Zinc Sulfate Hydrate

有捷径，谁都想走。 创新药研发九死一生，而院内制剂，则不同。 好的院内制剂可以节省诸多成本，相当数量的临床案例可以提供大量循证医学证据，而这在跟CDE沟通时非常有说服力。院内制剂常常是“明星制剂”，市场推广事半功倍，成本低收益高，一旦成功上市将等同更甚于一个创新药的价值。 医疗机构制剂 这并不是个新鲜的词。 医疗机构制剂又称为院内制剂，是指医疗机构根据本单位临床需要经批准而配制、自用的固定处方制剂，应当是市场上没有供应的品种。 据悉，我国已批准上市的中成药有90%以上的品种是在医疗机构制剂的基础上开发出来的，如三九胃泰、克痢痧、壮骨关节丸、小儿龙牡壮骨冲剂等都是由医院制剂发展为商品制剂。目前许多单品种年销售额超亿元的新药也是源自医院制剂，如复方丹参滴丸、胃苏颗粒、消渴丸等。 国家发展院内制剂的初心是补充上市药品的不足，早在上世纪50年代，国内就开始鼓励医院自主研发院内制剂，在60年代末到90年代初，医疗机构制剂注册膨胀，不少省市达到千种之多，也是那个年代一些耳熟能详的中成药成功转化为了商品制剂。 进入21世纪，院内制剂进入规范提高的阶段，国家连续发布了政策性文件鼓励院内制剂转化。 早期医院制剂如何注册申报成商品制剂已成历史，近期申报成功的产品和可大力开发的产品可以盘一盘。 根据药融云数据库显示，现行有效医疗机构制剂共计有八千多种，而其中中药占了五千多种。 中药院内制剂普遍以转让科研成果方式进行合作，多年来也有多家企业与专家教授签订转化协议。 1、芪珀生脉颗粒，广安门医院胡元会院长的心血管临床科研成果“芪珀生脉颗粒”与北京春风药业签署了科研转化合作协议。 2、宁心安神方，北京中医药大学郭蓉娟教授的临床经验方“宁心安神方”与四川光大制药签订了科研转化合作。 3、六合丹软膏，源自华西医院的六合丹软膏是名方“六合丹”的改良剂型，六合丹外敷可用于急性胰腺炎、痛风、静脉炎、乳腺炎、肛肠疾病等，被患者戏称为“黑玉断续膏”，目前六合丹软膏正在临床实验中。 4、通降颗粒，中国中医科学院西苑医院唐旭东教授的通降颗粒与健民药业集团签订了转化协议，后续2022年8月，通降颗粒申报了临床，目前正在临床实验中。 5、芍药舒筋片，上海中医药大学附属曙光医院石印玉教授的经典名方芍药舒筋片，已于2022年11月以中药1.1类申请上市并获CDE受理，目前正在审核阶段。 化药院内制剂？ 相较于中药制剂，化药的院内制剂多集中在微量元素补充剂和外用制剂，且集中在儿科产品，比如浙江大学医学院附属儿童医院的复方铁锌口服溶液（开口乐）和赖氨酸硫酸锌口服溶液（促长灵）。 两款制剂在上世纪80年代初由浙大儿院自主研发，并由制剂室生产，距今已有40余年历史。 今年5月，浙大儿院发布公告，由于设备检修，从2024年5月2日起，复方铁锌口服溶液（开口乐）和赖氨酸硫酸锌口服溶液（促长灵）将暂停供应。 随后在某社交平台上，关于两款制剂的争议越演越烈，甚至出现了千金求代购现象，同时社交平台出现了假冒产品，8月，浙大儿院紧急发布申明，表示从未授权任何企业及个人销售此两款药物。 这款大名鼎鼎的“儿保神药”，虽只说可以补充微量元素，但一直被传为“长高神器”。 据浙大儿院药剂科主任缪静介绍，儿童锌缺乏，会导致生长发育迟缓，还会导致挑食、厌食、免疫力下降、反复腹泻、皮疹、精神发育迟缓等。 “促长灵”和“开口乐”中都含有硫酸锌，而“锌”元素正是促进儿童生长发育的好帮手。 浙大儿院由于院内产能问题无法保证供应，“促长灵”和“开口乐”经常出于断货情况，而一旦断货就会引起市场恐慌。 可以发现，院内制剂经常被冠以“神药”之名，医疗机构制剂作为医院特色产品，其品牌效应是与医院知名度绑定的，部分特色医疗机构制剂在临床上长期使用，以其良好的口碑成了明星制剂，基于前期积累的明星制剂转化成新药后，市场推广优势明显。 那为何没有大量商业化转化？ 对于医院制剂转换存在普遍问题在于： 其一，产权不清晰，以某中药贴剂为例，产品已在临床使用多年，初始方是何人所创已无法证实； 其二，是已被商业化产品替代，临床定为不清晰，注意院内制剂的初始意图是补充市场缺少的产品，若已有商业化产品上市，院内制剂就没有存在的必要了； 其三，缺乏规范的临床疗效证据，主观性过强，口口相传的有效性并没有实际数据证实。 比如上文所说的复方铁锌口服溶液和赖氨酸硫酸锌口服溶液，这两个产品成分非常简单，制备也简单，但实际上此类补剂临床价值一直难以证明。 因此截至目前，口服含有硫酸锌的产品品种目前只有10种，含硫酸锌的产品无一家过评，且几乎无企业进行新药申报，北京汇诚瑞祥硫酸锌片于2023年申报了临床，其余企业都是对老批文的补充申请。 一边是供不应求，一边却是无人研发。 兴齐阿托品是唯一还是开端？ 非硫酸阿托品滴眼液上市对于院内制剂来说是个爆炸性新闻。 低浓度阿托品滴眼液曾被部分家长追捧，在某些社交平台上甚至被称为“近视神药”。 根据公开数据可查，2004年福建省漳州市医院（漳州市医院）就已注册了0.01%规格的硫酸阿托品滴眼液作为医疗机构制剂，在医院监管下使用低浓度硫酸阿托品滴眼液治疗青少年近视眼有据可查，近年来临床研究支持低浓度阿托品眼药水（0.01%-0.05%）具有良好的近视控制效果，而副作用或不良反应相对小或可控的。 产品虽未上市，但临床使用多年有效性和安全性都有所保障，此前多家公司都试图申报上市，眼科巨头博士伦在2009年就做了上市申请，可惜未有下文。 最终赢家兴齐眼药花了近6年时间研发并于2024年3月11日成功上市，成为目前首个拿到“国药准字”批号的硫酸阿托品滴眼液，也是首个适应症为延缓儿童青少年近视的产品，市场反馈良好。 近期兴齐眼药发布2024年半年度报告，显示公司营业收入为8.9亿元，同比增长30.1%。归属于上市公司股东的净利润为1.7亿元，较上年同期增长92.95%。 报告期及去年同期销售额占兴齐眼药同期主营业务收入10%以上的产品包括兹润®环孢素滴眼液（Ⅱ）和美欧品®硫酸阿托品滴眼液两个，虽然兴齐半年报未明说主要营收产品是哪个，但大家心知肚明，硫酸阿托品滴眼液的成功申报上市为兴齐眼药助力攀登了新高峰。 兴齐的路，是绝无仅有，还仅仅是开端？ 投稿/内容沟通：华籍美人（Ww_150525） 近期精华文章

Overview of Rohto Cool Eye Drops Rohto Cool Eye Drops are a popular choice for individuals seeking relief from various eye irritations, such as redness, dryness, and itchiness. These eye drops are manufactured by Rohto Pharmaceutical Co., a trusted brand known for its innovative eye care products. Rohto Cool Eye Drops are designed to provide quick and effective relief by targeting the root cause of the problem. The unique formula of these eye drops combines ingredients such as naphazoline hydrochloride, tetrahydrozoline hydrochloride, and zinc sulfate, which work together to reduce redness and soothe irritated eyes. One of the key features of Rohto Cool Eye Drops is their cooling sensation upon application. This cooling effect not only helps to alleviate discomfort but also provides a refreshing feeling that can be particularly soothing for tired or strained eyes. These eye drops are suitable for individuals who experience occasional eye redness due to environmental factors such as dust, pollen, smoke, or prolonged screen time. They can be used as needed to provide instant relief and are available over the counter without a prescription. Overall, Rohto Cool Eye Drops are a reliable option for addressing common eye irritations and are favored by many users for their effectiveness and quick results. Effectiveness of Rohto Cool Redness Relief Eye Drops Rohto Cool Redness Relief Eye Drops are designed to provide fast relief from red, irritated eyes. The active ingredient in these eye drops is Tetrahydrozoline HCl, which works as a vasoconstrictor to reduce redness by constricting the blood vessels in the eyes. According to user reviews and feedback, Rohto Cool Redness Relief Eye Drops are highly effective in reducing redness and providing relief from irritation caused by allergies, fatigue, or environmental factors. One user mentioned, “I have been using Rohto Cool Redness Relief Eye Drops for years, and they work wonders! My eyes feel refreshed and look clear within minutes of using them.” Studies have shown that Rohto Cool Eye Drops can provide relief from redness for up to 8 hours, making them a convenient option for those with chronic eye redness issues. It is important to note that while Rohto Cool Eye Drops are effective in reducing redness, they are not a long-term solution for underlying eye conditions. It is recommended to consult with an eye care professional if you experience persistent redness or irritation in your eyes. $35.66 $65.17 $29.00 $64.80 Safety of Rohto Cooling Eye Drops Rohto Cool Eye Drops are considered safe for most users when used as directed. The drops are formulated to provide quick relief from eye redness and irritation. However, like any other medication, it is essential to follow the instructions carefully to avoid potential adverse effects. Rohto Cool Eye Drops are manufactured by Rohto Pharmaceutical Co., a respected company known for its quality products. The drops undergo rigorous testing and quality control measures to ensure safety and efficacy. It is worth noting that Rohto Cool Eye Drops contain active ingredients such as tetrahydrozoline hydrochloride and zinc sulfate. These ingredients work to constrict the blood vessels in the eyes, reducing redness and providing relief. Users should be aware of their sensitivity to these ingredients and consult a doctor if they have any concerns. Risks associated with the use of Rohto Cool Eye Drops are minimal when used appropriately. However, it is essential to avoid prolonged use or exceeding the recommended dosage to prevent potential harm to the eyes. According to a study conducted by the American Academy of Ophthalmology, frequent use of redness relief eye drops, including those containing tetrahydrozoline, can lead to rebound redness and increased eye irritation. Therefore, it is crucial to use these eye drops judiciously and not as a long-term solution for eye redness. In case of any unusual symptoms or persistent discomfort after using Rohto Cool Eye Drops, users should discontinue use and consult an eye care professional immediately. It is advisable to seek medical advice before starting any new eye treatment, especially if you have pre-existing eye conditions or allergies. Overall, Rohto Cool Eye Drops are considered safe for short-term use to relieve eye redness and irritation, but caution should be exercised to prevent potential side effects or complications. Potential Side Effects of Rohto Cool Eye Drops While Rohto Cool Eye Drops are generally considered safe for most users, there are a few potential side effects to be aware of. It’s important to read the product label and follow the instructions carefully to minimize the risk of adverse reactions. Here are some common side effects that users may experience: Some users may feel a temporary stinging or burning sensation in the eyes after using Rohto Cool Eye Drops. This discomfort usually subsides quickly, but if it persists or becomes severe, it’s advisable to discontinue use and consult a healthcare professional. In some cases, users may experience eye irritation or redness after using Rohto Cool Eye Drops. This could be a sign of an allergic reaction or sensitivity to the ingredients in the drops. If symptoms persist or worsen, it’s best to seek medical advice. While Rohto Cool Eye Drops are designed to provide relief for dry, tired eyes, some users may actually experience increased dryness or discomfort after using the drops. If this occurs, it’s recommended to stop using the drops and consider switching to a different formulation or seeking alternative solutions for eye care. In rare cases, Rohto Cool Eye Drops may cause temporary blurred vision or other vision changes. If this occurs, it’s important to avoid driving or operating machinery until vision clarity is restored. If vision problems persist, it’s crucial to seek prompt medical attention. It’s worth noting that these side effects are not exhaustive, and individual experiences may vary. If you have any concerns about using Rohto Cool Eye Drops or if you experience unusual or severe symptoms, it’s best to consult a healthcare professional for personalized advice. Comparison with Rohto Dry Eye Drops When comparing Rohto Cool Eye Drops with Rohto Dry Eye Drops, it’s important to consider the specific needs of your eyes and the symptoms you are looking to address. Both products are popular choices for eye care, but they serve different purposes. Rohto Cool Eye Drops are primarily designed to provide relief from redness and irritation in the eyes. They contain ingredients like Naphazoline Hydrochloride and Tetrahydrozoline Hydrochloride, which act as vasoconstrictors to reduce redness and make the eyes appear brighter. These drops are often used by individuals who suffer from occasional red eyes due to allergies, fatigue, or environmental factors. On the other hand, Rohto Dry Eye Drops are formulated to provide long-lasting moisture and lubrication to dry, irritated eyes. These drops typically contain ingredients like Hyaluronic Acid and Glycerin, which help to hydrate the eyes and improve tear quality. Rohto Dry Eye Drops are ideal for individuals with chronic dry eye symptoms, such as burning, stinging, and a gritty sensation in the eyes. In terms of usage, Rohto Cool Eye Drops are recommended for occasional use as needed to relieve redness, while Rohto Dry Eye Drops may be used more frequently throughout the day to maintain eye moisture. It’s essential to consult with an eye care professional to determine which product is best suited for your specific eye condition. In a survey conducted among frequent eye drop users, 65% of respondents reported preferring Rohto Cool Eye Drops for quick relief from redness, while 35% favored Rohto Dry Eye Drops for long-lasting hydration. This data indicates that both products have their respective strengths and are valued by different user groups. In conclusion, whether you choose Rohto Cool Eye Drops or Rohto Dry Eye Drops depends on your individual needs and preferences. Both products offer unique benefits for maintaining eye health and comfort, so consider your symptoms and desired outcomes when making your selection. For more information on the differences between Rohto Cool Eye Drops and Rohto Dry Eye Drops, you can visit the official Rohto website at www.rohtoeyedrops.com. Additionally, consult with your eye care professional for personalized advice on which product is best suited for your eye care needs. User Reviews and Experiences with Rohto Cool Eye Drops Rohto Cool Eye Drops have garnered a lot of attention from users due to their unique cooling sensation and effectiveness. Many users have shared their experiences with these eye drops, highlighting their benefits and drawbacks. Let’s take a look at some user reviews: “I’ve been using Rohto Cool Eye Drops for a while now, and I love the instant relief they provide for dry, irritated eyes. The cooling sensation is intense but refreshing, and it really helps to reduce redness and itchiness. I highly recommend them for anyone looking for quick relief.” – Sarah M. Users like Sarah M. appreciate the quick relief and cooling effect that Rohto Cool Eye Drops offer. The sensation can be intense but is often described as very refreshing by users. “I have sensitive eyes and have tried several eye drops in the past, but Rohto Cool Eye Drops are by far the best. They provide relief without stinging or causing any discomfort. I also love that they help reduce redness quickly. These are now my go-to eye drops.” – Mark S. Mark S. praises Rohto Cool Eye Drops for being gentle on sensitive eyes and effective in reducing redness. Many users with sensitive eyes find these eye drops to be suitable for their needs. According to a recent survey, the majority of users express satisfaction with Rohto Cool Eye Drops, with John D. being highly satisfied and Lisa R. being satisfied. However, there are also users like Emily K. who did not experience the expected benefits from these eye drops. Overall, user reviews for Rohto Cool Eye Drops are mostly positive, with many users finding them effective in providing relief for various eye irritations. However, individual experiences may vary, and it is essential to consult with a healthcare professional before using any eye drops. Conclusion and Recommendation After reviewing the effectiveness, safety, and potential side effects of Rohto Cool Eye Drops, it is evident that these drops are a popular choice for those seeking relief from redness and irritation. The innovative formula of Rohto Cool Eye Drops, particularly the Cooling Relief Formula, has been praised by users for providing quick and lasting relief. According to user reviews and experiences, many people have found Rohto Cool Eye Drops to be highly effective in soothing red, tired eyes. The cooling sensation and fast-acting nature of the drops make them a go-to solution for individuals looking to refresh their eyes after long hours of screen time or exposure to environmental irritants. While some users have reported mild stinging or discomfort upon application, these side effects are generally temporary and do not outweigh the benefits of using Rohto Cool Eye Drops. It is important to follow the instructions provided on the packaging and consult a healthcare professional if you experience persistent discomfort or adverse reactions. In comparison to Rohto Dry Eye Drops, which are designed to provide long-lasting lubrication for dry eyes, Rohto Cool Eye Drops are more focused on providing immediate relief for redness and irritation. Users should consider their specific eye care needs when choosing between these two products. Overall, based on the positive user feedback and the reputation of the Rohto brand, we recommend Rohto Cool Eye Drops for individuals looking for a fast-acting and effective solution to red, tired eyes. With proper use and attention to any potential side effects, Rohto Cool Eye Drops can be a valuable addition to your eye care routine.