WO2023004963A1 - 一种低粘度硝酸舍他康唑乳膏的制备方法及其制备的产品 - Google Patents

一种低粘度硝酸舍他康唑乳膏的制备方法及其制备的产品 Download PDF

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WO2023004963A1
WO2023004963A1 PCT/CN2021/119263 CN2021119263W WO2023004963A1 WO 2023004963 A1 WO2023004963 A1 WO 2023004963A1 CN 2021119263 W CN2021119263 W CN 2021119263W WO 2023004963 A1 WO2023004963 A1 WO 2023004963A1
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viscosity
prescription
preparation
sertaconazole nitrate
low
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PCT/CN2021/119263
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French (fr)
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戴金林
王汕桃
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海南海神同洲制药有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02—Local antiseptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics

Definitions

  • the invention relates to the field of pharmaceutical preparations, in particular to a preparation method of low-viscosity sertaconazole nitrate cream and the prepared product.
  • Sertaconazole nitrate is a new type, broad-spectrum, high-efficiency topical antifungal agent, which was developed by the Spanish company Ferrer. It has a wide range of antibacterial activities against pathogenic bacteria that cause skin and mucous membrane infections, pathogenic yeasts, skin fungi, opportunistic pathogens, filamentous fungi, Gram-positive bacteria and Trichomonas.
  • Rapid and effective treatment of mycosis, candida and pityriasis versicolor includes fungi resistant to other therapeutic antifungal agents such as rubrum, Microsporum canis, Epidermophyton flocculus, barbadensis, tinea Compared with other clinical imidazole antibacterial agents, it has a wider complete range for the treatment of bacteria and other diseases.
  • the company has developed a sertaconazole nitrate cream in the early stage, and its formula includes: 2% sertaconazole nitrate, 12% mono- and diglycerides, 5% stearyl alcohol, 5% light liquid paraffin, 15% % propylene glycol, 3% polysorbate 80, 0.1% ethylparaben and the balance water.
  • the present invention provides a method for preparing low-viscosity sertaconazole nitrate cream and the product prepared therefrom.
  • the specific technical scheme is as follows:
  • the present invention at first provides a kind of preparation method of low-viscosity sertaconazole nitrate cream, comprising the following steps:
  • Emulsification Mix and emulsify the oil phase prepared in step (1), the water phase prepared in step (2) and the main drug dispersion liquid prepared in step (3) to obtain low-viscosity sertaconazole nitrate cream ;
  • the prescription of said low-viscosity sertaconazole nitrate emulsifiable cream includes 2% sertaconazole nitrate, 10% glyceryl monostearate, 5% stearyl alcohol, 3% light liquid paraffin, 15% propylene glycol, 7% polysorbate 80, 0.1% ethylparaben and the balance water.
  • each material is mixed and then heated to 80-85°C.
  • the amount of propylene glycol used in step (2) is 80% of the prescription amount.
  • each material is mixed and then heated to 80-85°C.
  • step (4) specifically includes:
  • the first mixed phase is mixed and emulsified with the remaining water phase under stirring to obtain a low-viscosity sertaconazole nitrate cream.
  • the present invention also provides the product prepared by the aforementioned preparation method.
  • the viscosity of the prepared product is less than 20000 mPa ⁇ s.
  • the viscosity of the prepared product is less than 14000-16000 mPa ⁇ s.
  • the present invention prepares low-viscosity sertaconazole nitrate cream on the basis of the existing prescription of sertaconazole nitrate cream by optimizing and adjusting the dosage of auxiliary materials. Through testing, its viscosity is less than 20000mPa ⁇ s, Viscosity is reduced by up to 40% compared to known formulations.
  • the ratio of the matrix was further screened with reference to the prescription before the change. Design 5 prescriptions. See Table 1 for the prescription form.
  • Appearance inspection human eye observation
  • Viscosity test According to the third method of viscosity determination in the 2015 edition of "Chinese Pharmacopoeia", take an appropriate amount of sample, put it into a 250ml beaker, drain the air, and equilibrate the paste in a water bath at 25°C for 1 to 2 hours before measuring.
  • prescription 6 is the prescription before the change. Compared with prescription 6 before the change, prescription 5 only decreased the amount of mono- and diglycerides by 2%, light liquid paraffin by 2%, and increased polysorbate 80 by 4%, which resulted in a significant decrease in viscosity. The drop was close to 40%.
  • prescription 4 Compared with prescription 5, the difference between prescription 4 and prescription 5 is that the polysorbate 80 content of prescription 4 is 9%, while the content of prescription 5 is 7%, and the viscosity of prescription 4 is obviously greater than that of prescription 5.
  • prescription 3 the difference between prescription 3 and prescription 2 is that the polysorbate 80 content of prescription 3 is 9%, while the content of prescription 2 is 7%, and the viscosity of prescription 2 is obviously greater than that of prescription 3.
  • prescription 2 Compared with prescription 5, the difference between prescription 2 and prescription 5 is that the amount of mono- and diglycerides in prescription 2 is less, but the viscosity of prescription 2 is higher.
  • Heat-resistant test Put the prepared cream samples into test tubes with stoppers and place them at a constant temperature of 60°C for 24 hours to observe whether there is liquefaction, delamination and discoloration.
  • Cold resistance test Put each cream sample into a stoppered test tube and place it at a constant temperature of -15°C for 24 hours to observe whether there is liquefaction, delamination and discoloration.
  • Centrifugal test put each cream sample into a 10cm centrifuge tube, centrifuge for 5 hours at a speed of 3750 rpm, and observe whether there is separation.
  • prescription 5 not only has a uniform appearance and color, is fine and smooth, has no rough feeling, and has no layering phenomenon, and its viscosity is relatively small. Therefore, the present invention takes prescription 5 as the final prescription to prepare low-viscosity sertaconazole nitrate cream.
  • Embodiment 4 influence factor test
  • Example 1 According to the preparation method of Example 1 and prescription 5, a batch of cream (batch number: 0801) samples were prepared and placed under strong light (4500 ⁇ 500lx), high temperature 40°C, and high humidity 75% for 10 days, respectively. Day, 10 days sampling, investigate its appearance, particle size, uniformity, related substances, layering phenomenon, content change, the investigation results are shown in Table 4 below.
  • the sample is placed under the conditions of high temperature 40°C, high humidity 75% and strong light (light intensity is 4500 ⁇ 500lx) for 10 days, the preparation properties have no obvious change, uniformity, particle size and layering phenomenon, The relevant substances are in compliance with the regulations. Under high temperature and high humidity conditions, the content does not change much, but under strong light conditions, the content decreases.
  • cream should be shading and sealed, should be stored below 25 °C, must not be frozen. Therefore, this product should be stored in a cool and dark place (protected from light and not exceeding 20°C).

Abstract

本发明公开了一种低粘度硝酸舍他康唑乳膏的制备方法，包括以下步骤：(1)制备油相：将处方量的轻质液状石蜡、单、双硬脂酸甘油酯、十八醇以及羟苯乙酯混合并加热，保温备用；(2)制备水相：将处方量的聚山梨酯80、纯化水以及部分处方量的丙二醇混合并加热，保温备用；(3)制备主药分散液：将硝酸舍他康唑用余下的丙二醇分散并研磨，得到主药分散液；(4)乳化：将步骤(1)制备的油相、步骤(2)制备的水相以及步骤(3)制备的主药分散液混合并搅拌乳化，得到低粘度的硝酸舍他康唑乳膏。通过测试，本发明提供的硝酸舍他康唑乳膏粘度小于20000mPa·s，与已知的处方相比，粘度显著降低。

Description

一种低粘度硝酸舍他康唑乳膏的制备方法及其制备的产品 技术领域
本发明涉及药物制剂领域，特别涉及一种低粘度硝酸舍他康唑乳膏的制备方法及其制备的产品。
背景技术
硝酸舍他康唑是一种新型的、广谱、高效的局部抗真菌剂，由西班牙Ferrer公司研制开发，1992年在西班牙首次上市，我国于2003年批注其软膏制剂上市。其对引起有皮肤和粘膜感染的病原菌、致病性酵母菌、皮肤真菌、机会致病菌、丝状真菌、革兰氏阳性菌和毛滴虫属菌，均有广泛的抗菌活性，对表真菌病、念珠菌和花斑糠疹病治疗迅速而高效，而且包括对其它治疗用抗真菌耐药的真菌，如红色癣菌、犬小孢子菌、絮状表皮癣菌、须疮、发癣菌等症的治疗，相比其他临床的咪唑类抗菌剂具有更广泛的完全范围。
本公司前期研制了一种硝酸舍他康唑乳膏，其配方包括：2％硝酸舍他康唑、12％单、双酸甘油酯、5％十八醇、5％轻质液状石蜡、15％丙二醇、3％聚山梨酯80、0.1％羟苯乙酯以及余量的水。
在实际生产过程中，发现该配方的硝酸舍他康唑乳膏过于粘稠，粘度在于20000mPa·s以上。不易灌装。这严重的影响了生成效率。有鉴于此，对硝酸舍他康唑乳膏的制备工艺进行调整，研制出低粘度的硝酸舍他康唑乳膏是亟待解决的技术问题。
发明内容
为解决上述技术问题，本发明提供了一种低粘度硝酸舍他康唑乳膏的制备方法及其制备的产品。具体技术方案如下：
本发明首先提供了一种低粘度硝酸舍他康唑乳膏的制备方法，包括以下步骤：
(1)制备油相：将处方量的轻质液状石蜡、单、双硬脂酸甘油酯、十八醇以及羟苯乙酯混合并加热，保温备用；
(2)制备水相：将处方量的聚山梨酯80、纯化水以及部分处方量的丙二醇混合并加热，保温备用；
(3)制备主药分散液：将硝酸舍他康唑用余下的丙二醇分散并研磨，得到主药分散液；
(4)乳化：将步骤(1)制备的油相、步骤(2)制备的水相以及步骤(3)制备的主药分散液混合并搅拌乳化，得到低粘度的硝酸舍他康唑乳膏；
其中所述低粘度硝酸舍他康唑乳膏的处方以质量百分数计，包括2％硝酸舍他康唑、10％单硬脂酸甘油酯、5％十八醇、3％轻质液状石蜡、15％丙二醇、7％聚山梨酯80、0.1％羟苯乙酯以及余量的水。
在本发明的一些实施方式中，步骤(1)中将各物料混合后加热至80-85℃。
在本发明的一些实施方式中，步骤(2)中所使用的丙二醇的量为80％的处方量。
在本发明的一些实施方式中，步骤(2)中将各物料混合后加热至80-85℃。
在本发明的一些实施方式中，步骤(4)具体包括：
将部分水相与主药分散液混合，得到第一水相；
将油相与第一水相在搅拌下混合并乳化，得到第一混合相；
将第一混合相与剩余的水相在搅拌下混合并乳化，得到低粘度硝酸舍他康唑乳膏。
本发明还提供了由前述的制备方法所制备的产品。
在本发明的一些实施方式中，所制备的产品的粘度小于20000mPa·s。
在本发明的一些实施方式中，所制备的产品的粘度小于14000-16000mPa·s。
有益效果
本发明在现有的硝酸舍他康唑乳膏的处方基础上，通过对辅料的用量进行优化调整，制备出了低粘度硝酸舍他康唑乳膏，通过测试，其粘度小于20000mPa·s，与已知的处方相比，粘度降低达40％。
具体实施方式
以下说明本发明的具体实施方式为使本申请的目的、技术方案和优点更加清楚，下面通过具体实施例将对本申请的技术方案进行清楚、完整地描述。
需要说明的是，以下实施例中未注明具体条件者，按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者，均为可以通过市售购买获得的常规产品。
实施例1 处方的优化
为了改善硝酸舍他康唑乳膏的粘度，便于车间灌装，参考变更前处方，对基质比例进行了进一步的筛选。设计5个处方。处方表参见表1。
分别采用表1中的处方，按以下步骤制备硝酸舍他康唑乳膏：
(1)制备油相：将处方量的轻质液状石蜡、单、双硬脂酸甘油酯、十八醇以及羟苯乙酯混合并加热至80℃左右，保温备用；
(2)制备水相：将处方量的聚山梨酯80、纯化水以及80％处方量的丙二醇混合并加热至85℃左右，保温备用；
(3)制备主药分散液：将硝酸舍他康唑用余下的丙二醇分散并研磨，得到主药分散液；
(4)a、乳化：将一半的水相与主药分散液混合，得到第一水相；
b、将油相与第一水相在搅拌下混合并乳化，得到第一混合相；
c、将第一混合相与剩余的水相在搅拌下混合并乳化30分钟，得到低粘度硝酸舍他康唑乳膏。
表1 处方表
Figure PCTCN2021119263-appb-000001
Figure PCTCN2021119263-appb-000002
注：表1中的单位为重量份。
实施例2 对硝酸舍他康唑乳膏处方的性能考察
对根据各处方所制备的硝酸舍他康唑乳膏的外观性状、粘度进行考察。
考察方法
外观检测：人眼观察
粘度检测：按照2015年版《中国药典》黏度测定法第三法，取样品适量，至250ml烧杯中，排尽其中空气，膏体于25℃水浴中平衡1～2h后测定。
考察结果见下表2。
表2 处方性能检测结果
Figure PCTCN2021119263-appb-000003
由上表可知：处方1～6的外观性状均为细腻柔软，处方5粘度值最小。处方6为变更前的处方。处方5与变更前的处方6相比，仅将单、双酸甘油酯的量下调2％，轻质液状石蜡下调2％，并将聚山梨酯80上调4％，就使得粘度值显著下降，下降幅度接近40％。
处方4与处方5相比，二者的区别仅在于处方4的聚山梨酯80含量为9％，而处方5的含量为7％，处方4的粘度明显大于处方5。
但是，处方3与处方2相比，二者的区别仅在于处方3的聚山梨酯80含量为9％，而处方2的含量为7％，处方2的粘度明显大于处方3。
处方2与处方5相比，二者的区别仅在于处方2的单、双酸甘油酯的量更少，但是处方2粘度却更大。
因此，根据表1以及表2分析推断，是处方整体的优化而非单个辅料的量的改变导致处方5粘度值如此大的下降幅度。
实施例3 稳定性考察
进一步对这6个处方的稳定性进行筛选。主要考察制剂对高温、低温及离心的耐受性。
试验方法
耐热试验：将所制成的各乳膏样品，分别装入带塞试管于60℃恒温放置24小时，观察有无液化、分层及变色现象。
耐寒试验：将各乳膏样品，分别装入带塞试管于-15℃恒温放置24小时，观察有无液化、分层及变色等现象。
离心试验：将各乳膏样品，分别装入10cm离心管中，离心5h，转速3750转/分钟，观察有无分离现象。
试验结果见表3
表3 耐热、耐寒、离心试验结果
Figure PCTCN2021119263-appb-000004
从上表3中可以看出，处方5稳定性更佳。
结论：
通过对各处方制得的样品的外观观察以及上述试验，上述乳膏处方1-6中，处方5不但外观色泽均匀一致、细腻无粗糙感且无分层现象，粘度又相对较小。因此本发明以处方5为最终处方，制备低粘度硝酸舍他康唑乳膏。
实施例4 影响因素试验
按实施例1的制备方法以及处方5，制备一批乳膏(批号：0801)样品分别置于强光(4500±500lx)、高温40℃、高湿75％条件下放置10天，分 别于5天、10天取样，考察其外观、粒度、均匀性、有关物质、分层现象、含量变化情况，考察结果见下表4。
表4 影响因素试验结果
Figure PCTCN2021119263-appb-000005
由影响因素试验可得：样品在高温40℃和高湿75％及强光(光照强度为4500±500lx)的条件下放置10天，制剂性状无明显变化，均匀性、粒度及分层现象、有关物质均符合规定。在高温高湿条件下，含量变化不大，但是强光条件下，含量有所下降。参照(中国药典2010年版二部附录I F)中第六项规定：乳膏剂应遮光密封，宜置25℃以下贮存，不得冷冻。故本品应在凉暗处(避光并不超过20℃)密闭保存。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。

Claims (8)

  1. 一种低粘度硝酸舍他康唑乳膏的制备方法，其特征在于，包括以下步骤：
    (1)制备油相：将处方量的轻质液状石蜡、单、双硬脂酸甘油酯、十八醇以及羟苯乙酯混合并加热，保温备用；
    (2)制备水相：将处方量的聚山梨酯80、纯化水以及部分处方量的丙二醇混合并加热，保温备用；
    (3)制备主药分散液：将硝酸舍他康唑用余下的丙二醇分散并研磨，得到主药分散液；
    (4)乳化：将步骤(1)制备的油相、步骤(2)制备的水相以及步骤(3)制备的主药分散液混合并搅拌乳化，得到低粘度的硝酸舍他康唑乳膏；
    其中所述低粘度硝酸舍他康唑乳膏的处方以质量百分数计，包括2％硝酸舍他康唑、10％单硬脂酸甘油酯、5％十八醇、3％轻质液状石蜡、15％丙二醇、7％聚山梨酯80、0.1％羟苯乙酯以及余量的水。
  2. 根据权利要求1所述的制备方法，其特征在于，步骤(1)中将各物料混合后加热至80-85℃。
  3. 根据权利要求1所述的制备方法，其特征在于，步骤(2)中所使用的丙二醇的量为80％的处方量。
  4. 根据权利要求1所述的制备方法，其特征在于，步骤(2)中将各物料混合后加热至80-85℃。
  5. 根据权利要求1-4中任一项所述的制备方法，其特征在于，步骤(4)具体包括：
    将部分水相与主药分散液混合，得到第一水相；
    将油相与第一水相在搅拌下混合并乳化，得到第一混合相；
    将第一混合相与剩余的水相在搅拌下混合并乳化，得到低粘度硝酸舍他康唑乳膏。
  6. 由权利要求1-5中任一项所述的制备方法制备的产品。
  7. 根据权利要求6所述的产品，其特征在于，粘度小于20000mPa·s。
  8. 根据权利要求7所述的产品，其特征在于，粘度小于14000-16000mPa·s。
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