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1、河北科技大学硕士学位论文岩鹿乳康片的研制姓名：张春华申请学位级别：硕士专业：化学工艺指导教师：李小云20091201摘 要 I摘 要 乳腺增生是女性最常见的乳房疾病，西医治疗乳腺增生的药物多存在一定不良反应。中医药在治疗乳腺增生病时根据病因病机,辨证论治，常采用疏肝理气、活血化瘀、消肿止痛、通络散结的口服药物，疗效较好，不良反应小。本论文研究的就是采用中药成分来治疗乳腺增生的制剂，具有很好的疗效。 本 文 岩 鹿 乳 康 片 是 根 据 国 家 药 品 标 准 “ 岩 鹿 乳 康 胶 囊 （ 试行）”(WS-10306(ZD-0306)-2002)制剂的组方制法改剂型而得，岩鹿乳康片的生产工艺
2、与岩鹿乳康胶囊的生产工艺相比，无质的改变。制剂中以岩白菜素为主要有效成分进行了含量测定，岩白菜素主要作用是止咳祛痰,但近来的药理实验发现岩白菜素还具有抗炎、护肝、抗溃疡、提高免疫等作用。 本论文围绕产品的有效性和产品质量的稳定性，主要开展了以下研究工作： 通过测定岩陀中有效成分岩白菜素的含量，来达到控制岩鹿乳康片的质量，因此有必要对原材料岩陀中的岩白菜素含量进行测定，规定其含量。参照国家药品标准“岩鹿乳康胶囊 （试行） ” (WS-10306(ZD-0306)-2002)中岩白菜素含量测定方法和相关文献报道，建立了岩陀药材中岩白菜素的测定方法，并对岩陀药材中岩白菜素的含量进行测定。 对产品的工
3、艺进行了摸索，确立了提取、浓缩、干燥、制粒等的工艺参数，采用乙醇回流提取，60减压浓缩，40干燥制粒进而压片包衣的方法生产成品。 对产品的稳定性进行了研究。在模拟上市包装条件下，经温度 40，相对湿度75放置 6 个月，进行加速试验考察，测定了其外观性状、样品含量、鉴别、崩解时限、微生物限度等指标，均未发生明显改变；经温度 25，相对湿度 60放置 18个月试验考察，结果表明:其外观性状、样品含量、鉴别、崩解时限、微生物限度等均未发生明显改变，表明岩鹿乳康片质量稳定。 关键词 乳腺增生；岩鹿乳康片；岩鹿乳康胶囊；岩陀；岩白菜素 河北科技大学硕士学位论文 IIAbstract Hyperplas
4、ia is the common breast disease in women. There is a certain number of adverse reactions when treat breast hyperplasia with western medicine. According to the syndrome differentiation of etiology and pathogenesis, the oral administration product with the function of relieving the depressed liver, pr
5、omoting blood circulation, removing swelling and pain relief often be used in Chinese medicine treatment. This is a method that has good efficacy and few side effects. The product mentioned in this paper is just a Chinese medicine for the treatment of breast hyperplasia; it has a good therapeutic ef
6、fectiveness. The studied product in this paper is named as Yan Lu Ru Kang Tablet, it is based on the National Drug Standards “ Yan Lu Ru Kang Capsule (Trial)” (WS-10306(ZD-0306)-2002). It has a similar formulation with the capsule but changed the dosage form. There is no nature change when compare t
7、he manufacturing process of the tablets with the capsules. The main active ingredient of this product is Bergeninum, its assay has been tested. The main function of Bergeninum cough expectorant, but according to the recent pharmacological experiments, Bergeninum has a lot of other functions such as
8、anti-inflammatory, hepatoprotectiving, anti-ulcering, improve the immunization, etc. Focused on the effectiveness and stableness of the product, this study performed the main works as bellow: The product quality is controlled by means of testing the assay of Bergeninum in Rhizoma Rodgersiae, so it i
9、s necessary test the Bergeninum content in the crude herbal of Rhizoma Rodgersiae. Refer to the National Drug Standards “Yan Lu breast capsule (for Trial Implementation)“ (WS-10306 (ZD-0306) -2002) in the determination of Bergeninum methods and reported in the literature, the testing method of Berge
10、ninum in Rhizoma Rodgersiae herbs was established, and the . Bergeninum content in the crude herbal of Rhizoma Rodgersiae was tested. The manufacturing process was studied and the parameters of extraction, concentration, drying and granulation were determined. The product was manufactured by the ste
11、ps of alcohol circumfluence extraction, vacuum concentration under 60 , drying under 40 , granulation, compression and coating. The stability study was carried out. Carried out the accelerate study under the condition of marketing packaging at the temperature of 40 , relative humidity of 75% Abstrac
12、t IIIfor 6-month, the testing items include: appearance, content, identification, disintegration time, microbial limits, etc., there was no significant changes took place; According to the long-term study at the temperature of 25 , relative humidity of 60% for 18 months, the results showed that: the
13、 appearance of characters, content of the sample, identification, disintegration time, microbial limits, etc. were not significantly changed, indicating that Yan Lu Ru Kang Tablet has a stable quality. Key words Hyperplasia; Yan Lu Ru Kang Tablet; Yan Lu breast capsule; Rhizoma Rodgersiae; Bergeninu
14、m 第1章 绪论 1第1章 绪论 1.1 立题目的与依据立题目的与依据 乳腺增生是女性最常见的乳房疾病，其发病率占乳腺疾病的首位。近些年来该病发病率呈逐年上升的趋势，年龄也越来越低龄化。据调查约有7080的女性都有不同程度的乳腺增生，多见于2545岁的女性。 乳腺自胚胎发育至老年萎缩的全过程受多种激素的影响，历经胚胎期、幼儿期、青春期、妊娠期和老年期的演变。乳腺作为女性生殖系统的一部分，是多种内分泌激素的靶器官，其发生、发育和分泌功能直接受内分泌腺所分泌激素的影响，以卵巢和垂体前叶的影响最大，其他如肾上腺皮质、甲状腺所分泌的激素也有一定的影响，大脑皮层的间接调节亦有相当重要的作用。 乳腺趋向萎
15、缩和纤维样变，乳腺导管及腺泡萎缩，导管周围纤维结缔组织增生、硬化、玻璃样变性，血管明显减少或消失，小乳管和血管逐渐硬化、闭塞，有时还可见钙化现象。 乳腺增生是指乳腺上皮和纤维组织增生，乳腺组织导管和乳小叶在结构上的退行性病变及进行性结缔组织的生长，其发病原因主要是由于内分泌激素失调。中医认为：情怀不畅，肝气不得正常疏泻而气滞血淤疾凝，冲任不调者，常有月经紊乱，面部色斑。现代医学认为：婚育、膳食、人生存的外环境和遗传因素是乳腺发病的主要原因。其本质上是一种生理增生与复旧不全造成的乳腺正常结构的紊乱。在我国，囊性改变少见，多以腺体增生为主，故多称乳腺增生症。乳腺增生病属于中医的“乳癖”范畴。有关本
16、病的描述最早见于中藏经 ，以后历代医家多有论述，对其病因病机、临床表现及治疗均有详尽的阐述。“乳癖”是形容气机不畅，在乳房部出现胀满疼痛，症情时缓时剧，疼痛时轻时重等特点。临床突出表现有乳房胀痛、乳内肿块、月经失调和情志改变等症状。乳腺增生是女性内分泌紊乱所致，如卵巢分泌黄体酮可使乳腺腺泡发育。分泌的动情素可使腺管发育，而经常保持动态平衡则乳腺正常。如果女性不结婚、不生育、不哺乳则造成内分泌失调，此时就易发生乳腺增生，表现为双乳腺腺管未端增生，此时乳房内有散在的小结节，经期前肿胀痛疼，活动更痛。 乳腺增生性疾病不是一个独立的疾病，是由于许多因素造成的特别是内分泌紊乱，即卵巢分泌的雄性激素和黄体素如因各种原因引起紊乱，均导致一系列疾病的发生，如面部的黄鹤斑，乳腺增生，月经失调子宫肌瘤等，因此，说如果发生了乳腺小叶增生性疾病，某些医生单纯去手术切除或局部用药均不能达到治愈目的，唯一的办法只能用中医中药根据四诊八纲，辨证治疗，针对病因，活血化瘀，软坚散河北科技大学硕士学位论文 2 结，疏肝理气去调整内分泌系统，必然会达到很好的疗效。临床将乳腺
