Qianzhou treatment Shukangtang tendon-relaxing and bone-

Abstract

The invention relates to the technical field of health-care external application agents, in particular to Qianzhou treatment Shukangtang tendon-relaxing and bone-penetrating health-care paste which is formed by combining subpackaged powder and subpackaged liquid. The powder comprises a mixture of the following Chinese herbal medicines according to a mass ratio: safflower, homalomena occulta, radix angelicae pubescentis, verbena, dragon's blood and centipede, and each component can be adjusted in a range of + / -20% as required; the liquid is based on a soaking decoction obtained by soaking and decocting safflower, radix angelicae, caulis spatholobi and mint as main medicinal materials in water, filtering and cooling, the content of ethanol in the liquid is 2-12%, the content of glycerol in the liquid is 1-6%, and the dosage of borneol is 0.1-2.0 g; the powder is a Chinese herbal medicine powder mixture which is dried, crushed and sieved. According to the invention, powder and liquid are subpackaged, and detectable indexes such as granularity, moisture and auxiliary material ratio and the like are determined, so that the standardization and repeatability of the formula and the process are realized, the stability and the transdermal permeation efficiency of the product are obviously improved, and the curative effect similar to that of a store can be obtained after on-site / family rapid blending.

Description

TECHNICAL FIELD

[0001] The present application relates to Qianli Shukangtang Shujin Tougu health care ointment, in particular to Qianli Shukangtang Shujin Tougu health care ointment, belonging to the technical field of health care external application. BACKGROUND

[0002] The existing Shujin Tougu external preparation exists in the form of finished ointment, ointment patch or on-site prepared external application agent, which is often prepared by technicians in stores and matched with heating equipment for treatment. Such products have many formulas but single form, poor portability and reusability, and are difficult to meet the needs of external promotion in chain stores and self-help use at home; And the existing packaging is mostly disposable or non-sealed for recycling use, which causes cross contamination and hygiene management problems. There is no unified standard for key physical parameters such as particle size, water content and auxiliary material ratio, resulting in inconsistent product stability, transdermal permeability and use experience. In view of the above status, the technical problems to be solved include: how to ensure convenient on-site preparation and maintain drug efficacy stability under the combination of sub-packaged powder and liquid; how to control the risk of microbiology and cross contamination in the design of recycling use; how to ensure the permeability and skin compatibility of the mixed ointment through measurable indicators such as particle size (such as D90), water content and auxiliary material ratio; and how to develop appropriate heating conditions and packaging structure to balance efficacy, operability, cost and regulatory compliance, so as to facilitate large-scale production and chain promotion. Therefore, it is urgent to improve Qianli Shukangtang Shujin Tougu health care ointment to solve the above problems. SUMMARY

[0003] The purpose of the present application is to provide Qianli Shukangtang Shujin Tougu health care ointment to solve the problems raised in the background art.

[0004] To achieve the above purpose, the present application provides the following technical scheme: Qianli Shukangtang Shujin Tougu health care ointment, which is composed of sub-packaged powder and sub-packaged liquid; The powder comprises a mixture of the following Chinese herbal medicines in a mass ratio: safflower, prunella vulgaris, radix angelicae pubescentis, ligusticum sinense, dragon's blood and centipede, and each component can be adjusted within ±20% as needed; The liquid agent is based on the water immersion decoction, filtration and cooling of safflower, radix angelicae pubescentis, radix morindae officinalis and mentha as main medicinal materials, and the content of ethanol in the liquid agent is 2-12%, the content of glycerol is 1-6%, and the amount of borneol is 0.1-2.0 g; The powder is a mixture of dried, crushed and sieved Chinese herbal medicine powder with an average particle size of less than 200 μm; the liquid agent is prepared by adding ethanol, glycerol and a small amount of borneol auxiliary materials to the medicinal material decoction liquid after cooling; The total amount of the powder is preferably about 60 g, and the volume of the liquid is preferably about 200 mL.

[0005] Preferably, the powder and the liquid are separately packed in sealable containers, with the powder being packed in a single box in an amount of 50-70 g and the liquid being packed in a single box in a volume of 150-250 mL. The health-care paste is configured to be used by pouring the liquid into the powder container and stirring to form a uniform paste, which is then applied to the pain site, and a heating pad can be used to heat the paste at 40-60°C for 30-60 minutes to enhance penetration and analgesic effect. The health-care paste is designed in terms of formulation and packaging to be used for 10-20 cycles while maintaining its main medicinal effect and stored in a sealed state.

[0006] Preferably, the container is optionally provided with a disposable inner liner bag or is wiped with a mild disinfectant after each use and is left to dry for a short time.

[0007] Preferably, the D90 of the powder particles is less than 200 μm, and the moisture content of the powder is controlled within a range that is not conducive to microbial growth.

[0008] Preferably, the number of cycles is preferably 15, and the remaining paste after each use is stored in the original powder container and placed in a well-ventilated and dry place.

[0009] Preferably, the health-care paste further comprises at least one of the following options: a preservative synergist, a humectant, a solvent regulator, or a transdermal enhancer, and the amount of addition is controlled within a safe and regulatory allowed range.

[0010] Preferably, the health-care paste is prepared using the following process: a) The Chinese herbal medicines used for the powder are selected, washed, dried, crushed, and sieved to obtain the powder, which is then packed in a sealed container; b) The Chinese herbal medicines used for the liquid are soaked in water according to the ratio, then boiled for 60-90 minutes, filtered, and cooled to ≤30°C, and then the auxiliary materials of ethanol, glycerol, and borneol are added, stirred uniformly, and packed as the liquid; c) The powder and the liquid obtained in steps a and b are packed in a single box and sealed; the average particle size and moisture content of the powder are controlled before packaging.

[0011] The present application has at least the following beneficial effects: In the present application, by separating the powder and liquid, and specifying the particle size, moisture content, and auxiliary material ratio, etc., the standardization and repeatability of the formula and process are achieved, the stability and transdermal penetration efficiency of the product are significantly improved, and the efficacy similar to that in the store can be obtained after rapid deployment on site / home; the use of disposable liners or simple disinfection and sealing preservation scheme effectively reduces the cross contamination and microbial risk during recycling, thereby ensuring safety while achieving a cost advantage of 10-20 times recycling per box; in addition, it is convenient for large-scale production, chain promotion and regulatory compliance, and improves operability, user experience and commercial feasibility. DETAILED DESCRIPTION

[0012] The embodiments of the present application will be described in detail below with examples, so that the implementation process of how to apply technical means to solve technical problems and achieve technical effects can be fully understood and implemented.

[0013] Related terms involved in the present application are explained as follows: D90 determination: "The D90 of the powder is determined by laser diffraction method, and the volume distribution result is used. When measuring, dry method (or wet method is indicated and the dispersion medium and ultrasonic conditions are given) is used, and the reported value is the particle size corresponding to the cumulative 90% of the sample volume distribution, and D90 is required to be <200 μm." Moisture determination: "The moisture content of the powder is determined by loss on drying method: the sample is placed in an oven at 105°C and dried to constant weight, and the percentage of weight loss is the moisture content; or it is determined by the corresponding method in Chinese Pharmacopoeia / enterprise standard, and the requirement is <6% (w / w).". Ethanol / glycerol content determination: "The ethanol and glycerol contents in the liquid can be determined by gas chromatography (GC) or corresponding chemical analysis method and expressed as volume percentage (v / v), ethanol 2-12% (v / v), and glycerol 1-6% (v / v).". Microbial limit: "The total bacterial count, mold and yeast, coliform group, Staphylococcus aureus, etc. are detected according to the relevant pharmacopoeia / standard to ensure compliance with the provisions of external health care products or enterprise standards." First use skin test: "After applying a small area on the inner side of the forearm for 10-15 min, no obvious redness, swelling, burning or pain reaction is allowed to use." Example 1 (recyclable box formula) Purpose: to demonstrate the preferred formula, preparation, use and quality control process.

[0014] Composition (single box) Powder (total amount 60.0 g): safflower powder 15.0 g, dragon's blood powder 6.0 g, centipede powder 3.0 g, przewalsk rhizoma ginseng powder 12.0 g, verbena powder 12.0 g, angelica pubescens / Chinese knotweed powder 12.0 g; Liquid (total 200 mL): safflower decoction (concentrated) about 80 mL, Baiji decoction about 40 mL, Jixueteng decoction about 40 mL, mint decoction about 20 mL, ethanol 10-20 mL (2-12% v / v), glycerol 5-10 mL (1-6% v / v), borneol 0.5-2.0 g (per box measurement), and purified water to 200 mL; Note: The components in the powder can be adjusted within ±20% as needed to obtain similar activity and physical properties.

[0015] Preparation method: Powder preparation: select medicinal materials → wash → dry (moisture <6% w / w) → crush → sieve (mesh size / sieve hole as needed to ensure D90 requirements described below) → mix evenly → divide (50-70 g / box) and seal.

[0016] Liquid preparation: soak safflower, Baiji, Jixueteng, and mint in water according to the ratio for 1 h → simmer for 60-90 min → cool and filter → cool to ≤30 ℃ → add ethanol, glycerol, and borneol → stir evenly → divide (150-250 mL / box) and seal.

[0017] Packaging: powder and liquid are separately packaged in sealable containers (such as food-grade PP bottles or cans with disposable inner bags) and labeled with batch number / production date.

[0018] Usage method (demonstration): pour all or part of the liquid into the powder container; use a clean stirring rod to stir for 30-90 s until a uniform paste is formed; evenly spread the paste on the painful area (recommended thickness 3-6 mm); cover with protective film; place on a heating pad and heat at 40-60 ℃ for 30-60 min (preferably 50 min); after removing the paste, store the remaining paste in the original powder container for next use; it is recommended to recycle 10-20 times (preferably 15 times) per box.

[0019] Quality control (before packaging / factory test): Powder particle size: D90 <200 μm (volume distribution, laser diffraction instrument is recommended, refer to ISO13320, dry or wet method needs to be specified in the instructions); Powder moisture: <6% (w / w), it is recommended to use the loss on drying method (oven method) or the method specified in the pharmacopoeia; Microorganisms: total bacterial count, mold and yeast, pathogenic bacteria (such as Staphylococcus aureus, coliform group) detection should meet applicable regulations or enterprise standards (it is recommended to meet the national pharmacopoeia or local testing standards in the instructions); Ethanol / glycerol content: 2-12% (v / v) and 1-6% (v / v) by gas chromatography or other methods; Heavy metals / pesticide residues / ash: detected according to regulations or enterprise standards and qualified.

[0020] Safety precautions and initial use test First use requires a small area of skin test on the forearm for 10-15 minutes. If there is no obvious redness, itching, and other adverse reactions, it can be continued to be used. It is forbidden for those who are allergic to any component in the formula.

[0021] Pay attention to temperature and time when heating to prevent burns; children, pregnant women, and special groups should be used with caution and according to doctor's advice.

[0022] Storage conditions and shelf life: Storage conditions: cool, dry, and light-proof, container sealed; Recommended shelf life: 12 months (determined according to stability test results).

[0023] Example 2 (one-time single-use bag) Purpose: suitable for one-time use scenarios (single physiotherapy at home / store), avoiding cross-contamination.

[0024] Formula: 6g of powder per bag, 20mL of liquid per bag (proportion of sub-packaging is reduced by equal proportion).

[0025] Packaging: powder and liquid are separately sealed in small bags (aluminum-plastic composite bags or medical-grade plastic bags), and the user mixes them according to the instructions and then discards them.

[0026] Advantages: no recycling risk, hygienic use, convenient for travel and take-out.

[0027] Quality control: same as Example 1, but detection is based on single quantity or batch sampling.

[0028] Example 3 (recycling box with disposable inner liner) Purpose: to balance recycling and hygiene safety.

[0029] A disposable medical-grade inner liner bag (membrane bag) is provided in the powder container. Each time the paste is used, it is placed back in the inner liner bag and sealed. The next time it is used, the inner liner bag is replaced or continued to be used until the recycling limit is reached.

[0030] The inner liner bag can reduce pollution caused by direct contact of the jar with the paste, extending the number of safe recycling times.

[0031] Example 4 (no animal ingredients / supervision-friendly alternative formula) Purpose: to replace ingredients such as centipede and dragon's blood that are restricted or cause concerns for some users, facilitating internationalization / regulatory compliance.

[0032] Powder substitute (60 g): Replace Eupolyphaga 3 g and Dragon's Blood 6 g with equivalent plant combination (e.g. increase Angelica pubescens 3 g, use pangolin cautiously or use plant extracts with similar pharmacology to replace - here only as an example, the actual replacement must be based on efficacy and compliance), or use plant extracts such as Gynostemma pentaphyllum, Corydalis to compensate for activity.

[0033] Liquid: Keep Crocus sativus, Angelica dahurica, Spatholobus suberectus, Mentha, or use plant transdermal enhancers (such as low-concentration capsaicin extract) to replace the penetration of animal ingredients.

[0034] Note: The replacement formula should be tested for equivalence (external effect, safety) and the corresponding instructions should be given.

[0035] As some terms are used in the description and claims to refer to particular components. Those skilled in the art should understand that hardware manufacturers may use different names to refer to the same component. The description and claims of this specification do not take the difference in name as a way to distinguish components, but take the difference in function as the criterion for distinguishing components. As mentioned throughout the specification and claims, "comprising" is an open term, which should be interpreted as "comprising but not limited to". "Approximately" means within an acceptable error range, and those skilled in the art can solve technical problems within a certain error range and basically achieve technical effects.

Claims

1. Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster, characterized in that, The health care paste is composed of a combination of dispensed powder and dispensed liquid. The powder contains a mixture of the following Chinese herbal medicines in the following mass ratios: safflower, Homalomena occulta, Angelica pubescens, verbena, dragon's blood, and centipede, and each component can be adjusted as needed within ±20%; The liquid preparation is based on the decoction obtained by soaking, decocting, filtering and cooling the main medicinal materials such as safflower, angelica, chicken blood vine and peppermint in water. The liquid preparation contains 2-12% ethanol, 1-6% glycerol and 0.1-2.0 g of borneol. The powder is a mixture of dried, pulverized, and sieved Chinese herbal medicine powders with an average particle size of less than 200 μm; the liquid is prepared by adding ethanol, glycerin, and a small amount of borneol excipients to the cooled decoction of medicinal materials. The powder is preferably about 60 g in total, and the liquid is preferably about 200 mL in volume.

2. The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster according to claim 1, characterized in that: The powder and liquid are packaged separately in sealable containers, with each box containing 50–70 g of powder and 150–250 mL of liquid. The health care ointment is prepared by pouring all or part of the liquid into the powder container and stirring until it becomes a uniform ointment before applying it to the painful area. A heating pad can be used to heat it at 40–60°C for 30–60 minutes to enhance the penetration and analgesic effect. The health-preserving ointment is designed with a specific formula and packaging method so that it can be reused 10–20 times without compromising its main medicinal effects and can be stored in a sealed container.

3. The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster according to claim 1, characterized in that: The container may be equipped with a disposable inner liner bag or, after each use, the rim and walls of the container may be wiped with a mild disinfectant and then briefly air-dried.

4. The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster according to claim 1, characterized in that: The powder particles have a D90 of less than 200 μm, and the moisture content in the powder is controlled within a range that is unfavorable to microbial growth.

5. The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster according to claim 1, characterized in that: The preferred number of times for recycling is 15 times, and after each use, the remaining paste should be sealed and stored in the original powder container and placed in a ventilated and dry place.

6. The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster according to claim 1, characterized in that: The health cream further comprises at least one of the following options: preservative synergist, moisturizer, solvent regulator or transdermal enhancer, and the amount added is controlled within the range permitted by safety and regulations.

7. The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster according to any one of claims 1-6, characterized in that: The Qianliao Shukangtang Muscle-Relaxing and Bone-Penetrating Health Plaster is prepared using the following process: a) Select, clean, dry, pulverize and sieve the Chinese herbal medicines used for powder preparation, and then package them into sealed containers. b) Soak the Chinese herbs used in the liquid preparation in water according to the specified ratio, then decoct for 60–90 minutes, filter and cool to ≤30°C, add ethanol, glycerin and borneol excipients, stir well and dispense into liquid preparation; c) The powder and liquid obtained in steps a and b are packaged in single boxes and sealed; the average particle size and moisture content of the powder are quality controlled before packaging.