Shuanghuang gel and preparation method thereof

Abstract

The invention provides double-huang gel and a preparation method thereof, and belongs to the technical field of medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25-35 parts of rheum officinale, 25-35 parts of phoenix-tail fern, 25-35 parts of paris polyphylla, 25-35 parts of cortex dictamni, 15-25 parts of golden cypress, 10-15 parts of radix sophorae flavescentis and 10-15 parts of radix angelicae. The Shuanghuang gel disclosed by the invention has the advantages of no greasy feeling, uniformity in smearing, easiness in cleaning, good coupling with skin and high bioavailability, can form a layer of very thin protective film on the affected skin after being smeared, and has a protective effect. The first-pass effect of the liver can be avoided, the medicine can directly exert the medicine effect in an external lesion area, and carrying, storage, transportation and the like are all convenient.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a double yellow gel and a preparation method thereof. Background Art

[0002] The etiology of eczema is complex and is often the result of the interaction of internal and external factors. Internal factors such as chronic digestive system diseases, mental stress, insomnia, excessive fatigue, mood changes, endocrine disorders, infections, metabolic disorders, etc., and external factors such as living environment, climate change, food, etc. can all affect the occurrence of eczema. External stimuli such as sunlight, cold, dryness, heat, hot water washing, and various animal furs, plants, cosmetics, soaps, and artificial fibers can all induce eczema. Therefore, eczema is a delayed allergic reaction caused by complex internal and external factors.

[0003] Gels are a new type of drug dosage form that has emerged in recent years. The Chinese Pharmacopoeia Edition I stipulates in the appendix that gels refer to extracts and suitable matrices with gel properties, semi-solid or thick liquid preparations that can be administered through multiple routes such as the oral cavity, nasal cavity, eye mucosa, digestive tract mucosa, vagina, rectum, and skin. Gels have been rapidly applied in chemical preparations in recent years, while Chinese medicine gels are only in the development stage. Chinese medicine gels are an innovation of traditional Chinese medicine in my country. They are a type of Chinese medicine gel that belongs to the modern Chinese medicine dosage form. They are a way of transdermal administration of Chinese medicine gels that can avoid the first-pass effect of the liver and allow the drug to directly exert its efficacy in the external lesion area. For some skin diseases, Chinese medicine gels are faster and more effective than oral administration of Chinese medicine. Therefore, the development of Chinese medicine gels and safety research is a direction for the development of modern Chinese medicine.

[0004] Currently, although there are many drugs for the treatment of eczema clinically, most of them contain hormones such as steroids, and therefore have many side effects on patients, such as recurrence of eczema after discontinuation of medication and poor treatment effect. Summary of the invention

[0005] The purpose of the present invention is to provide a double yellow gel and a preparation method thereof, which is non-greasy, evenly applied, easy to clean, well coupled with the skin, and has high bioavailability. After application, a very thin protective film can be formed on the skin of the affected part, which has a protective effect. The first-pass effect of the liver can be avoided, and the drug can be directly effective in the external lesion area, and it is convenient to carry, store, and transport.

[0006] The technical solution of the present invention is achieved in this way:

[0007] The invention provides a double yellow gel, which is prepared from the following raw materials: rhubarb, pteris viridis, parsley, dactylum bungeanum, cortex dichotoma, phellodendron amurense, sophora flavescens, angelica dahurica, etc.

[0008] As a further improvement of the present invention, the herb is prepared from the following raw materials by weight: 25-35 parts of rhubarb, 25-35 parts of pteris villosa, 25-35 parts of parsnip, 25-35 parts of dittany, 15-25 parts of phellodendron, 10-15 parts of sophora flavescens, and 10-15 parts of angelica dahurica.

[0009] As a further improvement of the present invention, the herb is prepared from the following raw materials by weight: 30 parts of rhubarb, 30 parts of pteris villosa, 30 parts of parsnip, 30 parts of dittany, 20 parts of phellodendron, 10-15 parts of sophora flavescens, and 12 parts of angelica dahurica.

[0010] The present invention further protects a method for preparing the above-mentioned double yellow gel, comprising the following steps:

[0011] (1) Weigh each raw material in proportion, add water to extract, and concentrate to obtain a clear paste;

[0012] (2) adding ethanol to the clear paste for precipitation, filtering, and concentrating the supernatant to obtain a thick paste;

[0013] (3) Take carbomer and add purified water to swell it, pour it into an ointment blender, add glycerin and mix well;

[0014] (4) Weigh ethylparaben and borneol, dissolve them in ethanol, add them into an ointment mixer and continue to stir evenly to prepare a blank gel;

[0015] (5) Weigh the thick paste, add it into an ointment mixer and stir it evenly, add triethanolamine to adjust the pH value, add water and stir it evenly, and package it to obtain double yellow gel.

[0016] As a further improvement of the present invention, the extraction time in step (1) is 0.5-1.5 hours; the relative density of the concentrated product at 60° C. is 1.02-1.05.

[0017] As a further improvement of the present invention, in step (2), ethanol is added to an ethanol content of 60-70%, precipitation is performed 1-3 times, each time lasting 20-28 hours, and the supernatant is concentrated to a relative density of 1.25-1.30 at 60°C.

[0018] As a further improvement of the present invention, the swelling time in step (3) is 10-14 hours.

[0019] As a further improvement of the present invention, the mass ratio of the carbomer, glycerin, ethylparaben, borneol and thick paste is 10-14:90-110:0.5-1.5:0.3-0.7:25-35.

[0020] As a further improvement of the present invention, the pH value adjusted in step (5) is 6-7.

[0021] As a further improvement of the present invention, every 1.0 g of the double yellow gel is equivalent to about 0.12-0.18 g of the decoction piece.

[0022] The present invention has the following beneficial effects:

[0023] The compound preparation of the present invention comprises the following ingredients:

[0024] Rhubarb (Rheum officinale): 25-35 parts, has the effects of clearing away heat and detoxifying, reducing swelling and draining pus.

[0025] Pteris multifida: 25-35 parts, has antibacterial and anti-inflammatory effects.

[0026] Paris polyphylla: 25-35 parts, mainly used for clearing away heat, detoxifying, reducing swelling and relieving pain.

[0027] Cortex Dictamni: 25-35 parts, has antibacterial, anti-inflammatory and antipruritic effects.

[0028] Phellodendron: 15-25 parts, has the effects of clearing away heat and dampness, and anti-inflammatory and antibacterial.

[0029] Sophora flavescens: 10-15 parts, has the effects of clearing away heat and dampness, and relieving itching.

[0030] Angelica dahurica: 10-15 parts, has the effects of reducing swelling, draining pus and relieving pain.

[0031] Each component of the present invention has the functions of clearing away heat and detoxifying, and antibacterial and anti-inflammatory. The combination of the compound can synergistically exert the therapeutic effect and comprehensively treat the symptoms of eczema. The preparation has good bioavailability, can be quickly absorbed by the skin, and directly reach the lesion.

[0032] The preparation of the present invention is mainly used to treat acute or chronic eczema, including patients with symptoms such as redness, swelling, itching, papules, exudation, etc. After using the compound preparation, the patient's symptoms are significantly relieved, the redness, swelling, itching and exudation phenomena gradually subside, and the skin gradually returns to normal. Since the gel dosage form is not greasy, the patient feels better when using it, avoiding the greasy discomfort of traditional eczema ointments.

[0033] The double yellow gel obtained by the present invention has no greasy feeling, is evenly applied, is easy to clean, has good coupling with the skin, has high bioavailability, and can form a very thin protective film on the skin of the affected part after application, which has a protective effect. It can avoid the first-pass effect of the liver, can make the drug directly exert its efficacy in the external lesion area, and is convenient to carry, store, and transport. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0035] Figure 1 This is a photo of a patient before treatment in a typical case of the present invention;

[0036] Figure 2 These are photos of patients after treatment in a typical case of the present invention. DETAILED DESCRIPTION

[0037] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] Example 1

[0039] Raw material composition (by weight): 25 parts of rhubarb, 25 parts of pteris viridis, 25 parts of parsley, 25 parts of licorice root, 25 parts of dittany, 15 parts of phellodendron, 10 parts of sophora flavescens, and 10 parts of angelica dahurica.

[0040] This embodiment provides a method for preparing double yellow gel, comprising the following steps:

[0041] (1) Weigh each raw material in proportion, add water to extract for 0.5 h, and concentrate to a relative density of 1.02 at 60°C to obtain a clear paste;

[0042] (2) adding ethanol to the clear paste until the ethanol content is 60%, precipitating once, each time for 20 hours, filtering, and concentrating the supernatant to a relative density of 1.25 at 60°C to obtain a thick paste;

[0043] (3) Take 10 g of carbomer and add 100 mL of purified water to swell for 10 h, pour into an ointment blender, add 90 g of glycerol and stir evenly;

[0044] (4) Weigh 0.5 g of ethylparaben and 0.3 g of borneol, dissolve in 10 mL of ethanol, add to an ointment blender and continue to stir evenly to prepare a blank gel;

[0045] (5) Weigh 2 g of thick paste, add it into an ointment mixer and stir evenly, add triethanolamine to adjust the pH value to 6, add water to 1000 g, stir evenly, and divide into packages to obtain double yellow gel. Each 1.0 g of the double yellow gel is equivalent to about 0.12 g of the decoction piece.

[0046] Example 2

[0047] Raw material composition (by weight): 35 parts of rhubarb, 35 parts of pteris viridis, 35 parts of parsley, 35 parts of licorice root, 35 parts of dittany, 25 parts of phellodendron, 15 parts of sophora flavescens, and 15 parts of angelica dahurica.

[0048] This embodiment provides a method for preparing double yellow gel, comprising the following steps:

[0049] (1) Weigh each raw material in proportion, add water to extract for 1.5 hours, and concentrate to a relative density of 1.05 at 60°C to obtain a clear paste;

[0050] (2) adding ethanol to the clear paste until the ethanol content is 70%, precipitating for 3 times, each time for 28 hours, filtering, and concentrating the supernatant to a relative density of 1.30 at 60°C to obtain a thick paste;

[0051] (3) Take 14 g of carbomer and add 100 mL of purified water to swell for 14 h, pour into an ointment blender, add 110 g of glycerol and stir evenly;

[0052] (4) Weigh 1.5 g of ethylparaben and 0.7 g of borneol, dissolve in 10 mL of ethanol, add to an ointment blender and continue to stir evenly to prepare a blank gel;

[0053] (5) Weigh 35 g of the thick paste, add it to an ointment mixer and stir evenly, add triethanolamine to adjust the pH to 7, add water to 1000 g, stir evenly, and divide into portions to obtain double yellow gel. Each 1.0 g of the double yellow gel is equivalent to about 0.18 g of the decoction piece.

[0054] Example 3

[0055] Raw material composition (by weight): 30 parts of rhubarb, 30 parts of pteris viridis, 30 parts of parsley, 30 parts of licorice root, 30 parts of dittany, 20 parts of phellodendron, 12 parts of sophora flavescens, and 12 parts of angelica dahurica.

[0056] This embodiment provides a method for preparing double yellow gel, comprising the following steps:

[0057] (1) Weigh each raw material in proportion, add water to extract for 1 hour, and concentrate to a relative density of 1.03 at 60°C to obtain a clear paste;

[0058] (2) adding ethanol to the clear paste until the ethanol content is 65%, precipitating twice, each time for 24 hours, filtering, and concentrating the supernatant to a relative density of 1.27 at 60°C to obtain a thick paste;

[0059] (3) Take 12 g of carbomer and add 100 mL of purified water to swell for 12 h, pour into an ointment blender, add 100 g of glycerol and stir evenly;

[0060] (4) Weigh 1 g of ethylparaben and 0.5 g of borneol, dissolve in 10 mL of ethanol, add to an ointment blender and continue to stir evenly to prepare a blank gel;

[0061] (5) Weigh 30 g of the thick paste, add it to an ointment mixer and stir evenly, add triethanolamine to adjust the pH value to 6.5, add water to 1000 g, stir evenly, and divide it into packages to obtain double yellow gel. Each 1.0 g of the double yellow gel is equivalent to about 0.16 g of the decoction piece.

[0062] Test Example 1

[0063] 40 patients with eczema were selected and randomly divided into 4 groups, 10 in each group, namely, Example 1-3 group and control group. The Example 1-3 group was smeared with the double yellow gel prepared in Example 1-3, and the control group was smeared with hydrocortisone cream, once a day, for 4 weeks. The total effective rate of TCM symptoms during the study is shown in Table 1.

[0064] Table 1

[0065] Group Number of cases get well Significant effect efficient invalid Total Effectiveness Example 1 10 6 1 1 2 80％ Example 2 10 7 1 1 1 90％ Example 3 10 7 2 1 0 100％ Control group 10 2 1 3 4 60％

[0066] It can be seen from the above table that the double yellow gel prepared in Examples 1-3 of the present invention can significantly improve the TCM symptoms of eczema in patients.

[0067] Test Example 2

[0068] KM mice were randomly divided into 6 groups according to the random number method: blank group, model group, positive drug group (compound dexamethasone acetate cream, 0.75 mg / cm 2 ), Example 1-3 group (correspondingly prepared double yellow gel 200mg / cm 2 ), 10 mice in each group. The back was depilated (2cm×2cm) 1 day before the experiment. On the day of the experiment, except for the blank group, 100mL of 5% DMCB solution (solvent is acetone-olive oil = 4:1) was applied to the depilated part of the back and 25mL of the right ear of the mice in other groups were sensitized. On the 6th day of the experiment, 0.7% DNCB was applied to the same part and the same dose to stimulate, and then stimulated once every 3 days, for a total of 4 times. The blank group was coated with an equal amount of acetone-olive oil solvent as a control. If the skin of the back and right ear of the mouse showed obvious swelling, redness, papules, itching, etc., it indicated that the model was successfully established.

[0069] The mice in each drug group were coated with the corresponding test drugs on the day of stimulation (i.e., the 6th day of the experiment), the blank group and the model group were coated with an equal volume of distilled water, and the blank matrix group was coated with an equal volume of a blank cream matrix without drugs, for 14 consecutive days. 24 hours after the last administration, the same area of ​​ear pieces were punched in the same part of both ears of the mice with a 6mm diameter puncher, and the ear pieces were removed and weighed, and the ear swelling was determined by the weight difference between the left and right ears.

[0070] The results are shown in Table 2.

[0071] Table 2

[0072] Group Ear swelling (mg) Blank group 0.15±0.11 Model Group 18.44±1.25* Positive drug group 10.26±0.92# Example 1 9.05±0.67# Example 2 9.11±0.83# Example 3 9.01±0.79#

[0073] Note: * compared with the blank group, P < 0.05; # compared with the model group, P < 0.05.

[0074] It can be seen from the above table that the double yellow gel prepared in Examples 1-3 of the present invention has a good anti-inflammatory effect.

[0075] Typical cases:

[0076] Zhang, who suffers from eczema, has redness, swelling, itching, papules, exudation, and other symptoms. Figure 1 , Use the Shuanghuang Gel prepared in Example 3 continuously, 2-3 times a day, apply it to the affected area, and spread it evenly until it is absorbed. It is recommended to use it continuously for 2-3 weeks, and the symptoms will basically disappear. Figure 2 After using the compound preparation, the patient's symptoms were significantly relieved, the redness, swelling, itching and exudation gradually subsided, and the skin gradually returned to normal. Because the gel formulation is not greasy, patients feel better when using it, avoiding the greasy discomfort of traditional eczema ointments.

[0077] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A double yellow gel, characterized in that: The medicine is prepared from the following raw materials: rhubarb, phoenix tail grass, seven-leaf parsley, white mulberry bark, phellodendron chinense, sophora flavescens, and angelica dahurica.

2. The double yellow gel according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 25-35 parts of rhubarb, 25-35 parts of pteris villosa, 25-35 parts of parsnip, 25-35 parts of licorice root, 15-25 parts of phellodendron amurense, 10-15 parts of sophora flavescens and 10-15 parts of angelica dahurica.

3. The double yellow gel according to claim 2, characterized in that: The invention is prepared from the following raw materials in parts by weight: 30 parts of rhubarb, 30 parts of pteris viridis, 30 parts of parsnip, 30 parts of licorice root, 30 parts of dittany bark, 20 parts of phellodendron amurense, 10-15 parts of sophora flavescens and 12 parts of angelica dahurica.

4. A method for preparing the double yellow gel according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) Weigh each raw material in proportion, add water to extract, and concentrate to obtain a clear paste; (2) adding ethanol to the clear paste for precipitation, filtering, and concentrating the supernatant to obtain a thick paste; (3) Take carbomer and add purified water to swell it, pour it into an ointment blender, add glycerin and mix well; (4) Weigh ethylparaben and borneol, dissolve them in ethanol, add them into an ointment blender and continue to stir evenly to prepare a blank gel; (5) Weigh the thick paste, add it into an ointment mixer and stir it evenly, add triethanolamine to adjust the pH value, add water and stir it evenly, and package it to obtain the double yellow gel.

5. The preparation method according to claim 4, characterized in that: The extraction time in step (1) is 0.5-1.5h; the relative density of the concentrated product at 60°C is 1.02-1.

05.

6. The preparation method according to claim 4, characterized in that: In step (2), ethanol is added until the ethanol content is 60-70%, precipitation is performed 1-3 times, each time lasting 20-28 hours, and the supernatant is concentrated to a relative density of 1.25-1.30 at 60°C.

7. The preparation method according to claim 4, characterized in that: The swelling time in step (3) is 10-14 hours.

8. The preparation method according to claim 4, characterized in that: The mass ratio of the carbomer, glycerin, ethylparaben, borneol and thick paste is 10-14:90-110:0.5-1.5:0.3-0.7:25-35.

9. The preparation method according to claim 4, characterized in that: The pH value in step (5) is adjusted to 6-7.

10. The preparation method according to claim 4, characterized in that: Every 1.0g of the double yellow gel is equivalent to about 0.12-0.18g of the medicinal piece.

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