CN106913515B - Taurine-chelated calcium external preparation for reestablishing skin barrier steady state and application thereof - Google Patents
Taurine-chelated calcium external preparation for reestablishing skin barrier steady state and application thereof Download PDFInfo
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- CN106913515B CN106913515B CN201510987963.XA CN201510987963A CN106913515B CN 106913515 B CN106913515 B CN 106913515B CN 201510987963 A CN201510987963 A CN 201510987963A CN 106913515 B CN106913515 B CN 106913515B
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- CN
- China
- Prior art keywords
- taurine
- calcium
- chelated calcium
- external preparation
- chelated
- Prior art date
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 title claims abstract description 230
- 239000011575 calcium Substances 0.000 title claims abstract description 226
- 229910052791 calcium Inorganic materials 0.000 title claims abstract description 226
- 238000002360 preparation method Methods 0.000 title claims abstract description 78
- 230000008591 skin barrier function Effects 0.000 title claims description 16
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 claims abstract description 222
- 229960003080 taurine Drugs 0.000 claims abstract description 111
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 43
- 239000013522 chelant Substances 0.000 claims abstract description 18
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- 238000010521 absorption reaction Methods 0.000 claims description 65
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 claims description 38
- 229910001424 calcium ion Inorganic materials 0.000 claims description 38
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 33
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 27
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- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 14
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- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 14
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Abstract
The invention discloses an external preparation containing taurine chelated calcium and application thereof, wherein the external preparation mainly comprises the following components: taurine chelate calcium, water, penetration enhancer and preservative. The external preparation containing taurine chelated calcium mainly has the function of repairing human epidermis barrier system, so as to achieve the effects of protecting skin, moisturizing, tightening, anti-allergy and the like, and can be applied to cosmetic external preparations, pharmaceutical external preparations, health product external preparations, medical and health external preparations and the like.
Description
Technical Field
The invention relates to an external preparation containing taurine chelated calcium for treating skin diseases or supplementing calcium to the whole body system, which can be used for directly supplementing calcium to the skin system of a human body, solves the problems of calcium deficiency and calcium disorder of the skin, has the effects of repairing skin barriers, preserving moisture, resisting inflammation and the like, researches a penetration promoting system suitable for the taurine chelated calcium preparation, and enhances the transdermal absorption effect of the taurine chelated calcium preparation. Can be used in the fields of cosmetics, medicines, health products, medical treatment and health care, etc. Also provides a preparation method of the taurine chelated calcium external preparation.
Background
Calcium is very important to human skin, the American skin medical community firstly discovers the importance of calcium ions to the skin and forms a theoretical basis, the calcium ions are considered to play a very important role in the steady state and the repair process of the skin barrier function, and at present, some hospital preparations are developed by the domestic medical community for the repair treatment of damaged skin.
A calcium ion concentration gradient exists in the epidermis of normal human skin, the calcium ion concentration is distributed in a T shape with a lower basal layer concentration and a higher concentration closer to the stratum corneum, and the calcium ion concentration inside and outside the cell is also increased from low to high. The special concentration gradient distribution of calcium ions in the epidermis regulates and controls the proliferation, normal division and differentiation of epidermal cells, synthesis of sebum among cells and intercellular connection, thereby influencing the formation and self-discipline of skin barriers and the regeneration of damaged skin. The American Dermatology community has shown that after epidermal injury, such as immediate recovery and maintenance of epidermal calcium ion concentration gradient, the recovery of skin barrier function is accelerated significantly (80% in 24 hours), while the wound surface with calcium ion concentration is not recovered in time, and the skin barrier function is recovered only 50%. Bathing in calcium-rich dead sea water can improve skin diseases related to skin barrier damage, such as allergic dermatitis, psoriasis, eczema, etc., and increase skin water content, all proved by using high-concentration calcium ions to accelerate normal skin barrier regeneration.
More and more researches show that the normal concentration gradient of calcium ions in the epidermis layer of the skin is adjusted, and the skin is repaired and the skin barrier is regenerated automatically; the treatment of skin diseases associated with impaired skin barrier is of considerable importance.
The human skin system calcium deficiency phenomenon is ubiquitous and relatively serious, various skin diseases can be caused by the human skin calcium deficiency, the skin barrier effect is poor, the human skin is susceptible to inflammation, is easy to damage, has long healing period after damage, is dry and sensitive, has imbalance of water and oil balance, accelerates skin aging, has weak environmental tolerance and other various skin problems, and particularly, various poor skin states can be caused easily when the facial skin is in a naked state and is influenced by adverse environments such as strong ultraviolet rays, pollution, radiation and the like. The long-term calcium deficiency of the human skin system is mainly caused by the following two factors:
1. ionic calcium deficiency in humans
Calcium in a human body is in a dynamic loss state for a long time, and at present, two ways of calcium supplement are provided for the human body, one way is to supplement the calcium by an oral way, and various calcium supplement preparations are mainly oral calcium tablets and oral liquid; one is to supplement calcium by intravenous injection, but the method of intravenous injection has great danger and needs to be carried out by a professional physician, so the current common calcium intake method is only oral calcium supplement.
When a human body is in a state of calcium deficiency, the orally supplemented calcium preparation is preferentially used for supplementing combined calcium required by bones, teeth and the like, and at the moment, the supplemented calcium loses physiological activity and can not be supplemented or can only be supplemented with ionized calcium in a very small amount, but the physiological activity for regulating the organism is insufficient, so that the calcium ion is transported to the epidermis layer through blood circulation to keep the balanced steady state of the calcium ion of the epidermis layer under the condition of calcium deficiency of the human body is very difficult.
Oral calcium preparations are difficult to absorb, have low absorption rate and are complicated by a large number of factors, which are mainly caused by the complex environment of the gastrointestinal tract. The oral supplementary calcium agent is digested and absorbed through gastrointestinal tracts, the stomach environment belongs to a strong acid environment, the pH value changes from 0.8 to 3.6, the small intestine environment belongs to weak alkalinity, the pH value changes from 7.2 to 8.0, the change of the acid-base environment is unfavorable for the absorption of calcium ions, for example, the calcium ions are easy to form a gelatinous calcium hydroxide precipitate in an alkaline intestinal tract environment, so that the calcium ions are difficult to be absorbed by a human body, and meanwhile, the gelatinous matter can be adhered to the intestinal wall to further influence the absorption of other nutrient elements. In particular, oral administration of calcium is susceptible to contamination by anions in the gastrointestinal tract to generate insoluble calcium, which greatly reduces the absorption rate of calcium ions, and for example, phytic acid, oxalic acid, alkaline phosphate, fat, uronic acid residues in dietary fibers, nucleotides, uric acid, and the like contained in ingested food can react with calcium ions to generate insoluble or poorly soluble calcium oxalate, calcium phytate, alkaline calcium phosphate, calcium urate, and the like, which not only interferes with the absorption of calcium ions, but also causes calcium to precipitate in tissues as calcifications, and continuously deposit in organs to form calculi, thus affecting the health of the body.
2. The human epidermal system has no blood circulation system, and the calcium ions with physiological activity are difficult to transport
The human body mainly conveys absorbed nutrient substances to all parts of each system of the human body through a blood circulation system, but a blood system does not exist in an epidermal system, the nutrient substances are mainly conveyed through tissue fluid, but the conveying amount and the conveying efficiency are very low, meanwhile, because the oral calcium ions are preferentially used for combining the requirement of calcium, the required ionized calcium is difficult to supplement to the epidermal system through oral administration, the ionized calcium with physiological activity is very important for maintaining the steady state and the health of the epidermal system of the human body, the epidermal system of the human body is the first defense line of the organism for resisting dehydration, injury, infection and bacteria, the normal ionized calcium concentration is the most main factor for maintaining the stability and the repair of the epidermal barrier system of the epidermal system of the human body after damage, and the epidermal barrier can be damaged when the calcium ions are deficient or disordered, thereby causing various skin problems and even pathological changes, maintaining normal calcium ion concentration in the epidermal system is very important for the epidermal barrier to remain stable or repair after damage. Therefore, it is very important to directly supplement physiologically active ionized calcium which is easily absorbed through the skin, especially to maintain the calcium balance of the epidermal system.
3. At present, the market lacks of external targeted calcium supplement
At present, various calcium supplements in the market are oral preparations, including various calcium tablets and oral liquids, which are mainly developed aiming at a special digestive system of the gastrointestinal tract, the pH value of the gastrointestinal tract is between 1.5 and 3.2, the calcium supplements belong to a strong acid environment, calcium ions are polluted by various bacteria, organic acids and anions, and become insoluble substances which are not absorbed by a human body, the normal pH value range of the human epidermis is between 5.2 and 6.5, and the calcium supplements belong to a weak acid environment, so the oral calcium generally used for the digestive absorption of the gastrointestinal tract is difficult to be absorbed by the skin. Meanwhile, inorganic calcium and ionic organic calcium such as calcium chloride, calcium carbonate, calcium lactate, calcium propionate, calcium citrate, calcium gluconate and the like are generally selected for oral calcium preparations, all of the calcium preparations are in an ionic state, and some calcium salts have the problem of poor solubility, so that in the field of percutaneous absorption, insoluble compounds and ionic compounds are very difficult to absorb.
Meanwhile, no scholars are available to research the problem of percutaneous absorption of calcium, so that research on calcium supplement agents beneficial to percutaneous absorption is very necessary and is a very innovative research subject, the mode of percutaneous absorption of calcium supplement can realize direct supplement of ionic calcium with physiological activity to a body, particularly, targeted calcium supplement to an epidermal system without a blood circulation system can be realized preferentially, the absorption efficiency is high, the influence of special and complex environments of the gastrointestinal tract is avoided, and the problem of low absorption utilization rate caused by the fact that calcium ions are easily polluted by anions can be solved.
In the field of cosmetics, all creams and water aqua cannot guarantee the action time of the cream and the water aqua on the face, particularly the water aqua is easy to evaporate and dissipate from the surface layer of the skin, so if calcium ions in the cosmetics cannot be absorbed and utilized by the skin in the shortest possible time, the corresponding action cannot be achieved due to the loss. Therefore, it is very important to increase the amount of calcium ions absorbed in the first 2 to 3 hours.
Therefore, the development of a calcium supplement preparation capable of being directly absorbed through skin and the research on the transdermal absorption effect of the penetration promoting system for enhancing calcium are necessary for reestablishing the steady gradient of epidermal calcium ions and further accelerating the repair of the epidermal barrier function, and the repair of the epidermal barrier can be improved in an all-round way.
Disclosure of Invention
In view of the importance of calcium to skin and the problems of calcium percutaneous absorption, the invention provides an external preparation containing taurine-chelated calcium, which mainly takes the taurine-chelated calcium as a main component and is matched with a permeation-promoting system to form the external preparation containing the taurine-chelated calcium, thereby solving the problem that the existing calcium preparation is difficult to be absorbed through skin and greatly improving the absorption capacity of the first 2 h-3 h. The water aqua of the invention is used in cosmetics and has good effects of moisturizing, resisting inflammation, restoring skin barrier and the like. The taurine chelated calcium external preparation can also be added with medicinal components with other efficacies, such as spot removing, whitening, sterilization, bacteriostasis, inflammation diminishing, pain relieving, nutrition supplementing and the like.
The invention compares the percutaneous absorption performance of the taurine chelated calcium with that of various calcium preparations sold on the market, and compares the percutaneous absorption effect of the taurine chelated calcium, the calcium chloride and the calcium gluconate aqueous solution, so that the taurine chelated calcium has good percutaneous absorption performance compared with other calcium preparations, particularly the percutaneous absorption amount of the taurine chelated calcium is far greater than that of the calcium chloride and the calcium gluconate in the initial stage, and the total absorption amount in 6 hours is far greater than that of the calcium chloride and the calcium gluconate.
The present invention also studies the effect of different amounts of calcium taurine chelate on the percutaneous absorption performance, and when the concentration of calcium taurine chelate is increased, the percutaneous absorption performance is increased, and particularly, the percutaneous absorption effect at the initial stage can be increased, and within the initial 1h, the percutaneous absorption amount of calcium taurine chelate with the concentration of 2% is about 9 times that of 0.5% and about 4 times that of 1%, which is very important for the application in cosmetics. Meanwhile, the absorption rate in 6h at the concentration of 2% reaches 75%, which is much higher than 37% at the concentration of 0.5%, and the total absorption amount in 6h at the concentration of 2% is 10 times or more of 0.5%.
The taurine-chelated calcium external preparation of the invention comprises less than 60.00% by mass, preferably less than 40% by mass, more preferably less than 20% by mass, and still more preferably less than 8% by mass of taurine-chelated calcium.
In the process of percutaneous absorption of the medicine, the penetration promoting system plays an important role in effectively improving the percutaneous absorption rate of the medicine, and due to the particularity of the dosage form of the liquid spray, the penetration promoting system is very important for quickly absorbing the effective components in the liquid spray.
Typical transdermal enhancers for pharmaceutical compositions include the following classes: terpenes, essential oils and lactones (such as menthol, borneol, eucalyptus oil, extracts of ligusticum chuanxiong hort and cardamom), pyrrolidones, phospholipids and phosphates, organic acids and esters and amides, surfactants, oleic acid, laurocapram, mints and polyols, and some amino acids and polysaccharides are newly found to have the penetration promoting effect. However, among these types of penetration enhancers, only the penetration enhancers of polyols, amino acids, and polysaccharides do not destroy the epidermal barrier, i.e., the stratum corneum, and other types of penetration enhancers increase the transdermal absorption effect of drugs by destroying the stratum corneum such as thinning the thickness of the stratum corneum and reducing the adhesion between corneocytes, while in cosmetics, in particular, taurine chelated calcium spray has an important effect of regulating and repairing the epidermal barrier function, so the present invention focuses on the research on the polyol system, amino acids, and polysaccharides, and selects one or more of them, wherein the penetration enhancers of polyols, polysaccharides, and amino acids also have the effects of moisturizing agents and nutritional agents;
the taurine chelated calcium external preparation of the invention has a mass percentage content of the penetration enhancer of less than 80.00%, preferably less than 50%, more preferably less than 30%.
Selection of the penetration enhancing system of the present invention for the polyol system: through research on the influence of the types and the proportion relation of the polyols on the percutaneous absorption performance of the taurine-chelated calcium, the research discovers that the permeation promoting effect of the polyols on the taurine-chelated calcium is better than that of the polyols when the polyols are used alone, the proportion relation of the polyols has different influence on the percutaneous absorption performance of the taurine-chelated calcium, and the polyol permeation promoter comprises one or more of glycerol, pentanediol, butanediol and propanediol. Wherein the content of the glycerol is less than 30 percent by mass, preferably less than 15 percent by mass and more preferably less than 6 percent by mass; the mass percentage content of the propylene glycol is less than 50 percent, preferably less than 30 percent, and more preferably less than 10 percent; the mass percentage content of the butanediol is less than 50%, preferably less than 30%, more preferably less than 10%; the mass percentage content of the pentanediol is less than 50%, preferably less than 30%, more preferably less than 10%.
The invention considers the influence of the addition amount of the polyol permeation-promoting system on the percutaneous absorption performance of the taurine-chelated calcium, finds that the polyol permeation-promoting system has great influence on the taurine-chelated calcium, the permeation-promoting effect is increased along with the increase of the addition amount, particularly, the polyol permeation-promoting system has obvious influence in the initial 1h, when the addition amount reaches 6 percent and 8 percent, the percutaneous absorption amount of the taurine-chelated calcium is not greatly different, and shows that the permeation-promoting effect gradually reaches the peak value when the addition amount of the polyol system reaches 6 percent, and the polyol permeation-promoting system is very favorable for the percutaneous absorption effect of the taurine-chelated calcium in 1 h.
The invention also considers the influence of the amino acid substance on the percutaneous absorption performance of the taurine-chelated calcium, and finds that the amino acid substance has a permeation promoting effect on the percutaneous absorption of the taurine-chelated calcium, which is probably caused by the amino group with a lipid structure and the carboxyl group with a hydrophilic structure which are simultaneously contained in the amino acid substance, and the structure with the amphipathy can possibly promote the percutaneous absorption effect of the medicine. The weight percentage content of amino acid substances in the taurine chelated calcium preparation is less than 50%, preferably less than 20.00%, and more preferably less than 6%.
The invention also considers the influence of polysaccharide substances on the percutaneous absorption effect of the taurine-chelated calcium, and finds that the polysaccharide substances have the permeation promoting effect on the percutaneous absorption of the taurine-chelated calcium, which is probably because the polysaccharide substances can absorb water and keep the water content in the skin, and the increase of the water content in the skin can soften the horny layer, reduce the barrier effect of the horny layer and increase the percutaneous absorption effect of the medicine components. The polysaccharide substances comprise trehalose, tremella polysaccharide, hydrolyzed chitin, sodium hyaluronate, zymosan and soluble proteoglycan, polysaccharide trehalose and hyaluronic acid are particularly selected for carrying out a transdermal effect influence experiment of taurine chelated calcium, and the influence of the addition amount of the trehalose and the hyaluronic acid on the taurine chelated calcium is researched, the result shows that the trehalose and the sodium hyaluronate have a permeation promoting effect on the percutaneous absorption of the taurine chelated calcium, but the sodium hyaluronate has a certain dose effect on the permeation promoting effect of the taurine chelated calcium, namely the sodium hyaluronate has the permeation promoting effect on the taurine chelated calcium within a certain concentration range, and when the concentration is higher than a certain concentration, the sodium hyaluronate has a percutaneous absorption and retraction inhibiting effect on the taurine chelated calcium, which is probably because substances with high molecular weight can adsorb or wrap medicinal ingredients so as to reduce the release rate of the medicament, further resulting in a decrease in the transdermal effect of the pharmaceutical ingredient. Meanwhile, the polysaccharide substances also have the effects of moisturizing, increasing the water content of the skin and further helping to improve the skin.
In the external preparation containing taurine-chelated calcium of the invention, the mass percentage of polysaccharide substances is less than 50%, preferably less than 20.00%, and more preferably less than 6%.
The taurine-chelated calcium external preparation comprises 0.01-99.99 wt% of water, preferably 5-99 wt%, more preferably 10-99 wt%, and even more preferably 20-99 wt%.
The taurine-chelated calcium external preparation further comprises a preservative, and the content of the preservative is less than 5%, preferably less than 1%.
The taurine chelated calcium external preparation can also contain other medicinal nutritional ingredients with the effects of removing freckles, whitening, sterilizing, inhibiting bacteria, diminishing inflammation, controlling oil, removing scars, supplementing nutrition and the like.
The taurine chelated calcium external preparation can be used as cosmetics, pharmaceutical external preparations, health product external preparations and medical and health external preparations.
When the external preparation of taurine chelated calcium is prepared by an integrated method, the central ion source required for synthesizing the taurine chelated calcium can be inorganic calcium salt such as calcium chloride, calcium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium silicate and the like, can also be non-chelated organic calcium salt such as calcium lactate, calcium propionate, calcium citrate, calcium gluconate and the like, can also be calcium oxide and calcium hydroxide, can be derived from calcium in mineral substances, and can also be biological sources such as bones of animals and the like; preferably calcium chloride, calcium carbonate, calcium lactate, calcium propionate, calcium citrate, calcium oxide, and calcium hydroxide.
The invention aims to prepare an external preparation containing taurine chelated calcium, which can be quickly absorbed by skin to fully absorb and utilize calcium by skin, and comprises two preparation methods: a step method and an integrated method, which are mainly used in the preparation process of the taurine chelated calcium. Wherein the step method comprises preparing taurine chelated calcium crystal, and preparing into external preparation containing taurine chelated calcium with other components such as penetration enhancer, nutritional agent, medicinal effective component and water under certain temperature, pH value and stirring speed; the integrated method is that a safe and non-irritating calcium source is selected to prepare the original solution containing the taurine-chelated calcium during the preparation of the taurine-chelated calcium, the original solution containing the taurine-chelated calcium is directly prepared with other components such as a penetration enhancer, a nutritional agent, a medicine functional component and water under the conditions of certain temperature, pH value and stirring speed without crystallizing and purifying the taurine-chelated calcium.
Detailed Description
Example 1
1. Preparing taurine chelated calcium: in the experiment, taurine is used as a ligand, and one of calcium chloride, calcium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium silicate, calcium lactate, calcium propionate, calcium citrate and calcium gluconate is arbitrarily selected as a calcium source for providing central ion calcium to prepare the amino acid chelated calcium for further experimental research, which specifically comprises the following steps:
1) weighing 45 g of taurine, dissolving the taurine in 150 ml of deionized water in a three-neck flask, heating the taurine in water bath to 80 ℃ and keeping the temperature constant until the glutamic acid is completely dissolved;
2) weighing 20g of calcium lactate, completely dissolving in enough water, and adjusting the pH value to 7.8;
3) gradually adding the calcium lactate solution prepared in the step 2) into the taurine solution in the step 1) dropwise, adding the calcium lactate solution while stirring gently, and keeping a constant temperature state in the stirring process;
4) after the calcium lactate solution is added, the reaction is carried out for about 60min, and the reaction is finished;
5) filtering to remove impurities, and directly using the filtrate or evaporating the filtrate until taurine chelated calcium is separated out, drying and crushing for later use;
2. qualitative detection of taurine-chelated calcium
Since calcium in the aqueous solution of taurine-chelated calcium does not exist in an ionic form, whether amino acid-chelated calcium is generated or not can be determined by detecting whether free calcium ions and free amino acid radicals exist in the obtained substance after the reaction, and the generation of amino acid-chelated calcium can be qualitatively detected. The experiment mainly compares the change before and after the reaction through the color reaction of the dithiohydrazone reagent and free metal calcium ions or the color reaction of the ninhydrin reagent and the taurinic acid radical to determine whether to generate the taurine chelated calcium, and the specific experiment is as follows:
reagent for experimental qualitative detection: a dithiohydrazone reagent, a ninhydrin reagent and sodium sulfide.
Purification of taurine chelated calcium: the experiment mainly eliminates the influence of unreacted calcium ions and taurine in the prepared taurine chelated calcium product.
Removing free calcium ions: weighing a small amount of the prepared sample of the taurine-chelated calcium, adding a proper amount of absolute ethyl alcohol, fully stirring, standing for a period of time for precipitation, filtering, adding a few drops of the dithizone reagent into a small amount of filtrate, observing whether the filtrate changes color, continuously washing and purifying the taurine-chelated calcium according to the method if the filtrate changes color until the filtrate does not change color after the dithizone reagent is added, so as to ensure that metal calcium ions are completely removed;
removing free taurine: dissolving a little of taurine chelated calcium from which free calcium ions are removed in water, adding a few drops of ninhydrin reagent, heating until the solution boils, if the color of the solution changes to bluish purple, then the free taurine still exists in the sample, and continuing to purify by using absolute ethyl alcohol as a purifying agent until the color of the heated solution does not change to bluish purple, so as to ensure that the free taurine is completely removed.
Example 2
Influence of the content of taurine-chelated calcium on the percutaneous absorption effect: in the invention, the comparison of the percutaneous absorption amounts of taurine-chelated calcium with different concentrations is carried out, taurine-chelated calcium solutions with concentrations of 0.5%, 1%, 1.5% and 2% are respectively prepared, a mouse skin is taken as a model, a 0.9% sodium chloride aqueous solution is taken as a receiving solution, the comparison of the transdermal performances of the taurine-chelated calcium aqueous solution within 6 hours under the condition of no addition of a penetration enhancer is investigated in a Franz intelligent transdermal diffusion cell, and the obtained results are shown in the following table:
TABLE 1 percutaneous absorption of taurine-chelated calcium at different concentrations
From the above experimental results, it can be seen that the higher the concentration of taurine-chelated calcium, the better the percutaneous absorption effect.
Example 3
Effect of the percutaneous absorption effect of taurine chelated calcium and other calcium agents: comparing the transdermal effect of the taurine chelated calcium with that of other different calcium agents, respectively preparing a taurine chelated calcium solution, a calcium chloride solution and a calcium gluconate solution with the same concentration of 2%, taking mouse skin as a model, selecting a 0.9% sodium chloride aqueous solution as a receiving solution, and examining the transdermal performance of the solutions within 6 hours in a Franz intelligent transdermal diffusion cell under the condition that no penetration enhancer is added, wherein the results are as follows:
TABLE 2 comparison of the percutaneous absorption effects of taurine chelated calcium-calcium chloride-calcium gluconate
| Time/h | Taurine chelated calcium | Calcium chloride | Calcium gluconate |
| 0.25 | 4.8193 | 0.1837 | 0.6608 |
| 0.5 | 5.9813 | 0.3479 | 1.1971 |
| 0.75 | 7.1741 | 0.5663 | 1.7874 |
| 1 | 8.5438 | 0.7517 | 2.3913 |
| 1.5 | 11.1079 | 1.1083 | 3.3703 |
| 2 | 13.1157 | 1.4172 | 4.5388 |
| 3 | 16.0673 | 1.7461 | 5.6717 |
| 4 | 18.2714 | 2.0783 | 6.5419 |
| 6 | 21.1469 | 2.3893 | 7.3272 |
From the above experimental results, the percutaneous absorption effect of the taurine chelated calcium is far better than that of other ionic calcium preparations.
Example 4
The influence of the polyalcohol penetration promoting system on the percutaneous absorption performance of the taurine-chelated calcium is as follows: in the invention, the influence of different polyalcohol systems on the percutaneous absorption performance of the taurine-chelated calcium is determined, mixed liquid of butanediol, propylene glycol and 1, 2-pentanediol in different proportions is prepared as penetration promoting liquid, in addition, a taurine-chelated calcium solution with a certain concentration is prepared, a mouse skin is taken as a model, a 0.9% sodium chloride aqueous solution is taken as a receiving liquid, the transdermal performance of the taurine-chelated calcium aqueous solution in 6 hours is compared under the condition that the penetration promoting liquid is added in a Franz intelligent transdermal diffusion cell, and the results are shown in the following table:
TABLE 3 Effect of different polyol systems on the transdermal absorption of taurine-chelated calcium
As can be seen from the above experimental results, different polyol permeation-promoting systems have different effects on the percutaneous absorption effect of calcium taurine chelate, and therefore, it is very useful to study the percutaneous absorption of calcium taurine chelate by different polyol permeation-promoting systems.
Example 5
In the invention, the influence of the addition amount of different polyol penetration-promoting systems on the percutaneous absorption performance of the taurine chelated calcium is determined according to the following steps of: propylene glycol: 1, 2-pentanediol = 1: 2: 2, preparing a penetration promoting liquid, preparing a taurine chelated calcium solution with the concentration of 2%, taking a mouse skin as a model, selecting a 0.9% sodium chloride aqueous solution as a receiving liquid, and observing the transdermal performance of the taurine chelated calcium aqueous solution within 6 hours when the addition amounts of the penetration promoting liquid are respectively 0, 2%, 6% and 8%, in a Franz intelligent transdermal diffusion cell, wherein the results are shown in the following table:
TABLE 4 influence of different polyol permeation-promoting system addition amounts on the transdermal absorption amount of taurine-chelated calcium
From the above experimental results, it can be seen that the addition amount of the polyhydric alcohol has a certain influence on the percutaneous absorption effect of the taurine chelated calcium.
Example 6
The invention relates to a method for measuring the influence of polysaccharide substances on the percutaneous absorption performance of taurine-chelated calcium, which mainly considers the influence of trehalose and sodium hyaluronate on the percutaneous absorption performance of taurine-chelated calcium and researches the influence of the addition amount of the trehalose and sodium hyaluronate on the taurine-chelated calcium, and the specific method comprises the following steps:
preparing a taurine-chelated calcium solution with the concentration of 2%, taking mouse skin as a model, selecting a 0.9% sodium chloride aqueous solution as a receiving solution, and examining the percutaneous absorption effect of the taurine-chelated calcium when the permeation enhancer is respectively added with trehalose in an amount of 0%, 1% and 2% and added with hyaluronic acid in an amount of 0%, 0.05%, 0.15% and 0.2% in a Franz intelligent transdermal diffusion cell, wherein the results are shown in the following table:
TABLE 5 influence of the amount of trehalose added on the amount of calcium taurine chelate absorbed transdermally
TABLE 6 influence of different amounts of sodium hyaluronate on the transdermal absorption of calcium taurine chelate
From the above experimental results, it can be seen that the polysaccharide substances have different effects on the percutaneous absorption effect of the taurine-chelated calcium, and have certain quantitative efficacy on the permeation promoting effect of some polysaccharide substances on the taurine-chelated calcium.
Example 7
The preparation method of the taurine chelated calcium water agent comprises the following steps: step by step method
1) Preparing a taurine chelated calcium crystal, putting 30% taurine solution and calcium lactate into a reaction container, adjusting the pH value to 7.5 with lactic acid, heating to 80 ℃, reacting for 140min, and drying the solution to obtain a taurine chelated calcium sample. And (3) adding anhydrous ethanol into a taurine chelated calcium sample, fully stirring, standing for a period of time, filtering, and adding a few drops of dithiol reagent into the filtrate. If the filtrate turns red, indicating that free metallic calcium ions may be present in the sample, the washing with ethanol is continued until the color of the dithiol tracer reagent does not change. A small sample was taken from the sample from which the free metallic calcium ions had been removed, dissolved in water, a few drops of ninhydrin reagent were added, and heated to boiling on an electric furnace. If the color changes to blue-purple, indicating that free taurine may be still present in the sample, washing with absolute ethanol is continued until the ninhydrin color reaction appears colorless. Drying the separated and purified sample in a freeze dryer to obtain a taurine chelated calcium sample with good purity;
2) weighing the following components in percentage by weight:
2% of taurine chelated calcium, 2% of trehalose, 0.15% of sodium hyaluronate, 1% of propylene glycol, 1% of glycerol, 2% of butanediol, 2% of 1, 2-pentanediol, 0.2% of taurine, 2% of hamamelis water, 0.05% of an antiseptic and antibacterial agent and 87.6% of deionized water;
3) preparing a penetration-promoting system solution, dissolving trehalose and taurine by using partial deionized water, adding sodium hyaluronate, continuously adding propylene glycol, glycerol, butanediol and 1, 2-pentanediol after full swelling and dissolution, and fully stirring and dissolving to obtain the penetration-promoting system solution;
4) dissolving taurine chelated calcium with the rest deionized water, adding the permeation promoting system solution, the hamamelis virginiana water and the antiseptic antibacterial agent after complete dissolution, and uniformly stirring;
5) discharging, bottling and packaging.
Example 8
The preparation method of the taurine chelated calcium water agent comprises the following steps: integrated method
1) According to the synthesis conditions of the taurine chelated calcium, the reaction conditions are determined as that the reaction time is 140min, the reaction pH value is 7.5, the reaction temperature is 80 ℃, and the concentration of the taurine is 30%;
2) weighing the following components in percentage by weight:
4% of taurine, 2% of calcium lactate, 2% of trehalose, 0.15% of sodium hyaluronate, 1% of propylene glycol, 1% of glycerol, 2% of butanediol, 2% of 1, 2-pentanediol, 2% of hamamelis water, 0.05% of antiseptic and antibacterial agent and 83.9% of deionized water;
3) preparing a penetration-promoting system solution, dissolving trehalose in partial deionized water, adding sodium hyaluronate, continuously adding propylene glycol, glycerol, butanediol and 1, 2-pentanediol after full swelling and dissolution, and fully stirring and dissolving to obtain the penetration-promoting system solution;
4) preparing 30% taurine solution, adding calcium lactate into the solution, stirring and heating to 80 ℃, adjusting pH to 7.5 with lactic acid, adding penetration-promoting system solution and Hamamelis virginiana water into the solution, reacting for 140min, adding antiseptic and antibacterial agent and residual deionized water into the solution, and stirring to obtain the water aqua containing taurine chelated calcium.
5) Discharging and packaging.
Example 9
And (3) investigating the stability of the taurine-chelated calcium aqueous solution: in this experiment, the stability of the taurine-chelated calcium preparation prepared in example 7 was examined, and the experimental results are shown below:
TABLE, stability of aqueous solutions of taurine chelated calcium under different conditions
From the above test results it can be seen that: the preparation of taurine chelated calcium is stable under different temperatures, and the stability is necessary for external liquid preparation, which indicates that the preparation is more suitable for preparing external water-containing preparation, such as spray, gel, smearing preparation, liniment and the like.
Example 10
In this experiment, the permeation promoting effect of laurocapram (Azone) on the percutaneous absorption of the taurine-chelated calcium is examined, the taurine-chelated calcium prepared in example 1 is used as a test sample in the experiment, a control group of Azone is arranged for carrying out the experiment, the transdermal test method is the same as that in the previous examples, the test time is 6h, and the experiment results are shown in the following table:
TABLE, Effect of Azone on the transdermal Performance of taurine chelated calcium
From the test results, the azo has a better promoting effect on the transdermal effect of the taurine chelated calcium.
Example 11
Effect of calcium taurine chelate on proliferation effect of isolated keratinocytes: in this experiment, the effect of the calcium taurine chelate on the recovery of the skin barrier effect was demonstrated by examining the effect of the calcium taurine chelate on the proliferation of isolated keratinocytes using the calcium taurine chelate prepared in example 1 as a test sample. In the test, mice are moved outwards to carry out an epidermal barrier repair test, taurine chelated calcium solution with certain concentration is used for treatment, a blank control group is additionally arranged for carrying out a parallel comparison test, epidermal keratinocytes are tracked by an immunofluorescence method, and the change condition of the keratinocytes in the proliferation process in the reconstructed epidermis after 24 hours is investigated. In the experiment, the change conditions of certain concentrations of taurine chelated calcium, calcium chloride and calcium gluconate on keratinocytes in the proliferation process in the epidermis reconstruction process are observed and compared, so that the proliferation effect of glutamic acid chelated calcium on keratinocytes in the epidermis barrier repair process is shown, and the specific results are shown in the following table:
proliferation effect of different calcium agents on keratinocytes in epidermal barrier repair process within 24h
| Blank group | Taurine chelated calcium | Calcium chloride | Calcium gluconate | |
| Keratinocyte growth rate/%) | 1.5 | 27.6 | 9.3 | 13.7 |
From the test results, the influence of the taurine-chelated calcium on the proliferation of the keratinocytes is the largest, which can indicate that the recovery performance of the taurine-chelated calcium on the barrier function of the epidermis of the skin is better than that of the group without the taurine-chelated calcium and other non-amino acid-chelated calcium.
Example 12
This experiment is with the taurine chelate calcium prepared in embodiment 1 as test sample, through designing blank group, the experiment of comparison control group, the influence of taurine chelate calcium to epidermis cuticle barrier recovery effect has been investigated, the influence of taurine chelate calcium to epidermis barrier recovery has been known directly perceivedly, carry out epidermis barrier repair experiment through mouse migrant skin in the experiment, use taurine chelate calcium spray to carry out 3 times/day's processing to the epidermis, carry out Trichrom-Masson dyeing to the epidermis layer in the experimentation, observe its epidermis thickness's the situation of change, the experimental result is shown below the table:
restoration of epidermal keratin layers by different calcium agents within 6 days
| Blank group | Taurine chelated calcium | Calcium chloride | Calcium gluconate | |
| Change in thickness of horny layer/%) | 0.9 | 24.7 | 7.5 | 9.3 |
The experimental results show that after the taurine chelated calcium is used for 6 days, the thickness of the epidermal layer of the skin is obviously increased and is superior to that of a blank group without the taurine chelated calcium and a control group without other calcium agents, and the taurine chelated calcium has an obvious effect in the epidermal barrier repair process.
Example 13
The taurine chelated calcium prepared in the example 1 is used as a raw material, the penetration enhancer in the previous example is added to prepare a spray, the test of a volunteer is carried out, a blank group, a control group and a test group are arranged in the test, the improvement and regulation effect of the taurine chelated calcium on the skin is examined, and the improvement and regulation effect is compared with other inorganic calcium and organic calcium. The test part is the face, the test time is two weeks, 40 tested volunteers are totally tested, 20 of the tested volunteers are dry sensitive skin, 20 of the tested volunteers are oily skin, other treatment modes are not carried out during the test period, and other skin care products are forbidden. The change conditions of the facial skin of the subject are tested by adopting a VISIA tester and SOFT5.5, including the change of the water content, the elasticity value, the sebum amount, the change of the facial pH value, the change of the facial bacterial growth, the skin glossiness, the tightening effect, the pore change, the anti-allergy effect, the adaptability of different types of skin and the like of the skin, and the repairing and regulating effects of the taurine-chelated calcium on the facial skin are comprehensively evaluated. VISIA skin image analysis tester and SOFT5.5 skin property test quantitatively evaluate the skin properties before and after treatment, and the indexes are as follows:
1) moisture content: the moisture value of the skin can be used for measuring the dryness degree of the skin and is one of important indexes for reflecting the barrier function of the skin; the higher the moisture test value is, the better the water replenishing effect is;
2) sebum: the skin oil secretion capacity is shown, and the higher the test result value is, the higher the oil content is shown;
3) elasticity: the higher the test result value, the better the skin elasticity is;
4) pH value: the low PH of oily skin is generally due to the fact that the secreted oil contains free fatty acids;
5) wrinkling: the dry lines, fine lines, static lines and other conditions of the face are reflected, and the wrinkles generally have close relation with the reduction of the elasticity of the skin;
6) texture: reflecting the smoothness and plumpness of the skin, the smaller the difference between the peak and the valley of the healthy stratum corneum is, the better the plumpness of the skin is, and the stronger the water locking and moisturizing capacities of the stratum corneum are;
7) purpurin: one of detection items concerned by oily skin has important significance for controlling skin inflammation and oil control effect, mainly detects metabolites of various bacteria at the hair follicle opening, such as propionibacterium acnes, malassezia and the like, and the lower the detection result is, the fewer the bacteria at the hair follicle opening are, and the bacteriostatic effect of the product is obvious;
8) pore: reflecting the dilation and flatness of sebaceous gland openings, because an open pore can be shaded and darker than normal skin color, VISIA uses this principle to identify the pores. Dry skin application test effects: the method comprises the following steps of randomly dividing 20 volunteers with dry skin types into 4 groups, wherein each group comprises 5 volunteers, namely a blank group, a taurine chelated calcium group, a calcium chloride group and a calcium gluconate group, observing effective volunteer cases in index change intervals of various projects in different groups in experiments, and carrying out effect comparison, wherein the experiment results are shown in the following table:
repairing effect of different calcium agents on dry skin
The application test effect of the oily skin is as follows: the results of an effect comparison test were performed by randomly dividing 20 volunteers of oily skin type into 4 groups of 5 persons each, namely a blank group, a taurine chelated calcium group, a calcium chloride group, and a calcium gluconate group, and the results of the test are shown in the following table:
repairing effect of different calcium agents on oily skin
The test results show that compared with the blank group, the calcium group has better skin repair effect than the blank group, and the taurine-containing chelated calcium group is obviously better than the calcium chloride group and the calcium gluconate group in the test groups of three different calcium agents, and is suitable for oily skin and dry skin, so that the taurine chelated calcium has good effect on repairing the skin epidermis barrier, and the skin barrier repair is different from simple water replenishing and moisture preserving in the improvement of the whole skin condition.
Example 14
The water aqua containing taurine-chelated calcium can be used for preparing cosmetic liquid spray, and spray and smearing preparations of other health care products and medicines with the effects of moisturizing, resisting inflammation, restoring skin barrier and the like.
Example 15
An external spray containing taurine-chelated calcium comprises the following components in percentage by mass: 0.5% of taurine chelated calcium, 2.5% of propylene glycol, 0.5% of glycerol, 4% of pentanediol, 0.3% of trehalose, 0.05% of sodium hyaluronate, 3% of witch hazel, 0.3% of glutamic acid, 0.2% of potassium sorbate, 0.5% of centella asiatica and 88.15% of deionized water.
Example 16
An external cream containing taurine-chelated calcium comprises the following components in percentage by mass: 1% of taurine chelated calcium, 3% of propylene glycol, 1.3% of glycerol, 3% of butanediol, 3.5% of squalane, 0.7% of tremella polysaccharide, 0.78% of VE1%, 1.5% of VC, 0.3% of proline, 0.1% of valine, 0.1% of potassium sorbate, 1.5% of emulsifier and 83% of deionized water.
Example 17
An external preparation containing taurine-chelated calcium comprises the following components in percentage by mass: 2% of taurine chelated calcium, 2% of propylene glycol, 5% of pentanediol, 2% of squalane, 0.6% of tremella polysaccharide, 0.2% of proline, 0.2% of leucine, 1% of whitening agents such as arbutin, glutathione, ellagic acid and the like, 1.5% of azone, 1.5% of emulsifier, 0.2% of preservative and 83.8% of deionized water.
While the foregoing is directed to embodiments of the present invention, and other embodiments and applications of the present invention, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the present invention.
Claims (16)
1. The external preparation containing the taurine-chelated calcium comprises the taurine-chelated calcium, water, a penetration enhancer and a preservative, wherein the mass percentage of the taurine-chelated calcium is less than 60.00 percent, the mass percentage of the water is more than 20.00 percent, the mass percentage of the penetration enhancer is less than 80.00 percent, the mass percentage of the preservative is less than 5 percent, and the external preparation containing the taurine-chelated calcium does not contain vitamin D; the calcium ion in the taurine chelated calcium is a chelate central ion, the taurine is a chelate, and the chelation ratio of the taurine to the calcium ion in the taurine chelated calcium is 1: 1-4: 1.
2. The external preparation containing taurine-chelated calcium as claimed in claim 1, wherein the molecular weight of taurine-chelated calcium is in the range of 100-1500.
3. The external preparation comprising taurine-chelated calcium as described in claim 2, wherein the molecular weight of taurine-chelated calcium is in the range of 100 to 650.
4. The external preparation containing taurine-chelated calcium according to claim 1, wherein the chelation ratio of taurine to calcium ion is 1:1 and 2: 1.
5. The external preparation containing taurine-chelated calcium as claimed in claim 1, wherein the content of taurine-chelated calcium is less than 20% by mass.
6. The external preparation of taurine-chelated calcium as claimed in claim 5, wherein the content of taurine-chelated calcium is less than 8% by weight.
7. The taurine-chelated calcium external preparation according to claim 1, wherein the penetration enhancer is one or more of polyols, polysaccharides, azone, and amino acids.
8. The taurine-chelated calcium external preparation according to claim 7, wherein the polyol penetration enhancer is glycerol with a mass percentage of less than 15%.
9. The taurine-chelated calcium external preparation according to claim 7, wherein the polyol penetration enhancer is propylene glycol, and the mass percentage content thereof is less than 10%.
10. The taurine-chelated calcium external preparation according to claim 7, wherein the polyalcohol penetration enhancer is butanediol with a mass percentage of less than 10%.
11. The taurine-chelated calcium external preparation according to claim 7, wherein the polyol penetration enhancer is pentanediol, and the mass percentage content thereof is less than 10%.
12. The taurine-chelated calcium external preparation according to claim 7, wherein the polysaccharide substance is one or more of trehalose, tremella polysaccharide, hydrolyzed chitin, sodium hyaluronate, zymosan and soluble proteoglycan, and the mass percentage content of the polysaccharide substance is less than 20.00%.
13. The external preparation of taurine-chelated calcium as claimed in claim 7, wherein the amino acids are one or more of protein amino acids and non-protein amino acids, and the mass percentage content thereof is less than 20.00%.
14. The use of the taurine-chelated calcium external preparation according to any one of claims 1 to 13 in the preparation of an external absorption preparation, wherein the preparation is a pharmaceutical external preparation, a medical device external preparation, a health product external preparation, or a cosmetic.
15. The use of claim 14, wherein the external preparation is a pharmaceutical preparation for treating or preventing diseases caused by calcium deficiency.
16. The use of claim 15, wherein the skin disorders caused by calcium deficiency are skin barrier damage, acne, skin disorders due to pigmentation disorders, skin disorders due to disorders of nutrition and metabolism, allergic skin disorders, skin vascular disorders, skin vasculitis disorders, erythematous skin disorders.
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Non-Patent Citations (3)
| Title |
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| "钙剂在皮肤病治疗中的应用";许文等;《临床皮肤科杂志》;20150831;第44卷(第8期);第525-527页 * |
| Penetration Profile of Taurine in the Human Skin and Its Distribution in Skin Layers;da Silva等;《Pharmaceutical Research》;20080426;第25卷(第8期);第1846-1850页 * |
| 牛磺酸配合物的合成与应用研究进展;沈娟等;《化工进展》;20060630;第25卷(第6期);第634-638页 * |
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Effective date of registration: 20230616 Address after: 605 North Anhua Building, No. 8 Yinghua West Street, Chaoyang District, Beijing, 100029 Patentee after: Beijing dairy innovation Biotechnology Co.,Ltd. Address before: 100085 room 02c-386, block C (second floor), No.A 28, information road, Haidian District, Beijing Patentee before: BEIJING RUNING CHUANGZHI BIOTECHNOLOGY RESEARCH AND DEVELOPMENT CENTER (L.P.) |