CN103191370A - Medicine composite for treating mastitis and preparation method and application of medicine composite - Google Patents
Medicine composite for treating mastitis and preparation method and application of medicine composite Download PDFInfo
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Abstract
本发明提供了一种治疗乳腺炎的药物组合物,它是由如下重量配比的原料药制备而成的制剂:黄芪9-15份,蒲公英干品20-28份或蒲公英鲜品40~55份,金银花9-15份,贝母6-10份,皂角刺16-24份,白芷7-13份,防风6-10份,乳香7-13份,没药7-13份,当归尾7-13份,赤芍7-13份,炮山甲6-10份,陈皮7-13份,瓜蒌壳9-15份,郁金9-15份,天花粉16-24份,甘草节6-10份。本发明药物组合物能有效治疗因乳汁淤积化热,热毒蕴结、气血壅滞所引起的乳痈或急性化脓性乳腺炎,为临床用药提供了一种新的选择。The invention provides a pharmaceutical composition for treating mastitis, which is a preparation prepared from raw materials in the following weight proportions: 9-15 parts of astragalus, 20-28 parts of dried dandelion or 40-55 parts of fresh dandelion 9-15 parts of honeysuckle, 6-10 parts of Fritillaria, 16-24 parts of saponins, 7-13 parts of Angelica dahurica, 6-10 parts of Fangfeng, 7-13 parts of frankincense, 7-13 parts of myrrh, angelica tail 7-13 parts, 7-13 parts of red peony root, 6-10 parts of Paoshanjia, 7-13 parts of tangerine peel, 9-15 parts of melon shell, 9-15 parts of turmeric, 16-24 parts of trichosanthes, 6 parts of licorice festival -10 copies. The pharmaceutical composition of the invention can effectively treat mastitis or acute suppurative mastitis caused by milk stasis, heat-toxin accumulation, stagnation of qi and blood, and provides a new choice for clinical medicine.
Description
技术领域technical field
本发明涉及一种治疗乳腺炎的药物组合物及其制备方法和用途。The invention relates to a pharmaceutical composition for treating mastitis, a preparation method and application thereof.
背景技术Background technique
乳痈,系指乳房红肿疼痛,乳汁排出不畅,以致结脓成痈的急性化脓性病证。系因乳汁淤积化热,热毒蕴结、气血壅滞所引起,症见通常为乳房胀痛,局部皮温高,出现边界不清的硬结,甚或局部皮肤红、肿、热、痛,出现较明显的硬结,触痛更甚,或伴寒战、高热、头痛、无力、腋下淋巴结肿大,舌红苔或腻,色白或黄,脉数有力,或滑或弦。Breast carbuncle refers to the acute suppurative syndrome of red, swollen and painful breasts, poor milk discharge, resulting in pus and carbuncles. It is caused by milk stasis and heat transformation, accumulation of heat and toxins, stagnation of qi and blood. Symptoms are usually breast tenderness, high local skin temperature, induration with unclear boundaries, and even local skin redness, swelling, heat, and pain. More obvious induration, worse tenderness, or accompanied by chills, high fever, headache, weakness, swollen axillary lymph nodes, red or greasy tongue coating, white or yellow in color, strong pulse, slippery or stringy.
现代医学之急性化脓性乳腺炎属于乳痈范畴,它是乳房的急性化脓性感染,是产褥期的常见病,多见于哺乳妇女,特别是初产妇在哺乳的开始阶段最为多发。其发病原因,一是由于乳汁的淤积,二是因为细菌的侵入。乳汁淤积的原因则可因乳头过小或内陷,妨碍哺乳;或因乳汁过多,而产妇没有及时将乳房内多余乳汁排空;或因乳管不通,乳管本身有炎症、肿瘤或外在压迫,均可导致乳管不通,此外,胸罩脱落的纤维亦可堵塞乳管,造成不通。细菌的侵入以金黄色葡萄球菌为常见。乳腺炎危害甚大,严重者可并发全身性化脓性感染。其初起时,乳房肿胀、疼痛,有肿块并压痛,表面红肿,发热,继则症状加重,乳房呈搏动性疼痛,可伴高烧、寒战、烦躁、头痛、乏力、便干结等,患侧腋下淋巴结肿大,压痛。若治疗不及时或治疗不当,其脓肿可穿破胸大肌筋膜前疏松结缔组织,形成乳房后脓肿,或乳汁自创口处溢出而形成乳漏,甚者可发生脓毒败血症。Acute suppurative mastitis in modern medicine belongs to the category of mastitis. It is an acute suppurative infection of the breast and is a common disease in the puerperium. It is more common in breastfeeding women, especially primiparous women at the beginning of breastfeeding. The causes of the disease are, one is due to the accumulation of milk, and the other is because of the invasion of bacteria. The cause of milk stasis may be that the nipple is too small or sunken, which hinders breastfeeding; or because the mother has too much milk, and the mother does not empty the excess milk in the breast in time; or because the milk duct is blocked, the milk duct itself has inflammation, tumor or external Compression can lead to blocked milk ducts. In addition, the fibers shed from the bra can also block the milk ducts, resulting in blocked milk ducts. Bacterial invasion is common with Staphylococcus aureus. Mastitis is very harmful, and severe cases may be complicated by systemic suppurative infection. At the beginning, the breast is swollen, painful, with lumps and tenderness, the surface is red and swollen, and fever, and then the symptoms aggravate, and the breast is throbbing pain, which may be accompanied by high fever, chills, irritability, headache, fatigue, dry stool, etc. The lower lymph nodes are swollen and tender. If the treatment is not timely or inappropriate, the abscess can penetrate the loose connective tissue in front of the pectoralis major fascia to form a retromammary abscess, or milk overflows from the wound to form galactorrhea, and even sepsis can occur.
由于乳痈多发于哺乳期的妇女,若给予西药,对用母乳喂养婴儿有不利影响,因此大都建议中医药治疗。多数中药均为天然植物,且治疗本病的中药完全可选用药性并不峻猛者组方,不会对母乳喂养产生不良影响。即便不用母乳喂养的患者,使用大剂量的抗生素治疗本病,也会带来“耐药菌问题”,而中医则具有规避西医使用大量抗生素所带来的诸多毒副作用的优势。Since mastitis is more common in breast-feeding women, if Western medicine is given, it will have adverse effects on breastfeeding infants, so most of them recommend traditional Chinese medicine for treatment. Most of the traditional Chinese medicines are natural plants, and the traditional Chinese medicines for the treatment of this disease are completely optional prescriptions for those with mild medicinal properties, which will not have adverse effects on breastfeeding. Even for patients who do not breastfeed, the use of large doses of antibiotics to treat this disease will also bring about the problem of "drug-resistant bacteria", while Chinese medicine has the advantage of avoiding many toxic and side effects caused by the use of large amounts of antibiotics in Western medicine.
发明内容Contents of the invention
本发明的目的在于提供一种治疗乳腺炎的药物组合物及其制备方法和用途。The object of the present invention is to provide a pharmaceutical composition for treating mastitis, its preparation method and application.
本发明提供了一种治疗乳腺炎的药物组合物,它是由如下重量配比的原料药制备而成的制剂:The invention provides a pharmaceutical composition for treating mastitis, which is a preparation prepared from raw materials with the following weight ratio:
黄芪9-15份,蒲公英干品20-28份或蒲公英鲜品40~55份,金银花9-15份,贝母6-10份,皂角刺16-24份,白芷7-13份,防风6-10份,乳香7-13份,没药7-13份,当归尾7-13份,赤芍7-13份,炮山甲6-10份,陈皮7-13份,瓜蒌壳9-15份,郁金9-15份,天花粉16-24份,甘草节6-10份。Astragalus 9-15 parts, 20-28 parts of dried dandelion or 40-55 parts of fresh dandelion, 9-15 parts of honeysuckle, 6-10 parts of Fritillaria, 16-24 parts of saponins, 7-13 parts of Angelica dahurica, Fangfeng 6-10 parts, 7-13 parts of frankincense, 7-13 parts of myrrh, 7-13 parts of angelica tail, 7-13 parts of red peony, 6-10 parts of Paoshanjia, 7-13 parts of tangerine peel, 9 parts of melon shell -15 parts, turmeric 9-15 parts, trichosanthes 16-24 parts, licorice festival 6-10 parts.
进一步地,它是由如下重量配比的原料药制备而成的制剂:Further, it is a preparation prepared from raw materials with the following weight ratio:
黄芪12份,蒲公英干品24份或蒲公英鲜品48份,金银花12份,贝母8份,皂角刺20份,白芷10份,防风8份,乳香10份,没药10份,当归尾10份,赤芍药10份,炮山甲8份,陈皮10份,瓜蒌壳12份,郁金12份,天花粉20份,甘草节8份。12 parts of astragalus, 24 parts of dried dandelion or 48 parts of fresh dandelion, 12 parts of honeysuckle, 8 parts of fritillaria, 20 parts of saponins, 10 parts of angelica, 8 parts of wind, 10 parts of frankincense, 10 parts of myrrh, angelica tail 10 parts, 10 parts of red peony, 8 parts of paoshanjia, 10 parts of tangerine peel, 12 parts of melon shell, 12 parts of turmeric, 20 parts of trichosanthes, and 8 parts of licorice festival.
其中,所述黄芪为生黄芪;所述皂角刺为炒皂角刺,生品药效大减,或可说基本无效;所述贝母为浙贝、川贝或伊贝,并宜研末随药液冲服;炮山甲研末冲服。Wherein, said Radix Astragali is raw Radix Astragali; said Saponaria thorn is fried Saponaria thorn, and the medicinal effect of the raw product is greatly reduced, or it can be said to be basically ineffective; The powder is taken after mixing with the medicine liquid; Paoshanjia is ground into powder and taken after mixing.
其中,所述药物组合物是以原料药的药粉、或原料药的水或/和乙醇提取物为活性成分,加上药学上常用的辅料或辅助性成分制备而成的制剂。Wherein, the pharmaceutical composition is a preparation prepared by taking the powder of the crude drug, or the water or/and ethanol extract of the crude drug as the active component, and adding commonly used pharmaceutical excipients or auxiliary components.
其中,所述制剂为口服制剂。Wherein, the preparation is an oral preparation.
进一步地,所述口服制剂为片剂、丸剂、滴丸剂、散剂、胶囊剂、软胶囊剂、颗粒剂、口服液。Further, the oral preparations are tablets, pills, dropping pills, powders, capsules, soft capsules, granules, and oral liquids.
本发明还提供了上述药物组合物的制备方法,它包括如下操作步骤:The present invention also provides a preparation method of the above-mentioned pharmaceutical composition, which comprises the following steps:
(1)按重量配比称取原料药;(1) Weigh the raw material medicine according to the weight ratio;
(2)取除贝母、炮山甲以外的其他药材,以水或乙醇水溶液提取后,合并提取液,与贝母、炮山甲的药材粉末一起,加上药学上常用的辅料或辅助性成分制备成制剂。此方加酒入煎疗效大增。(2) Take the medicinal materials other than Fritillaria and Paoshanjia, extract them with water or ethanol aqueous solution, combine the extracts, add the medicinal materials powder of Fritillaria and Paoshanjia, and add commonly used pharmaceutical excipients or auxiliary materials The ingredients are prepared into formulations. Adding wine into the decoction of this prescription greatly increases the curative effect.
本发明还提供了上述药物组合物在制备治疗乳痈的药物中的用途。The present invention also provides the application of the above pharmaceutical composition in the preparation of medicine for treating mastitis.
进一步地,所述药物是治疗急性单纯乳腺炎或急性化脓性乳腺炎的药物。Further, the medicine is a medicine for treating acute simple mastitis or acute suppurative mastitis.
进一步地,所述药物是治疗因乳汁淤积化热、热毒蕴结、气血壅滞所致乳痈的药物。其症见为乳房胀痛,局部皮温高,出现边界不清的硬结,甚或局部皮肤红、肿、热、痛,出现较明显的硬结,触痛更甚,或伴寒战、高热、头痛、无力、腋下淋巴结肿大,舌红苔或腻,色白或黄,脉数有力或滑或弦。Further, the medicament is a medicament for treating mastitis caused by stagnation of milk into heat, accumulation of heat and toxin, and stagnation of Qi and blood. Symptoms are breast distending pain, high local skin temperature, and induration with unclear boundaries, or local skin redness, swelling, heat, pain, more obvious induration, more tenderness, or accompanied by chills, high fever, headache, Weakness, swollen axillary lymph nodes, red tongue or greasy coating, white or yellow color, strong or slippery or stringy pulse.
目前已公认“整体观念”、“辨证施治”、“复方使用”、“复方配伍用药如用兵”是中医最科学最有效的几大优势,其中“复方配伍用药如用兵”是非常科学的中医药原创理论。中医组方中各药如行兵布阵那样环环相扣的严密配伍,是其优于西药配方的有效手段。中医方剂理论认为,每一方剂,不仅需要根据病因病机选择合适的药物妥善配伍,同时也应符合组方的基本结构,即“君、臣、佐、使”的组方配伍理论,所谓“君、臣、佐、使”的组方配伍,就是其建立在对疾病病机的全方位判断基础上的科学配比。中医用方通过多环节、多靶点整合调节的生物学机制,对乳腺炎这种急疾剧烈的化脓性疾患进行调控,可以取得比西药更持久、更绿色天然无毒副作用的治疗效果,而这种疗效是建立在上述中医传统原创理论的正确指导之上的,本发明组方正遵循了这一原则。At present, it has been recognized that "holistic concept", "treatment based on syndrome differentiation", "compound use", and "combination of compound medicines is like using soldiers" are the most scientific and effective advantages of traditional Chinese medicine. Original theory of medicine. The interlocking and tight compatibility of the various medicines in the prescription of traditional Chinese medicine is an effective means that it is superior to the formula of western medicine. The theory of traditional Chinese medicine prescriptions believes that each prescription not only needs to be properly compatible with the appropriate drugs according to the etiology and pathogenesis, but also should conform to the basic structure of the prescription, that is, the theory of prescription compatibility of "lord, minister, assistant, and envoy", the so-called " The prescription compatibility of "jun, minister, assistant, and envoy" is a scientific ratio based on an all-round judgment of the pathogenesis of the disease. TCM prescriptions can regulate mastitis, an acute and severe suppurative disease, through the biological mechanism of multi-link and multi-target integrated regulation, and can achieve a longer-lasting, greener, natural and non-toxic treatment effect than western medicine. This curative effect is based on the correct guidance of the above-mentioned traditional Chinese medicine original theory, and the composition of the present invention has followed this principle.
在中医传统理论中,急性化脓性乳腺炎为因乳汁淤积化热,热毒蕴结、气血壅滞所引起的乳痈,症见为乳房胀痛,局部皮温高,出现边界不清的硬结,甚或局部皮肤红、肿、热、痛,出现较明显的硬结,触痛更甚,或伴寒战、高热、头痛、无力、腋下淋巴结肿大,舌红苔或腻,色白或黄,脉数有力或滑或弦等。本发明使用清热解毒、行气活血、通乳散结、托毒排脓之法,本发明药物组合物中以长于清热解毒的蒲公英为君药,配以左殿之臣药金银花、天花粉、甘草节、白芷、防风疏散风热,通滞而发其结,使蕴结的热毒从外透解消散。然单清解热毒,则气滞血瘀难消,肿结不散,故再配以右殿之臣药陈皮行气化滞,乳香、没药、当归尾、赤芍药以活血通瘀,消肿止痛。气机阻滞每可导致液聚成痰成脓,脉络阻滞,坚结形成,故遣贝母化痰散结,炮山甲、皂角刺通行脉络,透脓溃坚,惟配一味长于辅助正气、托毒透脓的生黄芪,以振奋正气,与贝母、炮山甲、皂角刺、白芷共襄散结化痰、消肿溃坚之效,同为左路之佐药。而炮山甲善于走窜而通妇人乳汁,瓜蒌壳善于宽胸乳而去痰结,郁金善于疏肝气而宽解胸胁,故将此三味疏通胸乳之品任为右路之佐药。甘草节除具有清热解毒的作用外,更擅调和诸药,故为使药。In the traditional theory of traditional Chinese medicine, acute suppurative mastitis is mastitis caused by stagnant milk, accumulation of heat and toxin, stagnation of qi and blood. Induration, or even local skin redness, swelling, heat, pain, more obvious induration, more tenderness, or accompanied by chills, high fever, headache, weakness, swollen axillary lymph nodes, red or greasy tongue coating, white or yellow color, The pulse is strong or slippery or stringy. The present invention uses the methods of clearing heat and detoxifying, promoting qi and blood circulation, clearing milk and dispelling stagnation, and removing pus. Jie, Angelica, and Fangfeng evacuate wind-heat, unblock stagnation and send out its knots, so that the accumulated heat and poison can be dissipated from the outside. However, if the antipyretic and antipyretic drugs alone are used, the qi stagnation and blood stasis will be difficult to eliminate, and the swelling will not dissipate. Therefore, it is combined with the ministerial medicine of the right hall, tangerine peel, to promote qi stagnation, frankincense, myrrh, angelica tail, and red peony to promote blood circulation and remove blood stasis. Reduce swelling and relieve pain. Qi blockage can cause liquid to gather into phlegm and pus, veins to block, and hard knots to form. Therefore, Fritillaria is sent to resolve phlegm and disperse stagnation. Raw astragalus, which assists righteousness, relieves poison and penetrates pus, invigorates righteousness, and works together with Fritillaria, Paoshania, Saponaria thorn, and Angelica dahurica to dissipate stagnation, reduce phlegm, reduce swelling and ulcers, and is also an adjuvant for the left. Paoshanjia is good at walking and clearing women's milk, Gualou shell is good at widening breasts and removing phlegm knots, turmeric is good at soothing liver qi and loosening breasts and flanks, so these three flavors are used as adjuvant medicine for the right way . In addition to the effect of clearing away heat and detoxifying, licorice festival is also good at reconciling various medicines, so it is used as a medicine.
以上组方中,各组药味职司分明,相辅相成,充分发挥了中医学所独有的复方配伍用药如排军布阵般的思辨性科学研究方法论精髓,乳痈(乳腺炎)无论溃脓与否,都可使之消散或速溃,取得良好疗效,为临床用药提供了一种新的选择。In the above prescriptions, each group of medicines has distinct roles and functions, and complements each other, giving full play to the essence of speculative scientific research methodology unique to traditional Chinese medicine. No, it can be dissipated or quickly collapsed, and a good curative effect can be obtained, which provides a new option for clinical medication.
本发明药物组合物能有效治疗因乳汁淤积化热,热毒蕴结、气血壅滞所引起的乳痈或急性化脓性乳腺炎,为临床用药提供了一种新的选择。The pharmaceutical composition of the invention can effectively treat mastitis or acute suppurative mastitis caused by milk stasis, heat-toxin accumulation, stagnation of qi and blood, and provides a new choice for clinical medicine.
具体实施例specific embodiment
实施例1本发明药物组合物的制备The preparation of embodiment 1 pharmaceutical composition of the present invention
取生黄芪12克,蒲公英干品24克,金银花12克,贝母8克,皂角刺20克,白芷10克,防风8克,乳香10克,没药10克,当归尾10克,赤芍药10克,炮山甲8克,陈皮10克,瓜蒌壳12克,郁金12克,天花粉20克,甘草节8克。各药味按量称取,将贝母、炮山甲均分别研末备用,其余各药用酒与水各半煎熬。沸后将火调小,再煎10分钟至15分钟后,收集水煎液;药渣再加水、酒如法煎煮2次,合并各次水煎液,兑入贝母与炮山甲末,调匀,即得汤剂。Take 12 grams of raw astragalus, 24 grams of dried dandelion, 12 grams of honeysuckle, 8 grams of fritillaria, 20 grams of saponins, 10 grams of angelica, 8 grams of wind, 10 grams of frankincense, 10 grams of myrrh, 10 grams of angelica tail, red 10 grams of peony, 8 grams of Paoshanjia, 10 grams of tangerine peel, 12 grams of melon shell, 12 grams of turmeric, 20 grams of trichosanthin, and 8 grams of licorice festival. Weigh each herbal flavor according to the amount, grind Fritillaria and Paoshanjia into powder for later use, and boil the rest of the medicinal wine and water in half. After boiling, reduce the heat to a low level, fry for another 10 to 15 minutes, and collect the decoction; add water and wine to the dregs and decoct twice in the same way, combine each decoction, and add Fritillaria and Paoshanjia powder , and mix thoroughly to get the decoction.
实施例2本发明药物组合物的制备The preparation of embodiment 2 pharmaceutical composition of the present invention
取生黄芪9克,蒲公英干品28克,金银花15克,贝母10克,皂角刺24克,白芷13克,防风10克,乳香13克,没药13克,当归尾13克,赤芍13克,炮山甲10克,陈皮13克,瓜蒌壳15克,郁金15克,天花粉24克,甘草节10克。各药味按量称取,将贝母、炮山甲均分别研末备用,其余各药用酒与水各半煎熬。沸后将火调小,再煎10分钟至15分钟后,收集水煎液;药渣再加水、酒如法煎煮2次,合并各次水煎液,兑入贝母与炮山甲末,调匀,即得汤剂。Take 9 grams of raw astragalus, 28 grams of dried dandelion, 15 grams of honeysuckle, 10 grams of Fritillaria, 24 grams of saponins, 13 grams of Angelica dahurica, 10 grams of Fangfeng, 13 grams of frankincense, 13 grams of myrrh, 13 grams of angelica tail, 13 grams of peony root, 10 grams of Paoshanjia, 13 grams of tangerine peel, 15 grams of melon shell, 15 grams of turmeric, 24 grams of trichosanthes, and 10 grams of licorice section. Weigh each herbal flavor according to the amount, grind Fritillaria and Paoshanjia into powder for later use, and boil the rest of the medicinal wine and water in half. After boiling, reduce the heat to a low level, fry for another 10 to 15 minutes, and collect the decoction; add water and wine to the dregs and decoct twice in the same way, combine each decoction, and add Fritillaria and Paoshanjia powder , and mix thoroughly to get the decoction.
实施例3本发明药物组合物的制备The preparation of embodiment 3 pharmaceutical composition of the present invention
取生黄芪15克,蒲公英干品20克,金银花9克,贝母6克,皂角刺16克,白芷7克,防风6克,乳香7克,没药7克,当归尾7克,赤芍7克,炮山甲6克,陈皮7克,瓜蒌壳9克,郁金9克,天花粉16克,甘草节6克。各药味按量称取,将贝母、炮山甲均分别研末备用,其余各药用水煎熬。沸后将火调小,再煎10分钟至15分钟后,收集水煎液;药渣再加水如法煎煮2次,合并各次水煎液,浓缩后,兑入贝母与炮山甲末,再加入适量糊精、可溶性淀粉,混匀,制粒,即得颗粒剂。Take 15 grams of raw astragalus, 20 grams of dried dandelion, 9 grams of honeysuckle, 6 grams of Fritillaria, 16 grams of saponins, 7 grams of Angelica dahurica, 6 grams of Fangfeng, 7 grams of frankincense, 7 grams of myrrh, 7 grams of angelica tail, 7 grams of peony, 6 grams of Paoshanjia, 7 grams of tangerine peel, 9 grams of melon shell, 9 grams of turmeric, 16 grams of trichosanthin, and 6 grams of licorice festival. Each herbal medicine is weighed according to the amount, and the Fritillaria and Paoshania are respectively ground into powder for later use, and the rest of the medicines are boiled in water. After boiling, reduce the heat to a low level, fry for another 10 to 15 minutes, and then collect the decoction; add water to the medicinal residue and decoct twice as in the same way, combine each decoction, concentrate, add Fritillaria and Paoshania At the end, add an appropriate amount of dextrin and soluble starch, mix well, and granulate to obtain granules.
实施例4本发明药物组合物的制备Embodiment 4 Preparation of the pharmaceutical composition of the present invention
(1)取生黄芪12克,蒲公英鲜品48克,金银花12克,贝母8克,皂角刺20克,白芷10克,防风8克,乳香10克,没药10克,当归尾10克,赤芍药10克,炮山甲8克,陈皮10克,瓜蒌壳12克,郁金12克,天花粉20克,甘草节8克。各药味按量称取,将贝母、炮山甲均分别研末备用,其余各药用酒与水各半煎熬。沸后将火调小,再煎10分钟至15分钟后,收集水煎液;药渣再加水、酒如法煎煮2次,合并各次水煎液,兑入贝母与炮山甲末,调匀,即得汤剂;(1) Take 12 grams of raw astragalus, 48 grams of fresh dandelion, 12 grams of honeysuckle, 8 grams of Fritillaria, 20 grams of saponins, 10 grams of Angelica dahurica, 8 grams of Fangfeng, 10 grams of frankincense, 10 grams of myrrh, and 10 grams of angelica tail. 10 grams of red peony, 8 grams of paoshanjia, 10 grams of tangerine peel, 12 grams of melon shell, 12 grams of turmeric, 20 grams of trichosanthin, and 8 grams of licorice festival. Weigh each herbal flavor according to the amount, grind Fritillaria and Paoshanjia into powder for later use, and boil the rest of the medicinal wine and water in half. After boiling, reduce the heat to a low level, fry for another 10 to 15 minutes, and collect the decoction; add water and wine to the dregs and decoct twice in the same way, combine each decoction, and add Fritillaria and Paoshanjia powder , and mix thoroughly to get the decoction;
(2)取上述汤剂,静置,取上清液,浓缩后,干燥,粉碎,备用;取适量聚乙二醇4000,熔融后,将上述药粉加入熔融基质中,75-85℃下保温;采用各型滴丸机,滴口内/外径及滴速适度,将其滴入二甲基硅油中,收集滴丸,即得滴丸剂。(2) Take the above decoction, let it stand still, take the supernatant, concentrate, dry, crush, and set aside; take an appropriate amount of polyethylene glycol 4000, after melting, add the above powder into the molten matrix, and keep warm at 75-85°C ;Using various types of dropping pill machines, the inner/outer diameter of the dropping port and the dropping speed are moderate, drop it into simethicone oil, collect the dropping pills, and obtain the dropping pills.
以下通过试验例具体说明本发明的有益效果。The beneficial effects of the present invention will be specifically described below through test examples.
试验例1本发明药物组合物的临床(门诊)治疗情况Clinical (outpatient) treatment situation of test example 1 pharmaceutical composition of the present invention
(一)收治患者情况(1) Situation of admitted patients
患者年龄及性别范围:主要为成人,常见于哺乳妇女,尤其是初产妇,具备下述症状特点(具备部分即可,不必也不可能完全全部具备),共收治19例。Age and gender range of patients: mainly adults, common in breastfeeding women, especially primiparous women, with the following symptoms and characteristics (some of them are sufficient, not all of them are necessary and impossible), and a total of 19 cases were treated.
症状特点:Symptom characteristics:
早期时,首先是患者有局部不适感,有时会感到一侧乳房轻度疼痛不适,或一侧肩背部发沉、酸胀不适,甚至牵及该侧的上臂。继则可发现乳头溢液(若溢液呈血性、浆液血性时应注意进一步检查)。再次,乳腺外形有所改变,可见肿块处皮肤隆起,有的局部皮肤呈橘皮状,甚至水肿、变色、湿疹样改变等。另外,乳房内可触及蚕豆大小的肿块,较硬,可活动。一般无明显疼痛,少数有阵发性隐痛、钝痛或刺痛。In the early stage, the first thing is that the patient feels local discomfort, and sometimes feels mild pain and discomfort on one side of the breast, or heaviness, soreness and discomfort on one side of the shoulder and back, and even pulls the upper arm on that side. Next, nipple discharge can be found (if the discharge is bloody or serous bloody, further examination should be paid attention to). Thirdly, the shape of the mammary gland has changed, and the skin at the tumor can be seen to be raised, and some local skin is orange-peel-like, and even edema, discoloration, and eczema-like changes. In addition, there is a palpable broad bean-sized lump in the breast, which is hard and movable. Generally, there is no obvious pain, and a few have paroxysmal dull pain, dull pain or tingling pain.
过了早期,患侧乳房开始胀满、疼痛,哺乳时尤甚,局部皮温高,乳汁分泌不畅,乳房结块可有可无,或出现边界不清的硬结,甚或局部皮肤红、肿、热、痛,出现较明显的硬结,触痛更甚,全身症状可不明显,或伴有全身不适,食欲欠佳,胸闷烦躁等。然后,局部乳房变硬,肿块逐渐增大,此时可伴有明显的全身症状,如高烧、寒战、头痛、全身无力、大便干燥等。常可在4~5日内形成脓肿,可出现乳房搏动性疼痛,局部皮肤红肿,透亮。舌红苔或腻,色白或黄,脉数有力,或滑或弦。成脓时肿块中央变软,按之有波动感。若为乳房深部脓肿,可出现全乳房肿胀、疼痛,高热,但局部皮肤红肿及波动不明显,需经穿刺方可明确诊断。有时脓肿可有数个,或先后不同时期形成,可穿破皮肤,或穿入乳管,使脓液从乳头溢出。若治疗不善,失时失当,脓肿就有可能穿破胸大肌筋膜前疏松结缔组织,形成乳房后脓肿;或乳汁自创口处溢出而形成乳漏;严重者可发生脓毒败血症。急性乳腺炎常伴有患侧腋窝淋巴结肿大,有触痛;白细胞总数和中性粒细胞数增加。After the early stage, the breast on the affected side begins to be full and painful, especially during breastfeeding. The local skin temperature is high, the milk secretion is not smooth, breast lumps are optional, or induration with unclear boundaries appears, and even local skin redness and swelling , heat, pain, more obvious induration, more tenderness, systemic symptoms may not be obvious, or accompanied by general malaise, poor appetite, chest tightness and irritability, etc. Then, the local breast hardens and the mass gradually increases. At this time, it may be accompanied by obvious systemic symptoms, such as high fever, chills, headache, general weakness, and dry stool. An abscess can often form within 4 to 5 days, and there may be throbbing pain in the breast, local redness and swelling of the skin, and translucent. The tongue is red or greasy, white or yellow in color, and the pulse is strong, slippery or stringy. When pus is formed, the center of the lump becomes soft, and there is a sense of fluctuation when pressed. If it is a deep breast abscess, there may be swelling, pain, and high fever of the whole breast, but the local skin redness and fluctuation are not obvious, and a puncture is required to confirm the diagnosis. Sometimes there may be several abscesses, or they may form in different periods, which may penetrate the skin or penetrate into the milk duct, causing pus to overflow from the nipple. If the treatment is not good and the time is wrong, the abscess may penetrate the loose connective tissue in front of the pectoralis major fascia, forming a mammary abscess; or milk overflows from the wound to form galactorrhea; severe cases may cause sepsis. Acute mastitis is often accompanied by enlarged and tender axillary lymph nodes on the affected side; the total number of white blood cells and neutrophils increases.
(二)治疗标准(2) Standards of treatment
痊愈:上述症状特点完全消失,检验未见相关指标异常。Recovery: the above-mentioned symptoms and characteristics completely disappeared, and no abnormalities in relevant indicators were found in the examination.
疗效显著:上述症状明显减轻,同时检验指标有相当程度改善。Significant curative effect: the above symptoms were significantly relieved, and the test indicators were improved to a considerable extent.
有一定效果:患者症状有所减轻,或指标稍有改善。There is a certain effect: the patient's symptoms are alleviated, or the indicators are slightly improved.
无效:症状依旧,指标没改善。Invalid: Symptoms remain, indicators have not improved.
(三)治疗方法(3) Treatment methods
1、实施例1所制汤剂,每次服用200至400ml,或日常吃饭所用饭碗1碗,每隔6小时左右服用一次,每日至少服3次,按时按量服用。1. Take the decoction prepared in Example 1, take 200 to 400ml each time, or take 1 bowl of rice bowl for daily meals, take it every 6 hours or so, take it at least 3 times a day, take it on time and according to the amount.
2、注意并科学调理生活起居,遵守一些必要的注意事项,如:2. Pay attention to and scientifically regulate daily life, and observe some necessary precautions, such as:
(1)避免乳汁淤积。防止乳头损伤,有损伤时要及时治疗。不要让孩子养成含乳头睡觉的习惯。(1) Avoid milk stasis. Prevent nipple damage, and treat it in time when there is damage. Don't let your child get into the habit of sleeping with the nipple on.
(2)除忌食辛辣、肥甘厚味外,应多吃粗粮、豆类和蔬菜,适当控制动物蛋白的摄入,同时注意补充适量的微量元素。尽量不食咸菜、咸蛋与咸肉等腌制品,可常食海带肉皮冻,有一定软坚化瘀作用。(2) In addition to avoiding spicy, fat, sweet and thick flavors, eat more coarse grains, beans and vegetables, properly control the intake of animal protein, and pay attention to supplementing appropriate amounts of trace elements. Try not to eat salted vegetables, salted eggs, bacon and other pickled products. You can often eat kelp meat jelly, which has a certain effect of softening firmness and removing blood stasis.
(3)乳腺炎初发之时,即乳房有红、肿、热、痛但尚未形成脓肿时,可采取以下方法辅助:(3) At the initial onset of mastitis, that is, when the breast is red, swollen, hot, and painful but has not yet formed an abscess, the following methods can be used to assist:
1)排空乳汁:当感到乳房疼痛、肿胀甚至局部皮肤发红时,要勤给孩子喂奶,让孩子尽量把乳房里的乳汁吸吮尽净,必要时可用抽吸方法排空乳房。当炎症加重,皮肤水肿,硬而发烫,呈紫蓝色,乳头水肿。腋窝处有肿痛硬结,当用手法挤奶,每日多次,每次尽量将乳汁排空,可用梳子背部向乳头方向轻轻按摩以疏通乳腺,必要时可请外科医生帮助推拿。1) Empty milk: When you feel breast pain, swelling or even local skin redness, you should breastfeed your child frequently, let the child suck the milk in the breast as much as possible, and empty the breast by suction if necessary. When the inflammation is aggravated, the skin is edematous, hard and hot, purple-blue in color, and the nipples are edematous. There is swelling, pain and induration in the armpit. When expressing milk by hand, several times a day, try to empty the milk each time. You can gently massage the back of the comb toward the nipple to dredge the mammary gland. If necessary, you can ask a surgeon to help massage.
2)局部热敷:可用热毛巾热敷,每次20~30分钟,每日3次至4次。2) Local hot compress: hot towel can be used for hot compress, 20-30 minutes each time, 3 to 4 times a day.
(四)治疗结果(4) Treatment results
数十年间以本发明药物组合物治疗本病患者计19例,获得了较好的疗效。治疗时间,根据各患者病情轻重、体质强弱等具体情况之不同而稍有所差异,一般在三五天左右症状即可明显减轻,未成脓者继而红肿渐减渐消,已成脓者渐次熟透而溃,按上述科学调理生活起居,谨遵注意事项,可收全功。Nineteen cases of patients with this disease have been treated with the pharmaceutical composition of the present invention for decades, and better curative effect has been obtained. The treatment time varies slightly according to the specific conditions of each patient, such as the severity of the disease and the strength of the body. Generally, the symptoms can be significantly relieved in about three to five days. If it is overcooked and collapsed, according to the above-mentioned scientific regulation of daily life, follow the precautions, and you can get all the results.
按上述治疗标准,19例患者中,有13例痊愈,治愈率为68.4%;2例疗效显著,为10.5%;3例有一定效果,为15.8%;1例效果不明显(无效),占5.3%。总有效率达94.7%。According to the above treatment standards, 13 of the 19 patients were cured, with a cure rate of 68.4%; 2 cases had a significant effect, accounting for 10.5%; 3 cases had a certain effect, accounting for 15.8%; 1 case had no obvious effect (ineffective), accounting for 5.3%. The total effective rate is 94.7%.
典型病例Typical cases
患者,女,26岁,初产,突感左侧乳房胀满、疼痛,哺乳时尤甚,乳房似有结块,乳汁分泌不畅,食欲欠佳,胸闷烦躁,全身不适。继后,乳房局部变硬,肿块已渐增大,全身无力,恶寒,发烧,头疼。自行口服“安必仙”消炎,未效,过两日,乳房竟出现搏动性疼痛,局部皮肤红肿、透亮,腋下淋巴结也肿大、触痛,于是转请中医诊疗。诊之,患者乳房胀痛,有硬结,触痛更甚,局部皮温高,红、肿、热、痛明显,腋下淋巴结肿大,舌红苔黄,脉弦数有力,为乳痈之症。诊后,以本发明药物组合物治疗(实施例1制备),并严遵上述“治疗方法”之“1”的服药方法和“2”的科学调理及注意事项。患者服药2日,症状未见明显缓解,但亦未恶化,观其舌诊其脉,舌尚红润,脉尚顺而无逆像,唯添滑意,于是嘱其继续服用。又服4日,竟破溃出脓,嘱其引流,使之通畅,自此症状逐日减轻,仍照前调理,症状终于全消,日趋向愈。后经查体,未见指标异常。The patient, female, 26 years old, primiparous, suddenly felt fullness and pain in the left breast, especially when breastfeeding, the breast seemed to have lumps, the milk secretion was not smooth, the appetite was poor, chest tightness and irritability, and general discomfort. Afterwards, the breasts became hard locally, the lumps gradually increased, general weakness, chills, fever, and headaches. I took "Ambison" orally for anti-inflammatory by myself, but it didn't work. After two days, my breasts developed throbbing pain, local skin was red, swollen and translucent, and my axillary lymph nodes were also swollen and tender, so I referred to Chinese medicine for diagnosis and treatment. Diagnosed, the patient's breasts are distended and painful, with induration, tenderness is worse, local skin temperature is high, redness, swelling, heat, pain are obvious, axillary lymph nodes are swollen, red tongue with yellow coating, strong pulse strings, it is the symptom of mastitis. disease. After diagnosis, treat with the pharmaceutical composition of the present invention (prepared in Example 1), and strictly abide by the medication method of "1" and the scientific conditioning and precautions of "2" of the above "treatment method". The patient took the medicine for 2 days, and the symptoms did not show obvious relief, but they did not worsen. The pulse was checked by observing his tongue. After taking it for another 4 days, the pus was ruptured, and it was instructed to drain to make it unobstructed. Since then, the symptoms have been alleviated day by day, and the treatment is still as before, and the symptoms finally disappear completely and tend to heal day by day. After physical examination, no abnormal indicators were found.
仙方活命饮,出自《校注妇人良方》,具有清热解毒,消肿溃坚,活血止痛的功效,可用于治疗乳腺炎。前期研究期间,以仙方活命饮为阳性对照,用以证明本发明药物组合物的药效活性,结果如下:Xianfang Huomingyin, from "Xiaozhu Women's Good Prescriptions", has the effects of clearing heat and detoxifying, reducing swelling and ulceration, promoting blood circulation and relieving pain, and can be used to treat mastitis. During the preliminary research period, Xianfang Huomingyin was used as a positive control to prove the efficacy and activity of the pharmaceutical composition of the present invention. The results are as follows:
①在相同的治疗时间内,施用本发明药物组合物的痊愈率要比仙方活命饮原方高出30%,而无效率则较之低50%(1例︰2例),这表明本发明药物组合物治愈率更高。①In the same treatment time, the recovery rate of using the pharmaceutical composition of the present invention is 30% higher than that of the original prescription of Xianfang Huomingyin, while the ineffective rate is 50% lower than that (1 case: 2 cases), which shows that this The inventive pharmaceutical composition has a higher cure rate.
②对相近体质的患者给药后,发现仙方活命饮原方的治疗时间比本发明药物组合物长1~3天,这表明本发明药物组合物疗程更短。② After administration to patients with similar constitutions, it was found that the treatment time of the original prescription of Xianfang Huomingyin was 1-3 days longer than that of the pharmaceutical composition of the present invention, which indicated that the course of treatment of the pharmaceutical composition of the present invention was shorter.
综上所述,本发明药物组合物能有效治疗因乳汁淤积化热,热毒蕴结、气血壅滞所引起的乳痈或急性化脓性乳腺炎、急性单纯乳腺炎,为临床用药提供了一种新的选择。In summary, the pharmaceutical composition of the present invention can effectively treat mastitis or acute suppurative mastitis and acute simple mastitis caused by milk stasis and heat transformation, accumulation of heat and toxins, stagnation of Qi and blood, and provides a good foundation for clinical use. A new option.
Claims (10)
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Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103566154A (en) * | 2013-10-23 | 2014-02-12 | 孙斌 | Traditional Chinese medicine for treating acute mastitis |
| CN103751509A (en) * | 2014-01-13 | 2014-04-30 | 黑龙江八一农垦大学 | Chinese herbal medicine composition for treating clinical mastitis |
| CN104189310A (en) * | 2014-08-22 | 2014-12-10 | 严中明 | Composition for treating acute mastitis |
| CN104257911A (en) * | 2014-09-16 | 2015-01-07 | 韩旭 | Pharmaceutical composition, pharmaceutical preparation and application thereof |
| CN104258031A (en) * | 2014-09-26 | 2015-01-07 | 河南亚卫动物药业有限公司 | Chinese and western medicine compound for preventing and treating recessive mastitis of dairy cows |
| CN105213644A (en) * | 2015-11-12 | 2016-01-06 | 青岛友诚高新技术有限公司 | A kind of Chinese medicine preparation for the treatment of acute mastitis and preparation method thereof |
| CN105582036A (en) * | 2014-11-06 | 2016-05-18 | 株式会社Lg生活健康 | Composition for promoting synthesis of hyaluronic acid comprising Taraxacum herbs extracts and the use thereof |
| CN105727242A (en) * | 2016-04-27 | 2016-07-06 | 郑耀玲 | A traditional Chinese medicine preparation for treating heat-toxin-filled mastitis and its preparation method |
| CN105920542A (en) * | 2016-06-25 | 2016-09-07 | 董艳丽 | Chinese medicinal composition for treating acute mastitis |
| CN106214905A (en) * | 2016-08-29 | 2016-12-14 | 周智卿 | A kind of Chinese medicine composition treating mastitis and preparation method thereof |
| CN106552152A (en) * | 2015-09-24 | 2017-04-05 | 戚加井 | A kind of formula for controlling cyclomastopathy |
| CN107362193A (en) * | 2017-07-25 | 2017-11-21 | 上海中医药大学附属曙光医院 | Chinese medicine composition of preventing and treating acute mastitis at initial stage and its preparation method and application |
| CN111514252A (en) * | 2020-06-08 | 2020-08-11 | 首都医科大学附属北京中医医院 | Traditional Chinese medicine composition, medicine and preparation method and application thereof |
| CN114796382A (en) * | 2022-03-29 | 2022-07-29 | 杭州市第三人民医院 | Traditional Chinese medicine composition for treating acute yang syndrome pyocutaneous disease and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103566154A (en) * | 2013-10-23 | 2014-02-12 | 孙斌 | Traditional Chinese medicine for treating acute mastitis |
| CN103751509A (en) * | 2014-01-13 | 2014-04-30 | 黑龙江八一农垦大学 | Chinese herbal medicine composition for treating clinical mastitis |
| CN103751509B (en) * | 2014-01-13 | 2016-02-24 | 黑龙江八一农垦大学 | A kind of herbal composite for the treatment of clinic mastitis |
| CN104189310A (en) * | 2014-08-22 | 2014-12-10 | 严中明 | Composition for treating acute mastitis |
| CN104257911A (en) * | 2014-09-16 | 2015-01-07 | 韩旭 | Pharmaceutical composition, pharmaceutical preparation and application thereof |
| CN104257911B (en) * | 2014-09-16 | 2018-07-06 | 韩旭 | Pharmaceutical composition and pharmaceutical preparation and its application |
| CN104258031A (en) * | 2014-09-26 | 2015-01-07 | 河南亚卫动物药业有限公司 | Chinese and western medicine compound for preventing and treating recessive mastitis of dairy cows |
| CN105582036A (en) * | 2014-11-06 | 2016-05-18 | 株式会社Lg生活健康 | Composition for promoting synthesis of hyaluronic acid comprising Taraxacum herbs extracts and the use thereof |
| CN106552152A (en) * | 2015-09-24 | 2017-04-05 | 戚加井 | A kind of formula for controlling cyclomastopathy |
| CN105213644A (en) * | 2015-11-12 | 2016-01-06 | 青岛友诚高新技术有限公司 | A kind of Chinese medicine preparation for the treatment of acute mastitis and preparation method thereof |
| CN105727242A (en) * | 2016-04-27 | 2016-07-06 | 郑耀玲 | A traditional Chinese medicine preparation for treating heat-toxin-filled mastitis and its preparation method |
| CN105920542A (en) * | 2016-06-25 | 2016-09-07 | 董艳丽 | Chinese medicinal composition for treating acute mastitis |
| CN106214905A (en) * | 2016-08-29 | 2016-12-14 | 周智卿 | A kind of Chinese medicine composition treating mastitis and preparation method thereof |
| CN107362193A (en) * | 2017-07-25 | 2017-11-21 | 上海中医药大学附属曙光医院 | Chinese medicine composition of preventing and treating acute mastitis at initial stage and its preparation method and application |
| CN107362193B (en) * | 2017-07-25 | 2021-05-28 | 上海中医药大学附属曙光医院 | Traditional Chinese medicine composition for preventing and treating early stage acute mastitis, preparation method and application thereof |
| CN111514252A (en) * | 2020-06-08 | 2020-08-11 | 首都医科大学附属北京中医医院 | Traditional Chinese medicine composition, medicine and preparation method and application thereof |
| CN114796382A (en) * | 2022-03-29 | 2022-07-29 | 杭州市第三人民医院 | Traditional Chinese medicine composition for treating acute yang syndrome pyocutaneous disease and application thereof |
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