Breast dredging and stasis removing health care cream and preparation method thereof
By constructing a multi-level osmotic system and a targeted sustained-release system, the existing breast care creams have solved the problem of low transdermal efficiency and poor targeting of existing breast topical drugs, and effective treatment of breast hyperplasia, nodules and cysts has been achieved, which has significantly improved the patient's symptoms such as pain, swelling and nodule volume.
Patent Information
- Application Number
- CN202510331742.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-20
- Publication Date
- 2025-06-13
AI Technical Summary
Existing breast topical drugs are inefficient in transdermal efficiency and poor targeting, making it difficult to effectively improve sub-health symptoms such as pain and swelling caused by breast hyperplasia, nodules and cysts.
By building a multi-stage osmotic system and a targeted sustained release system, a breast care cream is prepared by using four components of anti-proliferative, blood circulation, anti-inflammatory and liver relief, combined with modern extraction technology. The preparation includes components such as catfish alcohol extract, sauerkrata water extract, saponin extract, panax notoginseng total saponin, safflower oil, chicken blood gamboli extract, peony phenol, dandelion polysaccharide, forsythia ester glycoside, Bupleurum volatile oil, peony red peony and lemon hydrocarbon extract. Through high-pressure homogenization and liposome wrapping technology, deep delivery and long-term effect of the drug are achieved.
This breast care cream significantly improves the transdermal efficiency and targeting of the drug, can effectively inhibit the proliferation of breast fibroblasts, improve microcirculation, reduce pain and swelling, significantly reduce the volume of nodules, and improve the patient's sub-health symptoms.
Smart Images
Figure CN120131818A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of traditional Chinese medicine compound external preparations, and specifically to a breast care cream combined with modern extraction technology and its preparation method, which is applicable to improving sub-healthy symptoms such as pain and swelling caused by mammary gland hyperplasia, nodules and cysts. Background Art
[0002] The incidence rate of mammary gland hyperplasia is as high as 60%-70%. Existing treatments mostly use endocrine drugs such as tamoxifen, which have side effects such as hot flashes and menstrual disorders. Traditional Chinese medicine ointments generally have technical defects such as poor transdermal absorption (such as the transdermal rate of ordinary creams <15%) and serious degradation of active ingredients. The present invention realizes the deep delivery and long-term effect of anti-hyperplasia components by constructing a multi-level penetration system and a targeted sustained-release system. Summary of the Invention Technical Problem
[0003] To provide an external preparation with both anti-fibrosis and microcirculation improvement functions, and solve the technical problems of low transdermal efficiency and poor targeting of existing external breast drugs. Technical Solution
[0004] 1. Composition of raw materials (by mass percentage): Anti-hyperplasia group (10-18%): Alcohol extract of cat's claw grass 3-6%, water extract of Prunella vulgaris 2-5%, extract of Paris polyphylla saponin 2-4% Blood-activating group (8-15%): Total saponins of Panax notoginseng 2-5%, safflower oil 1-3%, flavone extract of Spatholobus suberectus 2-4% Anti-inflammatory group (6-12%): Paeonol 1-3%, dandelion polysaccharide 2-4%, forsythoside 1-3% Liver-soothing group (5-10%): Volatile oil of Bupleurum chinense 2-4%, paeoniflorin 1-3%, extract of costunolide 1-2%.
[0005] Matrix excipients (55-70%): Glycerol monostearate and distearate 12-18%, trichosanthin colloid 3-5%, potassium sorbate 0.2-0.5%, purified water as the balance.
[0006] 2. Preparation method: a. Preparation of active ingredients: Alcohol extract: Cat's claw grass is refluxed and extracted 3 times with 70% ethanol and concentrated to a relative density of 1.25.
[0007] Water extract: Prunella vulgaris and trichosanthin are decocted twice, and the extract is filtered through a ceramic membrane.
[0008] Volatile oil: Bupleurum and Aucklandia were extracted by steam distillation (material-liquid ratio 1:8, distillation for 4 hours).
[0009] b. Emulsion system construction: Oil phase: Glyceryl monostearate and dioleate, and safflower oil were mixed and heated to 70 °C.
[0010] Aqueous phase: The water extract of Prunella vulgaris, dandelion polysaccharide, and potassium sorbate were dissolved in purified water and heated to 70 °C.
[0011] The aqueous phase was injected into the oil phase under high-pressure homogenization (15,000 rpm), and the temperature was lowered to 45 °C, then the remaining active components were added.
[0012] c. Targeted modification: Add liposome encapsulant (soybean lecithin:cholesterol = 3:1) accounting for 1-2% of the total mass.
[0013] d. Filling and sterilization: After dispensing, moist heat sterilization was used (121 °C, 15 min).
[0014] Beneficial effects 1. Four-dimensional action mechanism: Ranunculus ternatus Thunb. inhibits the proliferation of mammary gland fibroblasts (IC50 = 12.4 μM).
[0015] Total saponins of Panax notoginseng reduce blood viscosity (the whole blood viscosity decreased by 23.6%).
[0016] Liposome encapsulation enables targeted delivery (the drug concentration in breast tissue is 3.2 times higher than that of ordinary cream). Trichosanthin colloid forms a temperature-sensitive sustained-release film (sustained release for 8 hours at 37 °C).
[0017] 2. Clinical data: 120 patients with mammary gland hyperplasia were externally applied twice a day. After 8 weeks: Those with a reduction in nodule volume of ≥ 30% accounted for 68.3%. The VAS score for pain decreased by 65.2%. Description of the drawings Figure 1 It is the process flow chart of Rutong Sanjie health care cream. Detailed implementation manners Examples
[0018] Raw material ratio (total mass 1000 g): Anti-hyperplasia group: 50 g of alcohol extract of Ranunculus ternatus Thunb., 30 g of water extract of Prunella vulgaris, 20 g of paris saponin extract Blood-activating group: 40 g of total saponins of Panax notoginseng, 20 g of safflower oil, 30 g of flavonoid extract of Spatholobus suberectus Anti-inflammatory group: 20 g of paeonol, 30 g of dandelion polysaccharide, 20 g of forsythoside Soothe the Liver Group: 30 g of volatile oil of Bupleurum chinense, 20 g of paeoniflorin, 10 g of costunolide extract Matrix Excipients: 150 g of glyceryl monostearate and distearate, 40 g of trichosanthin colloid, 3 g of potassium sorbate, 547 g of purified water.
[0019] Preparation Process: 1. The ethanol extract is purified by macroporous resin (AB-8 type, ethanol gradient elution).
[0020] 2. The water extract is ultrafiltered and concentrated (cut-off molecular weight 5000 Da).
[0021] 3. The oil phase and water phase are homogenized and emulsified at 70 °C (15000 rpm, 5 minutes).
[0022] 4. Cool down to 45 °C and add liposome encapsulant (18 g of soybean lecithin + 6 g of cholesterol).
[0023] 5. After moist heat sterilization, it is sub-packed into aluminum tubes.
[0024] Effect Verification In vitro permeation experiment on porcine mammary tissue: The cumulative permeation amount reaches 2.35 mg / cm² in 12 hours (3.1 times that of commercially available cream).
[0025] Micro-CT shows that after 6 weeks of using the rat mammary hyperplasia model, the alveolar density decreases by 41.7%.
Claims
1. A health-care cream for removing lumps and dispersing lumps, characterized in that It is composed of the following components in percentage by mass: Anti-proliferation group 10-18%: cat's scratch grass ethanol extract 3-6%, selfheal water extract 2-5%, Paris polyphylla saponin extract 2-4%.
2. Blood circulation group 8-15%: notoginseng total saponins 2-5%, safflower oil 1-3%, Millettia spatholobi flavonoids extract 2-4%.
3. Anti-inflammatory group 6-12%: Paeonia suffruticosa 1-3%, dandelion polysaccharide 2-4%, forsythiaside 1-3%.
4. Soothing the liver group 5-10%: Bupleurum volatile oil 2-4%, erythropein 1-3%, costus alcohol extract 1-2%.
5. Matrix excipients 55-70%: glyceryl mono- and distearate 12-18%, trichosanthes colloid 3-5%, potassium sorbate 0.2-0.5%, and the balance purified water.
6. The health cream according to claim 1, characterized in that Also included is a liposome encapsulation agent, which is composed of soybean lecithin and cholesterol in a mass ratio of 3:1, and the added amount is 1-2% of the total mass.
7. The health cream according to claim 1, characterized in that The preferred ratio of active components is: 5% cat's scratch grass alcohol extract, 3% selfheal water extract, 2% parsley saponin extract, 4% notoginseng total saponins, 2% safflower oil, 3% millettia flavonoids extract, 2% peony phenol, 3% dandelion polysaccharide, 2% forsythia glycosides, 3% bupleurum volatile oil, 2% erythropein, and 1% costus alcohol extract.
8. A method for preparing the health-care cream for removing lumps and dispersing lumps according to any one of claims 1 to 3, characterized in that The following steps are involved: a. Preparation of alcohol extract, water extract and volatile oil components b. Constructing a high-temperature emulsification system of oil phase and water phase c. Add liposome encapsulation agents and heat-sensitive components at low temperature d. Packaging after moist heat sterilization.