A traditional chinese medicine fumigation medicine bag preparation for dry eye and a preparation and use method thereof
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-02-02
- Publication Date
- 2026-08-11
AI Technical Summary
[0003]现有治疗手段中，人工泪液为常用对症药物，但存在依赖感强、无法从根本调理的缺陷；西药抗炎、免疫抑制剂类药物易引发眼部刺激、眼压升高等副作用；传统中医熏蒸虽有一定疗效，但现有药包存在配方针对性不足、药物释放不均、起效慢、使用不便等问题，且缺乏标准化的制剂工艺，难以满足临床推广需求
[0014]本发明的优点在于：1.配伍科学，协同增效：菊花、决明子清肝明目、润肠通便，为君药，针对肝阴不足之本；桑叶疏散风热、润肺润燥，薄荷清凉解表、开窍透肤，二者为臣，助君药滋阴润燥，且薄荷挥发油可促进药物透皮吸收；川芎活血行气、通络止痛，改善眼部血液循环，为佐药，解决“不通则涩”之标；冰片芳香开窍、引药上行，直达病所，为使药，增强全方疗效；全方君臣佐使分明，标本兼顾，共奏清肝润燥、活血明目之效；2.剂型优化，起效迅速：采用细粉配伍+缓释载体设计，药物与温水接触后快速溶出有效成分，且挥发油成分通过熏蒸直接作用于眼表黏膜，避免胃肠道代谢损失，起效时间较传统煎剂缩短30%以上；3.透气无纺布包装便于药物释放，同时防止药粉直接接触眼部造成刺激，安全性高；4.制备简便，易于推广：工艺无需复杂设备，低温烘干、粉碎、混合等步骤可实现标准化生产，成本较低；真空包装便于储存运输，使用时无需额外煎煮，直接搭配常规熏蒸仪即可，适合家庭及医疗机构使用；4.安全性高，无副作用：所选药材均为药食同源或常用中药，外用熏蒸避免口服给药的肝肾负担，临床试用未发现眼部刺激、过敏等不良反应，适合长期使用。
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Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine fumigation pack preparation for dry eye syndrome and its preparation and usage method. Background Technology
[0002] Dry eye syndrome, also known as keratoconjunctivitis sicca, falls under the category of "eye dryness" and "blurred vision" in Traditional Chinese Medicine. Its core pathogenesis is attributed to liver yin deficiency, lung dryness leading to fluid depletion, and insufficient nourishment of the eyes. Common symptoms include dry eyes, a foreign body sensation, burning sensation, photophobia, tearing, and blurred vision. With the widespread use of electronic products, dry environments, and excessive eye strain, the incidence of dry eye syndrome is increasing year by year and showing a trend towards affecting younger people.
[0003] Among existing treatments, artificial tears are commonly used symptomatic medications, but they have drawbacks such as strong dependence and inability to address the root cause of the problem. Western anti-inflammatory and immunosuppressant drugs are prone to causing side effects such as eye irritation and increased intraocular pressure. Although traditional Chinese medicine fumigation has certain therapeutic effects, existing medicine packs have problems such as insufficient targeted formulation, uneven drug release, slow onset of action, and inconvenience of use. Furthermore, they lack standardized formulation processes, making it difficult to meet the needs of clinical promotion.
[0004] Based on the principles of traditional Chinese medicine, namely "clearing the liver and improving eyesight, nourishing yin and moistening dryness, and promoting blood circulation and unblocking collaterals", this application selects seven Chinese medicinal herbs, including chrysanthemum and cassia seed, optimizes the compatibility ratio and preparation process, and develops a fumigation medicine pack for dry eye syndrome that is effective, convenient to use and safe, filling the existing technological gap. Summary of the Invention
[0005] The purpose of this invention is to overcome the shortcomings of existing dry eye treatment drugs and provide a traditional Chinese medicine fumigation pack preparation that is scientifically formulated, synergistically effective, fast-acting, and easy to use. Its preparation and use methods are simple, it is highly stable, and it can be industrialized, providing a safe and effective external treatment solution for dry eye patients.
[0006] To achieve the above objectives, the present invention adopts the following technical solution:
[0007] A traditional Chinese medicine fumigation pack preparation for dry eye syndrome, the raw materials are composed of the following parts by weight: 10-15 parts chrysanthemum, 8-12 parts cassia seed, 8-12 parts mulberry leaf, 6-10 parts peppermint, 5-8 parts chuanxiong rhizome, 1-3 parts borneol, and 3-5 parts sustained-release hygroscopic carrier; the sustained-release hygroscopic carrier is made by mixing starch and hydroxypropyl methylcellulose in a 2:1 ratio.
[0008] Furthermore, the preferred raw material composition by weight is as follows: 12 parts chrysanthemum, 10 parts cassia seed, 10 parts mulberry leaf, 8 parts peppermint, 6 parts chuanxiong rhizome, 2 parts borneol, and 4 parts slow-release hygroscopic carrier.
[0009] A method for preparing a traditional Chinese medicine fumigation pack for dry eye syndrome includes the following steps:
[0010] (1) Raw material pretreatment: First, remove impurities from chrysanthemum, cassia seed, mulberry leaf and chuanxiong and wash them. Then dry them at a low temperature of 60-70℃ and grind them into a mixed fine powder of 80-100 mesh. Take peppermint leaves and grind them into peppermint fine powder of 100-120 mesh. Peppermint fine powder of 100-120 mesh can retain its volatile oil components. Grind borneol into borneol fine powder of 120-150 mesh and store it in the dark for later use.
[0011] (2) Mixing treatment: In an environment with a room temperature of 15-25 degrees Celsius and a humidity of 45%-65%, first mix the fine powder with the slow-release hygroscopic carrier for 15-20 minutes, then add the peppermint powder and stir at low speed for 5-8 minutes. Low speed stirring avoids loss of volatile oil. Finally, add the borneol powder and stir quickly for 3-5 minutes to ensure uniform dispersion. Such an environment is conducive to the preservation and processing of Chinese medicinal materials, as well as the stability and quality of Chinese medicine preparations.
[0012] (3) Packaging: The powder after stirring and mixing in step 2 is divided into 10-15g packets and packaged into medical breathable non-woven bags. Then, the bags are heat-sealed to make medicine packs. Finally, the outer layer of the medicine packs is vacuum-packed in aluminum foil bags.
[0013] A method for using a traditional Chinese medicine fumigation pack for dry eye syndrome: Mix the pack with warm water at 40-45℃ at a weight-to-volume ratio of 1:15-1:20, soak for 5-10 minutes, and then perform eye fumigation for 15-20 minutes each time, 1-2 times daily. A fumigation device can be used as an aid during use.
[0014] The advantages of this invention are: 1. Scientific formulation and synergistic effect: Chrysanthemum and Cassia seed clear the liver and improve eyesight, moisten the intestines and promote bowel movement, serving as the principal herbs, targeting the root cause of liver yin deficiency; Mulberry leaf disperses wind-heat, moistens the lungs and relieves dryness, while peppermint cools and relieves exterior symptoms, opening the orifices and penetrating the skin, serving as the assistant herbs, assisting the principal herbs in nourishing yin and moistening dryness, and peppermint volatile oil can promote transdermal absorption of the medicine; Ligusticum chuanxiong invigorates blood and qi, unblocks collaterals and relieves pain, improving blood circulation in the eyes, serving as the adjuvant herb, addressing the superficial cause of "absence leads to stagnation"; Borneol is aromatic and opens the orifices, guiding the medicine upwards to the affected area, serving as the guiding herb, enhancing the overall efficacy of the formula; the entire formula clearly distinguishes between principal, assistant, adjuvant, and guiding herbs, addressing both the root cause and the symptoms, working together to clear the liver and moisten dryness, invigorate blood and improve eyesight; 2. Optimized dosage form and rapid onset of action: Using a fine powder formulation + sustained-release carrier design, the effective components are quickly dissolved after the medicine comes into contact with warm water, and the volatile oil becomes... 1. The fumigation process directly targets the ocular mucosa, avoiding gastrointestinal metabolic losses and shortening the onset time by more than 30% compared to traditional decoctions; 2. The breathable non-woven fabric packaging facilitates drug release while preventing direct contact of the powder with the eyes, ensuring high safety; 3. The preparation is simple and easy to promote: the process does not require complex equipment, and steps such as low-temperature drying, pulverization, and mixing can achieve standardized production at a low cost; vacuum packaging facilitates storage and transportation, and no additional decoction is required during use. It can be directly used with a conventional fumigation device, making it suitable for home and medical institution use; 4. High safety and no side effects: the selected medicinal materials are all food-grade or commonly used Chinese medicines. External fumigation avoids the liver and kidney burden of oral administration. Clinical trials have not found any adverse reactions such as eye irritation or allergies, making it suitable for long-term use. Detailed Implementation
[0015] Example 1
[0016] A traditional Chinese medicine fumigation pack preparation for dry eye syndrome, the raw materials are composed of the following parts by weight: 12 parts chrysanthemum, 10 parts cassia seed, 10 parts mulberry leaf, 8 parts peppermint, 6 parts chuanxiong rhizome, 2 parts borneol, and 4 parts sustained-release moisture-absorbing carrier; the sustained-release moisture-absorbing carrier is made by mixing 2.67 parts starch and 1.33 parts hydroxypropyl methylcellulose by weight.
[0017] A method for preparing a traditional Chinese medicine fumigation pack for dry eye syndrome includes the following steps:
[0018] (1) Raw material pretreatment: First, remove impurities from chrysanthemum, cassia seed, mulberry leaf and chuanxiong and wash them. Then, dry them at a low temperature of 65℃ for 2 hours and grind them into a 90-mesh fine powder. Take mint leaves and grind them into 110-mesh mint powder. Grind borneol into 130-mesh borneol powder.
[0019] (2) Mixing treatment: In an environment with a room temperature of 20 degrees Celsius and a humidity of 50%, first mix the fine powder with the slow-release moisture-absorbing carrier for 18 minutes, then add the fine peppermint powder and stir at low speed for 6 minutes, and finally add the fine camphor powder and stir quickly for 4 minutes.
[0020] (3) Packaging: The powder after stirring and mixing in step 2 is divided into 12g packets and packaged into medical breathable non-woven bags. Then, the bags are heat-sealed to make medicine packs. Finally, the outer layer of the medicine packs is vacuum-packed in aluminum foil bags.
[0021] A method for using a traditional Chinese medicine fumigation pack for dry eye syndrome: Mix the pack with warm water (40-45℃) at a weight-to-volume ratio of 1:15-1:20, soak for 5-10 minutes, then perform eye fumigation for 18 minutes each time, twice daily, for 7 days as one course of treatment. Alternatively, a fumigation device can be used as an auxiliary treatment. The specific steps are: place the pack in the device's container, add 150-200ml of warm water (40-45℃), soak for 5-10 minutes, turn on the device, and fumigate the eyes for 15-20 minutes each time, 1-2 times daily, for 7 days as one course of treatment.
[0022] Example 2
[0023] A traditional Chinese medicine fumigation pack preparation for dry eye syndrome, the raw materials are composed of the following parts by weight: 15 parts chrysanthemum, 8 parts cassia seed, 12 parts mulberry leaf, 6 parts peppermint, 5 parts chuanxiong rhizome, 1.5 parts borneol, and 3 parts sustained-release moisture-absorbing carrier; the sustained-release moisture-absorbing carrier is made by mixing 3 parts starch and 1 part hydroxypropyl methylcellulose by weight.
[0024] A method for preparing a traditional Chinese medicine fumigation pack for dry eye syndrome includes the following steps:
[0025] (1) Raw material pretreatment: First, remove impurities from chrysanthemum, cassia seed, mulberry leaf and chuanxiong and wash them. Then, dry them at a low temperature of 65℃ for 2 hours and grind them into 80 mesh fine powder. Take mint leaves and grind them into 100 mesh mint powder. Grind borneol into 120 mesh borneol powder.
[0026] (2) Mixing treatment: In an environment with a room temperature of 25 degrees Celsius and a humidity of 65%, first mix the fine powder with the slow-release moisture-absorbing carrier for 15 minutes, then add the peppermint powder and stir at low speed for 5 minutes, and finally add the borneol powder and stir quickly for 3 minutes.
[0027] (3) Packaging: The powder after stirring and mixing in step 2 is divided into 10g packets and packaged into medical breathable non-woven bags. Then, the bags are heat-sealed to make medicine packs. Finally, the outer layer of the medicine packs is vacuum-packed in aluminum foil bags.
[0028] A method for using a traditional Chinese medicine fumigation pack for dry eye syndrome: Mix the pack with warm water at 40-45℃ at a weight-to-volume ratio of 1:15-1:20, soak for 5-10 minutes, and then perform eye fumigation for 20 minutes each time, once a day, for 10 days as one course of treatment.
[0029] Example 3
[0030] A traditional Chinese medicine fumigation pack preparation for dry eye syndrome, the raw materials are composed of the following parts by weight: 10 parts chrysanthemum, 12 parts cassia seed, 8 parts mulberry leaf, 10 parts peppermint, 8 parts chuanxiong rhizome, 3 parts borneol, and 5 parts sustained-release moisture-absorbing carrier; the sustained-release moisture-absorbing carrier is made by mixing 3.33 parts starch and 1.67 parts hydroxypropyl methylcellulose by weight.
[0031] A method for preparing a traditional Chinese medicine fumigation pack for dry eye syndrome includes the following steps:
[0032] (1) Raw material pretreatment: First, remove impurities from chrysanthemum, cassia seed, mulberry leaf and chuanxiong and wash them. Then, dry them at a low temperature of 65℃ for 2 hours and grind them into 100 mesh fine powder. Take mint leaves and grind them into 120 mesh mint powder. Grind borneol into 150 mesh borneol powder.
[0033] (2) Mixing treatment: In an environment with a room temperature of 15 degrees Celsius and a humidity of 45%, first mix the fine powder with the slow-release moisture-absorbing carrier for 20 minutes, then add the fine peppermint powder and stir at low speed for 8 minutes, and finally add the fine camphor powder and stir quickly for 5 minutes.
[0034] (3) Packaging: The powder after stirring and mixing in step 2 is divided into 15g packets and packaged into medical breathable non-woven bags. Then, the bags are heat-sealed to make medicine packs. Finally, the outer layer of the medicine packs is vacuum-packed in aluminum foil bags.
[0035] A method for using a traditional Chinese medicine fumigation pack for dry eye syndrome: Mix the pack with warm water at 40-45℃ at a weight-to-volume ratio of 1:15-1:20, soak for 5-10 minutes, and then perform eye fumigation for 20 minutes each time, twice a day, for 14 days as one course of treatment.
[0036] Usage effect
[0037] Example 1: Thirty patients with dry eye were selected. After the course of treatment, the symptoms of dryness and foreign body sensation were significantly relieved in 26 patients, with an effective rate of 86.7% and no adverse reactions.
[0038] Example 2: Thirty patients with dry eye were selected. After the course of treatment, the symptoms of dryness and foreign body sensation were significantly relieved in 25 patients, with an effective rate of 83.3%. Patients reported a significant improvement in eye comfort.
[0039] Example 3: Thirty patients with severe dry eye were selected. After the course of treatment, 24 patients showed significant improvement in blurred vision, with an effective rate of 80.0%.
[0040] To more scientifically demonstrate the effectiveness of the traditional Chinese medicine fumigation pack preparation of this invention, a clinical trial was conducted using Example 1 as the experimental group and artificial tears as the control group. Specific experimental data are shown in Tables 1-6.
[0041] Experimental design: Sixty patients with dry eye syndrome were selected as the experimental group and 60 as the control group.
[0042] Experiment duration: 4 weeks
[0043] Follow-up period: 1 month after treatment
[0044] The diagnostic criteria are as follows:
[0045]
[0046] The drug administration regimen and experimental methods are shown in Table 2 below:
[0047]
[0048] The treatment evaluation criteria are shown in Table 3:
[0049]
[0050] The observation indicators are shown in Table 4:
[0051]
[0052] The experimental results are shown in Table 5:
[0053]
[0054] The clinical efficacy comparisons are shown in Table 6:
[0055]
[0056] The safety evaluation is shown in Table 7:
[0057]
[0058] The experimental results showed that the experimental group (traditional Chinese medicine fumigation) was significantly better than the control group (artificial tears) in improving the core indicators of dry eye syndrome. Moreover, the incidence of adverse reactions in both groups was very low and the degree was mild, and they could be relieved on their own. This indicates that the traditional Chinese medicine fumigation therapy is safe under the experimental conditions and is comparable to conventional artificial tears.
[0059] Although the specific embodiments of the present invention have been described and illustrated in detail above, it should be noted that various changes and modifications can be made to the above embodiments without departing from the spirit of the present invention and the scope set forth in the appended claims.
Claims
1. A traditional Chinese medicine fumigation pack preparation for dry eye syndrome, characterized in that, The raw material composition by weight is as follows: 10-15 parts chrysanthemum, 8-12 parts cassia seed, 8-12 parts mulberry leaf, 6-10 parts peppermint, 5-8 parts chuanxiong rhizome, 1-3 parts borneol, and 3-5 parts slow-release hygroscopic carrier; the slow-release hygroscopic carrier is made by mixing starch and hydroxypropyl methylcellulose in a 2:1 ratio.
2. The traditional Chinese medicine fumigation pack preparation for dry eye syndrome according to claim 1, characterized in that, The preferred raw material composition by weight is as follows: 12 parts chrysanthemum, 10 parts cassia seed, 10 parts mulberry leaf, 8 parts peppermint, 6 parts chuanxiong rhizome, 2 parts borneol, and 4 parts slow-release hygroscopic carrier.
3. A method for preparing a traditional Chinese medicine fumigation pack for dry eye syndrome as described in claim 1 or 2, characterized in that, Includes the following steps: (1) Raw material pretreatment: First, remove impurities from chrysanthemum, cassia seed, mulberry leaf and chuanxiong and wash them. Then dry them at a low temperature of 60-70℃ and grind them into a mixed fine powder of 80-100 mesh. Take mint leaves and grind them into mint fine powder of 100-120 mesh. Grind borneol into borneol fine powder of 120-150 mesh. (2) Mixing treatment: In an environment with a room temperature of 15-25 degrees Celsius and a humidity of 45%-65%, first mix the fine powder with the slow-release moisture-absorbing carrier for 15-20 minutes, then add the peppermint powder and stir at low speed for 5-8 minutes, and finally add the borneol powder and stir quickly for 3-5 minutes. (3) Packaging: The powder after stirring and mixing in step 2 is divided into 10-15g packets and packaged into medical breathable non-woven bags. Then, the bags are heat-sealed to make medicine packs. Finally, the outer layer of the medicine packs is vacuum-packed in aluminum foil bags.
4. The method of using the traditional Chinese medicine fumigation pack preparation for dry eye syndrome as described in claim 3, characterized in that, When using, mix the medicine packet with warm water at 40-45℃ at a weight-to-volume ratio of 1:15-1:20, soak for 5-10 minutes, and then perform eye fumigation for 15-20 minutes each time, 1-2 times a day.