WO2024103378A1 - 用于治疗肌肉酸痛的中草药外用制剂及其制法 - Google Patents

用于治疗肌肉酸痛的中草药外用制剂及其制法 Download PDF

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WO2024103378A1
WO2024103378A1 PCT/CN2022/132802 CN2022132802W WO2024103378A1 WO 2024103378 A1 WO2024103378 A1 WO 2024103378A1 CN 2022132802 W CN2022132802 W CN 2022132802W WO 2024103378 A1 WO2024103378 A1 WO 2024103378A1
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chinese herbal
starch
extract
herbal medicine
muscle soreness
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PCT/CN2022/132802
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English (en)
French (fr)
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谢丞威
陈子力
张恒鸿
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谢丞威
陈子力
张恒鸿
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Priority to PCT/CN2022/132802 priority Critical patent/WO2024103378A1/zh
Publication of WO2024103378A1 publication Critical patent/WO2024103378A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • 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
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system

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  • the invention relates to treating muscle soreness, and in particular to a Chinese herbal medicine external preparation for treating muscle soreness and a preparation method thereof.
  • the present invention provides a Chinese herbal external preparation for treating muscle soreness, which includes an extract, starch and an external carrier, wherein the extract is made from medicinal materials including peony and licorice, and the external carrier carries concentrated granules formed by mixing the extract and starch.
  • the ratio of the extract to starch of the present invention is 1:1 to 1:3.
  • the extract is prepared by using the above-mentioned peony and licorice in a ratio of 1:1 to 3:1 by weight of the raw materials.
  • the above-mentioned peony of the present invention is white peony root or white peony root wine.
  • the licorice root of the present invention is raw licorice root or roasted licorice root.
  • the starch of the present invention is rice starch, corn starch, wheat starch or potato starch.
  • the particle size of the starch of the present invention is 3 ⁇ m to 125 ⁇ m.
  • the external carrier of the present invention can be water plus lipids, vaseline, wine, or a patch.
  • the present invention also provides a method for preparing a Chinese herbal ointment for treating muscle soreness, which comprises the following steps: (a) preparing an extract from peony and licorice in a weight ratio of 1:1 to 3:1; (b) mixing the extract with starch to form concentrated granules; and (c) preparing an ointment from the concentrated granules to obtain the Chinese herbal ointment for treating muscle soreness.
  • step (c) of the present invention specifically includes the following steps: (c1) taking 1 weight unit of the concentrated granules and 4 to 8 weight units of vaseline, mixing them evenly to obtain a mixture; (c2) heating the mixture obtained in step (c1) with steam while stirring; (c3) after stopping heating, continuously stirring during cooling until it forms a paste, thereby obtaining the Chinese herbal ointment for treating muscle soreness.
  • the steam heating time is 20 minutes.
  • the present invention also provides a method for preparing a Chinese herbal emulsion for treating muscle soreness, which comprises the following steps: (a) preparing an extract from peony and licorice in a weight ratio of 1:1 to 3:1; (b) mixing the extract with starch to form concentrated granules; and (c) preparing an emulsion from the concentrated granules to obtain the Chinese herbal emulsion for treating muscle soreness.
  • the above step (c) of the present invention specifically includes the following steps: (c1) taking shea butter and olive emulsified wax, heating them together until they melt, and obtaining a first mixture; (c2) taking 0.3 to 0.6 weight units of the concentrated granules, adding 7 weight units of water, and heating; (c3) pouring the first mixture and the second mixture obtained in step (c1) and step (c2) into a blender and blending them until the emulsion is formed, thereby obtaining the Chinese herbal emulsion for treating muscle soreness.
  • step (c1) of the above-mentioned emulsion preparation method of the present invention 3 weight units of shea butter and 0.3 weight unit of olive emulsified wax are taken and heated together until melted to obtain the first mixture.
  • step (c2) of the method for preparing the emulsion of the present invention the temperature is heated to 60°C.
  • the topical preparation of the present invention can be prepared into topical preparations simply and quickly by adding concentrated granules to different topical carriers, and can also effectively deliver effective medicinal ingredients directly to the affected area through the skin for relief.
  • FIG1 is a block diagram showing the composition of the Chinese herbal medicine external preparation of the present invention.
  • Fig. 2 is a flow chart of the preparation method of the Chinese herbal ointment of the present invention.
  • FIG3 is a flow chart of the preparation method of the Chinese herbal medicine emulsion of the present invention.
  • a preferred embodiment of the Chinese herbal medicine external preparation of the present invention comprises an extract, starch and an external carrier, wherein the extract is made of peony (Paeonia lactiflora Pall) and licorice (Radix Glycyrrhiza), wherein peony has the effect of relieving acute pain, in this embodiment, white peony or wine white peony is used; and licorice has the effect of anti-inflammatory and reducing the uncomfortable symptoms such as redness, swelling, heat, pain, etc., in this embodiment, raw licorice or roasted licorice is used.
  • the weight ratio of peony and licorice in the extract is 1:1 to 3:1.
  • starch is used as the excipient, and the above-mentioned extract is made into concentrated granules by adding starch, wherein the starch can be rice starch, corn starch, wheat starch or potato starch, and the particle size range of the starch is between 3 ⁇ m and 125 ⁇ m, and the ratio of the above-mentioned extract to starch is 1:1 to 1:3.
  • the concentrated granules are mixed with various external carriers or prepared into various external preparations.
  • water and lipids can be added to make an emulsion
  • vaseline can be added to make an ointment
  • rice wine can be added to make a paste
  • a herbal patch can be made through a patch, so that the Chinese herbal external preparation becomes an emulsion, ointment, paste or Chinese herbal patch.
  • the present invention provides a method for preparing a Chinese herbal ointment for treating muscle soreness, comprising the following steps: (a) preparing an extract from peony and licorice in a weight ratio of 1:1 to 3:1; (b) mixing the extract with starch to form a concentrated granule; (c) taking 1 weight unit of the concentrated granule and 8 weight units of vaseline, uniformly mixing to obtain a mixture; (d) heating the mixture obtained in step (c) with steam for 20 minutes while stirring; (e) stopping heating, and continuously stirring during cooling until the mixture forms a paste.
  • the ratio of the aforementioned concentrated granule to vaseline is not greater than 1:4.
  • the present invention also provides a method for preparing a Chinese herbal emulsion for treating muscle soreness, comprising the following steps: (a) preparing an extract from peony and licorice in a weight ratio of 1:1 to 3:1; (b) mixing the extract with starch to form a concentrated granule; (c) heating 3 weight units of shea butter and 0.3 weight units of olive emulsified wax together until melted to obtain a first mixture; (d) adding 7 weight units of water to 0.3 weight units of the concentrated granule and heating to 60° C.
  • step (e) pouring the first mixture and the second mixture obtained in step (c) and step (d) into a stirrer and stirring until the emulsion is formed.
  • the aforementioned concentrated granule does not exceed 0.6 units.
  • starch has a homogenizing effect on the extract in addition to the excipient effect, and achieves the best balance when the ratio of the crude drug to the obtained extract is controlled to be no more than 6: 1. Since the maximization of skin absorption efficiency requires a certain concentration ratio range, it can be seen that starch has the effect of promoting skin absorption in the Chinese herbal medicine external preparation for treating muscle soreness of the present invention.
  • preparation method (II) the proportion of crude drugs contained in each gram of the preparation is higher and the starch content is lower, so the homogenization effect is poor.
  • preparation method (I) four subjects with muscle soreness in the biceps of both hands applied the finished products obtained by preparation method (I) and preparation method (II) to the affected area respectively. Three subjects said that the relief effect of preparation method (I) was better, and one subject said that there was no difference.
  • the present invention can effectively deliver effective medicinal ingredients to the affected part through the skin to treat muscle soreness.
  • the above concentrated granules are prepared by adding different external carriers, and the following comparative tests are carried out on multiple subjects:
  • Paste preparation method Add rice wine to the above concentrated granules and mix well until it becomes a paste.
  • Subject's symptoms delayed onset muscle soreness.
  • the VAS of the left foot was 7 before application and dropped to 5 during application; the VAS of the right foot was 7 before application and dropped to 3 during application.
  • Test results (2) Fitness enthusiasts applied the Shaoyao Gancao Decoction paste containing the concentrated granules of the present invention on their left and right feet after training.
  • the VAS of the left and right feet was 5 before application, 3 during application, and 4 after the paste was removed.
  • Preparation method of ointment containing concentrated granules Take 10 grams of the concentrated granules of the present invention and 80 grams of vaseline, add them in equal amounts and mix them evenly, heat them with steam for 20 minutes, stir them continuously during heating, stop heating, and continue stirring during cooling until it forms a paste.
  • Placebo preparation method Take 10 grams of starch and 80 grams of vaseline, add equal amounts of the two and mix them evenly, heat with steam for 20 minutes, stir constantly during heating, and continue stirring during cooling until it forms a paste.
  • Test results Three subjects underwent a double-blind test. All three subjects were able to accurately distinguish between the ointment and the placebo, and pointed out that the ointment was more effective.
  • Preparation method of ointment containing concentrated granules Take concentrated granules equivalent to 3 qian of white peony root and 3 qian of roasted licorice slices, soak them in 80 ml of olive oil and heat them to 70°C, add 20 grams of vaseline and 5 grams of beeswax to the olive oil, stir evenly, then put it into an aluminum can and wait for it to cool into a paste.
  • Preparation method of ointment containing medicinal pieces Take 3 qian of white peony root and 3 qian of roasted licorice medicinal pieces, soak them in 100 ml of olive oil for 3 weeks, heat the medicinal materials and oil in a water bath until the medicinal materials lose their elasticity, then remove the medicinal materials, take out 80 ml of olive oil, add 20 grams of vaseline and 5 grams of beeswax to the oil, mix them evenly, and then put them into an aluminum can and wait for them to cool into a paste.
  • Subject's symptoms delayed onset muscle soreness.
  • Test results Three subjects had delayed onset muscle soreness in the quadriceps of both feet. A double-blind test was conducted, and the finished products obtained by the above two methods were applied to the affected areas respectively. All three subjects said that the concentrated granule ointment had a better relief effect.
  • Ointment containing powdered pieces of medicinal materials Grind the pieces of white peony root and roasted liquorice into powder and pass through a 80-mesh sieve, take 13.3 grams of each (converted to the crude drug content equivalent to the preparation method of concentrated granule ointment), add the powder and 80 grams of vaseline in equal amounts in succession and mix evenly, heat with steam for 20 minutes, stirring constantly during heating, and continue stirring during the cooling process until it forms a paste.
  • Subject's symptoms delayed onset muscle soreness.
  • Test results Five subjects had delayed onset muscle soreness in the biceps of both hands. A double-blind test was conducted. The finished products obtained by the above two methods were applied to the affected areas respectively. Four subjects said that the concentrated granule ointment had a better relief effect, and one subject said there was no difference.
  • the topical preparation of the present invention is prepared by boiling peony 111A and liquorice 111B into an extract 111, and then adding starch 112 to prepare concentrated granules 11.
  • the concentrated granules 11 are then added with different topical carriers 12 according to the needs of the user to prepare a Chinese herbal topical preparation 1, which is then applied or applied to the user's muscle sore area to improve the muscle soreness symptoms.

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Abstract

本发明提供一种用于治疗肌肉酸痛的中草药外用制剂及其制法，该外用制剂包括芍药与甘草所制成的浸膏、淀粉及外用载体，其中，所述外用载体用以承载浸膏及淀粉两者混合而成的浓缩颗粒剂。

Description

用于治疗肌肉酸痛的中草药外用制剂及其制法 技术领域
本发明与治疗肌肉酸痛相关，尤指一种用于治疗肌肉酸痛的中草药外用制剂及其制法。
背景技术
市面上的各式治疗肌肉酸痛的药剂琳琅满目，药剂的成份主要分为中药与西药，含有西药成份的酸痛药剂往往需要特别注意使用的方式，以免造成身体的伤害，而中药成份的酸痛内服药剂进入肠胃道消化后，会通过肝门静脉***到达肝脏之后再进入全身血液循环，接着通过血液送至身体患部，不仅需要长时间的输送且输送过程中的有效成分将受到稀释或破坏，药效大打折扣，因此，需要一种更有效的制剂来缓解酸痛症状，并提供给使用者一种新的选择。
发明内容
为提供使用者一种新的中草药外用制剂，本发明提供一种用于治疗肌肉酸痛的中草药外用制剂，其包括浸膏、淀粉及一外用载体，其中，所述浸膏是以包括芍药与甘草的药材制成，所述外用载体承载所述浸膏与淀粉混合而成的浓缩颗粒剂。
在一实施例中，本发明上述浸膏与淀粉的比例为1：1至1：3。
在一实施例中，本发明上述芍药与甘草以生药重量1：1至3：1的比例制成所述浸膏。
在一实施例中，本发明上述芍药为白芍或酒白芍。
在一实施例中，本发明上述甘草为生甘草或炙甘草。
在一实施例中，本发明上述淀粉为米淀粉、玉蜀黍淀粉、小麦淀粉或马铃薯淀粉。
在一实施例中，本发明上述淀粉的粒径为3μm至125μm。
在一实施例中，本发明上述外用载体可以为水加脂质、凡士林、酒、或贴布。
本发明还提供一种用于治疗肌肉酸痛的中草药软膏的制法，其包括下列步骤：(a)取生药重量比例为1：1至3：1的芍药与甘草制成浸膏；(b)将所述浸膏与淀粉混合，以形成浓缩颗粒剂；(c)将上述浓缩颗粒剂制成软膏，得到所述用于治疗肌肉酸痛的中草药软膏。
在一实施例中，本发明上述步骤(c)具体包括以下步骤：(c1)取1个重量单位的所述浓缩颗粒剂，以及取4至8个重量单位的凡士林，均匀混合，得到混合物；(c2)将步骤 (c1)所制得的混合物以蒸气加热，并同时搅拌；(c3)停止加热后，冷却的过程中持续搅拌直至其形成膏状，得到所述用于治疗肌肉酸痛的中草药软膏。
在一实施例中，本发明上述步骤(c2)中，所述蒸气加热时间为20分钟。
本发明还提供一种用于治疗肌肉酸痛的中草药乳剂的制法，其包括下列步骤：(a)取生药重量比例为1：1至3：1的芍药与甘草制成浸膏；(b)将所述浸膏与淀粉混合，以形成浓缩颗粒剂；(c)将上述浓缩颗粒剂制成乳剂，得到所述用于治疗肌肉酸痛的中草药乳剂。
在一实施例中，本发明上述步骤(c)具体包括以下步骤：(c1)取乳油木果脂及橄榄乳化蜡，一起加热至融化，得到第一混合物；(c2)取0.3至0.6个重量单位的所述浓缩颗粒剂加入7个重量单位的水，并加热；(c3)将步骤(c1)及步骤(c2)所制得的第一混合物与第二混合物倒入搅拌器中搅拌至乳剂成型，得到所述用于治疗肌肉酸痛的中草药乳剂。
在一实施例中，本发明上述乳剂制法的步骤(c1)中，取3个重量单位的乳油木果脂及0.3个重量单位的橄榄乳化蜡，一起加热至融化，得到所述第一混合物。
在一实施例中，本发明上述乳剂制法的步骤(c2)中，加热至60℃。
相较于现有技术，本发明的外用制剂可以通过浓缩颗粒剂加上不同的外用载体，不仅简便且快速地制成外用药剂且可以将有效的药用成分透过皮肤直接有效地输送到患部进行舒缓。
附图说明
图1为本发明的中草药外用制剂的组成方块图。
图2为本发明的中草药软膏的制法流程图。
图3为本发明的中草药乳剂的制法流程图。
主要符号说明：
中草药外用制剂1；
浓缩颗粒剂11；
浸膏111；
芍药111A；
甘草111B；
淀粉112；
外用载体12。
具体实施方式
本发明的中草药外用制剂的一较佳实施例，其包括浸膏、淀粉及一外用载体，其中，所述浸膏以芍药(Paeonia lactiflora Pall)与甘草(Radix Glycyrrhiza)所制成，其中芍药具有缓急止痛的功效，在本实施例中，使用白芍或酒白芍；而甘草具有消炎且降低红、肿、热、痛等不适症状的功效，在本实施例中，使用生甘草或炙甘草，在本实施例中，浸膏里芍药与甘草的生药重量比例为1：1至3：1。
在本实施例中，赋形剂使用淀粉，上述的浸膏通过淀粉的添加制成浓缩颗粒剂，其中，淀粉可以是米淀粉、玉蜀黍淀粉、小麦淀粉或马铃薯淀粉，且淀粉的粒径范围在3μm至125μm之间，而上述浸膏与淀粉的比例为1：1至1：3。
接下来，把浓缩颗粒剂与各式的外用载体调制或制作出各种外用制剂，例如添加水加脂质可以调制成乳剂，添加凡士林可以调制成软膏，添加米酒可以调制成糊剂，或是通过贴布可以制作成草药贴布，以使中草药外用制剂成为乳剂、软膏、糊剂或中草药贴布。
如图2所示，本发明提供一种用于治疗肌肉酸痛的中草药软膏的制法，包括下列步骤：(a)取生药重量比例为1：1至3：1的芍药与甘草制成浸膏；(b)将所述浸膏与淀粉混合，以形成浓缩颗粒剂；(c)取1个重量单位的浓缩颗粒剂，以及取8个重量单位的凡士林，均匀混合，得到混合物；(d)将步骤(c)所制得的混合物以蒸气加热20分钟，并同时搅拌；(e)停止加热后，冷却的过程中持续搅拌直至其形成膏状。在本实施例中，前述浓缩颗粒剂与凡士林的比例不大于1：4。
如图3所示，本发明还提供一种用于治疗肌肉酸痛的中草药乳剂的制法，包括下列步骤：(a)取生药重量比例为1：1至3：1的芍药与甘草制成浸膏；(b)将所述浸膏与淀粉混合，以形成浓缩颗粒剂；(c)取3个重量单位的乳油木果脂及0.3个重量单位的橄榄乳化蜡，一起加热至融化，得到第一混合物；(d)取0.3个重量单位的所述浓缩颗粒剂加入7个重量单位的水，并加热至60℃，得到第二混合物；(e)将步骤(c)及步骤(d)所制得的第一混合物与第二混合物倒入搅拌器中搅拌至乳剂成型。在本实施例中，前述浓缩颗粒剂不超过0.6个单位。
此外，上述淀粉除了具有赋形效果之外，还对浸膏有均质化的效果，并且在控制生药与所得浸膏比例不超过6:1的情况下达最佳的平衡。因皮肤吸收效率的最大化需一定的浓度比例范围，由此可知，淀粉在本发明治疗肌肉酸痛的中草药外用制剂中具有能够促进皮肤吸收的功效。
为了比较淀粉在本发明外用制剂的效果，进行芍药甘草汤浓缩颗粒剂与芍药甘草汤浓缩散剂的比对测试：制法(一)：以芍药甘草汤浓缩颗粒剂制作，取相当于白芍生药12克与炙甘草生药12克的9克芍药甘草汤浓缩颗粒剂，将其与80克凡士林等量递加均匀混合，以蒸气加热20分钟，加热时不断搅拌，停止加热后，冷却的过程中持续搅拌直至其形成膏状；制法(二)：以芍药甘草汤浓缩散剂制作，取相当于白芍生药12克与炙甘草生药12克的7.5克芍药甘草汤浓缩散剂，将其与80克凡士林等量递加均匀混合，以蒸气加热20分钟，加热时不断搅拌，停止加热后，冷却的过程中持续搅拌直至其形成膏状。
在上述制法(二)中，每克的制剂中所含的生药量比例较高，淀粉含量较少，因此在均质化的效果较差。在进行双盲测试中，针对四位双手肱二头肌皆有肌肉酸痛的受试者，将制法(一)与制法(二)所得成品分别涂抹于患部，三位受试者表示制法(一)的缓解效果较佳，一位受试者表示没有差异。
综合上述可知，本发明可以将有效的药用成分透过皮肤直接有效地输送到患部进行肌肉酸痛的治疗。上述浓缩颗粒剂添加不同的外用载体的制作方式，对于多位受试者实施下列对比试验：
(一)以糊剂作VAS(Visual analogue scale)测试：
1.糊剂制作方式：上述浓缩颗粒剂加入米酒调匀至呈现糊状。
2.受试者症状：延迟性肌肉酸痛。
3.受试结果(1)：长跑跑者赛后涂抹，左脚使用一条根精萃舒缓贴，右脚使用含本发明浓缩颗粒剂的芍药甘草汤糊剂，左脚VAS敷药前为7，敷药中降至5；右脚VAS敷药前为7，敷药中降至3。
4.受试结果(2)：健身爱好者训练后涂抹，左、右脚均使用含本发明浓缩颗粒剂的芍药甘草汤糊剂，左脚与右脚敷药前VAS为5，敷药中VAS为3，将糊剂移除后VAS为4。
(二)含浓缩颗粒剂软膏与安慰剂测试：
1.含浓缩颗粒剂软膏制作方式：取10克本发明浓缩颗粒剂与80克凡士林，将两者等量递加均匀混合，以蒸气加热20分钟，加热时不断搅拌，停止加热后，冷却的过程中持续搅拌直至其形成膏状。
2.安慰剂制作方式：取10克淀粉与80克凡士林，将两者等量递加均匀混合，以蒸气加热20分钟，加热时不断搅拌，冷却的过程中持续搅拌直至其形成膏状。
3.受试者症状：肌肉酸痛。
4.受试结果：三名受试者进行双盲测试，三名受试者皆能准确分辨出软膏与安慰剂，并指出软膏效果较佳。
(三)含浓缩颗粒剂软膏与含饮片软膏测试：
1.含浓缩颗粒剂软膏制作方式：取相当于3钱白芍与3钱炙甘草饮片的浓缩颗粒剂，浸泡于80毫升橄榄油并加热到70℃，在橄榄油中加入20克凡士林与5克蜜蜡搅拌均匀，再将其装入铝罐待其冷却成膏状。
2.含饮片软膏制作方式：取3钱白芍与3钱炙甘草饮片，于100毫升橄榄油中浸泡3周后，将药材与油隔水加热至药材失去弹性后移除药材，取出80毫升橄榄油，在油中加入20克凡士林与5克蜜蜡，使其均匀混合，再将其装入铝罐待其冷却成膏状。
3.受试者症状：延迟性肌肉酸痛。
4.受试结果：三位受试者的双脚股四头肌皆有延迟性肌肉酸痛，进行双盲测试，将上述两种制法所得成品分别涂抹于患部，三位受试者皆表示含浓缩颗粒剂软膏的缓解效果较佳。
(四)含浓缩颗粒剂软膏与含饮片磨粉软膏测试：
1.含浓缩颗粒剂软膏制法：取10克浓缩颗粒剂与80克凡士林，将两者等量递加均匀混合，以蒸气加热20分钟，加热时不断搅拌，冷却的过程中持续搅拌直至其形成膏状。
2.含饮片磨粉软膏：白芍与炙甘草饮片磨粉并且过80目筛，各取13.3克(换算为相当于含浓缩颗粒剂软膏制法的生药含量)，将粉末与80克凡士林等量递加均匀混合，以蒸气加热20分钟，加热时不断搅拌，冷却的过程中持续搅拌直至其形成膏状。
3.受试者症状：延迟性肌肉酸痛。
4.受试结果：五位受试者双手肱二头肌皆有延迟性肌肉酸痛，进行双盲测试，将上述两种制法所得成品分别涂抹于患部，四位受试者表示含浓缩颗粒剂软膏的缓解效果较佳，一位受试者表示没有差异。
综合上述可知，如图1所示，本发明外用制剂是将芍药111A及甘草111B熬制成浸膏111后，再加上淀粉112制成浓缩颗粒剂11，再把浓缩颗粒剂11依照使用者的需求，加上不同的外用载体12制成中草药外用制剂1，并涂抹或贴覆到使用者的肌肉酸痛患部，进而改善肌肉酸痛症状。

Claims (15)

  1. 一种用于治疗肌肉酸痛的中草药外用制剂，其包括浸膏、淀粉及一外用载体，其中，所述浸膏是以包括芍药与甘草在内的药材制成，所述外用载体承载所述浸膏与淀粉混合而成的浓缩颗粒剂。
  2. 如权利要求1所述的中草药外用制剂，其中，所述浸膏与淀粉的比例为1：1至1：3。
  3. 如权利要求1所述的中草药外用制剂，其中，所述芍药与甘草以生药重量1：1至3：1的比例制成所述浸膏。
  4. 如权利要求1所述的中草药外用制剂，其中，所述芍药为白芍或酒白芍。
  5. 如权利要求1所述的中草药外用制剂，其中，所述甘草为生甘草或炙甘草。
  6. 如权利要求1所述的中草药外用制剂，其中，所述淀粉为米淀粉、玉蜀黍淀粉、小麦淀粉或马铃薯淀粉。
  7. 如权利要求1所述的中草药外用制剂，其中，所述淀粉的粒径为3μm至125μm。
  8. 如权利要求1所述的中草药外用制剂，其中，所述外用载体为水加脂质、凡士林、酒、或贴布。
  9. 一种用于治疗肌肉酸痛的中草药软膏的制法，其包括下列步骤：
    (a)取生药重量比例为1：1至3：1的芍药与甘草制成浸膏；
    (b)将所述浸膏与淀粉混合，以形成浓缩颗粒剂；
    (c)将上述浓缩颗粒剂制成软膏，得到所述用于治疗肌肉酸痛的中草药软膏。
  10. 如权利要求9所述的制法，其中，步骤(c)具体包括以下步骤：
    (c1)取1个重量单位的所述浓缩颗粒剂，以及取4至8个重量单位的凡士林，均匀混合，得到混合物；
    (c2)将步骤(c1)所制得的混合物以蒸气加热，并同时搅拌；
    (c3)停止加热后，冷却的过程中持续搅拌直至其形成膏状，得到所述用于治疗肌肉酸痛的中草药软膏。
  11. 如权利要求10所述的制法，其中，步骤(c2)中，所述蒸气加热时间为20分钟。
  12. 一种用于治疗肌肉酸痛的中草药乳剂的制法，其包括下列步骤：
    (a)取生药重量比例为1：1至3：1的芍药与甘草制成浸膏；
    (b)将所述浸膏与淀粉混合，以形成浓缩颗粒剂；
    (c)将上述浓缩颗粒剂制成乳剂，得到所述用于治疗肌肉酸痛的中草药乳剂。
  13. 如权利要求12所述的制法，其中，步骤(c)具体包括以下步骤：
    (c1)取乳油木果脂及橄榄乳化蜡，一起加热至融化，得到第一混合物；
    (c2)取0.3至0.6个重量单位的所述浓缩颗粒剂加入7个重量单位的水，并加热，得到第二混合物；
    (c3)将步骤(c1)及步骤(c2)所制得的第一混合物与第二混合物倒入搅拌器中搅拌至乳剂成型，得到所述用于治疗肌肉酸痛的中草药乳剂。
  14. 如权利要求13所述的制法，其中，步骤(c1)中，取3个重量单位的乳油木果脂及0.3个重量单位的橄榄乳化蜡，一起加热至融化，得到所述第一混合物。
  15. 如权利要求13所述的制法，其中，步骤(c2)中，加热至60℃。
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