【Minoxidil 米诺科斯迪尔】

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回答: 【叶惠芳大夫 】--- ZT弓尒2017-11-19 04:12:07

 

 

 

古汉生发精说明: 

  主要成份:当归、干姜、苦参、皂角、灵芝、何首乌、天麻、桑椹子等萃取液。 

 

《千金要方》载:桑白皮洗发方:桑白皮(锉)1200克,以水淹浸,煮五六沸,去渣,频频洗沐。功效防止脱发。适用于脱发刚开始,或预防脱发。《千金要方》称其“频频洗沐、自不落也”。

 

【蔓荊子《本草經集注》:主發禿落。《藥性論》:治賊風,能長髭發。】

 

古方中得知桑葉(桑葚、桑根白皮)、側柏葉(柏枝、柏子)、紅花、首烏、生薑、皂莢、零陵香、白芷、川芎、附子、木瓜、黑芝麻(麻油)、蔓荊子十三種藥物通常被用於防止脫髮和生髮藥方中。

------------------------

米诺地尔英语:Minoxidil)是一种钾通道开放药,这类药物在降压时常伴有反射性心动过速和心输出量的增加。对于血管扩张的作用具有选择性,见于冠状动脉,胃肠道血管和脑血管,而不扩张肾和皮肤血管。它還可以減低或停止掉髮並且促進毛髮再生。現在一般的門診病人不需要處方就可以取得,用於雄性禿

 

 

歷史[编辑]

米諾地爾本來是用於控制高血壓。後來偶然發現有一個有趣的副作用,就是扭轉或減慢禿頭過程。Upjohn推出了含2%的米諾地爾的外用藥液,用來治療禿頭及脫髮。該藥液在美國及加拿大以Rogaine名稱銷售,在歐洲及亞太區則使用Regaine名稱,在台灣譯為「落建」。5%濃度的藥液專供男性使用,而2%濃度的藥液則適合女性使用。在台灣販售的含5%濃度的米諾地爾成分生髮藥液產品如:落建生髮系列的落健生髮液、萌髮生髮液等。米諾地爾的專利保護期在1996年2月11日已經到期。5%泡沫配方的米諾地爾,跟液體配方一樣有效。

機轉[编辑]

米諾地爾促進毛髮生長的機轉目前還未完全了解。此藥物的結構式中有一氧化氮基團且可能做為一氧化氮的致效劑。[1] 它同樣是鉀通道開放劑,造成細胞膜的去極化。對於大面積的掉髮,米諾地爾就比較沒有效果。另外,對於年輕男性有五年以下的掉髮困擾,它有非常顯著的效果。目前,米諾地爾只用於頭頂的掉髮。[2]它同樣也是個血管擴張劑。理論上,藉由擴張血管及開通鉀離子通道,使更多的氧氣及養分到毛囊,會促使毛囊從休止期到生長期。

副作用[编辑]

常見的副作用有對眼睛的燒灼感及刺激性,治療部位搔癢、紅腫及刺激性,非預期位置的毛髮生長。如果使用者有以下的嚴重副作用,立即尋求醫療照護:嚴重的過敏反應(紅疹、蕁麻疹、搔癢、呼吸困難、胸悶等);胸痛;暈眩;火燒心;立即且非預期的體重增加;手或腳的脹大。

酒精丙二醇可能會使頭皮乾燥,造成頭皮屑接觸性皮膚炎。有些配方改用奈米液滴為的就是減少因為酒精和丙二醇所造成的接觸性皮膚炎。

應用[编辑]

動物毒性[编辑]

米諾地爾對來說是致命的。

參見[编辑]

 
 

Hair Loss Treatments: A Word of Caution

09/04/2008
 
 

M ore than 50% of the population of men in their 50s has cosmetically significant male pattern hair loss. No doubt, the pressure on individuals to look younger comes from all directions in our society. Also, our culture is impatient — we want superior solutions, and we want them now. All of these factors have converged over the past 2 years to drive the marked increase in the number of products promoted as solutions to hair loss. These formulations and devices pander to the population’s desire to find some way to halt this visible sign of aging. Wading through the myriad choices can be daunting enough for dermatologists — let alone for patients. In this article, I’ll give you a good look at the treatment choices — Rx and over the counter — that your patients have available to them. By knowing what’s available, you’ll be better able to discuss appropriate options for your patients and steer them clear of treatments that may just be wasting their time and money. Who Seeks Treatments The latest statistics report that an estimated 80 million men and women are affected by hair loss in the United States. Yet, only 3% of this patient population searches out some sort of solution — whether it’s medical, surgical or non-medical. Only three medically proven methods of dealing with hair loss exist: 1. hair transplantation 2. minoxidil (Rogaine) 3. finasteride (Propecia). Of these, surgical hair transplantation is the only permanent solution to hair loss. Both minoxidil and finasteride are often successful options, but they require continued use to become and remain efficacious; once discontinued, hair loss ensues. Despite the availability of these proven methods, many people suffering from hair loss try unproven hair loss remedies. Numerous products claiming to be natural, safe, drug-free and effective against hair loss are heavily marketed in the media. These buzz words, coupled with the virtual anonymity of purchase, are attractive and are garnering huge attention. A Look Back Historically, there have been two dramatic influxes of these types of products. The first began in 1988 and was spurred by the FDA approval of minoxidil. Copycat products could not offer clinical statistics to substantiate their claims and, eventually, the Federal Trade Commission (FTC) stepped in to regulate these products. The introduction of Rogaine 5% and Rogaine’s new over-the-counter (OTC) status in 1996 raised further awareness in the public, as did the introduction of finasteride (Propecia) in 1997. The second big wave of hair loss treatments came in December 2000 when Rogaine’s patent expired. A generation of non-prescription products that proclaim to be natural, safe and effective solutions for hair loss are usually not what they claim. Products are often based on minoxidil in some form, saw palmetto (an unproven herbal remedy) and/or other products that claim to be dihydrotestosterone (DHT) inhibitors. Yet, Propecia is the only DHT inhibitor the FDA has approved for hair loss. Compounding the problem is that distribution of potentially bogus products has never been easier. Consumers can purchase them anonymously from numerous Internet sites, and the FTC has been slow to regulate efficacy of these unproven products, which hasn’t helped the matter. Here, I’ll take a look at the wide ranging category of hair loss treatments to give you a better idea of what’s available to your patients. What Works • Minoxidil. As mentioned before, this was the first of the drugs approved for hair loss. Introduced in 1988, Rogaine has been an effective medication for hair loss for both men and women. The topical formulation is now available in 2% and 5% strengths and has been OTC since 1996. The treatment is a hair growth stimulator and works by activating potassium channels in follicular cells. VEGF and prostaglandin synthase expression is indicated. Numerous clinical studies have been done and reported for both hair growth and hair maintenance endpoints. • Finasteride. The newest medication to be approved by the FDA for hair loss, this 5-alpha-reductase inhibitor was approved in 1997. The drug lowers DHT levels, resulting in hair maintenance and may result in hair growth. Clinical studies show that 90% of the study participants either gained or maintained their hair for more than 5 years compared to placebo. • Hair Restoration. This method offers the only permanent solution for hair loss. A surgical treatment, the procedure transplants viable hair from the donor area to the recipient locations. What’s Trendy Presently, the products generating the most interest are Avacor, Nioxin, Dutasteride and saw palmetto. Here’s a closer look at each. • Avacor. From Global Vision 2001, this heavily marketed product is a three-fold system of a DHT blocker, topical solution and scalp detoxifying shampoo. It claims to be an all-natural, herbal formulation that is immediately effective with results shown in 4 to 6 months. It’s a hair-growth stimulator based on a formulation of 2,4-di-amino-6d piperidino-pyrimidine 3 oxide, or in other words, minoxidil 2%. It also contains sabal serulate, an androgen modulator, commonly known as saw palmetto. While the company uses clinical data to support its claims, the data actually come from a “non-peer-reviewed, non-double-blind, seemingly scientific study subsidized by the makers of the product.”1 Average cost is $220 for a 3-month supply. • Nioxin. This product is a cleanser scalp therapy and scalp serum. It contains niocidin, which inhibits demodex-produced lipase.2 However, there has never been any study that implicates demodex lipase in hair loss or that shows that hair will benefit from getting rid of mites or their lipase.3 Nioxin is based upon bionutrient actives and protectives. The primary methodology of these agents is to clean the scalp of DHT and to provide chemically enhanced hair with moisture/vitamin nourishment. Primarily available in salons, the product can now be found in other retail outlets. • Dutasteride. Available from GlaxoSmithKline, this is the most promising of the products or medications. Approved by the FDA only for use with prostate indication, it was not submitted for male pattern baldness. It is a DHT blocker that blocks both forms of 2-alpha-reductase enzymes (type 1 and 2). Early studies show promising results, with slightly better results than finasteride; however, the potential side effects require further trials and testing for overall efficacy and safety. Other early indications show that it has a longer half life than finasteride and that the safety data are consistent with DHT reduction. The drug is still awaiting Phase III trials. Dutasteride has been marketed with the brand name Avodar. • Saw Palmetto. Available from multiple sources, this OTC herb has been touted as an effective supplement for helping thinning hair. It has shown to be beneficial in men with benign prostatic hyperplasia but does not affect testosterone, DHT or PSA levels.4 It has exhibited alpha androgenetic receptor blocking activity in vitro.5 General usage recommends taking 400 mg of standardized extract with 100 mg of beta sitosterol daily. This product claims to produce results in 5 months. A Closer Look at the Other Popular Contenders There are numerous other products and devices available to the consumer. Here’s a random sampling of the most prominent lotions, potions and creams. I’ve categorized them by the operative mechanism or by their key, active ingredients. In this category, I’ll discuss products that are based on minoxidil, herbals, oils or vitamins. Minoxidil-Based • Folliguard Extra. Manufactured by Jungle MD, this product is very similar to Avacor both in terms of usage and formulation. Specifically, it uses a system of DHT blocker and scalp detoxifying shampoo. Its active ingredients are minoxidil 2% and saw palmetto. Cost is approximately $200 for a 3-month supply. • Hair Advantage. This product is from Daniel Rogers Laboratory, and it’s very similar to Avacor and Folliguard. This scalp detoxifying shampoo incorporates a DHT blocker and nutrient serum. The ingredients are composed of loniten (better identified as minoxidil), saw palmetto, tarakaci, notoptcryl, maidenhair tree, vaccinium murtillus and equisetum. Estimated cost is $180 for a 3-month supply. B>• Xandrox. This product also claims to contain a DHT blocker as well as a topical solution. Its active ingredients are minoxidil 12.5% micronized and azeleic acid 5% +/- betamethasone valerate. The company reports that the 12.5% micronized minoxidil works on temple and hairlines (non-responsive areas) while they say the azeleic acid can act as a DHT inhibitor. Herbal Products • Hair Genesis. This product, which is manufactured by Dr. Geno Marcovici and Sunset Marketing, sells for $270 for a 3-month supply. It uses a system of a special shampoo, conditioner, supplements and a serum. The shampoo employs “botanicals” to inhibit type I and II 5-alpha reductase and decrease DHT. The product claims to provide results in 6 months and is safe for men and women. • Nu Hair. From Biotech Corp., this product sells for $180 for a 3-month supply. It claims to be a supplement for thinning hair. Its active ingredients are he shou wou, saw palmetto, horsetail, henna, rosemary, progesterone and nettle. • Hair Prime. This product from Universal Biologics sells for $210 for a 3-month supply. It requires a regimen of shampoo, lotion and primer to deliver “nutrients.” It has two herbal and vitamin supplement tablets containing pantothenic acid, biotin and zinc. It claims to be a natural herbal treatment and claims that 9 out of 10 people have healthier hair growth. Biologic Products • Emu Oil. This substance has been studied by Boston University Medical Center and is a topical product that sells for $9.50 an ounce. Its credentials cite a Dr. Michael Holick who reported a clinical study that Emu Oil accelerated skin regeneration and stimulated hair growth. The product claims 80% of hair follicles began to grow hair in non-clinical studies. • Thymuskin. Manufactured by Biotechne Complex Inc., this solution sells for $210 for a 3-month supply. This topical solution must be massaged directly into the scalp. It contains the extract of calf thymus glands and claims to boost immune function. However, product claims admit that it’s not effective for male pattern baldness or androgenetic alopecia, the most common types of hair loss. • FNS. Otherwise known as Follicle Nutrient Serum, this product is from Osmotics and sells for $65 for a 4-ounce tube. It’s a topical solution that claims to contain a unique delivery system of nutrients. It has a three-fold mechanism that includes a growth hormone potentiator, a cell culture medium and a vehicle. This is marketed as a cosmetic product and will not be submitted for FDA approval. No trials have been performed to date. Vitamin and Mineral Products • Hair ZX. Available from Vitafree, this product sells for $250 for a 3-month supply. It is a three-part system including a shampoo, a topical and a DHT blocker. It’s available through Internet and direct sales. This product claims to regrow lost hair as well as produce larger, healthier follicles. • Folligen. This product comes in three formulations: a cream for hairlines, a lotion for denser areas of hair and a solution therapy spray for misting over the hair. It’s available through the Internet and direct sales. A copper-peptide-based product, this product’s functionality is based on the theory of increasing blood supply to the scalp to combat hair loss. • Triaxon. This topical treatment is available through the Internet and direct sales. It contains a combination of vital nutrients and vitamins and reports it has a higher level of active ingredients designed to promote new growth. Product claims include helping to reduce DHT levels by 90% and giving users immediate results. • EPM. From Sumitomo Electronics, this OTC topical treatment contains 10 amino acids. Its active ingredient is epimorphin. No clinical trial data are available, and this product isn’t available in the United States. Miscellaneous Products • Kevis. By Farmaka, this product sells for $650 to $975, depending upon the package you choose. It’s available through Internet and direct sales. The product includes a topical lotion, a shampoo and a topical “accelerator” that must be applied with an applicator and massaged into the scalp. The product claims to work by blocking DHT or the androgen receptor. The company indicates that clinical testing was conducted in Europe. • Procyanidin B-2. This combination shampoo, lotion and primer is marketed as a regimen to deliver nutrients to the scalp. The agent, a polyphenol compound, is found in apples, which is said to act on hair epithelial cells as a growth-promoting factor. The company’s own study indicated “an increase in the number of hairs and the diameter of hairs in the designated scalp area compared to placebo.” No statistics or data were provided. • Revivogen. Available from Advanced Skin and Hair, this product costs $99 for a 3-month supply. This OTC product includes a scalp therapy formula and bio-cleansing shampoo. The company claims that its product is an anti-DHT product and that it has no systemic side effects and is safe for men and women. On the Web site for this non FDA-approved treatment, the following is stated: This product is “not a drug, medication, treatment or cure for hair loss.” However, the company discusses an internal study that was performed that resulted in a significant decrease in hair loss in a 3-month period. Rx Products • Nizoral. This Janssen Pharmaceuticals’ shampoo contains ketoconazole 2% (an anti-fungal agent). Ketoconazole, taken in tablet form, has been shown to lower serum testosterone. The effect has been compared to that of minoxidil 2%. The shampoo is available in a 1% form over the counter or in 2% form as a prescription.• Spironolactone. A potassium-sparing diuretic, this agent is used in treatment for blood pressure and has been found to have anti-androgen activity. It’s a DHT blocker in topical form, and it must be applied daily followed by the application of a minoxidil solution. This product is available by prescription in tablet or foam. Devices and Other Options • Laser comb.Manufactured by Lexington International, this $695 comb employs photobiostimulation with low-level cold beam laser therapy. The company claims to show improvements or activation of hair in the first 5 to 10 weeks. It requires usage twice a day for 10 minutes per session. The device has received some mixed reactions. Some of the positive responses are from respondents using other forms of hair loss remedies. FDA clinical trials with the device are underway. • Hairogenics.This company offers a hair storage service, with hair being stored in a temperature-controlled vault. The principle involves storing hair until cloning or other reproduction methods are viable. Concerns revolve around the extraction of hair and that DNA taken from existing hair would be sufficient for any cloning or reproducing possibilities. Based in Oregon, cost is an initial $50 plus $10 per annum for storage. • Dermal Fusion. This technique, developed by Ryan Livingston, claims to be a hair “multiplication” technique in which microscopic biopsies of hair or scalp tissue are removed without scarring or bleeding. Follicles are multiplied in a type of incubation chamber. A pipette then inserts surviving cells. The procedure claims immediate hair growth without any trauma or a resting phase. It’s generally believed to be a hoax. Summing Up the Options It’s worth noting that most of these products have similar recommended treatment regimens and ingredients. Many of the so-called natural products actually contain minoxidil in some form, which is a clinically proven hair loss remedy. Also, many of these treatments don’t provide sufficient information on their formulations, or they disguise some of their ingredients with terminology not usually recognized by the public. Almost unilaterally, many of these products list a DHT blocker but this ingredient may not be identified as such. Another thing many of these products also have in common is that they allude to clinical trials, but in many instances the specific data to substantiate the claims aren’t supplied. Lastly, there’s often no satisfactory mechanism of action provided within the product. With the population’s growing interest in anti-aging treatments, herbal formulas and holistic medicine and the perceived need to look younger, we’ll continue to see a slew of products that claim to effectively treat hair loss. Some may live up to their claims, but most are bound not to. We must be aware that many of our patients may be trying these products in vain, so the need for better educating them is paramount. Hair transplantation, Rogaine and Propecia are the only clinically proven medical hair loss treatments at present. Until a new drug is found, cloning is perfected or genetic therapy refined, they remain the best solutions for the hair loss population.

 

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米诺地尔乱象:假药扎堆,真药太贵。


米诺地尔应该说是一个老药。上世纪70年代,作为治疗高血压的药物。在临床上开始使用。其靶点很明确是钾离子通道。在使用的过程中人们发现他有促进毛发生长的作用。美国FDA的药品信息显示,1988年由美国一家公司重新将米诺地尔注册为治疗脱发的新药上市,该公司对米诺地尔的新的治疗作用进行了新的临床前和临床实验确认米诺地尔外用可以改善脱发。因此该公司也享受了新药大约10年的专利保护。但是用于治疗脱发的药理学靶点不明确,因此我们没有看到,类似的药品上市。这家公司生产的米诺地尔的商品名是ROGAINE。上世纪末该药的专利保护到期,米诺地尔的仿制药品大量上市。药价也有了大幅度的下降。其中最经典也是最便宜的仿制药就是costco出的kirkland米诺地尔了。(下图截止FDA官方数据库)

001f5E4Lgy6LlMQgLL5a3&690

米诺地尔的生产和销售在国外合理,合规。但是在国内似乎是乱象横生。

首先,我们说米诺地尔是药品,不能添加在化妆品中。国家食品药品监督管理局明确规定,米诺地尔不得用于化妆品中。2010年章华101中被查出含有违禁成分米诺地尔,被浙江省药监局调查并处罚。因此,任何含有米诺地尔的化妆品都是违法的,米诺地尔必须作为药品进行销售和使用。所以,作为药品生产和销售米诺地尔就必须具有批准文号。作为药品进口米诺地尔也应该有进口药品的批准文号。

那么,我们很容易在国家食药总局的网站上找到合法的米诺地尔药品了。其他的任何米诺地尔制品都是非法的。同时我们应该注意,药品上互联网上销售是需要资质的,需要得到药监局的批准。换句话说,绝大部分淘宝网店都在非法销售米诺地尔这个外用的甲类非处方药。还好最近淘宝进行了整治,少了很多。但是我想问为什么这些药品有市场呢?

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最后,让我们简单的看一看互联网上可以轻易找到的用于治疗雄激素源性脱发(AGA)的米诺地尔药品。

1. 美国costco出的kirkland米诺地尔,没有药品进口许可证不得在中国销售。

2. 原研药厂家生产的Rogaine,同样没有药品进口许可证不得在中国销售。

3. 其他进口的米诺地尔药品,几乎100%都没有进口药品的许可证都不得在中国销售。若以化妆品在中国销售也是违法的。

4. 国内的米诺地尔制品,比如,苏州海博生物科技有限公司研发生产的密发康生发剂,没要药品批准文号。可以毫不客气的说是假药。

5.据我所知有些医院也在配制米诺地尔制剂销售,这些药品作为医院制剂在医院内进行销售是合法的。但是这些药品不能在其他地方进行销售。

6. 国内生产的合法合规的药品如下。

001f5E4Lgy6LlN2EZwQ68&690

那么,这些正规药品的价格又是怎么样的呢。我们不妨在比较一下这些药品的价格。

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美国6瓶可兰是26美元,中国一瓶大概是120人民币(实体店销售价格更高)。结果很显然,中国的药价几乎是美国药价的6倍。为什么这么贵呢,是工艺成本技不如人,还是药品的销售体制出现了问题呢,我想你懂的。这样大的差距,这么大的利润,在全球化的今天,在大家削尖了脑袋拼命挣钱的今天,试问又怎能不乱呢。

来源:blog.sina.com.cn/future0;原标题:《米诺地尔乱象》

 

http://www.tutoushe.com/post/2203.html

 

从2017年4月使用至今(2017年10月),生发效果还是比较明显的。副作用除了局部红疹和头屑增多外,最严重的是体毛也随之变长变密。目前主要集中在手背脚背处,手臂与眼角周围也开始逐渐增多。这就是比较麻烦的事情了。

 

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