Composition for promoting pelvic floor muscle function repair and preparation method thereof

Abstract

The invention belongs to the technical field of medical compositions, and provides a composition for promoting pelvic floor muscle function repair and a preparation method thereof.The composition is prepared from sodium hyaluronate, asiaticoside, fructus cnidii essential oil, bletilla striata extract, silver ions, carbomer 940, glycerin, methyl chloride isothiazolinone and a proper amount of sodium hydroxide serving as a pH regulator. The purified water is supplemented until the total weight of the composition is 100%; the sodium hyaluronate disclosed by the invention has excellent moisturizing and repairing capabilities, can promote regeneration and repairing of vaginal mucosa and relieve inflammation and discomfort, and is beneficial to enhancing the elasticity and toughness of cervical tissues and improving the overall reproductive health level by adjusting the expression of collagen I / III; various active ingredients in the composition have a synergistic effect, the function of pelvic floor muscles can be improved, the supporting force and contractility of the muscles can be enhanced, pelvic floor dysfunction diseases can be prevented and relieved, the preparation method is simple and clear, the product quality is easy to control, and the composition is suitable for large-scale production.

Description

Technical Field

[0001] The invention belongs to the technical field of medical compositions, in particular to a composition for promoting the repair of pelvic floor muscle function and a preparation method thereof. Background Art

[0002] The pelvic floor muscles refer to the muscle group that closes the pelvic floor. This muscle group is like a "hanging net" that tightly holds the urethra, bladder, vagina, uterus, rectum and other organs, thereby maintaining their normal position to perform their functions. Once the elasticity of this "net" deteriorates and the "hanging force" is insufficient, the organs in the "net" will not be able to maintain their normal position, resulting in corresponding functional disorders, such as incontinence and pelvic organ prolapse.

[0003] There are various pelvic floor muscle function repair products on the market, but they often have problems such as insignificant effects, large side effects, or complex ingredients leading to cumbersome preparation processes, which makes it impossible to promote the current pelvic floor muscle function repair products on a large scale.

[0004] To this end, those skilled in the art have proposed a composition for promoting the repair of pelvic floor muscle function and a preparation method thereof to solve the problems raised by the background technology. Summary of the invention

[0005] In order to solve the above technical problems, the present invention provides a composition for promoting the repair of pelvic floor muscle function and a preparation method thereof, so as to solve the problems that the pelvic floor muscle function repair products in the prior art are various, but often have the problems of insignificant effects, large side effects or complex ingredients resulting in cumbersome preparation process.

[0006] A composition for promoting the repair of pelvic floor muscle function. The composition comprises, by weight percentage, 0.08% to 0.12% of sodium hyaluronate, 0.2% to 0.3% of total Centella asiatica glycosides, 0.08% to 0.2% of total Cnidium monnieri essential oil, 0.1% to 0.3% of Bletilla striata extract, 0.18% to 0.3% of total silver ions, 0.5% to 1.0% of total carbomer 940, 1% to 3% of total glycerol, 0.1% to 0.3% of total methylchloroisothiazolinone, and an appropriate amount of sodium hydroxide as a pH regulator, and purified water supplemented to 100% of the total weight of the composition.

[0007] Preferably, the composition contains, by weight percentage, 0.1% of sodium hyaluronate, 0.25% of Centella asiatica total glycosides, 0.14% of Cnidium monnieri essential oil, 0.2% of Bletilla striata extract, 0.24% of silver ions, 0.75% of carbomer 940, 2.0% of glycerol, 0.2% of methylchloroisothiazolinone, and an appropriate amount of sodium hydroxide as a pH regulator, and purified water to make up to 100% of the total weight of the composition.

[0008] Preferably, the sodium hyaluronate, total glucosides of Centella asiatica, essential oil of Cnidium monnieri, extract of Bletilla striata and silver ions are the main substances of the composition, the carbomer 940 and glycerol are excipients, the methylchloroisothiazolinone is a preservative, the sodium hyaluronate, total glucosides of Centella asiatica, essential oil of Cnidium monnieri and extract of Bletilla striata meet the enterprise standards, and the carbomer 940, glycerol, sodium hydroxide, methylchloroisothiazolinone and purified water meet the requirements of the Chinese Pharmacopoeia.

[0009] Preferably, the composition further comprises the composition packaged in a syringe dispenser, wherein each syringe dispenser contains 3.0 g of the composition.

[0010] A method for preparing a composition for promoting the repair of pelvic floor muscle function comprises the following steps:

[0011] S1. Add purified water (batch × 50%) into a batching pot and stir. Under stirring, add sodium hyaluronate and carbomer 940 to part of the purified water (batch × 50%) and let it stand to swell to obtain solution A for standby use.

[0012] S2. Add purified water (batch × 40%) into another batching pot, heat and start stirring, then add total glucosides of Centella asiatica, Bletilla striata extract, silver ions and methylchloroisothiazolinone into the batching pot, stir and dissolve to obtain solution B;

[0013] S3, mixing the Cnidium monnieri essential oil and glycerol evenly to obtain solution C, and then adding solution C to solution A and stirring;

[0014] S4, add solution B to solution A and stir until uniform;

[0015] S5. Use sodium hydroxide solution to adjust pH, add purified water (batch × 10%) to a sufficient amount, stir and cool;

[0016] S6. Conduct intermediate testing, filling, outsourcing, irradiation sterilization, finished product inspection and warehousing;

[0017] 1) Intermediate detection

[0018] Steps:

[0019] ① Sampling: Sampling from the key steps in the preparation process (such as after mixing solution A, solution B, and solution C, etc.);

[0020] ②Physical and chemical property testing: testing whether the pH value, viscosity, appearance, etc. of the sample meet the expected standards;

[0021] ③ Microbial limit test: ensure that there is no microbial contamination in the sample or the contamination is within an acceptable range;

[0022] ④ Determination of active ingredient content: Use appropriate methods (such as HPLC, UV-Vis, etc.) to determine the content of the main active ingredient to ensure that it is within the specified range;

[0023] ⑤ Record and evaluate: record the test results and evaluate whether they meet the requirements of the next production step;

[0024] 2) Potting

[0025] Steps:

[0026] ① Preparation: Clean and disinfect the filling equipment to ensure a sterile environment;

[0027] ②Filling: Fill the qualified composition liquid into the pre-prepared syringe dispenser, each syringe dispenser contains a predetermined amount of composition (such as 3.0g);

[0028] ③ Sealing: Seal the filled syringe applicator to prevent contamination;

[0029] ④Inspection: Check whether the filling volume is accurate and the seal is intact;

[0030] 3) Outsourcing

[0031] Steps:

[0032] ① Prepare packaging materials: ensure that packaging materials (such as cartons, instructions, labels, etc.) meet the specified requirements and have been disinfected or cleaned;

[0033] ② Packaging: Put the filled syringe applicator into the packaging box and attach the instructions and label;

[0034] ③ Sealing: Seal the packaging box to ensure sealing;

[0035] ④Inspection: Check whether the packaging is complete and the label information is accurate;

[0036] 4) Irradiation sterilization

[0037] Steps:

[0038] ① Preparation: Place the packaged product into the irradiation sterilization equipment;

[0039] ② Irradiation: According to the product characteristics and the requirements of the irradiation equipment, set the appropriate irradiation dose and time for sterilization;

[0040] ③Inspection: Check whether the appearance and performance of the product have changed after irradiation to ensure the sterilization effect;

[0041] 5) Finished product inspection

[0042] Steps:

[0043] ① Sampling: Random sampling from the irradiated sterilized products;

[0044] ② Re-test of physical and chemical properties: re-test the sample's pH value, viscosity, appearance and other physical and chemical properties;

[0045] ③ Microbial limit retest: to ensure product sterility;

[0046] ④ Retesting of active ingredient content: re-testing the content of the main active ingredient;

[0047] ⑤Stability test (optional): Conduct accelerated stability test for a certain period of time to evaluate the long-term stability of the product;

[0048] ⑥Record and evaluation: record all inspection results and evaluate whether the product is qualified;

[0049] 6) Storage

[0050] Steps:

[0051] ① Classification and storage: The qualified products are stored in the warehouse according to batches, specifications, etc.;

[0052] ② Labeling: Set up obvious labels in the warehouse to indicate the product name, specification, batch, production date, expiration date and other information;

[0053] ③Records: Establish detailed warehousing records, including product quantity, warehousing time, storage location and other information.

[0054] Preferably, in step S2, the heating temperature is 50°C-55°C.

[0055] Preferably, in step S4, the stirring time is 2 hours.

[0056] Preferably, in step S5, the pH is adjusted to 5.5-7.5.

[0057] Preferably, in step S5, the stirring time is 1 hour.

[0058] Preferably, in step S5, the cooling temperature is 30°C.

[0059] Compared with the prior art, the present invention has the following beneficial effects:

[0060] The sodium hyaluronate of the present invention has excellent moisturizing and repairing abilities, can promote the regeneration and repair of the vaginal mucosa, reduce inflammation and discomfort, and at the same time, by regulating the expression of collagen I / III, helps to enhance the elasticity and toughness of cervical tissue and improve the overall reproductive health level; the multiple active ingredients in the composition act synergistically to improve the function of the pelvic floor muscles, enhance the supporting force and contraction force of the muscles, prevent and alleviate pelvic floor dysfunction diseases, and the preparation method of the invention is simple and clear, easy to control product quality, and suitable for large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 The present invention is a flow chart of the preparation method of the composition for promoting the repair of pelvic floor muscle function. DETAILED DESCRIPTION

[0062] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0063] The invention provides a composition for promoting the repair of pelvic floor muscle function. The composition comprises, by weight percentage, 0.08% to 0.12% of sodium hyaluronate, 0.2% to 0.3% of total Centella asiatica glycosides, 0.08% to 0.2% of total Cnidium monnieri essential oil, 0.1% to 0.3% of total Bletilla striata extract, 0.18% to 0.3% of total silver ions, 0.5% to 1.0% of total Carbomer 940, 1% to 3% of total glycerol, 0.1% to 0.3% of total methylchloroisothiazolinone, and an appropriate amount of sodium hydroxide as a pH regulator, and purified water supplemented to 100% of the total weight of the composition.

[0064] like Figure 1 As shown:

[0065] Embodiment 1: The present invention provides a composition for promoting the repair of pelvic floor muscle function, wherein the composition comprises the following by weight percentage:

[0066]

[0067]

[0068] A method for preparing a composition for promoting the repair of pelvic floor muscle function from the above composition components (10 kg batches) comprises the following steps:

[0069] S1. Add purified water (batch × 50%) into a batching pot, slowly add sodium hyaluronate and carbomer 940 under stirring, and let stand overnight to swell to obtain solution A for later use;

[0070] S2. Add purified water (batch x 40%) into another batching pot, then raise the temperature to 50°C-55°C, start stirring, add total glucosides of Centella asiatica, Bletilla striata extract, silver ions, and methylchloroisothiazolinone, and stir to completely dissolve them to obtain solution B;

[0071] S3, mixing Cnidium monnieri essential oil and glycerin uniformly to obtain solution C, then adding solution C into solution A and stirring, and the temperature of solution A needs to be raised to 50°C-55°C;

[0072] S4, adding solution B to solution A, stirring until uniform (continuous stirring for 2 hours);

[0073] S5. Use sodium hydroxide solution to adjust the pH to 5.5-7.5, add purified water to a sufficient amount, continue stirring for 1 hour to obtain a uniform gel, and then cool the temperature to 30°C.

[0074] Embodiment 2: This embodiment proposes a composition for promoting the repair of pelvic floor muscle function, and the composition comprises the following by weight percentage:

[0075]

[0076]

[0077] A method for preparing a composition for promoting the repair of pelvic floor muscle function from the above composition components (10 kg batches) comprises the following steps:

[0078] S1. Add purified water (batch × 50%) into a batching pot, slowly add sodium hyaluronate and carbomer 940 under stirring, and let stand overnight to swell to obtain solution A for later use;

[0079] S2. Add purified water (batch x 40%) into another batching pot, then raise the temperature to 50°C-55°C, start stirring, add total glucosides of Centella asiatica, Bletilla striata extract, silver ions, and methylchloroisothiazolinone, and stir to completely dissolve them to obtain solution B;

[0080] S3, mixing Cnidium monnieri essential oil and glycerin uniformly to obtain solution C, then adding solution C into solution A and stirring, and the temperature of solution A needs to be raised to 50°C-55°C;

[0081] S4, adding solution B to solution A, stirring until uniform (continuous stirring for 2 hours);

[0082] S5. Use sodium hydroxide solution to adjust the pH to 5.5-7.5, add purified water to a sufficient amount, continue stirring for 1 hour to obtain a uniform gel, and then cool the temperature to 30°C.

[0083] Embodiment 3: This embodiment proposes a composition for promoting the repair of pelvic floor muscle function, and the composition comprises the following by weight percentage:

[0084] Serial number composition Prescription dosage (%) Function Implementation Standards 1 Sodium Hyaluronate 0.12 Main substances Enterprise Standards 2 Centella asiatica total glucosides 0.3 Main substances Enterprise Standards 3 Cnidium monnieri essential oil 0.2 Main substances Enterprise Standards 4 Bletilla striata extract 0.3 Main substances Enterprise Standards 5 Silver Ion 0.3 Main substances Chinese Pharmacopoeia 6 Carbomer 940 1.0 Excipients Chinese Pharmacopoeia 7 glycerin 1 Excipients Chinese Pharmacopoeia 8 Sodium hydroxide Moderate pH Adjuster Chinese Pharmacopoeia 9 Methylchloroisothiazolinone 0.3 preservative Chinese Pharmacopoeia 10 Purified water to Make up to 100 Solvents Chinese Pharmacopoeia 11 Syringe medication dispenser 3.0g / piece Packaging Enterprise Standards

[0085] A method for preparing a composition for promoting the repair of pelvic floor muscle function from the above composition components (10 kg batches) comprises the following steps:

[0086] S1. Add purified water (batch × 50%) into a batching pot, slowly add sodium hyaluronate and carbomer 940 under stirring, and let stand overnight to swell to obtain solution A for later use;

[0087] S2. Add purified water (batch x 40%) into another batching pot, then raise the temperature to 50°C-55°C, start stirring, add total glucosides of Centella asiatica, Bletilla striata extract, silver ions, and methylchloroisothiazolinone, and stir to completely dissolve them to obtain solution B;

[0088] S3, mixing Cnidium monnieri essential oil and glycerin uniformly to obtain solution C, then adding solution C into solution A and stirring, and the temperature of solution A needs to be raised to 50°C-55°C;

[0089] S4, adding solution B to solution A, stirring until uniform (continuous stirring for 2 hours);

[0090] S5. Use sodium hydroxide solution to adjust the pH to 5.5-7.5, add purified water to a sufficient amount, continue stirring for 1 hour to obtain a uniform gel, and then cool the temperature to 30°C.

[0091] Comparative example: a pelvic floor muscle function repair product currently on the market and its preparation method;

[0092] Ingredients: hyaluronic acid, collagen, epidermal growth factor (EGF), plant extracts (including witch hazel extract, mangosteen extract, motherwort extract), carbomer, excipients (glycerin, triethanolamine, disodium edetate, purified water);

[0093] A method for preparing a pelvic floor muscle function repair product of the above ingredients comprises the following steps:

[0094] S101. Raw material preparation: accurately weigh hyaluronic acid, collagen, epidermal growth factor, plant extracts, carbomer and other raw materials and auxiliary ingredients according to the formula ratio;

[0095] S102, dissolving and mixing: adding carbomer and other ingredients that need to be dissolved into an appropriate amount of purified water, stirring until completely dissolved, and then adding hyaluronic acid, collagen and other bioactive ingredients into the solution, stirring evenly;

[0096] S103. Adjust pH value: Use disodium edetate or other acid-base regulators to adjust the pH value of the mixed solution to an appropriate range (e.g., 5.8-6.3) to ensure the stability and effectiveness of the product;

[0097] S104, filling and sterilization: filling the evenly mixed product into a sterile packaging container;

[0098] S105, Quality Inspection: Conduct quality inspection on finished products, including appearance inspection, pH value determination, microbial limit inspection, etc., to ensure that product quality meets standard requirements;

[0099] S106, Packaging and warehousing: Carry out outer packaging for qualified products, print labels and instructions and other information, and finally store or ship the packaged products for sale.

[0100] Test Example: The effects of the preparations according to Examples 1 to 3 and the comparative example were compared to obtain the following table:

[0101]

[0102] It can be seen from the above table that the composition for promoting the repair of pelvic floor muscle function and the preparation method thereof of this embodiment are significantly better than the comparative example in promoting the repair of pelvic floor muscle function, improving the elasticity and toughness of cervical tissue, and enhancing the function of pelvic floor muscles. For female stress urinary incontinence, the composition for promoting the repair of pelvic floor muscle function of this embodiment can be promoted and applied on a large scale.

[0103] In summary, the present invention has the following beneficial effects:

[0104] 1) Promote the repair of pelvic floor muscle function: Sodium hyaluronate has excellent moisturizing and repairing abilities, can promote the regeneration and repair of the vaginal mucosa, and reduce inflammation and discomfort.

[0105] 2) Promote the expression of collagen I / III in cervical tissue: By regulating the expression of collagen I / III, it helps to enhance the elasticity and toughness of cervical tissue and improve overall reproductive health.

[0106] 3) Improve pelvic floor muscles: The various active ingredients in this composition work synergistically to improve the function of the pelvic floor muscles, enhance the supporting force and contraction force of the muscles, and prevent and alleviate pelvic floor dysfunction diseases.

[0107] 4) Simple preparation process: The preparation method of the present invention is simple and clear, easy to control product quality, and suitable for large-scale production.

[0108] 5) High safety: All ingredients comply with the Chinese Pharmacopoeia or corporate standards and are scientifically formulated to ensure product safety and effectiveness.

[0109] The embodiments of the present invention are provided for the purpose of illustration and description. Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be understood as limitations of the present invention. Ordinary technicians in this field can change, modify, replace and modify the above embodiments within the scope of the present invention.

Claims

1. A composition for promoting the repair of pelvic floor muscle function, characterized in that: The composition comprises, by weight percentage, 0.08% to 0.12% of sodium hyaluronate, 0.2% to 0.3% of total Centella asiatica glycosides, 0.08% to 0.2% of total Cnidium monnieri essential oil, 0.1% to 0.3% of Bletilla striata extract, 0.18% to 0.3% of total silver ions, 0.5% to 1.0% of total carbomer 940, 1% to 3% of total glycerol, 0.1% to 0.3% of total methylchloroisothiazolinone, an appropriate amount of sodium hydroxide as a pH regulator, and purified water supplemented to 100% of the total weight of the composition.

2. A composition for promoting the repair of pelvic floor muscle function as claimed in claim 1, characterized in that: The composition comprises, by weight percentage, sodium hyaluronate accounting for 0.1% of the total weight of the composition; total Centella asiatica glycosides accounting for 0.25% of the total weight of the composition; cnidium monnieri essential oil accounting for 0.14% of the total weight of the composition; bletilla striata extract accounting for 0.2% of the total weight of the composition; silver ions accounting for 0.24% of the total weight of the composition; carbomer 940 accounting for 0.75% of the total weight of the composition; glycerol accounting for 2.0% of the total weight of the composition; methylchloroisothiazolinone accounting for 0.2% of the total weight of the composition; and an appropriate amount of sodium hydroxide as a pH regulator, and purified water supplemented to 100% of the total weight of the composition.

3. A method for preparing a composition for promoting the repair of pelvic floor muscle function according to any one of claims 1-2, characterized in that: The following steps are involved: S1. Add sodium hyaluronate and carbomer 940 to partially purified water and allow to swell to obtain solution A. S2, add purified water into the batching pot, heat it and start stirring, then add the total glucosides of Centella asiatica, Bletilla striata extract, silver ions and methylchloroisothiazolinone into the batching pot, stir and dissolve, and obtain solution B; S3, mixing the Cnidium monnieri essential oil and glycerol to obtain solution C, and then adding solution C to solution A and stirring; S4, add solution B to solution A and stir until uniform; S5. Use sodium hydroxide solution to adjust the pH, add purified water to a sufficient amount, stir and cool.

4. A method for preparing a composition for promoting the repair of pelvic floor muscle function as claimed in claim 3, characterized in that: In step S2, the heating temperature is 50°C-55°C.

5. A method for preparing a composition for promoting the repair of pelvic floor muscle function as claimed in claim 3, characterized in that: In step S4, the stirring time is 2 hours.

6. A method for preparing a composition for promoting the repair of pelvic floor muscle function as claimed in claim 3, characterized in that: In step S5, the pH is adjusted to 5.5-7.

5.

7. A method for preparing a composition for promoting the repair of pelvic floor muscle function as claimed in claim 3, characterized in that: In step S5, the stirring time is 1 hour.

8. A method for preparing a composition for promoting the repair of pelvic floor muscle function as claimed in claim 3, characterized in that: In step S5, the cooling temperature is 30°C.

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