CN1129430C - 控制人虱的制剂 - Google Patents
控制人虱的制剂 Download PDFInfo
- Publication number
- CN1129430C CN1129430C CN99810049A CN99810049A CN1129430C CN 1129430 C CN1129430 C CN 1129430C CN 99810049 A CN99810049 A CN 99810049A CN 99810049 A CN99810049 A CN 99810049A CN 1129430 C CN1129430 C CN 1129430C
- Authority
- CN
- China
- Prior art keywords
- louse
- preparation
- hair
- spinosyn
- salt
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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- 150000003839 salts Chemical class 0.000 claims abstract description 29
- 238000000034 method Methods 0.000 claims abstract description 20
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Abstract
较安全的灭虱制剂，它含有刺糖多孢菌素或其生理可接受的衍生物或盐和生理可接受的载体，并且提供使用这些制剂控制人中虱子骚扰的方法。
Description
虱子对人体的骚扰在许多国家(包括美国)越来越成为普遍的社会和健康问题。虱子是非常小的虫子(长约2-3mm)。它们在头发或织物纤维上产卵并用粘合类排泄物坚固地附着于其上。所产的卵依据温度的不同通常在大约6到10天中孵出。蛹从卵中出现后残留的空壳看上去像白色的沙粒。这些壳被称为虮子。
虱目和吮吸虱是在几乎所有哺乳动物群上可发现的寄生虫。在15个已被认识的虱目科中，人体上发现有两个科(虱科和Pthiridae)的种。Pediculus humanus是虱科中感染人的唯一种类。包括头虱(Pediculus humanus capitis)；和体虱或衣虱(Pediculus humanus humanus，有时称作Pediculus corporis)。阴虱(Pthirus pubis)是一种有区别的种并且是Pthiridae科中感染人的唯一成员。本文所使用的术语“人虱”包括Pediculus humanus或Pthirus pubis中的成员。
人虱经聚集以及共用衣服和梳子来传播。起初，骚扰至多导致刺激，但刺激可导致刺激面感染。至少有三种主要的由虱子起初传播的疾病：虱传斑疹伤寒、胫骨热和回归热。
尽管人虱变种是相关的，但它们的每一种就其生境和摄取食物上都有其各自具体的特点。例如，头虱是小的硬壳状外寄生物，附着于发体上并在其上摄取食物、交配和产卵。头虱必须保留在头上，否则会在短时间内死去。头虱以难以置信的速度增殖。孵化后，虱子准备交配并在10小时内繁殖。理想条件下，雌性虱子在其一生中可生产多达300个卵。理想条件包括足够的食物供应、约28℃到约32℃的环境温度和约70％到约90％的相对湿度。
已知不良的卫生和穿着习惯对虱子传播起显著的作用。因此，虱子骚扰在生活环境存在有不合规格的卫生设施和习惯的地理区域最严重。然而，甚至在相对较卫生的条件下，虱子也仍是一个问题。
虱子的硬壳质外甲起保护作用以避免外部要素的影响。类似地，虱卵(或卵)通过卵周围的的壳质鞘来保护并附着在发干上。尽管虱子可受杀虫剂的影响，但卵对袭击常常是是耐受的。因此，虱子骚扰的最佳治疗包括灭虱药(杀死成虱)和灭卵剂(干扰卵子的发育)。
有时，试图使用生物活性剂来控制虱子。例如，在虱子治疗制剂中使用林丹(γ-六氯化苯)、有机磷酸酯(马拉硫磷)、天然除虫菊酯和称作拟除虫菊酯的合成化合物(如苄氯菊酯)作为灭虱药。然而，这些活性剂有缺点。例如，林丹安全性较差，并且虱子已对其产生耐受性。天然除虫菊酯需要频繁不断治疗，因为其仅仅产生短期的残存作用。合成的拟除虫菊酯尽管在对抗虱子上比天然除虫菊酯更有效，但对被治疗受体常常有更高的毒性。
刺糖多孢菌素(spinosyn，也称作A83453因子)是农业杀虫剂，对下列昆虫显示出活性：1)南方粘虫和其他鳞翅目昆虫，2)棉蚜虫和其他同翅目成员，和3)厩赦蝇(stable fly)、蝇卵和蚊子，都是双翅目昆虫成员。(参见美国专利5362634，下同)。刺糖多孢菌素A具有极好的人和动物安全性和毒理学特性。
本发明涉及用于控制虱子骚扰人的制剂，含有刺糖多孢菌素或其生理可接受的衍生物或盐和生理可接受的载体。本发明还涉及控制虱子骚扰人的方法，包括局部给予人一定量的控制虱子的刺糖多孢菌素或其生理可接受的衍生物/盐。本发明的制剂和方法比目前可使用的更安全和更有效。本发明制剂的特别优点是其对目前所使用的产品有耐受性的虱子种类有效。本发明优选的制剂和方法是护发制剂(如香波、洗剂和调理剂)和用这些护发制剂控制虱子骚扰人的方法。本发明特别有用的灭虱/灭卵(抗虱)制剂是护发制剂。特别有用的护发制剂是香波。
另一方面，本发明提供刺糖多孢菌素或其生理可接受的衍生物或盐，或者含有刺糖多孢菌素或其衍生物或盐的制剂在制备用于控制人虱的药物中的应用。
术语“控制虱子骚扰”涉及治疗已存在的虱子骚扰或预防对可能受虱子骚扰的人受骚扰。
刺糖多孢菌素是天然衍生的发酵产物。它们是刺糖多孢菌培养生产的大环内酯物。发酵产生多个因子，包括刺糖多孢菌素A和刺糖多孢菌素D(也称作A83543A和A83543D)。刺糖多孢菌素A和刺糖多孢菌素D是作为杀虫剂最有活性的两种刺糖多孢菌素。主要含有这两种刺糖多孢菌素(约85％A和15％D)的产品可从Dow Agrosciences以spinosad为商品名购得。商品名“spinosad”来自刺糖多孢菌素“A”和“D”的缩写。
刺糖多孢菌素都具有一个独特四环系统部分的12元大环和与其连接的两个不同的糖(氨基-糖forosamine和天然糖2N，3N，4N-三-O-甲基鼠李糖)。这种独特的结构使刺糖多孢菌素区别于其他大环化合物。
刺糖多孢菌素A(A83543A)是第一个在刺糖多孢菌发酵肉汤中分离和鉴定的刺糖多孢菌素。发酵肉汤随后的检查揭示刺糖多孢菌的亲本菌株产生多种刺糖多孢菌素，标记为A-J(A83543A-J)。与刺糖多孢菌素A相比，刺糖多孢菌素B-J的特点是在forosamine氨基上的取代方式、在四环系统和2N，3N，4N-三-O-甲基鼠李糖上的选择部位不同。目前使用刺糖多孢菌菌株产生以刺糖多孢菌素A(约85％)和刺糖多孢菌素D(约15％)为主要成分的刺糖多孢菌素混合物。从刺糖多孢菌的突变菌株中确定了另外的刺糖多孢菌素，标记为K-W。
本文中使用的术语“刺糖多孢菌素或其衍生物”涉及各个刺糖多孢菌素因子(A，B，C，D，E，F，G，H，J，K，L，M，N，O，P，Q，R，S，T，U，V，W或Y)、各个刺糖多孢菌素因子的N-去甲基衍生物或其组合物。为方便期间，术语“刺糖多孢菌素成分”也会在本文用来指各个刺糖多孢菌素或其生理可接受的衍生物或盐或其组合物。
Boeck等人在美国专利5362634(出版于1994年11月8日)、5496932(出版于1996年3月5日)和5571901(出版于1996年11月5日)中描述了刺糖多孢菌素A-H和J(它们被称作A83543因子A，B，C，D，E，F，G，H和J)及其盐。Mynderse等人在美国专利5202242(出版于1993年4月13日)中描述了刺糖多孢菌素L-N(它们被称作A83543因子L，M，和N)、其N-去甲基衍生物及其盐；并且Turner等人在美国专利5591606(出版于1997年1月7日)和5631155(出版于1997年5月29日)中描述了刺糖多孢菌素Q-T(它们被称作A83543因子Q，R，S和T)、其N-去甲基衍生物及其盐。这些专利引入本文供参考。例如，刺糖多孢菌素K，O，P，U，V，W和Y由Carl V.DeAmicis、James E.Dripps、Chris J.Hatton和Laura I.Karr描述于美国化学社专题论文集系列：害虫控制的植物化学(Phytochemicalsfor Pest Control)，第11章，“刺糖多孢菌素的物理和生化特性：发酵制备的新的大环内酯害虫控制剂”，146-154页(1997)。
刺糖多孢菌素可反应形成盐。生理可接受的盐也可用于本发明的制剂和方法。使用制备盐的常规方法来制备盐。例如，可用合适的酸中和刺糖多孢菌素A以形成酸加成的盐。刺糖多孢菌素的酸加成的盐是特别有用的。代表性合适酸加成的盐包括通过与有机或无机酸反应形成的盐，所述酸如硫酸、盐酸、磷酸、乙酸、琥珀酸、柠檬酸、乳酸、马来酸、富马酸、胆酸、双羟萘酸、粘液酸、谷氨酸、樟脑酸、戊二酸、乙醇酸、邻苯二甲酸、酒石酸、甲酸、月桂酸、硬脂酸、水杨酸、甲磺酸、苯磺酸、山梨酸、苦味酸、苯甲酸、肉桂酸等。
除了刺糖多孢菌素成分外，本发明制剂还可包括一种或多种其他具有对抗虱子活性的化合物，如，合成的拟除虫菊酯、天然除虫菊酯和林丹。本文讨论的所有比例、百分数和份数都是“重量比”，除非另有说明。
可以多种方法制备本发明的抗虱子制剂。特别有用的制剂是香波、调理剂和洗剂。这些制剂也可包括可有可无的一种或多种下列组分：a)表面活性剂；b)约1％到约10％的非挥发性聚硅氧烷材料；和/或c)约0.5％到约5％的悬浮剂。
本发明的香波制剂含有刺糖多孢菌素或其生理可接受的衍生物或盐与水、表面活性剂和酰胺，并且含有可有可无的另外一种抗虱子活性剂、聚硅氧烷化合物、悬浮剂和其他化妆品可接受的成分。
人的头发由于与周围环境接触并与头分泌的油脂结合而变得污垢。头发染污时，产生脏的感觉和不美的外观。本发明的香波制剂既能清洁头发又能有效地控制虱子骚扰。
在香波制剂中使用时，刺糖多孢菌素成分以约0.1％到约30％的浓度存在，优选约1％到约10％。
适于这些制剂使用的表面活性剂可以是任何各种各样的合成的阴离子、两性、两性离子和非离子表面活性剂。香波制剂中，表面活性剂通常以约5％到约30％的浓度存在，优选约15％到约25％。
合成阴离子表面活性剂的例子是有机硫反应产物的碱金属盐，所述的反应产物具有含8-22个碳原子的烷基和磺酸或硫酸酯基(术语烷基包括较高酰基基团的烷基部分)。优选烷基硫酸的钠、铵、钾或三乙醇胺盐，特别是可通过高级醇(C8-C18碳原子)硫酸化获得的；椰子油脂肪酸单甘油酯硫酸和磺酸的钠钠；1摩尔高级脂肪醇(如，牛脂或椰子油醇)和1-12摩尔环氧乙烷反应产物的硫酸酯的钠或钾盐；烷基苯酚环氧乙烷醚硫酸酯的钠或钾盐(每摩尔具有1-10单位的环氧乙烷并且其中的烷基含有8-12个碳原子)；烷基甘油醚磺酸钠；10-22个碳原子的脂肪酸被羟乙磺酸酯化并用氢氧化钠中和的反应产物；以及脂肪酸与肌氨酸缩合产物的水溶性盐。
两性离子表面活性剂的实例是脂肪族季铵、磷翁、有机四价硫化合物，其中脂肪族基团可以是直链的或支链的，并且脂肪族取代基之一含有约8-18个碳原子而另一个含有阴离子性增高水溶性的基团，如羧基、磺酸根、硫酸根、磷酸根、膦酸根。这些化合物的通式为：其中R2含有约8-18个碳原子的烷基、链烯基或羟基烷基基团、0到约10个环氧乙烷部分和0到约1个甘油基部分；Y是氮、磷或硫原子；R3是含有1到约3个碳原子的烷基或单羟基烷基基团；Y为硫时，x是1而Y为氮或磷时，x是2；R4是1到约4个碳原子的亚烷基或羟基亚烷基，并且Z是羧酸根、磺酸根、硫酸根、膦酸根或磷酸根。
实例包括：4-[N，N-二(2-羟基乙基)-N-十八烷基铵]-丁烷-1-羧酸盐；5-[S-3-羟基丙基-S-十六烷基锍]-3-羟基-戊烷-1-硫酸盐；3-[P，P-二乙基-P-3，6，9-三氧杂十四烷基磷翁]-2-羟基丙烷-1-磷酸盐；3-[N，N-二丙基-N-3-十二氧基-2-羟基丙基铵]-丙烷-1-磷酸盐；3-(N，N-二甲基-N-十六烷基铵)丙烷-1-磺酸盐；3-(N，N-二甲基-N-十六烷基铵)-2-羟基-丙烷-1-磺酸盐；N，N-二(2-羟基乙基)-N-(2-羟基十二烷基)铵]-丁烷-1-羧酸盐；3-[S-乙基-S-(3-十二氧基-2-羟基丙基)锍]-丙烷-1-磷酸盐；3-[P，P-二甲基-P-十二烷基磷翁]-丙烷-1-膦酸盐；和5-(N，N-二(3-羟基丙基)-N-十六烷基铵]-2-羟基戊烷-1-硫酸盐。
其他两性离子表面活性剂如甜菜碱也可用于本发明的制剂。甜菜碱的例子包括高级烷基甜菜碱，如椰子二甲基羧甲基甜菜碱、月桂基二甲基羧甲基甜菜碱、月桂基二甲基α-羧乙基甜菜碱、鲸蜡基二甲基羧甲基甜菜碱、月桂基二-(2-羟乙基)羧甲基甜菜碱、硬脂基二-(2-羟丙基)羧甲基甜菜碱、油基二甲基γ-羧丙基甜菜碱和月桂基二-(2-羟丙基)α-羧乙基甜菜碱。磺基甜菜碱可提及椰子二甲基磺基丙基甜菜碱、硬脂基二甲基磺基丙基甜菜碱、月桂基二甲基磺基乙基甜菜碱、月桂基二-(2-羟基乙基)磺基丙基甜菜碱等。酰氨基甜菜碱和酰氨基磺基甜菜碱(RCONH(CH2)3基团与甜菜碱上的氮原子连接)也可用于本发明的制剂。
可用于本发明制剂的两性表面活性剂的例子是脂肪族仲胺或叔胺衍生物，其中脂肪族基团是直链的或支链的并且其中一个脂肪族取代基包含约8到约18个碳原子并且有一个包含阴离子增加水溶性基团，如，羧基、磺酸根、硫酸根、磷酸根或膦酸根。两性表面活性剂的例子是3-十二烷基氨基丙酸钠、3-十二烷基氨基丙烷磺酸钠、N-烷基牛磺酸如通过N-十二烷基胺与羟乙基磺酸盐钠反应制备的(参见美国专利2658072，实施例3)、N-高级烷基天门冬氨酸(参见美国专利2438091)和以“Miranol”为商品名出售的并在美国专利2528378中描述的产品。
优选用于与阴离子、两性或两性离子表面活性剂组合的非离子表面活性剂是通过烯化氧基(自然界中亲水性的)与有机疏水性化合物(可以是自然界中脂肪族或烷基芳香族的)缩合产生的化合物。非离子表面活性剂的例子包括：
1)烷基苯酚的聚环氧乙烷缩合物，如，具有含约6到12个碳原子的直链或支链构型的烷基苯酚与环氧乙烷缩合的产物，环氧乙烷存在量等于每摩尔烷基苯酚10到60摩尔的环氧乙烷。这些化合物中的烷基取代基例如可由聚合的丙烯、二异丁烯、辛烷或壬烷衍生。
2)环氧乙烷与1，2-环氧丙烷和1，2-乙二胺反应产物的缩合物，该缩合物在制剂中可根据所需的疏水和亲水成分平衡来变化。例如，含有约40％到约80％(重量比)聚氧乙烯并且具有约5000到约11000分子量的化合物是满意的，它通过环氧乙烷基团与含有1，2-乙二胺和过量1，2-环氧丙烷的反应产物并具有2500到3000级分子量的疏水性碱反应来制备。
3)直链或支链构型的具有8-18个碳原子的脂肪醇与环氧乙烷的缩合产物，如，每摩尔椰子醇有10-30摩尔环氧乙烷的椰子醇环氧乙烷缩合物，椰子醇部分具有10-14个碳原子。
4)下列通式的长链叔氧化胺：
R1R2R3N→O其中R1含有约8到约18个碳原子的烷基、链烯基或单羟基烷基基团、0到约10个环氧乙烷部分和0到1个甘油基部分，并且R2和R3含有1到约3个碳原子和0到约1个羟基，如，甲基、乙基、丙基、羟基乙基或羟基丙基基团。式中的箭头表示半极性键。适于这些制剂使用的氧化胺的实例包括二甲基十二烷基氧化胺、油基二(2-羟基乙基)氧化胺、二甲基辛基氧化胺、二甲基-癸基氧化胺、二甲基十四烷基氧化胺、3，6，9-三氧杂十七烷基二乙基氧化胺、二(2-羟基乙基)-十四烷基氧化胺、2-十二烷氧基乙基二甲基氧化胺、3-十二烷氧基-2-羟基丙基二(3-羟基丙基)氧化胺和二甲基十六烷基氧化胺。
5)下列通式的长链叔膦氧化物：
RR’R”→O其中R包括含有约8到18个碳原子的烷基、链烯基或单羟基烷基基团、0到约10个环氧乙烷部分和0到1甘油基部分，并且R’和R”各自为含有1到3个碳原子的烷基或单羟基烷基基团。式中的箭头代表半极性键。
合适膦氧化物的例子包括：氧化十二烷基二甲基膦，氧化十四烷基二甲基膦，氧化十四烷基甲基乙基膦、氧化3，6，9-三氧杂十八烷基二甲基膦、氧化鲸蜡基二甲基膦、氧化3-十二烷氧基-2-羟基丙基二(2-羟基乙基)膦、氧化硬脂基二甲基膦、氧化鲸蜡基乙基丙基膦、氧化油基二乙基膦、氧化十二烷基二乙基膦、氧化十四烷基二乙基膦、氧化十二烷基二丙基膦、氧化十二烷基二(羟基甲基)膦、氧化十二烷基二(2-羟基乙基)膦、氧化十四烷基甲基-2-羟基丙基膦、氧化油基二甲基膦、氧化2-羟基十二烷基二甲基膦。
6)长链二烷基亚砜，含有一个1到3个碳原子(通常为甲基)的短链烷基或羟基烷基基团和一个含约8到约20个碳原子的含烷基、链烯基、羟基烷基或酮基烷基基团的长链疏水链、0到约10个环氧乙烷部分和0到1个甘油基部分。实例包括：十八烷基甲基亚砜、2-酮基十三烷基甲基亚砜、3，6，9-三氧杂十八烷基2-羟基乙基亚砜、十二烷基甲基亚砜、油基3-羟基丙基亚砜、十四烷基甲基亚砜、3-甲氧基十三烷基甲基亚砜、3-羟基十三烷基甲基亚砜和3-羟基-4-十二烷氧基丁基甲基亚砜。
在McCutchenon’s Detergents and Emulsifiers(1998年度，M.C.出版公司出版；McCutcheon Division，175 Rock Rd.，Glen Rck，NJ，07425美国)中描述了许多另外的非皂类表面活性剂。
阴离子表面活性剂，特别是烷基硫酸盐、乙氧基化的烷基硫酸盐及其混合物以及酰氨基甜菜碱优选用于本发明的香波制剂。
酰胺通过乳化香波成分和活性成分来增强制剂的泡沫。用于本发明制剂的酰胺可以是任何已知在香波中使用的脂肪酸的链烷醇酰胺。这些通常为具有约8到约14个碳原子的脂肪酸的单和二乙醇酰胺。其他合适的酰胺是具有多乙氧基基团的如PEG-3月桂酰胺。
在香波制剂中，酰胺通常以制剂约1％到约7％的浓度存在，优选约2％到约5％。优选酰胺是椰子单乙醇酰胺、椰子二乙醇酰胺及其混合物。
本发明的香波制剂也含有水。香波中水通常以约50％到80％的浓度存在，优选约60％到约75％。加入水后，制剂的相对粘度通常在约4000厘泊(cp)到约25000厘泊的范围内，优选约4000cp到约12000cp，最优选约4000cp到约5500cp，该粘度是使用Wells-Brookfield粘度仪DV-CP-2 DVII型，Cone CP-41型在26.7℃温度下以1RPM测量3分钟获得的。可以包括粘度改良剂和水溶助剂以使制剂粘度符合这些范围。
香波制剂也可包含一种或多种可有可无的成分如聚硅氧烷化合物、悬浮剂和使制剂成为更易为人们接受的化妆品的成分。
聚硅氧烷化合物调理头发并便于去除死的虱子、其卵和虮子。以制剂约1％到约10％的浓度使用非挥发性聚硅氧烷材料。在美国专利5292504(Cardin等人，出版于1994年3月8日)中公开了可使用的聚硅氧烷化合物的实例，该文献引入本文供参考。
非挥发性含聚硅氧烷的化合物是优选的并且以制剂约0.1％到约10％的浓度(重量比)使用，优选约0.25％到约3％。非挥发性聚硅氧烷的实例是聚烷基硅氧烷、聚烷基芳基硅氧烷、聚醚硅氧烷共聚物及其混合物。
可使用的聚烷基硅氧烷包括如聚二甲基硅氧烷(PDMS)，25℃时其粘度在约5到15000000cp的范围内。这些硅氧烷可购得，如从General Electric Company购得Viscasil系列并从Dow Corning购得Dow Corning 200系列。粘度可按照Dow Corning Corporate Test Method CTM0004(1970年7月20日)描述的玻璃毛细管粘度计法来测量。
可使用的聚烷基芳基硅氧烷包括聚甲基苯基硅氧烷，在25℃时其粘度约5到15000000cp。这些硅氧烷可购得，如从General Electric Company购得SF1075甲基苯基液体或从Dow Corning购得556化妆品级液体。
可使用的聚醚硅氧烷共聚物包括聚丙烯氧化物改性的聚二甲基硅氧烷(如，可从Dow Corning购得DC-1248)、环氧乙烷或环氧乙烷与1，2-环氧丙烷的混合物。最有用的是水不溶性的。
这些硅氧烷因其润滑头发、提供水分和有益于干燥梳理的能力而能够调理头发。粘稠、高分子量的硅氧烷提供最好的调理效果并且因此是优选的。最理想的是硅氧烷聚合物的液体和胶。硅氧烷聚合物胶是刚性的(这与液体或流体相反的)、具有约200000到约1000000的高分子量、25℃时约100000cp到约150000000cp的粘度。在美国专利5292504(同上)中公开了这类胶。
可以包括悬浮剂来改善长期稳定性。可使用的悬浮剂包括具有似针状或片状结构的脂肪两亲性结晶材料、聚合物材料、粘土、雾状金属氧化物及其混合物。这些悬浮剂在本领域中是已知的(参见美国专利5292504)。
合适的结晶两亲性材料是具有针状或片状结构的。这些化合物包括长链(C16-C22)酰基衍生物，如脂肪酸乙二醇酯(如，二硬脂酸乙二醇酯)；脂肪酸的长链(C16-C22)烷醇酰胺，如硬脂酰胺MEA、硬脂酰硬脂酸酯和二硬脂酰二硫代丙酸酯及其混合物。
可用作悬浮剂的聚合物材料包括交联的聚丙烯酸(如Carbopol系列，可购自B.F.Goodrich Chemical Company)、瓜尔胶及其衍生物、黄原胶、乙烯/马来酸酐的交联共聚物及其混合物。
粘土和雾状金属氧化物也是有效的的悬浮剂。实例包括硅酸铝镁(如，Veegum系列，可购自R.T.Vanderbilt Company，Inc.)、硅酸铝钠(如Laponite系列，可购自Laponite United States)、雾状硅胶、雾状氧化铝、雾状二氧化钛及其混合物。
在本发明的香波制剂中，悬浮剂通常以约0.5％到约5％的量存在，优选约0.5％到约3％。优选长链酰基衍生物如脂肪酸的乙二醇酯。最优选的是二硬脂酸乙二醇酯。
改善可接受制剂化妆品可接受性的其他可有可无的成分在本领域中是已知的并且包括如防腐剂(如对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、甲基异噻唑啉酮和咪唑烷基脲)；增稠剂和粘度改善剂，如氧化胺、环氧乙烷和1，2-环氧丙烷的嵌段共聚物(如由BASF Wyandotte提供的Pluronic F88)、脂肪醇(如鲸蜡硬脂醇)、氯化钠、氯化铵、硫酸钠、聚乙烯醇、丙二醇和乙醇；水溶助剂如二甲苯磺酸盐；pH调节剂如柠檬酸、琥珀酸、磷酸、氢氧化钠和碳酸钠；香料、染料、季铵化合物如Polyquatemium 41，螯合剂如乙二胺四乙酸二钠；以及珠光剂如乙二醇的二硬脂酸酯、聚乙二醇的硬脂酸和棕榈酸二酯和硬脂酸单乙醇胺。一般来说，这些可有可无的成分各自以制剂大约0.1％到10％的浓度来使用。
本发明的香波制剂以常规方式用于清洁头发。使用大约10g到大约30g的制剂来湿润头发并遍及头发和头皮。制剂保留在头发和头皮上大约6-10分钟，然后经漂洗除去。重复该过程直到头发清洁。
本发明可使用的灭虱香波包括：
(a)约0.1％到约10％的刺糖多孢菌素或其生理可接受的衍生物或盐；
(b)约5％到约30％的合成表面活性剂；
(c)约1％到约7％的酰胺；和
(d)水。
本发明的头发调理制剂含有刺糖多孢菌素成分和调理剂，并且可含有可有可无的另一种抗虱剂，如苄氯菊酯和林丹。这些调理制剂也可有效地用于治疗虱子骚扰。
头发调理剂是改善头发外观、感觉和易处理性的产品。头发因处理如长效卷发、染发、梳理和漂白或因环境条件如阳光引起光催化的氧化而受损时，调理剂是特别重要的。这些因素使头发具有差的结构、难以处理和梳理，或者潮湿或者干燥。
在头发调理制剂中使用时，刺糖多孢菌素成分以大约0.1％到约30％的浓度存在，优选约1％到约10％。
调理产品是公知的并且包括“漂洗型”产品(其用于清洗头发后立刻洗去)和“深度调理剂”(其长期保留在头发上)。
本发明头发调理制剂中可使用的一组调理剂是与脂质材料如脂肪醇结合的长链季铵化合物(参见美国专利3155591，Hilfer，出版于1964年11月3日和美国专利4269824，Villamarin等人，出版于1981年5月26日)。另一组调理剂是脂质和季铵化合物。这些调理剂用于形成凝胶型调理产品，它具有良好的化妆效果和流变特性。通常在下列文献中描述了这些类型的凝胶型制剂：Barry，“混合乳化剂十二烷基硫酸钠/鲸蜡醇的自身增稠作用”，J.of Colloid and InterfaceScience，28，82-91(1968)；Barry等人“烷基三甲基溴化铵/鲸蜡硬脂醇混合乳化剂的自身增稠作用”；Influence of Quarternary Chain Length”，J.of Colloid andInterface Science，35，689-708(1971)；和Barry等人“含Cetomacrogo/1000-(鲸蜡硬脂醇)系统的流变学研究，I.自身增稠作用”，J.of Colloid and Interface Science，38，616-625(1972)。
在这些调理剂中使用的脂质材料以约0.5％到约3％的浓度存在。这些脂质基本上是水不溶性的并且含有疏水和亲水部分。它们包括选自酸、酸衍生物、醇、酯、醚、酮、酰胺及其混合物的天然的和合成衍生的脂肪材料，其烷基链长度约12到约22个碳原子，优选16到18碳原子。优选脂肪醇和脂肪酯。
可使用的脂肪醇是已知的(参见如美国专利3155591，同上；美国专利4165369(Watanable等人，出版于1981年5月26)；英国专利说明书1532585，出版于1978年11月15日；Fukushima等人“鲸蜡硬脂醇在化妆品乳液中的作用”，Cosmetics & Toiletries，98，89-102(1983)和Hunting，Encyclopedia ofConditioning Rinse Ingredients，204(1987))。脂肪醇是C12-C16醇，选自鲸蜡硬脂醇、鲸蜡醇、异硬脂醇、羊毛脂醇、月桂醇、油醇、硬脂醇及其混合物。优选鲸蜡醇、硬脂醇及其混合物。特别优选的脂肪醇是由鲸蜡醇和硬脂醇组成的，其中含有约55％到约65％(混合物的重量比)的鲸蜡醇。
可使用的脂肪酯也是已知的(参见Kaufman等人，美国专利3341465，出版于1967年9月12日)。脂肪酯是活性氢被一元醇的烷基置换的脂肪酸。一元醇是上文所述的脂肪醇，文献同上。在这些调理剂制剂中可以使用的脂肪酯包括乳酸鲸蜡醇酯、辛酸鲸蜡醇酯、棕榈酸鲸蜡醇酯、硬脂酸鲸蜡醇酯、单硬脂酸甘油酯、月桂酸甘油酯、豆蔻酸甘油酯、油酸甘油酯、硬脂酸甘油酯、单乙酸甘油酯及其混合物。优选的是棕榈酸鲸蜡醇酯和单硬脂酸甘油酯或共混合物。
在这些调理剂制剂中可使用单一的或组合的阳离子表面活性剂，通常其浓度为最终制剂的约0.1％到约5％。这些表面活性剂含有氨基或季铵亲水部分，当其溶于本发明的水性制剂时带有正电荷。这些阳离子表面活性剂在本领域中是已知的(参见McCutcheon’s Detergents & Emulsifiers，同上；Schwartz等人，SurfaceActive Agents，Their Chemistry and Technology，纽约：Interscience Publishers，1949；美国专利3155591，同上；美国专利3929678(Laughlin等人，出版于1975年12约30日)；美国专利3959461(Bailey等人，出版于1976年5月25日)；和美国专利4387090(Bolich，Jr.，出版于1983年6月7日))。
可使用的季铵阳离子表面活性剂材料是下列通式所示的：其中R1是氢、1到22个碳原子的脂肪族基团或具有12到22个碳原子的芳族芳基或烷基芳基；R2是具有1到22个碳原子的脂肪族基团；R3和R4各自是具有1到3个碳原子的烷基并且X是选自卤素、乙酸根、磷酸根、硝酸根和烷基硫酸根基团的阴离子。除碳和氢原子外，脂肪族基团可含有醚键和其他基团如酰氨基团。
其他可使用的季铵盐具有下式结构：
其中R基团中至少一个但不多于3个是具有16到22个碳原子的脂肪族基团，剩余的R基团选自氢和具有1到4个碳原子的烷基基团，并且X是是选自卤素、乙酸根、磷酸根、硝酸根和烷基硫酸根基团的离子。牛脂丙烷二氯化二铵(Tallowpropane diammonium dichloride)是这种类型季铵盐的实例。
本文可使用的季铵盐也包括二烷基二甲基氯化铵，其中烷基具有12到22碳原子。这些烷基基团可衍生于长链脂肪酸，如氢化的牛脂脂肪酸。牛脂脂肪酸产生其中R1和R2大多数具有16到18个碳原子的季铵化合物。实例包括二牛脂二甲基氯化铵、二牛脂二甲基甲基硫酸铵、双十六烷基二甲基氯化铵、二(氢化牛脂)二甲基氯化铵、双十八烷基二甲基氯化铵、双二十烷基二甲基氯化铵、双二十二烷基二甲基氯化铵、二(氢化牛脂)二甲基铵乙酸盐、双十六烷基二甲基氯化铵、双十六烷基二甲基铵乙酸盐、二牛脂二丙基铵磷酸盐、二牛脂二甲基铵硝酸盐、二(椰子烷基)二甲基氯化铵和硬脂基二甲基苯甲基氯化铵。本文可使用的优选的季铵盐包括二牛脂二甲基氯化铵、双十六烷基二甲基氯化铵、硬脂基二甲基苯甲基氯化铵、十六烷基三甲基氯化铵、三(十六烷基)甲基氯化铵及其混合物。二(氢化牛脂)二甲基氯化铵(Quaternium-18)是特别优选的季铵盐并可从Sherex Chemical Company，Inc.购得Adogen 442和Adogen 442-100P。
伯、仲和叔脂肪胺的盐也可用作阳离子表面活性剂。此胺的烷基基团优选具有12到22个碳原子，并且可以是取代的或不取代的。仲和叔胺是优选的；并且叔胺是特别优选的。可以使用的胺的实例包括十八酰氨基丙基二甲基胺、二乙基氨基乙基十八胺、二甲基十八胺、二甲基大豆胺、大豆胺、十四烷基胺、十三烷基胺、乙基十八烷基胺、N-牛脂丙烷二胺、乙氧基化(5摩尔E.O.)十八烷基胺、二羟基乙基十八烷基胺和花生基二十二烷基胺。合适的胺盐包括卤化物的盐、乙酸盐、磷酸盐、硝酸盐、柠檬酸盐、乳酸盐和烷基硫酸盐。实例包括十八烷基胺盐酸盐、大豆胺盐酸盐、十八烷基胺甲酸盐、N-牛脂丙烷二胺二盐酸盐和十八酰氨基丙基二甲基胺柠檬酸盐。在美国专利4275055(Nachtigal等人，出版于1982年6月23日)中也公开了可使用的阳离子胺表面活性剂。
在调理制剂中，水是必要组分。水是在调理剂制备的最后一步中加入的，使用足以使混合物达到100％的量(适量)。
调理制剂中的可有可无的组分包括可利用其化妆和流变特性的聚硅氧烷调理剂。硅油和聚硅氧烷聚合物是公知的调理剂。例如，在美国专利5292502(同上)中公开了挥发性聚硅氧烷、在水醇混合物中的低聚聚硅氧烷聚合物和挥发性聚硅氧烷液体。
制剂可包括一种或多种公开用于香波制剂的聚硅氧烷(同上)。这些聚硅氧烷包括挥发性的和非挥发性的聚烷基硅氧烷、聚烷基芳基硅氧烷及其混合物。它们可以按最终制剂约0.2％到约5％的浓度来使用。
与香波一样，公开的硅氧烷中较高粘度的聚硅氧烷胶(同上)是优选的。这些胶是刚性的，这与液体相反，具有约200000到约1000000的高分子量并在25℃下粘度为约100000cp到约150000000cp。最优选的是聚二甲基硅氧烷胶。
调理剂中显著量的脂质材料常常沉积在头发上，产生油腻性。所以，调理制剂可掺入聚硅氧烷共聚醇(copolyols)以提供具有抗虱子治疗作用的最佳调理效果。参见欧洲专利申请155806，公开于1985年9月25日。
聚硅氧烷共聚醇是聚氧化烯改性的二甲基聚硅氧烷，本文称作“聚二甲基硅氧烷共聚醇”，起乳化剂的作用并减少载体材料(脂质材料和/或阳离子表面活性剂)在头发上的沉积。在美国专利5292504(同上)中也公开了可使用的聚二甲基硅氧烷共聚醇。
聚硅氧烷共聚醇通常以最终制剂约0.1％到约10％的浓度存在，优选约0.1％到约2％。
就此用途而言，优选聚二甲基硅氧烷共聚醇。Dow Corning 190聚硅氧烷表面活性剂是优选的聚二甲基硅氧烷共聚醇。
制剂也含有改善调理剂产品物理和外观特性的成分。此成分包括其他表面活性剂、盐、缓冲剂、增稠剂、溶剂、遮光剂、珠光助剂、防腐剂、香料、着色剂、染料、色料、螯合剂、防晒剂、维生素和药物。在美国专利4387090(Bolich，Jr.，出版于1983年6月7日)中公开了这些类型成分的实例。
制剂也可含有一定浓度的可有可无的表面活性剂，所述浓度使制剂中表面活性剂(包括阳离子表面活性剂载体材料，在上文所述文献中描述)的总浓度为约0.05％到约5％。这些可有可无的表面活性剂材料可以是阴离子、非离子或两性的。实例是ceteareth-20、steareth-20、脱水山梨糖醇单酯、牛脂烷基硫酸钠和牛脂甜菜碱。在McCutcheon’s Detergents & Emulsifiers(同上)；Schwarts等人(同上)；和美国专利3929678(同上)中描述了可有可无的表面活性剂材料。
优选的可有可无的表面活性剂材料是非离子的。此表面活性剂常常通过烯化氧(其性质是亲水的)与有机疏水化合物(通常为脂肪族或烷基芳香族的)缩合来产生。与任何特定疏水化合物缩合的亲水或聚亚烷基部分的沉淀可被调节来产生具有所需的亲水和疏水要素之间的平衡度的水溶性化合物。此非离子表面活性剂包括烷基苯酚的聚氧化乙烯缩合物、脂肪族醇与环氧乙烷的缩合物、环氧乙烷与通过1，2-环氧丙烷与丙二醇缩合形成的疏水基的缩合产物和环氧乙烷与由1，2-环氧丙烷和乙二胺反应所得产物的缩合产物。另一种非离子表面活性剂是非极性的非离子表面活性剂，代表性的是氧化胺表面活性剂。优选的非离子表面活性剂包括ceteareth-20、steareth-20和ceteth-2。
也可加入盐和缓冲剂以改善产品的流变性。例如，盐如氯化钾、氯化铵和氯化钠，可按约0.001％到约1％的浓度加入。也可加入缓冲剂如柠檬酸盐或磷酸盐缓冲剂。最终配制的本发明制剂优选具有约3到约10的pH，最优选约3到约7。
其他调理成分也可被混合到制剂中。例如，可按约0.1％到约10％的浓度加入蛋白质。阳离子蛋白质也可用作表面活性剂载体材料。
增稠剂是优选的可有可无成分。此增稠剂包括以约0.1％到约8％的浓度混入的非离子增稠剂。该增稠剂是在低剪切(约10-2秒-1)下粘度超过约20000cp的聚合物。实例是聚氧乙烯、瓜尔胶、甲基纤维素、甲基羟丙基纤维素、聚丙基纤维素、聚丙基羟乙基纤维素、羟乙基纤维素、淀粉和淀粉衍生物及其混合物。在美国专利4387090(Bolich等人，出版于1983年6月7日)中公开了非离子增稠剂。
增稠剂用来使制剂粘度达到约10625cp到约14375cp(用Wells-Brookfield粘度计RVT DV-CP-2型、DV-11、Cone CP-52型，以1/2ml、1rpm转速、26.7℃温度测量1分钟)。
本发明的头发调理制剂通常在所有香波用水漂洗除去之后用于头发上。
本发明也提供用于处理人头发以杀死和便于除去虱子及其卵子的方法，包括下列步骤：
(a)将大约10克到大约30克的本发明制剂用于润湿的头发上；
(b)使制剂遍及头发和头皮；
(c)使制剂保留在头发和头皮上大约6-10分钟；和
(d)通过用水漂洗从头发上除去制剂。
含有刺糖多孢菌素或其生理可接受的衍生物或盐和洗剂载体的抗虱子洗剂是本发明的另一方面。这些洗剂以液体形式或喷雾形式直接用在头发上。将它们配制成用于头发保留一定时间并且不通过用水漂洗立即除去的形式。
用于洗剂制剂时，刺糖多孢菌素成分通常以大约0.1％到约30％的浓度存在，优选约1％到约10％。
除刺糖多孢菌素成分之外，洗剂制剂包含液体载体如醇、水或其混合物，有助于将刺糖多孢菌素成分释放到头发上。合适的醇是一元醇如甲醇、乙醇、异丙醇或其混合物。由于醇对制剂的稳定性具有有害的影响，水单独作为载体是最优选的。以制剂达到100％所需的量加入载体(适量)。
洗剂制剂可包含可有可无的成分以便对头发提供除抗虱子活性之外的有利作用。可有可无的成分包括：防腐剂和抗微生物剂，如DMDM乙内酰脲和EDTA四钠；pH平衡剂，如柠檬酸钠和柠檬酸；乳化剂，如PEG-60蓖麻油；以及增稠剂和粘度改善剂，如聚乙烯吡咯烷酮。包含时，这些成分通常各自以大约0.01％到约10％的浓度来使用。
可以包括调理剂以便从头发上除去死的虱子和卵子并提供好的湿润性和干燥梳理性。上文调理制剂中描述的同类型的调理剂可在洗剂中使用；这些调理剂包括季铵盐、脂肪胺及其混合物。调理剂以大约0.1％到约1％的浓度来使用，优选大约0.4％到约0.6％。
优选调理剂是季铵盐。优选的季铵盐包括二烷基二甲基氯化铵，其中烷基基团具有12到22个碳原子。这些烷基基团可由长链脂肪酸来衍生，所述脂肪酸如氢化的牛脂脂肪酸。牛脂脂肪酸产生季铵混合物，其中R1和R2多数具有16到18个碳原子。在洗剂制剂中可使用的季铵盐的实例包括二(氢化的)牛脂二甲基氯化铵、二(十六烷基)二甲基氯化铵、三(十六烷基)甲基氯化铵、十六烷基三甲基氯化铵、硬脂基二甲基苯甲基氯化铵及其混合物。在优选的是二(十六烷基)二甲基氯化铵。
也可将醇协同剂加到洗剂制剂中以增强其抗虱子活性。在洗剂制剂中使用的醇选自苯基C2-C6链烷醇、苯基C2-C6二醇、C2-C8烯二醇及其混合物。可按约0.25％到约10％的浓度含有这些协同剂，其中苯基链烷醇、苯基二醇及其混合物的浓度不超过制剂的5％，优选为约0.5％到约5％，最优选约2％到约4％。优选的协同剂是己二醇。
洗剂制剂可直接用到头发上。洗剂的用量通常为约10ml到约50ml。洗剂被遍及头发并在头发上保留约10分钟，优选约30分钟。然后清洗头发，通常用香波，再用水漂洗。
下列实施例举例说明本发明的制剂：
实施例1
如下制备洗剂制剂：成分 重量(％)聚乙烯吡咯烷酮 0.50DMDM乙内酰脲 0.20EDTA四钠 0.13柠檬酸 0.05PEG-60蓖麻油 0.50己二醇 4.00二(十六烷基)二甲基氯化铵 0.38刺糖多孢菌素A 0.50水 适量到100.00
在35-38℃下，将刺糖多孢菌素加到含有PEG-60蓖麻油、己二醇、丙二醇和二(十六烷基)二甲基氯化铵的罐中。在第二个罐中，混合聚乙烯吡咯烷酮、DMDM乙内酰胺、EDTA四钠和柠檬酸并将混合物加热到35-38℃的温度。将第一罐的成分加到第二罐中并混合均匀。混合物冷却到约27℃并置于贮存罐中。
实施例2
使用实施例1所述的方法但用下列配方来制备洗剂制剂。成分 重量(％)聚乙烯吡咯烷酮 0.50DMDM乙内酰脲 0.20EDTA四钠 0.13柠檬酸 0.05PEG-60蓖麻油 0.50己二醇 2.00丙二醇 2.00二(十六烷基)二甲基氯化铵 0.38刺糖多孢菌素AD 0.25水 适量到100.00
实施例3
使用实施例1所述的方法但用下列配方来制备洗剂制剂。成分 重量(％)聚乙烯吡咯烷酮 0.50DMDM乙内酰脲 0.20EDTA四钠 0.13柠檬酸 0.05异丙醇 1.00PEG-60蓖麻油 0.50己二醇 4.00二(十六烷基)二甲基氯化铵 0.60刺糖多孢菌素或分 0.10水 适量到100.00
为了控制虱子骚扰，将实施例1-3的洗剂制剂用于头发上并保留至少1/2小时，然后经洗发或漂洗除去。
实施例4
如下制备香波制剂：成分 重量(％)月桂基醚(laureth)硫酸铵 10.40月桂基硫酸铵 9.50椰子单乙醇酰胺 4.00二硬脂酸乙二醇酯 3.00DMDM乙内酰脲 0.20磷酸二氢钠 0.10磷酸氢二钠 0.25柠檬酸 0.07二甲苯磺酸铵 1.58刺糖多孢菌素A 0.50水 适量到100.00
将月桂基硫酸铵加到罐中并加热到约66℃到约69℃。保持该温度的同时，加入磷酸二氢钠水溶液，然后加入磷酸氢二钠水溶液。到69℃时，将二甲苯磺酸铵加到混合物中并加热到约74℃到77℃；加入椰子单乙醇酰胺，混合直到均匀分散，再加入二硬脂酸乙二醇酯和约4.5％的水。继续混合直到均匀并冷却混合物到约41℃。将混合物泵入第二个罐中并加入月桂基醚硫酸铵、DMDM乙内酰脲和柠檬酸水溶液。将刺糖多孢菌素加到第二个罐中并用适量水补足到100％。彻底混合，冷却到约27℃并将混合物泵入贮存罐中。
实施例5
如下制备香波制剂：成分 重量(％)月桂基醚硫酸铵 14.15月桂基硫酸铵 3.14椰子单乙醇酰胺 3.00二硬脂酸乙二醇酯 3.00聚硅氧烷胶1 10.50聚二甲基硅氧烷液体(350cp) 0.50三(十六烷基)甲基氯化铵 0.29十六烷醇 0.42十八烷醇 0.18DMDM乙内酰脲 0.20氯化钠 0.90氯化铵 0.05二甲苯磺酸铵 1.25刺糖多孢菌素AD 0.40水 适量到100.00
1聚硅氧烷胶可从General Electric Co.购得SE-30或SE-76胶。
将大约0.5％的月桂基醚硫酸铵和聚二甲基硅氧烷加到容器中并混合大约30分钟。将大约2％的月桂基醚硫酸铵加到制备罐中并加热到68℃到71℃。将大约0.12％十八烷醇、大约0.06％的十六烷醇和第一个容器中的成分加到制备罐中。混合均匀并将混合物温度保持在68℃到71℃之间。在第二个制备罐中加入月桂基硫酸铵并加热到约71℃。保持该温度的同时，将0.05％氯化铵、约18％水、二甲苯磺酸铵和剩余的十八烷醇和十六烷醇。加入椰子单乙醇酰胺、三(十六烷基)甲基氯化铵、二硬脂酸乙二醇酯、大约一半的DMDM乙内酰脲和第一罐中的成分加到第二罐中，并将温度保持在约77℃。混合均匀并冷却到约41℃。泵入第三个罐中并加入剩余的月桂基醚硫酸铵、DMDM乙内酰脲和氯化钠。将刺糖多孢菌素加到混合物中并用适量水补足到100％。彻底混合，冷却到约27℃并将混合物泵入贮存罐中。
实施例6
如下制备香波制剂：成分 重量(％)月桂基醚硫酸铵 12.81月桂基硫酸铵 9.10椰子单乙醇酰胺 2.30异十八烷基乙基midonium ethosulfate 1.25DMDM乙内酰脲 0.20磷酸二氢钠 0.50磷酸氢二钠 0.38氯化钠 0.04柠檬酸 0.10二甲苯磺酸铵 1.35刺糖多孢菌素成分 0.56水 适量到100.00
将约6.5％的水和月桂基醚硫酸铵加到混合罐中并将混合物加热到约35℃。保持该温度的同时，依次分别加入下列成分，混合使每一成分均匀分布在其中：月桂基硫酸铵、二甲苯磺酸铵、磷酸二氢钠、磷酸氢二钠、DMDM乙内酰脲、氯化钠、柠檬酸和水的溶液、椰子二乙醇酰胺溶液和异十八烷基乙基midoniumethosulfate。将刺糖多孢菌素加到混合物中并用适量水补足到100％。彻底混合，冷却到约27℃并将混合物泵入贮存罐中。
实施例7
如下制备本发明的调理制剂：成分 重量％十六烷醇 1.00十八烷醇 0.72DMDM乙内酰脲 0.20羟基乙基纤维素 0.50Quaternium-18 0.85Ceteareth-20 0.35硬脂基二甲基苄基氯化铵 0.85单硬脂酸甘油酯 0.25柠檬酸 0.08聚硅氧烷胶1 0.30环(二)甲基硅酮液体 1.70刺糖多孢菌素A 1.00水 适量到100.001聚硅氧烷胶可从General Electric Co.购得SE-30或SE-76胶。
在制备罐中合并除DMDM乙内酰脲、柠檬酸、聚硅氧烷胶、环(二)甲基硅酮和刺糖多孢菌素外的其余成分并将混合物加热到约88℃。将溶液彻底混合后，冷却到大约48℃。在另一罐中，预先将聚硅氧烷胶和环(二)甲基硅酮混合，加热并搅拌以形成胶体溶液。将刺糖多孢菌素加到该混合物中。加入胶体溶液和所有剩余的成分并用适量水补足。彻底混合，冷却到约27℃并将混合物贮存罐中。
实施例8
采用实施例7所述方法但用下列配方来制备调理制剂：成分 重量％十六烷醇 1.00十八烷醇 0.72DMDM乙内酰脲 0.20羟基乙基纤维素 0.50Quaternium-18 0.85Ceteareth-20 0.35硬脂酰氨基丙基二甲基胺(SAPDMA) 0.50单硬脂酸甘油酯 0.25柠檬酸 0.08柠檬酸钠 0.05硬脂氧基聚二甲基硅氧烷 0.10聚硅氧烷胶1 10.05环(二)甲基硅酮液体 1.70刺糖多孢菌素成分 1.00水 适量到100.001聚硅氧烷胶可从General Electric Co.购得SE-30或SE-76胶。
该调理抗虱子产品以类似于实施例7所述的方法来制备。
实施例9香波制剂的效能
在该研究中使用含有各种浓度刺糖多孢菌素AD的香波制剂。通过湿法研磨30分钟将足量的工业级刺糖多孢菌素AD分散在商购的香波(Johnson’s婴儿香波，具有蜂蜜和维生素E的保湿配方，Johnson & Johnson Consumer Products，Inc.)中以形成10％储备刺糖多孢菌素AD/香波混合物来制备制剂。用另外的香波稀释该混合物以制备下列刺糖多孢菌素AD浓度：10％(使用原始制备的)、1％、0.1％和0.01％刺糖多孢菌素AD/香波(w/w)。
按标准试验方法试验香波中4个浓度的刺糖多孢菌素AD和自来水对照对抗成人体虱(Pediculus humanus humanus)的作用，所述试验方法是ASTM StandardE 938-83(Reapproved 1988)，可购自American Society for Testing and Materals，100Barr Harbor Drive，West Conshohocken Pennsylvania USA[http：//www.astm.org/]。试验中，分别在4个香波浓度中浸入25个成熟的虱子，10分钟后，在水中洗涤1分钟并在水中再漂洗1分钟。对照组中，25个成熟的虱子(Pediculus humanushumanus)被浸入自来水中10分钟，然后在水中洗涤1分钟，并在水中再漂洗1分钟。共进行5组试验。
1小时后，检查虱子以确定击倒的数目。按虱子活动相当快速(1分钟内)消失来测量“击倒”，这种活动的消失是由垂死状态到杀死状态导致的。24小时后，再一次检查虱子以确定杀死的数目。表1中概述了此试验的结果。
表1：比较香波中的各种浓度
刺糖多孢菌素AD杀灭虱子的效果
死亡数据制剂 +1小时 +24小时
％击倒 ％死亡对照 0.2 1.010％刺糖多孢菌素AD/香波 96.6 100.01％刺糖多孢菌素AD/香波 48.0 100.00.10％刺糖多孢菌素AD/香波 19.8 97.40.01％刺糖多孢菌素AD/香波 14.7 35.5
研究表明含有1％和10％刺糖多孢菌素AD的香波制剂是高度有效的灭虱药，在+24小时时产生100％的死亡率。10％浓度时产生最快速的击倒作用(在+1小时时为96.6％)，甚至1％浓度也产生48％的击倒率。0.1％的刺糖多孢菌素AD/香波制剂也是有效的灭虱药，在24小时时产生近100％的死亡率。
Claims (15)
1、一种控制人中虱子骚扰的护发制剂，它含有作为活性组分的刺糖多孢菌素或其生理可接受的衍生物或盐，以及生理可接受的载体。
2、权利要求1的制剂，是洗剂或调理制剂。
3、权利要求1或2的制剂，是香波。
4、权利要求1、2或3的任一制剂，还含有表面活性剂。
5、权利要求3或4的任一制剂，其中含有
(a)约0.1％到约2.5％的刺糖多孢菌素或其生理可接受的衍生物或盐；
(b)约5％到约30％的合成表面活性剂；
(c)约1％到约7％的酰胺；和
(d)水。
6、权利要求1-5的任一制剂，另外还含有约1％到约10％的非挥发性聚硅氧烷材料。
7、权利要求1-6的任一制剂，另外还含有约0.5％到约5％的悬浮剂。
8、刺糖多孢菌素或其生理可接受的衍生物或盐在制备控制人虱子的护发制剂的用途。
9、权利要求8的用途，其中虱子是头虱或体虱。
10、权利要求10的用途，其中虱子是阴虱。
11、一种控制人中虱子骚扰的方法，包括局部给予人权利要求1-4的任一制剂。
12、权利要求11的方法，其中虱子骚扰是头虱。
13、权利要求11的方法，其中虱子骚扰是体虱。
14、权利要求11的方法，其中虱子骚扰是阴虱。
15、一种用于处理人头发以杀死和便于除去虱子及其卵子的方法，包括下列步骤：
(a)将大约10克到大约30克的含有刺糖多孢菌素或其生理可接受的衍生物或盐和生理可接受的载体的制剂用于润湿的头发上；
(b)使制剂遍及头发和头皮；
(c)使制剂保留在头发和头皮上大约6-10分钟；和
(d)通过用水漂洗从头发上除去制剂。
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2000
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2001
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2002
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