CN110882270B

CN110882270B - Pharmaceutical composition containing silicon-based regenerative medical material and preparation method thereof

Info

Publication number: CN110882270B
Application number: CN201911253593.1A
Authority: CN
Inventors: 于晓丽; 仇越秀; 王菲
Original assignee: Beijing Xingfu Yisheng Regeneration Medical Technology Co ltd
Current assignee: Beijing Xingfu Yisheng Regeneration Medical Technology Co ltd
Priority date: 2019-12-09
Filing date: 2019-12-09
Publication date: 2021-03-12
Anticipated expiration: 2039-12-09
Also published as: CN110882270A

Abstract

The invention provides a nail care cream containing a silicon-based regenerative medical material, which is prepared from the following raw materials in parts by weight: 5-50 parts of silicon-based regenerative medical material, 60-100 parts of vaseline, 5-20 parts of radix sophorae flavescentis, 10-30 parts of liquorice, 5-20 parts of scutellaria baicalensis, 5-30 parts of monkshood, 5-20 parts of golden larch bark, 5-15 parts of golden cypress, 5-20 parts of garden balsam stem, 5-25 parts of herba pistaci chinensis, 5-20 parts of cantharis, 3-15 parts of fructus cnidii and 5-20 parts of rheum officinale. The invention has the beneficial effects that: the silicon-based regenerative medical material is added into the Chinese herbal medicines, and the silicon-based regenerative medical material can form a solution enriched with inorganic elements such as Si, Ca and P ions when meeting water. The elements can be precipitated and crystallized on the surface of the nail to form a hydroxyapatite mineral layer, so that the strength of the nail can be enhanced; the material has strong permeability, and can be used for rapidly diminishing inflammation and sterilizing by being matched with Chinese herbal medicines to be smeared on the surface of the nail.

Description

Pharmaceutical composition containing silicon-based regenerative medical material and preparation method thereof

Technical Field

The invention belongs to the field of medicines, and relates to a cosmetic composition for nail care and a pharmaceutical composition in the field of medical treatment. More particularly, the present invention relates to a nail care cream containing a silicon-based regenerative medical material and a method for preparing the same. The invention also relates to a method for preparing a nail care cream.

Background

Nails, which are used as appendages to human skin, are composed of a hard keratin derived from epithelial keratinocytes and are composed of a plurality of closely spaced layers of keratinocytes. The development of the nails is influenced by various factors, wherein the internal factors comprise irregular life, frequent staying up, insufficient metabolism or certain pathological states, the external factors comprise various detergents such as nail polish and soap, the damage of cigarette smoke and the like, and the different factors easily influence the growth of the nails, make the nails brittle and fragile, influence the beauty and seriously suffer from nail diseases.

Currently, the main solutions proposed in the field of nail care are the use of nail varnishes, certain moisturizing active cosmetics, or topical administration to alleviate symptoms. For topical administration, the main challenge is to deliver sufficient nutrients and metabolites through the nail into the deep tissues, and the symptoms return after the traditional topical treatment is discontinued.

Disclosure of Invention

The present invention is directed to overcoming the deficiencies of the prior art as described above and providing a treatment cream for treating and caring nails which solves the problems associated with nail treatment and care.

The technical scheme of the invention is summarized as follows:

the invention provides a use of a silicon-based regenerative medical material selected from one or more of bioactive silicon, bioactive glass and calcium silicate in the preparation of a medicament for treating, preventing, improving or slowing nail diseases or a health product for protecting nails.

In some embodiments, the nail disease is selected from a nail disease caused by candida albicans, yeast, and/or mold.

In some embodiments, the nail disease is a onychomycosis disease.

In some embodiments, the bioactive silicon is selected from regesi bioactive silicon.

In some embodiments, the regesi bioactive silicon is free form SiO at 50-75 w/w%₂Is mainly 5-15% w/w P₂O₅In which bioactive Silicon (SiO) with 20-35 w/w% CaO is embedded₂、P₂O₅The sum of the weights of CaO, CaO and unavoidable impurities being 100%;

the bioactive silicon can be prepared according to the method described in the patent application with the publication number of CN106362214A, and the commercial product of Regesi regenerated silicon of Beijing Happy Probiotics high-tech limited company can also be adopted, and the Regesi regenerated silicon of any type can be used in the invention, and the material is made of SiO₂、CaO、P₂O₅The formed Regesi regenerated silicon is solid powder, has huge specific surface area and stable pH after contacting body fluid.

The bioactive silicon may be a POSS-based regenerated silicon material prepared by the method described in chinese patent application 201810030488.0, which is a product obtained by calcining polyhedral oligomeric silsesquioxane to remove organic components thereof, and forms a polyhedral structure composed of Si-O-Si bonds in silicon oxide as a framework. .

The bioactive silicon may also be a regenerated silicon material prepared according to the method described in chinese patent application 201610955130.X, which comprises 40-70 wt% of silicon dioxide and 30-60 wt% of an oxide selected from phosphorus, calcium and sodium, wherein the silicon dioxide forms a three-dimensional network structure, calcium ions and phosphorus ions are distributed in the middle of the three-dimensional network silicon atoms in an ordered manner, and the content of the phosphorus oxide is 2-5 wt%.

The specific surface area of the silicon-based regenerative medical material is 100-1000m²The active component is great, and can be used as a drug carrier to enter the root of the nail quickly to promote the treatment of nail diseases.

In some embodiments, the bioactive glass is at least one of 45S5 bioactive glass powder, 58S bioactive glass powder, 70S bioactive glass powder, 77S bioactive glass powder.

In a second aspect, the present invention provides a pharmaceutical composition, which comprises the following raw materials: the silicon-based regenerative medical material comprises a silicon-based regenerative medical material and a pharmaceutic adjuvant, wherein the silicon-based regenerative medical material is selected from one or more of bioactive silicon, bioactive glass and calcium silicate.

In some embodiments, the regesi bioactive silicon is free form SiO at 50-75 w/w%₂Mainly, 5-15 w/w% of P₂O₅In which bioactive Silicon (SiO) with 20-35 w/w% CaO is embedded₂、P₂O₅The sum of the weights of CaO, CaO and unavoidable impurities being 100%.

In some embodiments, the pharmaceutical excipient is a paste excipient.

In some embodiments, the ointment excipient is selected from petrolatum.

In some embodiments, the pharmaceutical composition is in a dosage form selected from the group consisting of: and (3) ointment.

In some embodiments, the component materials of the pharmaceutical composition comprise 5-50 parts by weight of silicon-based regenerative medical materials and 60-90 parts by weight of pharmaceutical excipients.

In some embodiments, the component materials of the pharmaceutical composition comprise 5-30 parts by weight of silicon-based regenerative medical materials and 70-90 parts by weight of pharmaceutical excipients.

In some embodiments, the raw materials of the pharmaceutical composition further comprise traditional Chinese medicinal materials comprising any 1, any 2, any 3, any 4, any 5, any 6, any 7, any 8, any 9, any 10 or 11 of radix sophorae flavescentis, radix glycyrrhizae, radix scutellariae, radix aconiti, cortex pseudolaricis, cortex phellodendri, speranskia tuberculata, herba Ophioglossi, cantharis, fructus cnidii and radix et rhizoma rhei.

The selected traditional Chinese medicinal materials have the following effects:

RADIX Sophorae Flavescentis (Sophorae flagescriptis RADIX): clear heat and dry dampness, kill parasites and induce diuresis. Can be used for treating dysentery with heat, hematochezia, jaundice, anuria, leucorrhea with red and white discharge, pudendal swelling, pruritus vulvae, eczema, skin pruritus, scabies, tinea, and leprosy; it can be used for treating trichomonas vaginitis.

Licorice (GLYCYRRHIZAE RADIX ET RHIZOMA): invigorating spleen and replenishing qi, clearing away heat and toxic material, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, short breath, cough, excessive phlegm, abdominal and limb spasm, pain, carbuncle, swelling, sore, and drug toxicity and strong nature.

Scutellaria baicalensis (SCUTELLARIAE RADIX): clear heat and dry dampness, purge fire and remove toxicity, stop bleeding, prevent abortion. Can be used for treating damp-warm syndrome, summer-heat dampness, chest distress, emesis, dampness and heat distention, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion.

RADIX ACONITI (ACONITI RADIX): dispel wind and dampness, warm meridians and alleviate pain. Can be used for treating arthralgia due to wind-cold-dampness, arthralgia, psychroalgia of heart and abdomen, cold hernia pain, and anesthesia and pain relieving.

Golden larch bark (pseudoraricis CORTEX): kill parasites, cure tinea and relieve itching. Can be used for treating scabies, tinea and pruritus.

Phellodendron (phellodendron chinense CORTEX): clear heat and dry dampness, purge fire and remove steam, remove toxicity and cure sore. Can be used for treating damp-heat dysentery, jaundice, dark urine, leukorrhagia, pudendal pruritus, pyretic stranguria, pain, tinea pedis, atrophy 36484, hectic fever, night sweat, spermatorrhea, pyocutaneous disease, toxic swelling, eczema, and eczema. Salted cortex phellodendri is used for nourishing yin and reducing internal heat. Can be used for treating hyperactivity of fire due to yin deficiency, night sweat and steaming bone.

Speranskia herb (Phryma leptostachya l. subsp. asitica (Hara) Kitamura): the part used as the medicine is the whole plant. The whole herb is green, dry, tender and free of impurities. Wind-dispelling and dampness-removing, it is pungent and warm, pungent and capable of dispersing and warm-prevailing cold-dampness. The eight liver meridians can dispel wind and remove dampness. It has the actions of relaxing tendons and activating collaterals, because it is pungent, dispersing, warming and unblocking, entering liver meridian, and liver governing tendons. Activate blood and alleviate pain, this herb is pungent and warm in property, and enters liver meridian blood system, so it can activate blood and alleviate pain. It can be used for all kinds of pain in the upper and lower parts of the body, heart, abdomen, waist and knee, and both inside and outside, and it is pungent and warm in property, and has the actions of activating blood and promoting qi circulation, and blood and qi circulation without pain. The external washing of the medicine also has the characteristics of guiding the medicine to penetrate into meridians and blood vessels to expel wind, activate blood and relieve pain.

An arrow (Ophiogonsum pedunculosum Desv.): can be used for treating carbuncle, sore, scabies, hemorrhoid, venomous snake bite, burn, scald, traumatic injury, and infantile malnutrition.

Cantharis (MYLABRIS): break blood and remove stasis, dissipate stagnation and eliminate mass, counteract toxic pathogen and corrode sores. Can be used for treating abdominal mass, amenorrhea, intractable tinea, scrofula, wart, carbuncle, cellulitis, ulcer, and necrotic tissue.

Cnidium fruit (CNIDII frutus): dry dampness and dispel wind, kill parasites and relieve itching, warm kidney and strengthen yang. Can be used for treating pruritus vulvae, leukorrhagia, eczema, pruritus, lumbago due to damp arthralgia, sexual impotence due to kidney deficiency, and infertility due to cold womb.

Rhubarb (RHEI RADIX ET rhezoma): purgation and eliminating accumulation, clearing heat and purging fire, cooling blood and removing toxicity, removing blood stasis and dredging channels, promoting diuresis and eliminating jaundice. Can be used for treating constipation due to excessive heat accumulation, hematemesis, epistaxis, conjunctival congestion, pharyngeal swelling, carbuncle, furuncle, intestinal carbuncle, abdominal pain, blood stasis, amenorrhea, puerperal blood stasis, traumatic injury, damp-heat dysentery, jaundice, dark urine, stranguria, and edema; it can be used for external treatment of burn and scald. The wine rhubarb is good at clearing heat-toxin in the upper energizer blood system and is used for treating conjunctival congestion, swollen throat and gum swelling and pain. The cooked rhubarb has the functions of relieving the purgative force, purging fire and removing toxicity, and is used for treating fire-toxin sores and ulcers. Rhubarb charcoal has the effects of cooling blood, removing blood stasis and stopping bleeding, and is used for treating blood heat with blood stasis and hemorrhage.

The compatibility of the 11 medicinal materials is as follows: radix Sophorae Flavescentis, cortex pseudolaricis, herba Ophioglossi, Mylabris, and fructus Cnidii have remarkable effects in treating skin pruritus, eczema, and tinea, and other medicinal materials have effects in clearing away heat, removing toxic substances, promoting blood circulation, and relieving pain.

The above materials act together to synergistically exert the effects of relaxing muscles and tendons, activating collaterals, disinfecting and relieving itching.

In some embodiments, the component materials of the pharmaceutical composition comprise, by weight, 5-50 parts of a silicon-based regenerative medicine material, 60-90 parts of a pharmaceutic adjuvant, 0-20 parts of radix sophorae flavescentis, 0-30 parts of liquorice, 0-20 parts of scutellaria baicalensis, 0-20 parts of monkshood, 0-18 parts of golden larch bark, 0-15 parts of golden cypress, 0-18 parts of garden balsam stem, 0-20 parts of a rocket, 0-20 parts of cantharis, 0-15 parts of fructus cnidii and 0-20 parts of rheum officinale.

The materials not mentioned in the present invention are all regarded as inevitable impurities or doping substances.

In some embodiments, the component materials of the pharmaceutical composition comprise, by weight, 5-50 parts of a silicon-based regenerative medicine material, 60-90 parts of a pharmaceutic adjuvant, 5-20 parts of radix sophorae flavescentis, 10-30 parts of liquorice, 0-20 parts of scutellaria baicalensis, 0-20 parts of monkshood, 0-18 parts of golden larch bark, 0-15 parts of golden cypress, 0-18 parts of garden balsam stem, 0-20 parts of a rocket, 0-20 parts of cantharis, 0-15 parts of fructus cnidii and 5-20 parts of rheum officinale.

In some embodiments, the component materials of the pharmaceutical composition comprise, by weight, 5-50 parts of a silicon-based regenerative medicine material, 60-90 parts of a pharmaceutic adjuvant, 5-20 parts of radix sophorae flavescentis, 10-30 parts of liquorice, 5-20 parts of scutellaria baicalensis, 5-20 parts of monkshood, 5-18 parts of golden larch bark, 5-15 parts of golden cypress, 5-18 parts of garden balsam stem, 5-20 parts of herba pistaci chinensis, 5-20 parts of cantharis, 3-15 parts of fructus cnidii and 5-20 parts of rheum officinale.

In some embodiments, the component materials of the pharmaceutical composition comprise, by weight, 5-30 parts of a silicon-based regenerative medicine material, 70-90 parts of a pharmaceutic adjuvant, 6-15 parts of radix sophorae flavescentis, 12-25 parts of liquorice, 6-18 parts of scutellaria baicalensis, 8-15 parts of monkshood, 8-18 parts of golden larch bark, 8-12 parts of golden cypress, 8-16 parts of garden balsam stem, 8-20 parts of a rocket, 5-15 parts of cantharis, 5-10 parts of fructus cnidii and 5-15 parts of rheum officinale.

In a third aspect of the present invention, there is provided a method for preparing the pharmaceutical composition according to the second aspect of the present invention, wherein when the pharmaceutical composition contains a Chinese medicinal material, the method comprises the following steps:

s1, mixing and crushing all the raw materials except the silicon-based regenerative medical material and the pharmaceutic adjuvant to obtain first mixed powder; or

Mixing all the raw materials except the silicon-based regenerative medical material and the pharmaceutic adjuvant, respectively crushing and then mixing to obtain first mixed medicinal powder;

s2, mixing the first mixed powder with the silicon-based regenerative medical material to obtain a second powder, and mixing the second powder with the pharmaceutic adjuvant to obtain the pharmaceutical composition; or

Mixing the first mixed medicinal powder and the silicon-based regenerative medical material with the pharmaceutic adjuvant simultaneously or sequentially to obtain the pharmaceutical composition; or;

when the pharmaceutical composition does not contain traditional Chinese medicinal materials, the preparation method comprises the following steps:

mixing the silicon-based regenerative medical material with the pharmaceutic adjuvant to obtain the pharmaceutical composition;

wherein the amount ratio of each material is used in accordance with the amount ratio of the corresponding material in the pharmaceutical composition according to the second aspect of the present invention.

In some embodiments, all of the raw materials except the silicon-based regenerative medical material and the pharmaceutical excipients are mixed and pulverized, and sieved with a 65-mesh sieve, preferably a 80-mesh sieve, and the undersized powder is taken out to obtain the first mixed medicinal powder.

In some embodiments, all the raw materials except the silicon-based regenerative medical material and the pharmaceutical excipients are mixed and separately pulverized, sieved through a 65-mesh sieve, preferably sieved through a 80-mesh sieve, and undersized powder is taken and then mixed to obtain the first mixed medicinal powder.

In some embodiments, all the raw materials except the silicon-based regenerative medical material and the pharmaceutical excipients are mixed and separately pulverized, mixed, and sieved with a 65-mesh sieve, preferably with a 80-mesh sieve, and the sieved powder is taken out to obtain the first mixed medicinal powder.

In some embodiments, all raw materials except the silicon-based regenerative medical material and the pharmaceutical excipients are washed, dried, separately or mixed, and then used to prepare the pharmaceutical composition.

In some embodiments, the oven drying temperature is 60-65 ℃.

In some embodiments, the first mixed powder is mixed with the silicon-based regenerative medical material to obtain a second powder, and the second powder is mixed with the pharmaceutical excipients and stirred to obtain the pharmaceutical composition; or

In some embodiments, the first mixed powder and the silicon-based regenerative medical material are mixed and stirred with the pharmaceutical excipients simultaneously or sequentially to obtain the pharmaceutical composition.

In a fourth aspect, the invention provides a use of the process of the third aspect of the invention for the manufacture of a medicament for the treatment, prevention, amelioration or alleviation of nail disease.

In some embodiments, the nail disease is selected from diseases caused by candida albicans, yeast, and/or mold.

In some embodiments, the nail disease is a onychomycosis disease.

The invention also includes any reasonable combination of the features or sub-arrangements of the foregoing which, under the knowledge and skill of a person skilled in the art, is capable of expecting an approximate technical effect.

The invention also comprises the replacement of any active medicinal material by one medicinal material or the combination of a plurality of medicinal materials with the same or similar medicinal properties.

The invention also comprises the step of replacing auxiliary materials except medicinal materials from which the medicinal active ingredients are derived with one material or a combination of a plurality of materials with similar performance, and the step of removing the auxiliary materials, which are expected to prevent the treatment effect of the disclosed medicinal composition from disappearing after the corresponding auxiliary materials are removed.

The invention also comprises the addition of the medicinal materials which are conventional in the field and used for treating the onychomycosis and/or the conventional components for increasing the drug effect and/or the components which do not generally work and/or the components which do not generate antagonism or toxic and side effects with the disclosed formula to the medicinal materials of the medicinal active ingredient source.

The parts by weight of the invention mainly comprise the disclosed numerical range, any numerical value (including integers and decimal points) or any two numerical intervals in the disclosed range, or discontinuous multiple intervals, and also comprise numerical values or numerical ranges which are close to the end value of the numerical range and can be expected to have similar effects, for example, 5-10 parts, not only 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts and any two intervals, but also other numerical ranges, not examples, are all included in the invention. Thus, the invention also includes any sub-range of the numerical range that has been disclosed directly or any specific value therein.

The present invention also includes combinations contemplated by those skilled in the art, such as the use of the pharmaceutical composition of the present invention together with other drugs orally or by mixing other drugs with the pharmaceutical composition of the present invention and applying the mixture to the affected area.

The invention also comprises adding other conventional medicines into the medicine, such as antibiotics and the like according to the theory of Chinese and western medicine combination.

When in use, the nail surface is moistened with water, and the prepared ointment is uniformly smeared on the nail surface before the water is volatilized, and the best time is kept for 20min to 48 h.

The invention can be used for nail nursing independently, and can also be used for treating by firstly using the ointment and then matching with other medicines.

Detailed Description

The present invention will be further described with reference to the following examples.

Except garden balsam stem and a sword, the medicinal parts, medicinal properties, identification, inspection, content measurement, processing, storage and the like of the medicinal materials are shown in 2015 edition of pharmacopoeia of the people's republic of China. The use of Tu Ji and Yi Xian Jian can be seen in the Chinese medicine dictionary.

Example 1:

a pharmaceutical composition containing silicon-based regenerative medical materials comprises the following raw materials in parts by weight:

25 parts of V-type Regesi bioactive silicon, 75 parts of vaseline, 8 parts of radix sophorae flavescentis, 12 parts of liquorice, 10 parts of scutellaria baicalensis, 15 parts of monkshood, 16 parts of golden larch bark, 12 parts of golden cypress, 8 parts of garden balsam stem, 10 parts of herba cichorii, 15 parts of cantharis, 10 parts of fructus cnidii and 10 parts of rheum officinale.

The preparation method of the pharmaceutical composition comprises the following steps: weighing the raw materials except the bioactive silicon and the vaseline according to the weight ratio, cleaning, drying in an oven at 60 ℃ for 0.5-1 hour, grinding the dried raw materials into powder, sieving by a 80-mesh sieve, taking the powder under the sieve, adding the bioactive silicon according to the weight ratio, uniformly mixing, adding the vaseline according to the weight ratio, uniformly stirring and mixing to form a paste, so as to form the pharmaceutical composition, namely the nail care paste.

Example 2:

30 parts of V-type Regesi bioactive silicon, 70 parts of vaseline, 12 parts of radix sophorae flavescentis, 15 parts of liquorice, 10 parts of scutellaria baicalensis, 20 parts of monkshood, 10 parts of golden larch bark, 12 parts of golden cypress, 10 parts of garden balsam stem, 15 parts of a rocket, 5 parts of cantharis, 10 parts of fructus cnidii and 12 parts of rheum officinale.

The preparation and use of the pharmaceutical composition are the same as in example 1.

Example 3:

10 parts of V-type Regesi bioactive silicon, 90 parts of vaseline, 7 parts of radix sophorae flavescentis, 18 parts of liquorice, 15 parts of scutellaria baicalensis, 20 parts of monkshood, 18 parts of golden larch bark, 10 parts of golden cypress, 12 parts of garden balsam stem, 10 parts of herba Ophioglossi, 10 parts of cantharis, 5 parts of fructus cnidii and 15 parts of rheum officinale.

Example 4:

5 parts of V-type Regesi bioactive silicon, 60 parts of vaseline, 5 parts of radix sophorae flavescentis, 30 parts of liquorice, 20 parts of scutellaria baicalensis, 5 parts of monkshood, 12 parts of golden larch bark, 15 parts of golden cypress, 5 parts of garden balsam stem, 5 parts of herba Ophioglossi, 20 parts of cantharis, 15 parts of fructus cnidii and 5 parts of rheum officinale.

Example 5:

50 parts of V-type Regesi bioactive silicon, 75 parts of vaseline, 20 parts of radix sophorae flavescentis, 10 parts of liquorice, 5 parts of scutellaria baicalensis, 20 parts of monkshood, 10 parts of golden larch bark, 8 parts of golden cypress, 8 parts of garden balsam stem, 10 parts of a rocket, 10 parts of cantharis, 3 parts of fructus cnidii and 20 parts of rheum officinale.

Example 6:

25 parts of V-type Regesi bioactive silicon, 75 parts of vaseline, 12 parts of radix sophorae flavescentis, 15 parts of liquorice, 20 parts of scutellaria baicalensis, 15 parts of monkshood, 5 parts of golden larch bark, 5 parts of golden cypress, 18 parts of garden balsam stem, 20 parts of herba cichorii, 5 parts of cantharis, 15 parts of fructus cnidii and 5 parts of rheum officinale.

Example 7:

30 parts of V-type Regesi bioactive silicon, 80 parts of vaseline, 15 parts of radix sophorae flavescentis, 20 parts of liquorice and 15 parts of rheum officinale.

Example 8:

30 parts of V-type Regesi bioactive silicon and 80 parts of vaseline.

The preparation method of the pharmaceutical composition comprises the following steps: the silicon-based regenerative medical material is added into vaseline according to the weight ratio, and is uniformly stirred and mixed into paste, so that the pharmaceutical composition, namely the nail care paste, is formed.

The method of use of the pharmaceutical composition is the same as in example 1.

Example 9:

80 parts of vaseline, 15 parts of radix sophorae flavescentis, 20 parts of liquorice and 15 parts of rheum officinale.

The preparation method of the pharmaceutical composition comprises the following steps: weighing the other raw materials except the vaseline according to the weight ratio, cleaning, drying in a 65 ℃ oven for 0.5-1 hour, grinding the dried raw materials into powder, sieving by a 80-mesh sieve, taking the powder under the sieve, adding the silicon-based regenerative medical material according to the weight ratio, uniformly mixing, adding the vaseline according to the weight ratio, uniformly stirring and mixing to form a paste, and forming the pharmaceutical composition, namely the nail care paste.

Product detection:

experiment for inhibiting bacteria

The experimental scheme is as follows: the silicon-based regenerative medical materials and pharmaceutical compositions prepared in examples 1 to 9 of the present invention were tested for their bacteriostatic effects on candida albicans (strain: beijing three pharmaceutical technology development company 98001), yeast (strain: shanghai beino biotechnology limited ATCC 26603) and mold (strain: beijing three pharmaceutical technology development company 98003), and the bacteriostatic experiments were examined with reference to "non-sterile product microbial limit examination" part 1105 of "chinese pharmacopoeia": microbial enumeration method ".

The results of the experiment are shown in table 1:

TABLE 1 bacteriostatic experiments

According to the evaluation standard specified in GB 15979-2002-supplement C4, the bacteriostatic rate is more than or equal to 50-90%, the product has the bacteriostatic action, the bacteriostatic rate is more than or equal to 90%, and the product has strong bacteriostatic action.

Therefore, the silicon-based regenerative medical material and the pharmaceutical composition prepared by the invention have stronger bacteriostatic action and better effect.

Case and clinical effects:

patient 1, Zhao somewhat, female, age 36, had ringworm of the nails for more than one year, had 2 toenails discolored to be grey white, had cracks on the surface of the nail plate, and had no improvement after half a year on treatment with an externally applied drug (New brilliant nail acetic acid solution) according to the instructions. The nursing paste of the embodiment 1 of the invention is used, the nursing paste with the size of a nail cover is smeared on an affected part after being soaked in warm water for 5 minutes before being smeared so as to cover the affected part, and the affected part is wrapped by gauze 2-3 times a day after being smeared, and the affected part is healed after lasting for two months.

After 2 patients, Wangzhi, women and 25 years old are coated with nail polish for a long time, the nails become crisp, fragile and rough and uneven in surface, and the nursing effect by using various nursing oils (coating the nail polish and moisturizing cream) is not good. After that, the care cream of the invention example 2 was used for care three times a day, and the application was carried out after hand washing, and the nail became smooth and firm after one month.

The patient 3, Zhou Zhi, 40 years old, male, had ringworm of the nails for more than two years, the nail plate thickened to become brown, and no obvious improvement was seen after the treatment of the external application of the medicine and the oral antifungal medicine. The nursing cream provided by the embodiment 5 of the invention is used for treatment, three times a day, hands are washed and then the nursing cream is smeared, the affected part is wrapped by a preservative film or gauze after the smearing, most of new nails grow after the nursing cream is continuously used for a month, and no obvious abnormality exists.

Patients 4 and Liu, 31 years old, women, who have onychomycosis for more than one year, have the nail plates become yellow and empty, and have not been treated by any medicine before, the nail plates at the empty positions are smeared after the nursing cream of the embodiment 7 of the invention is used for washing hands in the morning and evening every day and then are wrapped by the band-aid, and after two months, the empty nail plates disappear by more than 90 percent and are basically cured.

The judgment standard of the curative effect is as follows:

(1) the effect is shown: the diseased nails at the positions where the nursing cream is applied completely disappear, most of new nails grow out, and the diseased positions have no other abnormalities; the nail at the position where the nursing cream is smeared is obviously smooth and firm;

(2) improvement: part of new nails grow out at the position where the nursing paste is applied, diseased nails at the position where the nursing paste is applied are obviously improved compared with the diseased nails before the nursing paste is applied, and the diseased parts have no other abnormal appearance; the nail at the position where the nursing cream is applied is smooth and firm;

(3) and (4) invalidation: the affected part is not obviously improved after the medicine is taken.

In addition, 99 onychomycosis patients were selected and divided into three groups of 33 patients, and the nursing cream of examples 7-9 was used for each group, and the using method was: three times a day, washing hands, smearing, wrapping the affected part with a preservative film after smearing, and counting the treatment effect of three groups of patients (taking the nursing cream with the size of the nail cover to be smeared on the affected part) using the nursing cream of the embodiment 7-9 of the invention 1 month later, 3 months later and 6 months later. Statistics are shown in the table below:

therefore, the silicon-based regenerative medical material and the nursing paste can well treat nail diseases, and the latter has better effect.

While the principles and preferred embodiments of this invention have been shown and described, various changes and modifications can be made without departing from the spirit and scope of the invention, which is to be protected.

Claims

1. Use of a silicon-based regenerative medical material in the manufacture of a medicament for treating, preventing, ameliorating or slowing onychomycosis, said silicon-based regenerative medical material being regesi bioactive silicon, said regesi bioactive silicon being in the form of a silica gel containing 50-75 w/w% amorphous SiO₂Is mainly 5-15% w/w P₂O₅In which bioactive Silicon (SiO) with 20-35 w/w% CaO is embedded₂、P₂O₅The sum of the weights of CaO, CaO and unavoidable impurities being 100%.

2. The pharmaceutical composition for treating, preventing, improving or slowing onychomycosis comprises the following raw materials in parts by weight: 5-50 parts of silicon-based regenerative medical material and 60-90 parts of Vaseline, wherein the silicon-based regenerative medical material is regesi bioactive silicon which is non-fixed SiO with the content of 50-75 w/w%₂Mainly, 5-15 w/w% of P₂O₅In which bioactive Silicon (SiO) with 20-35 w/w% CaO is embedded₂、P₂O₅The sum of the weights of CaO, CaO and unavoidable impurities being 100%.

3. The pharmaceutical composition of claim 2, wherein: the dosage form of the pharmaceutical composition is selected from: and (3) ointment.

4. The pharmaceutical composition of claim 2, wherein: the component materials of the pharmaceutical composition comprise 5-30 parts of silicon-based regenerative medical materials and 70-90 parts of vaseline according to parts by weight.

5. The pharmaceutical composition of claim 2, wherein: the component materials of the pharmaceutical composition comprise, by weight, 5-50 parts of silicon-based regenerative medical materials, 60-90 parts of pharmaceutic adjuvant, 5-20 parts of radix sophorae flavescentis, 10-30 parts of liquorice, 5-20 parts of scutellaria baicalensis, 5-20 parts of monkshood, 5-18 parts of golden larch bark, 5-15 parts of golden cypress, 5-18 parts of garden balsam stem, 5-20 parts of herba pistrae chinensis, 5-20 parts of cantharis, 3-15 parts of fructus cnidii and 5-20 parts of rheum officinale.

6. A process for preparing a pharmaceutical composition according to any one of claims 2 to 5, when said pharmaceutical composition comprises a Chinese medicinal material, said process comprising the steps of:

s1, mixing the silicon-based regenerative medical material and all the raw materials except vaseline, and crushing to obtain a first mixed powder; or

Mixing the silicon-based regenerative medical material and all the raw materials except the vaseline, respectively crushing and then mixing to obtain first mixed medicinal powder;

s2, mixing the first mixed powder with the silicon-based regenerative medical material to obtain a second powder, and mixing the second powder with vaseline to obtain the pharmaceutical composition; or

Mixing the first mixed medicinal powder and the silicon-based regenerative medical material with vaseline simultaneously or sequentially to obtain the pharmaceutical composition; or;

mixing the silicon-based regenerative medical material and the vaseline to obtain the pharmaceutical composition.

7. A process for preparing a pharmaceutical composition according to claim 6, wherein: and mixing the silicon-based regenerative medical material and all the raw materials except the vaseline, crushing, sieving by a 65-mesh sieve, and taking the sieved powder to obtain the first mixed powder.

8. A process for preparing a pharmaceutical composition according to claim 6, wherein: and mixing the silicon-based regenerative medical material and all the raw materials except the vaseline, crushing, sieving by a 80-mesh sieve, and taking the sieved powder to obtain the first mixed powder.

9. A process for preparing a pharmaceutical composition according to claim 6, wherein: mixing and respectively crushing the silicon-based regenerative medical material and all the raw materials except the vaseline, sieving by a 65-mesh sieve, taking the sieved powder, and then mixing to obtain the first mixed powder.

10. A process for preparing a pharmaceutical composition according to claim 6, wherein: mixing and respectively crushing the silicon-based regenerative medical material and all the raw materials except the vaseline, sieving by a 80-mesh sieve, taking the sieved powder, and then mixing to obtain the first mixed powder.

11. A process for preparing a pharmaceutical composition according to claim 6, wherein: mixing the silicon-based regenerative medical material and all the raw materials except the vaseline, respectively crushing, mixing, sieving by a 65-mesh sieve, and taking the sieved powder to obtain the first mixed powder.

12. A process for preparing a pharmaceutical composition according to claim 6, wherein: mixing the silicon-based regenerative medical material and all the raw materials except the vaseline, respectively crushing, mixing, sieving by a 80-mesh sieve, and taking the sieved powder to obtain the first mixed powder.

13. A process for preparing a pharmaceutical composition according to claim 6, wherein: all the raw materials except the silicon-based regenerative medical material and the vaseline are washed and dried separately or mixed, and then used for preparing the pharmaceutical composition.

14. The method of preparing a pharmaceutical composition of claim 13, wherein said oven drying temperature is 60-65 ℃.