，保持2小时，再逐渐升温至0℃，保持3小时，再逐渐升温至30℃干燥5小时，整个过程真空度保持在10帕以下。最后将装药的盛药皿盖盖紧，并装入铝箔袋进行密封得到一种维D钙组合物咀嚼片。
实验资料
将上述实施例制得的维D钙组合物咀嚼片进行如下质量研究试验：
1、硬度、脆碎度、口感对比试验
根据上述实施例制备的维D钙组合物咀嚼片与市售维D钙咀嚼片(市售)按《中国药典》2010年版二部附录X G检查法检测脆碎度和硬度，进行了对比，结果见下表：
Figure PCTCN2015075385-appb-000005
Figure PCTCN2015075385-appb-000006
实验数据表明，维D钙组合物咀嚼片较市售维D钙咀嚼片在硬度和脆碎度上无显著差异，符合《中国药典》2010年版对咀嚼片剂的要求，且口感上有很大改善，使之更符合患者的需求。
2、稳定性研究
样品来源：自制
样品批号：20130701(实施例1)、20130702(实施例2)
考察项目：性状、含量、有关物质、硬度、溶出度
考察方法：依据《中国药典》2010年版二部附录XIX C原料药与药物制剂稳定性试验指导原则，对本品的加速稳定性(1月、2月、3月、6月)和长期稳定性(3月、6月、9月、12月)进行了考察，试验结果如下表：
Figure PCTCN2015075385-appb-000007
Figure PCTCN2015075385-appb-000008
从上表可以看出，本发明的维D钙组合物咀嚼片各项指标在加速6个月内，长期12个月内均未发生显著变化，表明本品稳定性良好。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的仅为本发明的优选例，并不用来限制本发明，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。

Claims (2)

  1. 一种维D钙组合物咀嚼片，其特征在于，由如下原料制备而成：
    Figure PCTCN2015075385-appb-100001
  2. 一种权利要求1所述的维D钙组合物咀嚼片的制备方法，其特征在于，包括步骤如下：
    A、称取组份量的淀粉，加入一定量的纯化水搅拌，用pH调节剂将溶液的pH值控制在4～9之间,然后加热至72℃，保温120分钟，制成5～15％(W/V)的糊化玉米淀粉溶液；
    B、量取纯化水45ml，煮沸，加85g蔗糖，搅拌，溶解后，继续加热至100℃，用精制棉滤过，滤器用适量的热蒸馏水洗净，洗液与滤液合并，放冷，加适量的蒸馏水，使全量成100ml，搅匀，即得B溶液；
    C、将步骤A得到的药液与步骤B得到的溶液混合，充分搅拌30分钟，后将药液降至常温得到糊化玉米-蔗糖体系药液；
    D、称取碳酸钙750g，维生素D32.5mg，加入1L糊化玉米-蔗糖体系药液，搅拌25～35分钟；
    E、对步骤D得到的药液取样测量碳酸钙含量；
    F、药液测量碳酸钙含量后，按装量将药液分装于盛药皿中，每个盛药皿装约1.0ml，然后利用盛药皿盖未压紧状态盖住盛药皿，盛药皿为塑料或其他材料制成的圆柱状载药包装；
    G、将装有药液的盛药皿放入冷冻干燥箱，降温至零下45℃，保持2小时，抽真空，然后逐渐升温至0℃，保持2小时，再降温至零下45℃，保持2小时，再逐渐升温至0℃，保持2～4小时，再逐渐升温至28～32℃干燥4～6小时，整个过程真空度保持在10帕以下；最后将装药的盛药皿盖盖紧，并装入铝箔袋进行密封得到维D钙组合物咀嚼片。
PCT/CN2015/075385 2014-12-05 2015-03-30 一种维d钙组合物咀嚼片及其制备方法 WO2016086557A1 (zh)

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CN1286629A (zh) * 1997-12-29 2001-03-07 宝洁公司 片剂组合物
CN102258193A (zh) * 2011-07-19 2011-11-30 江西省农业科学院 芦笋咀嚼片的生产方法

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CN1286629A (zh) * 1997-12-29 2001-03-07 宝洁公司 片剂组合物
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