CN110585312A - Liduodeoxyemulsion and preparation method and application thereof - Google Patents
Liduodeoxyemulsion and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a lidocaine cream and a preparation method and application thereof, which is prepared by taking lidocaine and phenylephrine hydrochloride as active ingredients, and matching with aloe extract with anti-inflammatory effect and a certain amount of matrix, humectant, emulsifier and the like. The invention is easy to be coated on skin or mucous membrane, does not melt, has moderate viscosity, has no rancidity, foreign odor, discoloration, hardening and other deterioration phenomena after long-term storage, and meets the quality standard requirements of cream. The invention can treat and relieve pain, pruritus and discomfort caused by anus and rectum diseases, and can also be used for treating hepatic portal diseases such as congestion, swelling and the like of hemorrhoid tissues.
Description
Technical Field
The invention belongs to the field of chemical research and development, and particularly relates to a Lidongduo cream, and a preparation method and application thereof.
Technical Field
Pruritus ani is also called pruritus ani, and refers to a skin disease with pruritus symptoms without any primary skin damage on the skin around the anus. Anal pruritus is related to various factors such as anal diseases, sanitation, bacterial or fungal infection and the like, for example, pruritus ani can occur at the anal part of anal eczema, helminth and the like, and the pruritus ani is also shown as pruritus ani.
The pain of the liver is generally caused by anal sinusitis, anal papillitis, perianal abscess, anal fistula, inflammation of external hemorrhoids, anal fissure, anal rhagadia, anal foreign body injury, spicy and hot food stimulation and the like.
Lidocaine, which is a local anesthetic and an antiarrhythmic drug, has a strong and durable anesthetic effect and good surface penetration, generally takes effect after one to three minutes, and can maintain the effect for one to three hours. Can be used for treating oral ulcer.
Phenylephrine hydrochloride is an alpha adrenergic receptor agonist, is used for preventing and treating hypotension caused by spinal anesthesia, general anesthesia, chlorpromazine and the like, and is also used for supraventricular tachycardia, mydriasis and the like.
The aloe extract is prepared by using an aloe medicinal material as a raw material and performing macroporous resin adsorption and purification, and modern researches show that the aloe has strong anti-inflammatory, antiviral, antibacterial and insecticidal effects and the like.
Disclosure of Invention
The invention relates to a lidocaine and deoxidation cream and a preparation method thereof, which is a cream prepared by using lidocaine and phenylephrine hydrochloride as active ingredients, matching with aloe extract with anti-inflammatory effect and a certain amount of matrix, humectant, emulsifier and the like.
The invention solves the technical problem that the cream preparation is more suitable for clinical use aiming at the treated part and symptoms.
The technical scheme for realizing the invention is as follows:
prescription: calculated according to the weight percentage:
the prescription of the invention can also be as follows according to the weight percentage:
| prescription composition | Amount of prescription | Prescription composition | Amount of prescription | Prescription composition | Amount of prescription |
| Lidocaine | 3-8％ | Cholesterol | 2％-4％ | Triethanolamine | 2％-4％ |
| Phenylephrine hydrochloride | 0.2-0.4％ | Hydrogenated phosphatidylcholine | 2％-4％ | Alpha-tocopheryl acetate | 1.0％-1.5％ |
| Aloe extract | 2％-4％ | Myristic acid isopropyl ester | 2％-4％ | Grape skin extract | 0.5％-1％ |
| Benzyl alcohol | 1.0％-1.5％ | Tween-80 | 2％-4％ | Water (W) | Proper amount of |
| Carbomer 934P | 1.0％-2.0％ | Propylene glycol | 2％-4％ |
The prescription of the invention can also be as follows according to the weight percentage:
| prescription composition | Amount of prescription | Prescription composition | Amount of prescription | Prescription composition | Amount of prescription |
| Lidocaine | 5％ | Cholesterol | 3％ | Triethanolamine | 3％ |
| Phenylephrine hydrochloride | 0.25％ | Hydrogenated phosphatidylcholine | 3％ | Alpha-tocopheryl acetate | 1％ |
| Aloe extract | 3％ | Myristic acid isopropyl ester | 3％ | Grape skin extract | 0.5％ |
| Benzyl alcohol | 1％ | Tween-80 | 3％ | Water (W) | Proper amount of |
| Carbomer 934P | 2％ | Propylene glycol | 3％ |
The preparation method comprises the following steps: the method comprises the following steps:
1. preparation of oil phase components:
placing cholesterol, isopropyl myristate, benzyl alcohol, and alpha-tocopherol acetate in a heating container, heating, stirring to completely dissolve to obtain oil phase solution;
2. preparation of aqueous phase component:
heating carbomer 934P and propylene glycol in a heating container, stirring to dissolve completely to obtain water phase solution;
3. preparation of primary emulsion:
under heating condition, adding the water phase solution into the oil phase solution, heating while stirring to obtain homogeneous solution, slowly adding into heated emulsifying machine, adding triethanolamine, hydrogenated phosphatidylcholine and part of tween-80, starting emulsifying machine, stirring at 300rpm for 15-30min to obtain primary emulsion;
4. preparation of a medicine phase:
adding a small amount of water into the rest tween-80, heating, stirring, adding lidocaine, phenylephrine hydrochloride, grape skin extract, and aloe extract, stirring to completely dissolve the medicinal materials to obtain medicinal phase solution;
5. preparing a cream;
starting an emulsifying machine under heating state, stirring at 300rpm, slowly adding the above medicinal phase dissolved solution into the primary emulsion, starting homogenizing at 3500r/m, homogenizing for 5-10min, stopping homogenizing, stirring for 15min, transferring the obtained cream into a cold water bath, starting stirring at 60-70rpm, rapidly cooling to below 25 deg.C, and packaging to obtain the final product.
The heating container refers to a container capable of being heated by electricity or steam.
And heating at 80-85 ℃.
The stirring is carried out electrically or manually.
The Liduodeoxy cream and the preparation method and the application thereof have the functions of treating and relieving pain, pruritus and discomfort caused by anus and rectum diseases, and can also be used for treating hepatic portal diseases such as congestion, swelling and the like of hemorrhoidal tissues.
The invention relates to an external cream which is applied to the affected part.
Advantageous effects
The invention relates to a lidocaine cream and a preparation method and application thereof, which is prepared by taking lidocaine and phenylephrine hydrochloride as active ingredients, and matching with aloe extract with anti-inflammatory effect and a certain amount of matrix, humectant, emulsifier and the like. The invention is easy to be coated on skin or mucous membrane, does not melt, has moderate viscosity, has no rancidity, foreign odor, discoloration, hardening and other deterioration phenomena after long-term storage, and meets the quality standard requirements of cream.
The invention can treat and relieve pain, pruritus and discomfort caused by anus and rectum diseases, and can also be used for treating hepatic portal diseases such as congestion, swelling and the like of hemorrhoid tissues.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention.
Example 1
Prescription: calculated according to the weight percentage:
| prescription composition | Amount of prescription | Prescription groupBecome into | Amount of prescription | Prescription composition | Amount of prescription |
| Lidocaine | 5％ | Cholesterol | 1％ | Triethanolamine | 1％ |
| Phenylephrine hydrochloride | 0.25％ | Hydrogenated phosphatidylcholine | 1％ | Alpha-tocopheryl acetate | 0.5％ |
| Aloe extract | 1％ | Myristic acid isopropyl ester | 1％ | Grape skin extract | 0.1％ |
| Benzyl alcohol | 0.5％ | Tween-80 | 1％ | Water (W) | Proper amount of |
| Carbomer 934P | 0.5％ | Propylene glycol | 1％ |
The preparation method comprises the following steps:
1. preparation of oil phase components:
placing the cholesterol, isopropyl myristate, benzyl alcohol and alpha-tocopherol acetate in a heating container according to the prescription amount, heating to 80 ℃, and stirring to completely dissolve the cholesterol, isopropyl myristate, benzyl alcohol and alpha-tocopherol acetate to obtain an oil phase dissolved solution for later use;
2. preparation of aqueous phase component:
taking carbomer 934P and propylene glycol in the formula amount into a heating container, heating to 80 ℃, and stirring to completely dissolve the carbomer and the propylene glycol to obtain a water-phase dissolved solution for later use;
3. preparation of primary emulsion:
heating to 80 deg.C, adding the above water phase solution into the oil phase solution, heating while stirring to obtain homogeneous solution, adding into heated emulsifying machine, adding triethanolamine, hydrogenated phosphatidylcholine and part of tween-80, starting emulsifying machine, stirring at 300rpm for 15min to obtain primary emulsion;
4. preparation of a medicine phase:
adding a small amount of water into the rest Tween-80, heating to 80 deg.C, stirring, adding lidocaine, phenylephrine hydrochloride, grape skin extract and aloe extract, stirring to dissolve the medicinal materials completely to obtain medicinal phase solution;
5. preparing a cream;
heating to 80 deg.C, starting emulsifying machine and stirring at 300rpm, slowly adding the above medicinal phase dissolved solution into the primary emulsion, starting homogenizing at 3500r/m, homogenizing for 5min, stopping homogenizing, stirring for 15min, transferring the obtained cream into cold water bath, starting stirring at 60rpm, rapidly cooling to below 25 deg.C, and packaging to obtain Lidongduo cream.
Example 2
Prescription: calculated according to the weight percentage:
| prescription composition | Amount of prescription | Prescription composition | Amount of prescription | Prescription composition | Amount of prescription |
| Lidocaine | 5％ | Cholesterol | 3％ | Triethanolamine | 3％ |
| Phenylephrine hydrochloride | 0.25％ | Hydrogenated phosphatidylcholine | 3％ | Alpha-tocopheryl acetate | 1％ |
| Aloe extract | 3％ | Myristic acid isopropyl ester | 3％ | Grape skin extract | 0.5％ |
| Benzyl alcohol | 1％ | Tween-80 | 3％ | Water (W) | Proper amount of |
| Carbomer 934P | 2％ | Propylene glycol | 3％ |
The preparation method comprises the following steps:
1. preparation of oil phase components:
placing the cholesterol, isopropyl myristate, benzyl alcohol and alpha-tocopherol acetate in a heating container according to the prescription amount, heating to 85 ℃, and stirring to completely dissolve to obtain an oil phase dissolved solution for later use;
2. preparation of aqueous phase component:
taking carbomer 934P and propylene glycol in the formula amount into a heating container, heating to 85 ℃, and stirring to completely dissolve the carbomer and the propylene glycol to obtain a water-phase dissolved solution for later use;
3. preparation of primary emulsion:
heating to 85 deg.C, adding the above water phase solution into the oil phase solution, heating while stirring to obtain homogeneous solution, adding into heated emulsifying machine, adding triethanolamine, hydrogenated phosphatidylcholine and part of tween-80, starting emulsifying machine, stirring at 300rpm for 30min to obtain primary emulsion;
4. preparation of a medicine phase:
adding a small amount of water into the rest Tween-80, heating to 85 deg.C, stirring, adding lidocaine, phenylephrine hydrochloride, grape skin extract and aloe extract, stirring to dissolve the medicinal materials completely to obtain medicinal phase solution;
5. preparing a cream;
heating to 85 deg.C, starting emulsifying machine and stirring at 300rpm, slowly adding the above medicinal phase dissolved solution into the primary emulsion, starting homogenizing at 3500r/m, homogenizing for 10min, stopping homogenizing, stirring for 15min, transferring the obtained cream into cold water bath, starting stirring at 70rpm, rapidly cooling to below 25 deg.C, and packaging to obtain Lidongduo cream.
Example 3
Prescription: calculated according to the weight percentage:
| prescription composition | Amount of prescription | Prescription composition | Amount of prescription | Prescription composition | Amount of prescription |
| Lidocaine | 5％ | Cholesterol | 5％ | Triethanolamine | 5％ |
| Phenylephrine hydrochloride | 0.25％ | Hydrogenated phosphatidylcholine | 5％ | Alpha-tocopheryl acetate | 2％ |
| Aloe extract | 5％ | Myristic acid isopropyl ester | 5％ | Grape skin extract | 1％ |
| Benzyl alcohol | 2％ | Tween-80 | 5％ | Water (W) | Proper amount of |
| Carbomer 934P | 3％ | Propylene glycol | 5％ |
The preparation method comprises the following steps:
1. preparation of oil phase components:
placing the cholesterol, isopropyl myristate, benzyl alcohol and alpha-tocopherol acetate in a heating container according to the prescription amount, heating to 85 ℃, and stirring to completely dissolve to obtain an oil phase dissolved solution for later use;
2. preparation of aqueous phase component:
taking carbomer 934P and propylene glycol in the formula amount into a heating container, heating to 85 ℃, and stirring to completely dissolve the carbomer and the propylene glycol to obtain a water-phase dissolved solution for later use;
3. preparation of primary emulsion:
heating to 85 deg.C, adding the above water phase solution into the oil phase solution, heating while stirring to obtain homogeneous solution, adding into heated emulsifying machine, adding triethanolamine, hydrogenated phosphatidylcholine and part of tween-80, starting emulsifying machine, stirring at 300rpm for 20min to obtain primary emulsion;
4. preparation of a medicine phase:
adding a small amount of water into the rest Tween-80, heating to 85 deg.C, stirring, adding lidocaine, phenylephrine hydrochloride, grape skin extract and aloe extract, stirring to dissolve the medicinal materials completely to obtain medicinal phase solution;
5. preparing a cream;
heating to 85 deg.C, starting emulsifying machine and stirring at 300rpm, slowly adding the above medicinal phase dissolved solution into the primary emulsion, starting homogenizing at 3500r/m, homogenizing for 8min, stopping homogenizing, stirring for 15min, transferring the obtained cream into cold water bath, starting stirring at 65rpm, rapidly cooling to below 25 deg.C, and packaging to obtain the final product.
Example 4
Stability test 1 (centrifugation, content uniformity determination)
10g of each of the Lidodeoxyemulsion prepared in the above examples 1 to 3 was put into a 50ml transparent centrifuge tube, centrifuged at 5000r/min for 5min, taken out and observed, and two samples were taken in parallel from the upper, middle and lower three parts of the centrifuge tube for content detection.
The content determination method comprises the following steps:
sample purification:
accurately weighing 0.5g of sample, placing the sample into a 10-15mL centrifuge tube, adding 8mL of 1% trichloroacetic acid and 2mL of acetonitrile, swirling for 1min, centrifuging for 5min at 5000r/min, sequentially activating the supernatant with 3mL of methanol and 5mL of 1% trichloroacetic acid by using a PCX solid phase extraction column, allowing the sample clear solution to be purified to flow through the column, eluting the column with 3mL of 1% methanol solution, discarding eluent, eluting with 10mL of 5% ammonia methanol (taking 5mL of ammonia water and adding methanol to 100mL), collecting eluent, drying with nitrogen, diluting to 10mL with methanol to a constant volume, filtering with a 0.45 mu m filter membrane, and taking the filtrate as a solution to be detected for later use;
content determination: measuring by high performance liquid chromatography (general rule 0512).
Precisely measuring 20 mu L of the solution to be detected, injecting the solution into a liquid chromatograph (taking 2ml of sodium dihydrogen phosphate solution and 30ml of 0.5mol/L disodium hydrogen phosphate solution, diluting the solution to 1000ml with water, shaking up) -7-nitrile (50: 50) (regulating p H value to 7.8 with phosphoric acid) as a mobile phase, detecting the wavelength to be 254nm, and recording a chromatogram;
taking appropriate amount of lidocaine control, precisely weighing, adding the above mobile phase, dissolving, and quantitatively diluting to obtain 1ml solution (containing about 2mg of lidocaine), and measuring by the same method. Calculating according to the peak area by an external standard method to obtain the product.
Table 1 lidocaine content determination results after centrifugation:
as can be seen from Table 1, the examples 1 to 3 did not undergo the phenomenon of delamination and emulsion breaking under the high-speed centrifugation condition, and had uniform contents.
Stability test 2:
the Lidodeoxycream obtained in example 3 was left at a temperature of 25 ℃ for 24 months for stability testing.
Table 2 (stability test investigation results)
Table 2 shows that: the invention is placed for 24 months at the temperature of 25 ℃, the appearance, the layering condition and the content of the lidocaine are checked at different periods, no appearance change and layering condition are found, and the content of the lidocaine is not obviously changed.
Claims (8)
1. The lidocaine cream is characterized in that the prescription comprises, by weight, 2-10% of lidocaine, 0.1-0.5% of phenylephrine hydrochloride, 1-5% of aloe extract, 0.5-2% of benzyl alcohol, 0.5-3% of carbomer 934P, 1-5% of cholesterol, 1-5% of hydrogenated phosphatidylcholine, 1-5% of isopropyl myristate, 1-5% of tween-801, 1-5% of propylene glycol, 1-5% of triethanolamine, 0.5-2% of alpha-tocopheryl acetate, 0.1-1% of grape skin extract and a proper amount of water.
2. The lidocaine cream of claim 1, wherein the formulation further comprises, by weight, 3-8% lidocaine, 0.2-0.4% phenylephrine hydrochloride, 2-4% aloe vera extract, 1.0-1.5% benzyl alcohol, 1.0-2.0% carbomer 934P, 2-4% cholesterol, 2-4% hydrogenated phosphatidylcholine, 2-4% isopropyl myristate, 2-4% tween-802-4% propylene glycol, 2-4% triethanolamine, 1.0-1.5% alpha-tocopheryl acetate, 0.5-1% grape skin extract, and an appropriate amount of water.
3. The lidocaine cream according to claims 1 and 2, wherein the formulation further comprises, in weight percent, lidocaine 5%, phenylephrine hydrochloride 0.25%, aloe vera extract 3%, benzyl alcohol 1%, carbomer 934P 2%, cholesterol 3%, hydrogenated phosphatidylcholine 3%, isopropyl myristate 3%, tween-803%, propylene glycol 3%, triethanolamine 3%, α -tocopheryl acetate 1%, grape skin extract 0.5%, and water in appropriate amounts.
4. Lidoxy cream according to claims 1, 2, 3, its preparation and use, characterized in that it comprises the following steps:
4.1 preparation of oil phase components:
placing cholesterol, isopropyl myristate, benzyl alcohol, and alpha-tocopherol acetate in a heating container, heating, stirring to completely dissolve to obtain oil phase solution;
4.2 preparation of the aqueous phase:
heating carbomer 934P and propylene glycol in a heating container, stirring to dissolve completely to obtain water phase solution;
4.3 preparation of Primary emulsion:
under heating condition, adding the water phase solution into the oil phase solution, heating while stirring to obtain homogeneous solution, slowly adding into heated emulsifying machine, adding triethanolamine, hydrogenated phosphatidylcholine and part of tween-80, starting emulsifying machine, stirring at 300rpm for 15-30min to obtain primary emulsion;
4.4 preparation of the drug phase:
adding a small amount of water into the rest tween-80, heating, stirring, adding lidocaine, phenylephrine hydrochloride, grape skin extract, and aloe extract, stirring to completely dissolve the medicinal materials to obtain medicinal phase solution;
4.5 preparing cream;
starting an emulsifying machine under heating state, stirring at 300rpm, slowly adding the above medicinal phase dissolved solution into the primary emulsion, starting homogenizing at 3500r/m, homogenizing for 5-10min, stopping homogenizing, stirring for 15min, transferring the obtained cream into a cold water bath, starting stirring at 60-70rpm, rapidly cooling to below 25 deg.C, and packaging to obtain the final product.
5. The lidocaine cream of claim 4, wherein the heating container is a container capable of being electrically heated or steam heated.
6. The lidocaine cream according to claim 4, wherein the heating is carried out at a temperature of 80-85 ℃.
7. Lidocuodesoxy cream according to claim 4, characterized in that the stirring is by electric or manual stirring.
8. The ritoduoxy cream according to claims 1 to 7, its preparation and use, characterized in that it has the effect of treating and relieving pain, itching and discomfort caused by anal and rectal diseases, and can also be used for treating hepatic portal diseases such as congestion and swelling of hemorrhoidal tissues.
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| 余建民等: "《呼吸危重症监护及药物治疗学》", 31 July 2007, 江西科学技术出版社 * |
| 刘华钢: "《中药化妆品学》", 30 November 2006, 中国中医药出版社 * |
| 於洪建: "《我国健康植物多酚产业发展研究》", 28 February 2017, 天津大学出版社 * |
| 杨抗: "《肛肠病奇效良方》", 30 June 2007, 人民军医出版社 * |
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Application publication date: 20191220 |