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CN-121987680-A - Formula and preparation process for repairing and improving ovarian aging

CN121987680ACN 121987680 ACN121987680 ACN 121987680ACN-121987680-A

Abstract

The application relates to a formula and a preparation process for repairing and improving ovarian aging, which comprises the steps of S1, raw material screening and pretreatment, S2, active ingredient extraction, S3, extract refining and purification, S4, formula component compounding, S5, preparation forming and packaging, wherein the formula and the preparation process for repairing and improving ovarian aging realize systematic intervention on multidimensional pathological mechanisms such as oxidative stress, mitochondrial dysfunction, follicular apoptosis and the like related to ovarian aging by scientifically matching a plurality of natural active ingredients with definite pharmacological actions, adopting an advanced dynamic circulation countercurrent extraction technology and a multistage membrane separation purification process, and simultaneously ensure the quality stability and the bioavailability of the active ingredients among product batches through strict raw material quality control, standardized preparation process and overall process quality monitoring.

Inventors

  • YU YIFENG

Assignees

  • 广州津唐生物科技有限公司

Dates

Publication Date
20260508
Application Date
20260316

Claims (10)

  1. 1. A formula and a preparation process for repairing and improving ovarian aging are characterized by comprising the following steps: S1, screening and preprocessing raw materials, carrying out sensory inspection, physical and chemical index detection and microorganism limit inspection on plant raw materials according to preset quality standards, removing unqualified products, and carrying out cleaning, drying and preliminary crushing treatment on the qualified raw materials; S2, extracting active ingredients, namely performing multistage countercurrent extraction at a temperature range of 40-60 ℃ by adopting a dynamic circulation countercurrent extraction technology and taking water or ethanol water solution with specific concentration as an extraction solvent; S3, refining and purifying the extracting solution, sequentially carrying out graded purification on the obtained extracting solution through ceramic membrane microfiltration, hollow fiber ultrafiltration and reverse osmosis membrane separation systems, removing macromolecular impurities, colloid particles and part of inorganic salts, and collecting active ingredients within a target molecular weight range; S4, compounding the formula components, mixing the purified active ingredients with pharmaceutically acceptable auxiliary materials according to a preset proportion, wherein the auxiliary materials comprise a filler, a disintegrating agent, a lubricant and a stabilizer, and mixing the powder by adopting an equivalent incremental method; And S5, forming and packaging the preparation, granulating the uniformly mixed powder by adopting a dry granulation or wet granulation process, pressing into tablets or filling into capsule shells, and finally carrying out aluminum plastic packaging under the conditions of 15-25 ℃ and 45-65% of relative humidity.
  2. 2. The formula and the preparation process for repairing and improving the ovarian aging are characterized in that the raw material screening in S1 comprises the steps of performing high performance liquid chromatography detection on soybean isoflavone raw materials, ensuring that the sum of the content of genistein and the content of soybean flavone is not lower than 40%, and simultaneously performing ultraviolet spectrophotometry detection on rhodiola rosea raw materials, and ensuring that the content of salidroside is not lower than 1%.
  3. 3. The formula and the preparation process for repairing and improving the ovarian aging are characterized in that the dynamic circulation countercurrent extraction equipment in the step S2 comprises 6 stages of extraction units connected in series, each stage of unit is provided with an independent temperature control system and a liquid level monitoring device, the mass ratio of an extraction solvent to raw materials is 8:1 to 12:1, and the residual alcohol content of residues discharged by a final stage of extraction unit is lower than 0.5%.
  4. 4. The formula and the preparation process for repairing and improving the ovarian aging are characterized in that the ceramic membrane in the S3 is a zirconia ceramic membrane with the pore diameter of 0.1 micron, the hollow fiber ultrafiltration is a polysulfone hollow fiber membrane, and the reverse osmosis membrane separation is a cellulose acetate composite membrane.
  5. 5. The formula and the preparation process for repairing and improving the ovarian aging are characterized in that the formula components in the S4 comprise 15-25% of soybean isoflavone extract, 8-15% of rhodiola rosea extract, 5-10% of epimedium extract, 3-8% of medlar polysaccharide, 1-3% of vitamin E, 0.5-1.5% of selenium yeast and the balance of pharmaceutical excipients, and all the components are screened by a 80-mesh screen.
  6. 6. The formula and the preparation process for repairing and improving the ovarian aging are characterized in that the auxiliary materials in the S4 comprise 40-50% of microcrystalline cellulose, 3-5% of crospovidone, 0.5-1.5% of magnesium stearate and 0.2-0.8% of silicon dioxide.
  7. 7. The formulation and preparation process for repairing and improving ovarian aging according to claim 1, further comprising the step of performing active ingredient stabilization treatment after S3, wherein the purified extract is subjected to spray drying under the conditions of vacuum degree of-0.08 to-0.1 megapascals and temperature of 50 to 60 ℃, the feeding rate is 10to 20 liters per hour, the atomization pressure is 0.2 to 0.4 megapascals, and the water content is lower than 5%.
  8. 8. The formulation and preparation process for repairing and improving ovarian aging according to claim 1, further comprising the step of performing intermediate quality detection before S5, performing content uniformity inspection, dissolution measurement and microorganism limit inspection on the uniformly mixed particles, wherein the content of main active ingredients in each unit preparation is in the range of 90-110% of the marked amount, the dissolution in 45 minutes is not less than 80%, and the total number of aerobic bacteria is less than 1000 per gram.
  9. 9. The formula and the preparation process for repairing and improving the ovarian aging are characterized in that soybean isoflavone extract in the formula comprises three main isoflavones of genistein, soybean flavone and glycitein, wherein the genistein content is 45-55% of the total isoflavone content, the soybean flavone content is 30-40% of the total isoflavone content, the glycitein content is 10-15%, rhodiola rosea extract is prepared by taking dried roots and rhizomes of rhodiola rosea as raw materials, extracting with ethanol under reflux and purifying with macroporous adsorption resin, wherein the rhodiola rosea glycoside content is not lower than 2%, the tyrosol content is not lower than 0.5%, the total polysaccharide content is not lower than 15%, the epimedium extract is prepared by taking dried leaves of epimedium koreanum as raw materials through an aqueous extraction and alcohol precipitation method, the total flavone content is not lower than 5%, the lycium barbarum polysaccharide is prepared by taking dried fruits of lycium barbarum as raw materials through hot water extraction, alcohol precipitation and sevage method deproteinization, and the polysaccharide content is not lower than 50%, and the protein content is lower than 2%, and the molecular weight is 10000-500 daltons.
  10. 10. The formula and the preparation process for repairing and improving the ovarian aging are characterized by further comprising an online quality monitoring system, wherein a near infrared spectrum probe is arranged in a key process step, the content of active ingredients and the content of moisture are monitored in real time, monitoring data are fed back to a central control system, process parameters are automatically adjusted, the particle size distribution of each component in the formula is controlled to be less than 75 microns in D90, the relative standard deviation of the content of the active ingredients among different batches is controlled to be less than 3%, and the product is subjected to accelerated test for 6 months under the conditions of 40 ℃ and 75% of relative humidity, wherein the content of the main active ingredients is maintained to be more than 95% of the initial content.

Description

Formula and preparation process for repairing and improving ovarian aging Technical Field The application relates to the technical field of repairing and improving ovarian aging, in particular to a formula for repairing and improving ovarian aging and a preparation process thereof. Background With the continuous improvement of female health consciousness, the maintenance of ovarian function has become a key link for delaying aging and guaranteeing reproduction and general health. The ovaries are used as core organs for regulating female endocrine and reproductive functions, and the functional decline of the ovaries not only causes perimenopausal symptoms such as menstrual disorder, hot flashes, insomnia and the like, but also obviously increases the long-term health risks such as osteoporosis, cardiovascular diseases, cognitive dysfunction and the like. Currently, the need for intervention of ovarian aging is urgent, especially in the context of increased lifestyle pressure, increased environmental toxin exposure and frequent iatrogenic injuries, premature ovarian failure and decreased reserve function present a trend of younger, and there is a need for safe, effective and long-term applicable repair strategies. The technical path for repairing and improving the ovarian aging mainly covers the directions of hormone replacement, surgical intervention, traditional Chinese medicine conditioning, dietary supplements and the like. Although hormone replacement therapy can rapidly relieve symptoms, serious tabu risks such as breast cancer, thrombus and the like exist, ovarian tissue injury cannot be reversed, an operation method is only suitable for specific organic lesions, the wounds are large, the indications are narrow, the traditional Chinese medicine compound has the overall conditioning advantages, but is limited by unknown components, slow onset of action and formulation lag, the traditional dietary supplement mostly adopts single or simple compound components, lacks systematic targeting design for core pathological mechanisms such as oxidative stress, mitochondrial dysfunction, follicular apoptosis and the like, is generally not fully clinically verified, and has insufficient curative effect reliability. In the prior art, the preparation process of the related formula also has obvious defects. The conventional physical mixing is difficult to release plant active ingredients, and key substances such as thermosensitive polyphenol, peptides and the like are easy to damage due to high temperature or organic solvent extraction, so that the bioactivity is lost, and meanwhile, the accurate quantification and standardized control of the active ingredients are lacked, so that the quality fluctuation among batches of products is large, the stability is poor, and the safety and the repeatability of clinical application are seriously influenced. Therefore, a formulation and preparation process for repairing and improving ovarian aging are needed. Disclosure of Invention The invention aims to provide a prescription for repairing and improving ovarian aging and a preparation process thereof, so as to solve the technical problems in the background technology. In order to achieve the aim, the invention provides the following technical scheme that a formula for repairing and improving the ovarian aging and a preparation process thereof comprise the following steps: S1, screening and preprocessing raw materials, carrying out sensory inspection, physical and chemical index detection and microorganism limit inspection on plant raw materials according to preset quality standards, removing unqualified products, and carrying out cleaning, drying and preliminary crushing treatment on the qualified raw materials; S2, extracting active ingredients, namely performing multistage countercurrent extraction at a temperature range of 40-60 ℃ by adopting a dynamic circulation countercurrent extraction technology and taking water or ethanol water solution with specific concentration as an extraction solvent; S3, refining and purifying the extracting solution, sequentially carrying out graded purification on the obtained extracting solution through ceramic membrane microfiltration, hollow fiber ultrafiltration and reverse osmosis membrane separation systems, removing macromolecular impurities, colloid particles and part of inorganic salts, and collecting active ingredients within a target molecular weight range; S4, compounding the formula components, mixing the purified active ingredients with pharmaceutically acceptable auxiliary materials according to a preset proportion, wherein the auxiliary materials comprise a filler, a disintegrating agent, a lubricant and a stabilizer, and mixing the powder by adopting an equivalent incremental method; And S5, forming and packaging the preparation, granulating the uniformly mixed powder by adopting a dry granulation or wet granulation process, pressing into tablets or filling into capsule shells,