CN107998071B - Method for improving stability of phenytoin silver and phenytoin silver external preparation - Google Patents
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Abstract
The invention provides a method for improving the stability of phenytoin silver and a phenytoin silver external preparation. The method of the invention is suitable for the following seven formulations of the phenytoin silver external preparation: ointments, gels, pastes, plasters, films, plastics, sprays and suspensions. The invention provides a method for improving the stability of phenytoin silver in a preparation, enlarges the application range of the phenytoin silver external preparation in the field of medicine, and the obtained preparation has the characteristics of relatively clear components, quick response, stable property, accurate quality control and the like, provides more optional types and dosage forms of external medicines for promoting wound healing for patients, and promotes the development of the external preparation for promoting wound healing.
Description
Technical Field
The invention belongs to the technical field of medicaments for promoting wound healing, and particularly relates to a method for improving the stability of phenytoin silver and a phenytoin silver external preparation.
Background
The skin is the largest organ of the human body, which protects various tissues and organs in the body from physical, mechanical, chemical and pathogenic microbial attacks. When the skin is damaged and the wound is large, the skin is difficult to heal quickly, external viruses and harmful substances enter the human body, and infection and suppuration at the wound are caused. Skin infection and the like can make wound healing difficult. At the same time, the wound infection can cause the defense mechanism in the human body to respond, and a series of reactions such as inflammation and the like are initiated.
The traditional wound treatment medicines applied to clinic are mostly used for inhibiting wound infection, and have no obvious effect on promoting wound healing. Especially for large wounds, the wound surface has long healing time and is easy to be infected, and the work and the life of a patient are seriously influenced.
CN201410009188.6 discloses a phenytoin derivative, phenytoin silver, which has the characteristics of bacteriostasis, sterilization, anti-inflammation, anti-infection and wound healing promotion. However, the phenytoin silver has unstable chemical property, thereby reducing the curative effect of the phenytoin silver, and the phenytoin silver coated on the wound is easy to cause the risk of wound allergy. Therefore, the stability of the phenytoin silver in the preparation is improved, and the method has important practical significance.
Disclosure of Invention
In view of the above, the present invention aims to provide a method for improving the stability of phenytoin silver and a phenytoin silver external preparation, so as to solve the problems of instability, easy wound allergy and unsatisfactory curative effect of the existing phenytoin silver.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
a method for improving the stability of phenytoin silver uses auxiliary materials with ultraviolet shielding function and/or auxiliary materials with ultraviolet absorbing function to improve the stability of phenytoin silver.
An external preparation of phenytoin silver, which contains phenytoin silver; the external preparation also contains auxiliary materials with ultraviolet shielding function or auxiliary materials with ultraviolet absorption function.
Furthermore, the external preparation also contains a combined drug capable of promoting wound healing or resisting inflammation.
Further, the auxiliary materials with the ultraviolet shielding function are as follows: one or more of camphor, cinnamate, salicylic acid, benzoate, ketone, triazine, benzoxazole and alkane sunscreens.
Furthermore, the auxiliary material with the ultraviolet shielding function accounts for 0.01-10% by mass.
Further, the auxiliary materials with ultraviolet absorption function in the phenytoin-silver compound external preparation comprise: one or more of kaolin, zinc oxide, talcum powder, titanium dioxide and novel organic sunscreen powder.
Furthermore, the phenytoin-silver compound external preparation contains 0.01-25% of auxiliary materials with ultraviolet absorption function by mass percent.
Furthermore, the phenytoin silver compound external preparation accounts for 0.01 to 50 percent by mass of the phenytoin silver.
Further, the external preparation is ointment, gel, paste, plaster, film, coating agent, spray and suspension.
The application of the external preparation of phenytoin silver in preparing medicines for inhibiting bacteria, sterilizing, diminishing inflammation, resisting infection and/or promoting wound healing.
Compared with the prior art, the method for improving the stability of the phenytoin silver has the following advantages:
the method for improving the stability of the phenytoin silver can effectively prevent the phenytoin silver from generating photochemical reaction, prevent the phenytoin silver from deteriorating and improve the stability of the phenytoin silver, thereby ensuring the effects of promoting wound healing and resisting inflammation of the phenytoin silver. The phenytoin silver external preparation prepared by the method has the effects of remarkably preventing wound infection, promoting wound healing and reducing scar formation, and can be used in the fields of wound healing, diabetic foot, surgical operation, war wound treatment and the like.
Drawings
Fig. 1 is a graph showing the results of effect 1 of example 1, comparative example 1, and comparative example 0.
Detailed Description
Unless defined otherwise, technical terms used in the following examples have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention belongs. The test reagents used in the following examples, unless otherwise specified, are all conventional biochemical reagents; the experimental methods are conventional methods unless otherwise specified.
The present invention will be described in detail with reference to the following examples and accompanying drawings.
Example 1
An external ointment of phenytoin silver, which consists of the following components in parts by weight: per 100 parts: 5 parts of phenytoin silver, 10 parts of glycerol, 9401 parts of carbomer, 25 parts of titanium dioxide, a proper amount of triethanolamine, 0.3 part of ethylparaben, 0.5 part of sodium sulfite and the balance of purified water.
The ointment preparation method comprises the following steps:
putting 1 part of carbomer 940 into 52 parts of purified water, after the carbomer naturally swells, adding 5 parts of phenytoin silver, 25 parts of titanium dioxide, 10 parts of glycerol, 0.3 part of ethylparaben and 0.5 part of sodium sulfite, and uniformly stirring; continuously stirring and dropwise adding a proper amount of triethanolamine, adjusting the pH value to 5.5, continuously adding purified water to 100 parts, uniformly stirring, and subpackaging to obtain the finished product.
Comparative example 1
An external ointment of phenytoin silver, which consists of the following components in parts by weight: per 100 parts: 5 parts of phenytoin silver, 10 parts of glycerol, 9401 parts of carbomer, a proper amount of triethanolamine, 0.3 part of ethylparaben, 0.5 part of sodium sulfite and the balance of purified water.
The ointment preparation method comprises the following steps:
putting 1 part of carbomer 940 into 52 parts of purified water, adding 5 parts of phenytoin silver, 10 parts of glycerol, 0.3 part of ethylparaben and 0.5 part of sodium sulfite after natural swelling, and uniformly stirring; continuously stirring and dropwise adding a proper amount of triethanolamine, adjusting the pH value to 5.5, continuously adding purified water to 100 parts, uniformly stirring, and subpackaging to obtain the finished product.
Comparative example 0
Per 100 parts: 10 parts of glycerol, 9401 parts of carbomer, 25 parts of titanium dioxide, a proper amount of triethanolamine, 0.3 part of ethylparaben, 0.5 part of sodium sulfite and the balance of purified water.
Putting 1 part of carbomer 940 into 52 parts of purified water, adding 25 parts of titanium dioxide, 10 parts of glycerol, 0.3 part of ethylparaben and 0.5 part of sodium sulfite after natural swelling, and uniformly stirring; continuously stirring and dropwise adding a proper amount of triethanolamine, adjusting the pH value to 5.5, continuously adding purified water to 100 parts, uniformly stirring, and subpackaging to obtain the finished product.
The performance tests were conducted on example 1, comparative example 1 and comparative example 0, and the results were analyzed as follows:
(1) effect 1: effect on wound healing in rats
Experimental animals: SD rats, female, body weight 180g-200 g.
Preparation and treatment of SD rat wound model: injecting 10% chloral hydrate into abdominal cavity of SD rat (5 rats), shaving hair on back with shaver after anesthesia, wiping skin with 75% ethanol, and eliminatingAnd (5) toxicity. The marker pen draws three circles with equal diameter of 1cm on the back of the mouse, and the skin is clipped by forceps and then cut by surgical scissors to reach the wound of the fascia. The wounds were wiped clean with 0.9% physiological saline and then treated with drug, the right side wound was smeared with the ointment provided in comparative example 0, the left side wound was smeared with the ointment provided in comparative example 1, and the middle side wound was smeared with the ointment provided in example 1, all of which were 1.5mm thick. The wound leaks outside after the model is made, and the daily use strength is 150W/m2The rats were irradiated with UV light for 12 hours and were raised in a single cage. Photographs were taken on the day of skin injury as day 1 in the experimental record, with dosing every 1 day.
The experimental results are as follows:
the healing of each group of wounds is shown in figure 1: the healing effect of the wound treated with the phenytoin silver ointment (i.e., example 1) and the phenytoin silver ointment (comparative example 1) added with titanium dioxide was better than that of the control group (comparative example 0). However, all the wounds of the rats given the ointment provided in example 1 healed substantially completely on day 9, and no suppuration occurred in the wounds throughout the healing process; whereas the wounds of rats given the ointment provided in comparative example 1 were substantially healed at day 13. Therefore, the stability of the phenytoin silver in the preparation is increased after the sunscreen agent is added, and the drug effect of the phenytoin silver is maintained.
(2) Effect 2: influence on wound healing of Guangxi Bama miniature fragrant pig
Experimental animals: guangxi Bama miniature pig with weight of 20kg
Preparation and treatment of a Bama miniature pig wound model:
the quality of the ambrosia hollandica herb injected in the abdominal cavity of the Guangxi Bama miniature pig is 2.5mg/kg (the dosage is shown in the specification), after the ambrosia hollandica herb is anesthetized, the hair on the back of the pig is shaved by scissors, and the skin is wiped by 75 percent ethanol for disinfection and cleaning. 6 circles with the same diameter of 2 cm are drawn on one side of the back of the pig by marks, and then the skin is cut off in a full layer by a scalpel (which is produced by experienced pathologists). The wounds were wiped clean with 0.9% physiological saline and then treated by divided administration. Randomly 2 wounds were selected as controls and the wounds were smeared as provided in comparative example 0Paste; 2 wounds are selected to be smeared with the ointment provided in the comparative example 1; another 2 wounds were applied with the ointment provided in example 1; the dosage was 1mm thick. Wrapping each closing up with thin gauze, and breeding in single cage. Removing gauze the next day, and applying the gauze with intensity of 150W/m daily from the next day2The rats were irradiated with UV light for 12 hours and administered 1 time every 1 day.
The experimental results are as follows:
the skin structure of mice is different from the skin structure of human skin, so that the drug effect of phenytoin silver applied to human wounds cannot be accurately evaluated. Porcine skin structure has been shown to be the closest to human skin structure. Therefore, the Bama miniature pig is selected as an experimental object to accurately evaluate whether the phenytoin silver can be selected when the human skin has a wound. With the delay of the healing process, after the Guangxi Bama miniature fragrant pig is modeled and administrated, new skin grows out of the wounds of each group: the wound applied with the ointment provided in example 1 began to scab on day 8, healed substantially on day 10, and the scab fell off on day 12; the wound applied with the ointment provided in comparative example 1 began to scab on day 10, healed substantially on day 12, and the scab fell off on day 15; while the control group applied with comparative example 0 started scabbing on day 15 and healed substantially on day 20 with a severe lag in healing time. Meanwhile, in the research process, the phenomena of suppuration and red swelling appear on most of the wounds of the control group smeared in the comparative example 0 on the 2 nd day, and meanwhile, the bleeding is serious. The wounds of the ointment provided in example 1 and the wounds of the ointment provided in comparative example 1 were relatively dry and clean. The healing rate is as follows: the wound applying the ointment provided in example 1 > the wound applying the ointment provided in comparative example 1 > the wound applying the aqueous solution of carbomer 940 with the mass fraction of 1% provided in comparative example 0.
Effect 3: bacteriostatic effect
The experimental method comprises the following steps:
(1) respectively taking 5 mu L of escherichia coli, staphylococcus aureus and pseudomonas aeruginosa glycerol bacteria, inoculating the escherichia coli, staphylococcus aureus and pseudomonas aeruginosa glycerol bacteria into three 5mL liquid LB culture media, placing a small test tube in a shaking table at 37 ℃, performing overnight culture at 220 rpm/min;
(2) taking 200 mu L of liquid of staphylococcus aureus, escherichia coli and pseudomonas aeruginosa which are cultured overnight, diluting by 10 times, and taking 200 mu L to coat on an antibiotic-free solid LB culture medium;
(3) punching a filter paper wafer with the diameter of 1cm by using a puncher, and putting the filter paper wafer into distilled water for autoclaving; (4) the filter paper sheets of example 1, comparative example 1 and comparative example 0, both sides of which were dipped with 1mm, were placed in culture plates full of staphylococcus aureus, escherichia coli, pseudomonas aeruginosa, respectively. And observing whether a bacteriostatic zone is formed around the filter paper in the culture dish after 24h and observing the size of the bacteriostatic zone.
The experimental results are as follows:
in the three culture plates full of staphylococcus aureus, escherichia coli and pseudomonas aeruginosa, the inhibition zones are clearly visible around the filter paper of the embodiment 1 and the filter paper of the comparative example 1, but the inhibition zone around the filter paper of the embodiment 1 is larger than that around the filter paper of the comparative example, and the phenomenon does not occur around the filter paper (the control group) stained with the comparative example, so that the phenytoin silver has a good inhibition effect on the staphylococcus aureus, the escherichia coli and the pseudomonas aeruginosa.
Examples 2 to 6 and comparative examples 2 to 6
Examples 2 to 6 provide a phenytoin silver ointment for external use prepared in the same manner as in example 1, and comparative examples 2 to 6 provide a phenytoin silver ointment for external use prepared in the same manner as in comparative example 1; wherein the difference is the content of each component and the selection of auxiliary materials with ultraviolet absorption function.
The contents of the respective components per 100 parts in examples 2 to 6 and comparative examples 2 to 6 are shown in Table 1.
TABLE 1
The ultraviolet absorbing auxiliary materials of examples 2 to 6 and comparative examples 2 to 6 are shown in Table 2.
TABLE 2
The test method for the external ointment of phenytoin silver provided in examples 2 to 6 and comparative examples 2 to 6 was the same as that of example 1, and the test results are shown in table 3.
TABLE 3
Examples 7 to 11 and comparative examples 7 to 11
Examples 7 to 11 provide a phenytoin silver ointment for external use prepared in the same manner as in example 1, and comparative examples 7 to 11 provide a phenytoin silver ointment for external use prepared in the same manner as in comparative example 1; wherein the difference is the content of each component and the selection of auxiliary materials with ultraviolet absorption function.
The contents of the respective components per 100 parts in examples 7 to 11 and comparative examples 7 to 11 are shown in Table 4.
TABLE 4
The auxiliary materials having UV ray resistance for examples 7 to 11 and comparative examples 7 to 11 are shown in Table 5.
TABLE 5
The test methods for the topical ointment of phenytoin silver provided in examples 7 to 11 and comparative examples 7 to 11 were the same as those of example 1, and the test results are shown in table 6.
TABLE 6
Example 12
An ointment for promoting wound healing, which consists of the following components in parts by weight: every 100 parts of phenytoin silver 5 parts, octocrylene 10 parts, glycerin 5 parts, gelatin 1 part, ethylparaben 0.3 part, sodium sulfite 0.5 part, and the balance of purified water.
The preparation method comprises the following steps:
putting 1 part of gelatin into 70ml of purified water, after natural swelling, adding 5 parts of phenytoin silver, 10 parts of octocrylene, 5 parts of glycerol, 0.5 part of sodium sulfite and 0.3 part of ethylparaben, continuously adding purified water to 100 parts, uniformly stirring and subpackaging to obtain the finished product.
Comparative example 12
An ointment for promoting wound healing, which consists of the following components in parts by weight: every 100 parts of phenytoin silver 5 parts, glycerin 5 parts, gelatin 1 part, ethylparaben 0.3 part, sodium sulfite 0.5 part, and the balance of purified water.
The preparation method comprises the following steps:
putting 1 part of gelatin into 70ml of purified water, after natural swelling, adding 5 parts of phenytoin silver, 5 parts of glycerol, 0.5 part of sodium sulfite and 0.3 part of ethylparaben, continuing to add the purified water to 100 parts, uniformly stirring and subpackaging to obtain the gelatin oral liquid.
Example 13
This example 13 provides an ointment for promoting wound healing, the remaining components being the same as in example 12 except that octocrylene was replaced with 5 parts of titanium dioxide and 5 parts of salicylic acid, as in example 12.
The test method for the external ointment of phenytoin silver provided in examples 12 and 13 and comparative example 12 was the same as that of example 1, and the test results are shown in table 7.
TABLE 7
The application can obviously increase the stability of the external phenytoin silver preparation by adding the auxiliary material with the ultraviolet shielding function or the auxiliary material with the ultraviolet absorption function into the external phenytoin silver preparation, expands the application range of the external phenytoin silver preparation in the field of medicine, and the obtained preparation has the characteristics of relatively clear components, quick response, stable property, accurate quality control and the like, provides more optional types and dosage forms of external medicines for promoting wound healing for patients, promotes the development of the external preparation for wound healing, and has better application prospect.
In addition, the stability of the external preparation can be obviously improved by adding auxiliary materials with ultraviolet shielding function or auxiliary materials with ultraviolet absorption function into the gel, paste, plaster, film agent, film coating agent, spray and suspension of the external preparation of phenytoin silver, and the external preparation has better wound healing effect.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (8)
1. A method for improving the stability of phenytoin silver is characterized by comprising the following steps: the stability of the phenytoin silver is improved by using auxiliary materials with an ultraviolet shielding function and/or auxiliary materials with an ultraviolet absorbing function;
the auxiliary material with the ultraviolet shielding function is one or more of camphor, sodium cinnamate, salicylic acid, sodium benzoate and benzotriazole;
the auxiliary material with the ultraviolet absorption function is one or more of kaolin, zinc oxide, talcum powder and titanium dioxide.
2. An external preparation of phenytoin silver, which is characterized in that: the external preparation contains phenytoin silver; the external preparation also contains an auxiliary material with an ultraviolet shielding function or an auxiliary material with an ultraviolet absorption function;
the auxiliary material with the ultraviolet shielding function is one or more of camphor, sodium cinnamate, salicylic acid, sodium benzoate and benzotriazole;
the auxiliary material with the ultraviolet absorption function is one or more of kaolin, zinc oxide, talcum powder and titanium dioxide.
3. The external preparation of phenytoin silver as claimed in claim 2, wherein: the external preparation also contains a combined medicament capable of promoting wound healing or resisting inflammation.
4. The external preparation of phenytoin silver as claimed in claim 3, wherein: the auxiliary material with the ultraviolet shielding function accounts for 0.01-10% by mass.
5. The external preparation of phenytoin silver as claimed in claim 4, wherein: the phenytoin silver external preparation comprises 0.01-25% of auxiliary materials with ultraviolet absorption function by mass percent.
6. The external preparation of phenytoin silver as claimed in claim 5, wherein: the phenytoin silver external preparation accounts for 0.01-50% by mass.
7. The external preparation of phenytoin silver as described in any one of claims 2 to 6, wherein: the external preparation is ointment, gel, cataplasm, plaster, film agent, film coating agent, spray and suspension.
8. Use of the external preparation of phenytoin silver as claimed in claim 7 for the preparation of a medicament for bacteriostasis, sterilization, anti-inflammation, anti-infection and/or promotion of wound healing.
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| CN104016923A (en) * | 2014-01-08 | 2014-09-03 | 南开大学 | Phenytoin derivative as well as preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104016923A (en) * | 2014-01-08 | 2014-09-03 | 南开大学 | Phenytoin derivative as well as preparation method and application thereof |
Non-Patent Citations (3)
| Title |
|---|
| "Phenytoin silver:a new nanocompound for promoting dermal wound healing via comprehensive pharmacological action";Xiao-yu Ai et al.;《Theranostics》;20170105;第7卷(第2期);第425-435页 * |
| "光敏性银类化合物的光稳定性与光催化活性";余火根等;《第十三届全国太阳能光化学与光催化学术会议论文集》;20130528;第155页 * |
| "紫外线吸收剂增进氨基酸光稳定性的作用研究";徐从刚等;《浙江理工大学学报（自然科学版）》;20140331;第31卷(第2期);第112-116、132页 * |
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