CN111956697A - Soluble microneedle patch for treating chloasma and preparation method thereof - Google Patents
Soluble microneedle patch for treating chloasma and preparation method thereof Download PDFInfo
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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Abstract
The invention discloses a soluble microneedle patch for treating chloasma and a preparation method thereof, and the soluble microneedle patch comprises the following raw materials in parts by weight: 1-5 parts of tanshinone IIA, 1-5 parts of total glucosides of paeony, 1-5 parts of total saponins of panax notoginseng, 30-60 parts of sodium hyaluronate, 10-25 parts of excipient and 30-100 parts of water. The invention combines tanshinone IIA, total glucosides of paeony and panax notoginseng saponins for use, and has obvious treatment effect on chloasma; the soluble microneedle patch is prepared from the sodium hyaluronate and the excipient, has good performances such as hardness and mechanical strength, can puncture the stratum corneum to generate drug transport micro-channels, and transfers the traditional Chinese medicine components to the subcutaneous part, so that the limitation of the skin on drug transport is reduced, the biocompatibility is high, and the drug release is rapid; the soluble microneedle can be dissolved rapidly, and the effective components can penetrate stratum corneum to enhance the effect of treating chloasma.
Description
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to a soluble microneedle patch for treating chloasma and a preparation method thereof.
Background
The micro-needle is a novel transdermal drug delivery form, the manufacturing materials of the micro-needle comprise metal, silicon dioxide, glass, nickel, titanium, soluble polymer and the like, an array containing a plurality of micro-needle heads is prepared by adopting a micro-electro-mechanical system, a micro-molding method and the like, and the length of the needle is generally dozens of micrometers to several millimeters. Compared with the traditional transdermal drug delivery preparation, the microneedle forms a drug release hole by piercing the stratum corneum of the skin, and the drug can be quickly absorbed in a shorter time; on the other hand, due to the formation of the drug release holes, the micro-needle can promote the absorption of the macromolecular drugs and the water-soluble drugs. Although the micro needle is used for drug delivery in a mode of piercing stratum corneum, the needle body is tiny and short, and cannot touch subcutaneous nerves, so that pain and discomfort cannot be caused, and the tiny hole can automatically heal within hours, bleeding and wound cannot be caused, and the micro needle has good compliance. Microneedles may be classified into solid microneedles, coated microneedles, hollow microneedles and soluble microneedles according to administration modes. The soluble micro-needle is prepared from a high molecular material which can be dissolved or degraded biologically, and the medicine coated in the micro-needle is gradually released along with the dissolution of the soluble material in the skin. Compared with insoluble microneedles, soluble microneedles have better biocompatibility and larger drug loading, and thus are regarded by researchers.
Chloasma is a clinically common, acquired disease of hyperpigmentation of the skin, occurring in the facial area, with lesions usually having symmetry and irregularities, clinically manifested as yellowish brown or dark brown patches of the cheeks, forehead, upper lip, nose and chin on both sides. The pathogenesis of chloasma is complex, at present, the chloasma is considered to be mainly related to melanin synthesis increase, skin barrier function damage, inflammation, blood vessel factors and the like, and in addition, various induction factors are involved, including ultraviolet irradiation, estrogen level, mental factors, genetic factors, improper skin care, systemic diseases, local microenvironment, oxidative stress and the like, so that the chloasma is one of skin diseases which are difficult to cure.
At present, the treatment method of chloasma mainly comprises the following steps: systemic or local application of tranexamic acid, vitamin C, vitamin E and the like, external application of drugs such as hydroquinone, arbutin, azelaic acid and the like, and medical cosmetic means such as: intense pulse light, Q-switch Nd, YAG1064nm laser and fruit acid treatment. However, the treatment methods have the problems of long treatment period, easy repetition, low patient compliance, more adverse reactions and the like, so that the search for a convenient and effective treatment method is particularly important.
Disclosure of Invention
In order to solve the problems, the invention aims to provide a soluble microneedle patch for treating chloasma and a preparation method thereof, which are characterized in that tanshinone IIA, total glucosides of paeony and total saponins of panax notoginseng are used in a matching way, so that an obvious treatment effect on the chloasma can be achieved; the soluble microneedle patch for treating chloasma is prepared from the soluble microneedle patch, sodium hyaluronate and an excipient material, has good performances such as hardness and mechanical strength, can puncture the stratum corneum to generate drug transport micro-channels, transfers traditional Chinese medicine components to the subcutaneous part, reduces the limitation of the skin on drug transport, and has high biocompatibility and rapid drug release; the soluble microneedle can be dissolved rapidly, and the effective components can penetrate stratum corneum to enhance the effect of treating chloasma.
In order to achieve the technical purpose and achieve the technical effect, the invention is realized by the following technical scheme:
the soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 1-5 parts of tanshinone IIA, 1-5 parts of total glucosides of paeony, 1-5 parts of total saponins of panax notoginseng, 30-60 parts of sodium hyaluronate, 10-25 parts of excipient and 30-100 parts of water.
Further, the excipient is at least one of sodium carboxymethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, hypromellose, fructose, lactose, sorbitol, dextran, trehalose and sucrose.
Further, the tanshinone IIA is 3 parts, the total glucosides of paeony is 2 parts, the panax notoginseng saponins are 5 parts, the sodium hyaluronate is 50 parts, and the excipient is 10 parts of polyvinylpyrrolidone and 100 parts of water.
Further, the tanshinone IIA is 5 parts, the total glucosides of paeony is 2 parts, the panax notoginseng saponins are 4 parts, the sodium hyaluronate is 30 parts, the excipient is 15 parts of hydroxypropyl methylcellulose, and the water is 100 parts.
Further, 4 parts of tanshinone IIA, 2 parts of total glucosides of paeony, 3 parts of panax notoginseng saponins, 35 parts of sodium hyaluronate, 25 parts of fructose as the excipient and 100 parts of water.
Further, 3 parts of tanshinone IIA, 2 parts of total glucosides of paeony, 3 parts of panax notoginseng saponins, 55 parts of sodium hyaluronate, 20 parts of glucan as an excipient and 100 parts of water.
Further, the tanshinone IIA can be replaced by ferulic acid with the same amount.
Further, the total glucosides of paeony may be replaced with the same amount of safflower yellow.
Furthermore, the panax notoginseng saponins can be replaced by the same amount of astragalus total saponins.
A preparation method of a soluble microneedle patch for treating chloasma comprises the following steps: dissolving the excipient in the water, adding the sodium hyaluronate, uniformly stirring, adding the tanshinone IIA, the total glucosides of paeony and the panax notoginseng saponins, and uniformly stirring to obtain a soluble microneedle patch stock solution; and injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
The invention has the beneficial effects that:
the invention combines tanshinone IIA, total glucosides of paeony and panax notoginseng saponins for use, and has obvious treatment effect on chloasma; the soluble microneedle patch for treating chloasma is prepared from the soluble microneedle patch, sodium hyaluronate and an excipient material, has good performances such as hardness and mechanical strength, can puncture the stratum corneum to generate drug transport micro-channels, transfers traditional Chinese medicine components to the subcutaneous part, reduces the limitation of the skin on drug transport, and has high biocompatibility and rapid drug release; the soluble microneedle can be dissolved rapidly, and the effective components can penetrate stratum corneum to enhance the effect of treating chloasma.
The foregoing is a summary of the present invention, and in order to provide a clear understanding of the technical means of the present invention and to be implemented in accordance with the present specification, the following is a detailed description of the preferred embodiments of the present invention. Specific embodiments of the present invention are given in detail by the following examples.
Detailed Description
The present invention will be described in detail with reference to examples.
Example 1
The soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 1 part of tanshinone IIA, 1 part of total glucosides of paeony, 1 part of total saponins of panax notoginseng, 60 parts of sodium hyaluronate, 25 parts of sodium carboxymethylcellulose and 100 parts of water.
The preparation method comprises the following steps: dissolving sodium carboxymethylcellulose in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, total glucosides of paeony and total saponins of panax notoginseng, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
Example 2
The soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 5 parts of tanshinone IIA, 5 parts of total glucosides of paeony, 5 parts of total saponins of panax notoginseng, 40 parts of sodium hyaluronate, 20 parts of polyvinyl alcohol and 100 parts of water.
The preparation method comprises the following steps: dissolving polyvinyl alcohol in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, total glucosides of paeony and total saponins of panax notoginseng, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
Example 3
The soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 3 parts of tanshinone IIA, 2 parts of total glucosides of paeony, 5 parts of panax notoginseng saponins, 50 parts of sodium hyaluronate, 10 parts of polyvinylpyrrolidone and 100 parts of water.
The preparation method comprises the following steps: dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, total glucosides of paeony and total saponins of panax notoginseng, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
Example 4
The soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 5 parts of tanshinone IIA, 2 parts of total glucosides of paeony, 4 parts of panax notoginseng saponins, 30 parts of sodium hyaluronate, 15 parts of hydroxypropyl methylcellulose and 100 parts of water.
The preparation method comprises the following steps: dissolving hydroxypropyl methylcellulose in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, total glucosides of paeony and Panax notoginsenosides, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
Example 5
The soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 4 parts of tanshinone IIA, 2 parts of total glucosides of paeony, 3 parts of total saponins of panax notoginseng, 35 parts of sodium hyaluronate, 25 parts of fructose and 100 parts of water.
The preparation method comprises the following steps: dissolving fructose in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, total glucosides of paeony and total saponins of panax notoginseng, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
Example 6
The soluble microneedle patch for treating chloasma comprises the following raw materials in parts by weight: 3 parts of tanshinone IIA, 2 parts of total glucosides of paeony, 3 parts of total saponins of panax notoginseng, 55 parts of sodium hyaluronate, 20 parts of glucan and 100 parts of water.
The preparation method comprises the following steps: dissolving dextran in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, total glucosides of paeony and total saponins of panax notoginseng, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
The traditional Chinese medicine represented by the traditional Chinese medicine has unique advantages in the aspect of treating chloasma due to the characteristics of overall treatment and small toxic and side effects.
The tanshinone IIA is extracted from traditional Chinese medicine salvia miltiorrhiza, has the effects of improving coronary artery circulation, protecting vascular endothelial cells, resisting Atherosclerosis (AS) formation, resisting myocardial hypertrophy and preventing and treating complications of diabetes, and is one of main effective components of the salvia miltiorrhiza for promoting blood circulation and removing blood stasis.
The total glucosides of paeony are extracted from the Chinese medicine of white paeony root, have the functions of resisting inflammation, easing pain, resisting oxidation, reducing blood fat, protecting liver, regulating immunity, resisting depression and the like, and are the main effective components of the white paeony root.
The panax notoginseng saponins are extracted from panax notoginseng, have the effects of protecting cardiac muscle, resisting arrhythmia, reducing blood fat, reducing blood pressure, resisting atherosclerosis, improving cerebral blood circulation, resisting thrombus, inflammation, oxidation and aging and the like, and are main effective components of the panax notoginseng for promoting blood circulation and removing blood stasis.
According to the active characteristics of tanshinone IIA, total glucosides of paeony and panax notoginseng saponins, under the guidance of the traditional medical theory and in combination with modern pharmacological research results, through a large number of experimental optimization and verification, the three components are matched for use, so that the effects of promoting blood circulation, removing blood stasis, regulating immunity and the like of the three components are fully exerted, an obvious treatment effect on chloasma can be achieved, the synergistic effect is achieved through the three components, and the treatment effect is better by matching with a dosage form of a microneedle.
In the above examples, tanshinone IIA can be replaced by ferulic acid with the same amount, total glucosides of paeony can be replaced by safflower yellow with the same amount, and Panax notoginsenosides can be replaced by total saponins of radix astragali with the same amount.
Comparative example 1
Referring to the preparation method of example 3, 3 parts of tanshinone IIA, 50 parts of sodium hyaluronate, 10 parts of polyvinylpyrrolidone and 100 parts of water. Dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring, adding tanshinone IIA, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, air-showering for drying at room temperature, and stripping the mould to obtain the product.
Comparative example 2
Referring to the preparation method of example 3, 2 parts of total glucosides of paeony, 50 parts of sodium hyaluronate, 10 parts of polyvinylpyrrolidone and 100 parts of water. Dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring uniformly, adding total glucosides of paeony, and stirring uniformly to obtain a soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, air-showering for drying at room temperature, and stripping the mould to obtain the product.
Comparative example 3
Referring to the preparation method of example 3, the preparation method comprises 5 parts of panax notoginseng saponins, 50 parts of sodium hyaluronate, 10 parts of polyvinylpyrrolidone and 100 parts of water. Dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring, adding Panax notoginsenosides, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, air-showering for drying at room temperature, and stripping the mould to obtain the product.
Comparative example 4
Referring to the preparation method of example 3, the tanshinone IIA is 3 parts, the total glucosides of paeony is 2 parts, the sodium hyaluronate is 50 parts, the polyvinylpyrrolidone is 10 parts, and the water is 100 parts. Dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring, adding tanshinone IIA and total glucosides of paeony, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, air-showering for drying at room temperature, and stripping the mould to obtain the product.
Comparative example 5
Referring to the preparation method of the embodiment 3, the white paeony root total glycosides comprise 2 parts of white paeony root total glycosides, 5 parts of panax notoginseng saponins, 50 parts of sodium hyaluronate, 10 parts of polyvinylpyrrolidone and 100 parts of water. Dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring, adding total glucosides of paeony and total saponins of panax notoginseng, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, air-showering for drying at room temperature, and stripping the mould to obtain the product.
Comparative example 6
Referring to the preparation method of example 3, the tanshinone IIA is 3 parts, the panax notoginseng saponins is 5 parts, the sodium hyaluronate is 50 parts, the polyvinylpyrrolidone is 10 parts, and the water is 100 parts. Dissolving polyvinylpyrrolidone in water, adding sodium hyaluronate, stirring, adding tanshinone IIA and Panax notoginsenosides, and stirring to obtain soluble microneedle patch stock solution; injecting the stock solution into a microneedle mould, air-showering for drying at room temperature, and stripping the mould to obtain the product.
Comparative example 7
Referring to the prescription of example 3, 3 parts of tanshinone IIA, 2 parts of total glucosides of paeony and 5 parts of total saponins of panax notoginseng, a common patch is prepared.
Selecting 80 volunteers (female, age 25-45 years old) with yellowish-brown or dark-brown patches on face, which are distributed on cheeks, periorbital, forehead, etc., with obvious edges. The volunteers were divided into 8 groups, example 3 and comparative examples 1 to 7, 10 persons per group. The using method comprises the following steps: the microneedle patch was pressed into the pigmented spot on the face of the volunteer, removed after 4 hours, and used twice a week for 8 weeks. The curative effect standard is as follows: effective-lightening or lightening of color of the stain; no effect-no apparent change in skin. The results are shown in Table 1.
TABLE 1
Table 1 is an evaluation table of a trial product by a trial user, and the results in the table show that, compared with comparative examples 1 to 7, the treatment effect of example 3 on chloasma is most significant, and the total effective rate can reach 80%. The results show that the using effect of the product in example 3 is better than that of a comparative product in which tanshinone IIA, total glucosides of paeony and panax notoginseng saponins are singly used, is also better than that of a comparative product in which the three components are matched in pairs, and is also better than that of a common patch in which the three components are matched. The tanshinone IIA, the total glucosides of paeony and the total saponins of panax notoginseng are used in a matching way, so that the remarkable synergistic effect is achieved, and the treatment effect is also remarkably improved by adopting a soluble microneedle administration way, so that the patch is superior to that of a common patch group.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The soluble microneedle patch for treating chloasma is characterized by comprising the following raw materials in parts by weight: 1-5 parts of tanshinone IIA, 1-5 parts of total glucosides of paeony, 1-5 parts of total saponins of panax notoginseng, 30-60 parts of sodium hyaluronate, 10-25 parts of excipient and 30-100 parts of water.
2. The soluble microneedle patch for treating chloasma according to claim 1, comprising: the excipient material is at least one of sodium carboxymethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, hydroxypropyl methylcellulose, fructose, lactose, sorbitol, dextran, trehalose and sucrose.
3. The soluble microneedle patch for treating chloasma according to claim 2, characterized in that: the tanshinone
A3 parts, white peony root total glycosides 2 parts, panax notoginseng saponins 5 parts, sodium hyaluronate 50 parts, and the excipient is polyvinylpyrrolidone 10 parts and water 100 parts.
4. The soluble microneedle patch for treating chloasma according to claim 2, characterized in that:the tanshinone
5 parts of A, 2 parts of total glucosides of paeony, 4 parts of panax notoginseng saponins, 30 parts of sodium hyaluronate, 15 parts of hydroxypropyl methylcellulose as a shaping material and 100 parts of water.
5. The soluble microneedle patch for treating chloasma according to claim 2, characterized in that: the tanshinone
A4 parts, 2 parts of total glucosides of paeony, 3 parts of panax notoginseng saponins, 35 parts of sodium hyaluronate, 25 parts of fructose as a excipient and 100 parts of water.
6. The soluble microneedle patch for treating chloasma according to claim 2, characterized in that: the tanshinone
A3 parts, 2 parts of total glucosides of paeony, 3 parts of panax notoginseng saponins, 55 parts of sodium hyaluronate, 20 parts of glucan as an excipient and 100 parts of water.
7. The soluble microneedle patch for treating chloasma according to any one of claims 1 to 6, comprising: the tanshinone IIA can be replaced by ferulic acid with the same amount.
8. The soluble microneedle patch for treating chloasma according to claim 7, wherein: the total glucosides of paeony can be replaced by the same amount of safflower yellow.
9. The soluble microneedle patch for treating chloasma according to claim 8, wherein: the total saponins of radix Notoginseng can be replaced by total saponins of radix astragali.
10. The preparation method of the soluble microneedle patch for treating chloasma according to claim 1, comprising the following steps: dissolving the excipient in the water, adding the sodium hyaluronate, uniformly stirring, adding the tanshinone IIA, the total glucosides of paeony and the panax notoginseng saponins, and uniformly stirring to obtain a soluble microneedle patch stock solution; and injecting the stock solution into a microneedle mould, drying by air showering at room temperature, and stripping the mould to obtain the soluble microneedle patch for treating chloasma.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113081895A (en) * | 2021-05-06 | 2021-07-09 | 无锡元旭生物技术有限公司 | Soluble noninvasive microneedle patch for removing chloasma and preparation method thereof |
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| CN111184942A (en) * | 2020-03-18 | 2020-05-22 | 四川大学华西医院 | Soluble microneedle for treating chloasma |
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| CN111184942A (en) * | 2020-03-18 | 2020-05-22 | 四川大学华西医院 | Soluble microneedle for treating chloasma |
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