CN105168703A - Traditional Chinese medicine gel plaster applied to acupoints to treat insomnia and preparation method thereof - Google Patents
Traditional Chinese medicine gel plaster applied to acupoints to treat insomnia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine gel plaster applied to acupoints to treat insomnia. The gel plaster comprises a back lining layer, an ointment layer and a cover lining layer. The ointment layer comprises medicine extract, framework material, sticking agent, humectant, filler, crosslinking agent, crosslinking modifier and transdermal enhancer. The medicine extract is prepared by extracting prepared radix astragali, radix codonopsis, angelica sinensis, rhizoma chuanxiong, semen platycladi, semen ziziphi spinosae, polygala tenuifolia (prepared), Chinese magnoliavine fruit (steamed), cinnamon, poria cocos, fermented pinellia, cinnabar and prepared liquorice. A preparation method of the traditional Chinese medicine gel plaster sequentially includes: preparing the medicine extract, preparing matrix, and preparing the gel plaster. By the traditional Chinese medicine gel plaster, insomnia can be treated effectively while adverse effect of intoxication caused by the fact that toxic components produced by orally taking preparation containing the cinnabar accumulate in the bodies of patients can be avoided.
Description
Technical field
The invention belongs to technical field of Chinese medicine, be specifically related to Traditional Chinese medicine gel cream of a kind of acupoint application treatment insomnia and preparation method thereof.
Background technology
Insomnia refers to a kind of disease that often sleep is not yet done or time for falling asleep is inadequate, and along with the quickening of people's rhythm of life, the increase of work, life and psychological each side pressure, insomnia has become clinical middle a kind of commonly encountered diseases and frequently-occurring disease.Insomnia comprises and having difficulty in going to sleep, insomnia-middle, Yi Xing, dreaminess etc., can with anxiety and depression symptom, and seriously affect quality of life of people and healthy, severe patient can induce the generation of Other diseases.Doctor trained in Western medicine is to the application of the treatment mainly sleeping pill of insomnia, but long-term taking sleeping pill can cause thinking and balanced capacity to decline, and can produce dependency.The method of Chinese traditional treatment is more, and wherein point application therapy has safe and effective, that untoward reaction is few advantage because of it, and becomes the external treatment with Chinese medicine therapy of effective Cure for insomnia.
Mind-easing tonic bolus with arborvitate seed (sheet) is evident in efficacy for controlling insomnia, the main component of mind-easing tonic bolus with arborvitate seed is Semen Platycladi, Radix Codonopsis, Radix Astragali Preparata, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Poria, Radix Polygalae (system), Semen Ziziphi Spinosae, Cortex Cinnamomi, Fructus Schisandrae Chinensis (steaming), Pinellia leaven, Radix Glycyrrhizae Preparata, Cinnabaris, major function is QI invigorating, nourish blood, calm the nerves, for motive deficiency and coldness, palpitation and being susceptible to fright, insomnia and dreamful sleep, forgetful.Radix Astragali Preparata tonifying Qi and lifting yang in side; Radix Codonopsis QI invigorating and blood producing, two medicines are harmonious temperature compensation QI and blood with strong the source of vital function; Radix Angelicae Sinensis, Rhizoma Chuanxiong are enriched blood and are invigorated blood circulation, and Semen Platycladi nourishes heart blood, tranquilizing mind; Semen Ziziphi Spinosae the liver benefiting nourishing blood to tranquillize the mind; The logical motive Fructus Alpiniae Oxyphyllae of Radix Polygalae a surname; Fructus Schisandrae Chinensis nourishing kidney yin fluid astringing mind calming; Cortex Cinnamomi the kidney warming is promoted blood circulation; Poria spleen-benefiting mind-tranquilizing; Pinellia leaven stomach function regulating eliminates the phlegm; Cinnabaris relieving palpitation is calmed the frightened; Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription; The body of Cinnabaris tool light, red complexion leads to the heart, and Beijing South Maxpower Technology Co. Ltd town is timid, trembles with fear and can win heat, sweet to promote the production of body fluid, and pressing down swimming of YIN-fire, with the vigour of the foster part of the body cavity above the diaphragm housing the heart and lungs, is first product of calming the nerves; The function of Semen Platycladi is nourishing the liver, mind calming, calm the nerves, arresting sweating, can treat restlessness of asrhenia type and insomnia, the palpitation with fear disease such as palpitation with a distress feeling, spontaneous sweating, modern age, pharmacology confirmed, Semen Platycladi truly has calmness, syngignoscism.With Semen Platycladi decoct to rat oral or lumbar injection, no matter daytime or night, all show good calmness and somnolence effect.
A small amount of Cinnabaris is had in mind-easing tonic bolus with arborvitate seed (sheet) prescription, Cinnabaris Main Ingredients and Appearance is cinnabar, so, if many clothes, for a long time Chinese medicine for oral administration of clothes containing mercurial, its toxic component is likely accumulated in vivo and causes poisoning, thin base in hydrargyrum and protein has special affinity, during high concentration, can suppress multiple enzyme and activity.Enter the hydrargyrum in body, be mainly distributed in Liver and kidney, and cause hepatorenal damage, and can pass through blood brain barrier, directly damage central nervous system.
Therefore, Chinese medicine containing Cinnabaris is made the gel ointment of external, acupuncture point sticks medicine, by the combined effect at medicine and acupuncture point, effective worry solving insomnia and bring, the toxic component simultaneously avoiding endo-medicine generation is accumulated in vivo and causes poisoning untoward reaction.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art and Traditional Chinese medicine gel cream providing a kind of acupoint application treatment to have a sleepless night and preparation method thereof, this gel cream, while effective Cure for insomnia, can avoid the toxic component containing the generation of Cinnabaris preparation for oral administration accumulate in vivo and cause poisoning untoward reaction.
A kind of Traditional Chinese medicine gel cream of acupoint application treatment insomnia, be made up of backing layer, ointment-containing body layer and lid lining, wherein, ointment-containing body layer is made up of the raw material of following parts by weight: drug extract 2 ~ 10 parts, framework material 8 ~ 15 parts, sticker 3 ~ 7 parts, wetting agent 15 ~ 22 parts, filler 3 ~ 8 parts, cross-linking agent 1 ~ 2 part, cross-linking regulator 1 ~ 2 part, transdermal enhancer 0.5 ~ 2 part; Described drug extract is extracted by following raw material and makes: Radix Astragali Preparata 40 ~ 120 parts, Radix Codonopsis 10 ~ 30 parts, Radix Angelicae Sinensis 10 ~ 30 parts, Rhizoma Chuanxiong 40 ~ 120 parts, Semen Platycladi 10 ~ 30 parts, Semen Ziziphi Spinosae 10 ~ 30 parts, Radix Polygalae (system) 10 ~ 30 parts, Fructus Schisandrae Chinensis (steaming) 10 ~ 30 parts, Cortex Cinnamomi 10 ~ 30 parts, 80 ~ 240 parts, Poria, Pinellia leaven 40 ~ 120 parts, 12 ~ 36 parts, Cinnabaris, Radix Glycyrrhizae Preparata 5 ~ 20 parts.
As the further improvement of foregoing invention, ointment-containing body layer is made up of following raw material by weight: drug extract 3 parts, framework material 12 parts, sticker 6 parts, wetting agent 20 parts, filler 5 parts, cross-linking agent 1 part, cross-linking regulator 1 part, transdermal enhancer 1.5 parts; Drug extract is extracted by following raw material and makes: Radix Astragali Preparata 40 parts, Radix Codonopsis 10 parts, Radix Angelicae Sinensis 10 parts, Rhizoma Chuanxiong 40 parts, Semen Platycladi 10 parts, Semen Ziziphi Spinosae 10 parts, Radix Polygalae (system) 10 parts, Fructus Schisandrae Chinensis (steaming) 10 parts, Cortex Cinnamomi 10 parts, 80 parts, Poria, Pinellia leaven 40 parts, 12 parts, Cinnabaris, Radix Glycyrrhizae Preparata 5 parts.
As the further improvement of foregoing invention, described framework material is selected from the one in sodium carboxymethyl cellulose, gelatin, Resina persicae or corn starch.
As the further improvement of foregoing invention, described sticker is selected from the one in sodium alginate, methylcellulose, polyacrylic acid or sodium polyacrylate.
As the further improvement of foregoing invention, described wetting agent is selected from the one in glycerol, Polyethylene Glycol or sorbitol.
As the further improvement of foregoing invention, described filler is selected from the one in Kaolin, micropowder silica gel or titanium dioxide.
As the further improvement of foregoing invention, described cross-linking agent is selected from the one in aluminum chloride or dihydroxyaluminum aminoacetate.
As the further improvement of foregoing invention, described crosslinking accelerator is selected from the one in EDTA-2Na, hydroxyl succinic acid or citric acid.
As the further improvement of foregoing invention, described transdermal enhancer is selected from the one in azone, propylene glycol, Mentholum or Borneolum Syntheticum.
The preparation method of the Traditional Chinese medicine gel cream of above-mentioned acupoint application treatment insomnia comprises the following steps:
Step 1, prepared by drug extract: get Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, under vacuum 60 ~ 80 DEG C stifling after, with 60% ~ 90% alcohol reflux, filter, obtain filtrate I, again by Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, after Radix Glycyrrhizae Preparata is placed in 95% alcohol vapour infiltration 2 ~ 4h, pulverize, decoct with water, decocting liquid filters, obtain filtrate II, merging filtrate I and filtrate II, washed with water by macroporous adsorptive resins, eluent discards, use 50% ~ 90% ethanol elution again, collect ethanol elution, drug extract is obtained through vacuum concentration,
Step 2, matrix composition: by framework material with after 2/3 weight wetting agent moistening, mix with filler, cross-linking agent, add the water with wetting agent identical weight, heated and stirred evenly obtains sol solutions I under 40 ~ 60 DEG C of conditions; By sticker with after the moistening of residue wetting agent, then add cross-linking agent and crosslinking accelerator, under 50 ~ 70 DEG C of conditions, heated and stirred evenly obtains sol solutions II; Added in sol solutions I by sol solutions II, mix homogeneously obtains bare substrate again;
Step 3, added in step 2 gained bare substrate together with step 1 gained extractum by transdermal enhancer, coat on back lining materials after stirring, close the lid lining, cutting, and packaging, obtains gel cream.
Traditional Chinese medicine gel cream specification of the present invention is: often paste 5 × 5cm, the every 100cm of paste containing amount
210g should be not less than.1 within every 8 hours, is used to paste.
Compared with prior art, its remarkable advantage is: the first in the present invention, with for oral administration containing compared with Cinnabaris preparation, avoid toxic component and accumulates in vivo and cause poisoning untoward reaction; The second, by point-application, extend the length of one's sleep, improve sleep quality, meanwhile, gel ointment external safety is high, to no skin irritation, easy to use, improves the compliance of patient.
Detailed description of the invention
Embodiment 1
A kind of Traditional Chinese medicine gel cream of acupoint application treatment insomnia, be made up of backing layer, ointment-containing body layer and lid lining, wherein, ointment-containing body layer is made up of the raw material of following parts by weight: drug extract 2 parts, framework material 8 parts, sticker 3 parts, wetting agent 15 parts, filler 3 parts, cross-linking agent 1 part, cross-linking regulator 1 part, transdermal enhancer 0.5 part; Described drug extract is extracted by following raw material and makes: Radix Astragali Preparata 40 parts, Radix Codonopsis 10 parts, Radix Angelicae Sinensis 10 parts, Rhizoma Chuanxiong 40 parts, Semen Platycladi 10 parts, Semen Ziziphi Spinosae 10 parts, Radix Polygalae (system) 10 parts, Fructus Schisandrae Chinensis (steaming) 10 parts, Cortex Cinnamomi 10 parts, 80 parts, Poria, Pinellia leaven 40 parts, 12 parts, Cinnabaris, Radix Glycyrrhizae Preparata 5 parts.
Described framework material is sodium carboxymethyl cellulose, and sticker is sodium alginate, and wetting agent is glycerol, and filler is Kaolin, and cross-linking agent is aluminum chloride, and crosslinking accelerator is selected from EDTA-2Na, and transdermal enhancer is azone.
The preparation method of the Traditional Chinese medicine gel cream of above-mentioned acupoint application treatment insomnia comprises the following steps:
Step 1, prepared by drug extract: get Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, under 0.08MPa vacuum condition 60 DEG C stifling after, use 60% alcohol reflux, filter, obtain filtrate I, again by Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, Radix Glycyrrhizae Preparata is placed in after 95% alcohol vapour infiltrates 2h, pulverize, decoct with water, decocting liquid filters, obtain filtrate II, merging filtrate I and filtrate II, washed with water by macroporous adsorptive resins, eluent discards, use 50% ethanol elution again, collect ethanol elution, drug extract is obtained through vacuum concentration,
Step 2, matrix composition: by framework material with after 2/3 weight wetting agent moistening, mix with filler, cross-linking agent, add the water with wetting agent identical weight, heated and stirred evenly obtains sol solutions I under 40 DEG C of conditions; By sticker with after the moistening of residue wetting agent, then add cross-linking agent and crosslinking accelerator, under 50 DEG C of conditions, heated and stirred evenly obtains sol solutions II; Added in sol solutions I by sol solutions II, mix homogeneously obtains bare substrate again;
Step 3, added in step 2 gained bare substrate together with step 1 gained extractum by transdermal enhancer, coat on back lining materials after stirring, close the lid lining, cutting, and packaging, obtains gel cream.
Embodiment 2
A kind of Traditional Chinese medicine gel cream of acupoint application treatment insomnia, be made up of backing layer, ointment-containing body layer and lid lining, wherein, ointment-containing body layer is made up of the raw material of following parts by weight: drug extract 5 parts, framework material 11 parts, sticker 5 parts, wetting agent 18 parts, filler 5 parts, cross-linking agent 1 part, cross-linking regulator 1 part, transdermal enhancer 1 part; Described drug extract is extracted by following raw material and makes: Radix Astragali Preparata 55 parts, Radix Codonopsis 15 parts, Radix Angelicae Sinensis 15 parts, Rhizoma Chuanxiong 60 parts, Semen Platycladi 15 parts, Semen Ziziphi Spinosae 15 parts, Radix Polygalae (system) 15 parts, Fructus Schisandrae Chinensis (steaming) 15 parts, Cortex Cinnamomi 15 parts, 115 parts, Poria, Pinellia leaven 75 parts, 19 parts, Cinnabaris, Radix Glycyrrhizae Preparata 8 parts.
Described framework material is gelatin, and sticker is methylcellulose, and wetting agent is Polyethylene Glycol, and filler is micropowder silica gel, and cross-linking agent is dihydroxyaluminum aminoacetate, and crosslinking accelerator is hydroxyl succinic acid, and transdermal enhancer is Mentholum.
The preparation method of the Traditional Chinese medicine gel cream of above-mentioned acupoint application treatment insomnia comprises the following steps:
Step 1, prepared by drug extract: get Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, under vacuum 70 DEG C stifling after, use 80% alcohol reflux, filter, obtain filtrate I, again by Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, Radix Glycyrrhizae Preparata is placed in after 95% alcohol vapour infiltrates 3h, pulverize, decoct with water, decocting liquid filters, obtain filtrate II, merging filtrate I and filtrate II, washed with water by macroporous adsorptive resins, eluent discards, use 70% ethanol elution again, collect ethanol elution, drug extract is obtained through vacuum concentration,
Step 2, matrix composition: by framework material with after 2/3 weight wetting agent moistening, mix with filler, cross-linking agent, add the water with wetting agent identical weight, heated and stirred evenly obtains sol solutions I under 50 DEG C of conditions; By sticker with after the moistening of residue wetting agent, then add cross-linking agent and crosslinking accelerator, under 60 DEG C of conditions, heated and stirred evenly obtains sol solutions II; Added in sol solutions I by sol solutions II, mix homogeneously obtains bare substrate again;
Step 3, added in step 2 gained bare substrate together with step 1 gained extractum by transdermal enhancer, coat on back lining materials after stirring, close the lid lining, cutting, and packaging, obtains gel cream.
Embodiment 3
A kind of Traditional Chinese medicine gel cream of acupoint application treatment insomnia, be made up of backing layer, ointment-containing body layer and lid lining, wherein, ointment-containing body layer is made up of following raw material by weight: drug extract 3 parts, framework material 12 parts, sticker 6 parts, wetting agent 20 parts, filler 5 parts, cross-linking agent 1 part, cross-linking regulator 1 part, transdermal enhancer 1.5 parts; Drug extract is extracted by following raw material and makes: Radix Astragali Preparata 40 parts, Radix Codonopsis 10 parts, Radix Angelicae Sinensis 10 parts, Rhizoma Chuanxiong 40 parts, Semen Platycladi 10 parts, Semen Ziziphi Spinosae 10 parts, Radix Polygalae (system) 10 parts, Fructus Schisandrae Chinensis (steaming) 10 parts, Cortex Cinnamomi 10 parts, 80 parts, Poria, Pinellia leaven 40 parts, 12 parts, Cinnabaris, Radix Glycyrrhizae Preparata 5 parts.
Described framework material is corn starch; Sticker is polyacrylic acid; Wetting agent is sorbitol; Filler is titanium dioxide; Cross-linking agent is aluminum chloride; Crosslinking accelerator is citric acid; Transdermal enhancer is Mentholum.
The preparation method of the Traditional Chinese medicine gel cream of above-mentioned acupoint application treatment insomnia comprises the following steps:
Step 1, prepared by drug extract: get Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, under vacuum 80 DEG C stifling after, use 90% alcohol reflux, filter, obtain filtrate I, again by Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, Radix Glycyrrhizae Preparata is placed in after 95% alcohol vapour infiltrates 4h, pulverize, decoct with water, decocting liquid filters, obtain filtrate II, merging filtrate I and filtrate II, washed with water by macroporous adsorptive resins, eluent discards, use 90% ethanol elution again, collect ethanol elution, drug extract is obtained through vacuum concentration,
Step 2, matrix composition: by framework material with after 2/3 weight wetting agent moistening, mix with filler, cross-linking agent, add the water with wetting agent identical weight, heated and stirred evenly obtains sol solutions I under 50 DEG C of conditions; By sticker with after the moistening of residue wetting agent, then add cross-linking agent and crosslinking accelerator, under 60 DEG C of conditions, heated and stirred evenly obtains sol solutions II; Added in sol solutions I by sol solutions II, mix homogeneously obtains bare substrate again;
Step 3, added in step 2 gained bare substrate together with step 1 gained extractum by transdermal enhancer, coat on back lining materials after stirring, close the lid lining, cutting, and packaging, obtains gel cream.
Embodiment 4
A kind of Traditional Chinese medicine gel cream of acupoint application treatment insomnia, be made up of backing layer, ointment-containing body layer and lid lining, wherein, ointment-containing body layer is made up of the raw material of following parts by weight: drug extract 10 parts, framework material 15 parts, sticker 7 parts, wetting agent 22 parts, filler 8 parts, cross-linking agent 2 parts, cross-linking regulator 2 parts, transdermal enhancer 2 parts; Described drug extract is extracted by following raw material and makes: Radix Astragali Preparata 120 parts, Radix Codonopsis 30 parts, Radix Angelicae Sinensis 30 parts, Rhizoma Chuanxiong 120 parts, Semen Platycladi 30 parts, Semen Ziziphi Spinosae 30 parts, Radix Polygalae (system) 30 parts, Fructus Schisandrae Chinensis (steaming) 30 parts, Cortex Cinnamomi 30 parts, 240 parts, Poria, Pinellia leaven 120 parts, 36 parts, Cinnabaris, Radix Glycyrrhizae Preparata 20 parts.
Described framework material is sodium carboxymethyl cellulose, and sticker is sodium alginate, and wetting agent is glycerol, and filler is Kaolin, and cross-linking agent is aluminum chloride, and crosslinking accelerator is selected from EDTA-2Na, and transdermal enhancer is azone.
The preparation method of the Traditional Chinese medicine gel cream of above-mentioned acupoint application treatment insomnia comprises the following steps:
Step 1, prepared by drug extract: get Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, under vacuum 70 DEG C stifling after, use 80% alcohol reflux, filter, obtain filtrate I, again by Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, Radix Glycyrrhizae Preparata is placed in after 95% alcohol vapour infiltrates 3h, pulverize, decoct with water, decocting liquid filters, obtain filtrate II, merging filtrate I and filtrate II, washed with water by macroporous adsorptive resins, eluent discards, use 70% ethanol elution again, collect ethanol elution, drug extract is obtained through vacuum concentration,
Step 2, matrix composition: by framework material with after 2/3 weight wetting agent moistening, mix with filler, cross-linking agent, add the water with wetting agent identical weight, heated and stirred evenly obtains sol solutions I under 40 DEG C of conditions; By sticker with after the moistening of residue wetting agent, then add cross-linking agent and crosslinking accelerator, under 50 DEG C of conditions, heated and stirred evenly obtains sol solutions II; Added in sol solutions I by sol solutions II, mix homogeneously obtains bare substrate again;
Step 3, added in step 2 gained bare substrate together with step 1 gained extractum by transdermal enhancer, coat on back lining materials after stirring, close the lid lining, cutting, and packaging, obtains gel cream.
Embodiment 5
The difference of the present embodiment and embodiment 3 is: in step 1, Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, fumigates, directly use alcohol reflux without heating in vacuum.
Embodiment 6
The difference of the present embodiment and embodiment 3 is: in step 1, Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, Radix Glycyrrhizae Preparata, infiltrates, pulverizes, directly decoct with water without alcohol vapour.
Test case:
1. embodiment 1 to 6 gained cataplasma is carried out fissility, viscosity, stretchability and uniformity test, the quantization method of desired value is as follows.
Test result is as follows:
| Fissility | Viscosity | Stretchability | Uniformity | General comment | |
| Embodiment 1 | 8 | 7 | 8 | 9 | 32 |
| Embodiment 2 | 8 | 8 | 7 | 7 | 30 |
| Embodiment 3 | 7 | 9 | 8 | 8 | 32 |
| Embodiment 4 | 8 | 8 | 8 | 7 | 31 |
| Embodiment 5 | 6 | 4 | 5 | 5 | 20 |
| Embodiment 6 | 5 | 6 | 4 | 5 | 20 |
From above result, gained gel cream fissility of the present invention, viscosity, stretchability, uniformity are all more excellent.
2. embodiment gained cataplasma is carried out initial bonding strength test: cataplasma is placed in long 30cm, the incline device central authorities of 15 ° or 30 ° are become with horizontal plane, cream faces up, top, inclined-plane 10cm and bottom 15cm mylar cover, centre reserves 5cm cream face, by steel ball from freely rolling down with top, observe and record the distance that steel ball rolls across.The initial bonding strength result recording the cataplasma of enforcement preparation of the present invention is as follows:
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | |
| Initial bonding strength (cm) | 10.64±0.14 | 11.23±0.21 | 12.17±0.32 | 11.87±0.29 | 7.43±0.35 | 6.95±0.43 |
From above result, gained cataplasma of the present invention has good initial bonding strength.
3. embodiment 1 to 6 gained cataplasma is carried out transdermal permeation in vitro: get mouse part skin, skin is fixed between Franz diffusion cell, cataplasma is attached in stratum corneum side, add in acceptance pool be heated in advance 37 DEG C containing 30% ethanol normal saline, start constant temperature (37 ± 2 DEG C) water-bath circulation and magnetic stirring apparatus (100rpm), 0.5,1,2,3,4,6,8,10,12, from acceptance pool, take out acceptable solution in 24h, measure content, carry out linear regression with Radix Astragali cumulative release amount and time.Gained cataplasma of the present invention can maintain 24h release, reaches slow release requirement, meets clinical needs.
Each embodiment transdermal permeation in vitro test result is as follows:
| 2h cumulative release amount (%) | 4h cumulative release amount (%) | 8h cumulative release amount (%) | 24h cumulative release amount (%) | |
| Embodiment 1 | 23.5±0.58 | 49.6±0.78 | 75.6±0.45 | 92.3±0.28 |
| Embodiment 2 | 24.7±0.26 | 50.3±0.37 | 76.4±0.29 | 91.8±0.43 |
| Embodiment 3 | 25.6±0.45 | 48.7±0.52 | 77.8±0.33 | 94.2±0.51 |
| Embodiment 4 | 27.1±0.22 | 47.5±0.39 | 79.2±0.53 | 95.6±0.22 |
| Embodiment 5 | 25.9±0.35 | 59.4±0.33 | 88.4±0.52 | 93.5±0.37 |
| Embodiment 6 | 26.1±0.22 | 57.6±0.31 | 89.5±0.33 | 87.8±0.32 |
4. rabbit skin irritation test
Healthy adult rabbit, male and female half and half, adopt self consubstantiality to contrast, normal skin and damaged skin single and repeatedly give embodiment cataplasma after, observe the outward appearance of skin after medication, have no the irritant reaction such as erythema, edema and anaphylaxis.
5. pharmacodynamic experiment
Case selection: include 42 routine insomniacs altogether, man 22 example, female 20 example, 35 ~ 73 years old age, on average (46.3 ± 4.1), the course of disease (6.9 ± 2.3), " diagnostic criteria that Chinese Spirit Disease Diagnosis Standard CCMD-3 has a sleepless night that all patients all meet.
Therapeutic scheme: before sleeping every night, 30min is by gel patch of the present invention in SHENQUE acupoint, Yongquan acupoint, takes off after indwelling 8h, 7d is a course for the treatment of, totally 4 courses for the treatment of.
Efficacy assessment standard:
Recovery from illness: symptom disappears completely or substantially;
Effective: symptom disappears substantially;
Effective: symptom is improved or partial symptoms is improved;
Invalid: unchanged or increase the weight of.
By above-mentioned 2 therapeutic schemes, stick in acupoint therapy to 42 routine clinical insomniacs, the results are shown in following table:
As seen from the above table, gel high energy of the present invention extends the length of one's sleep, improves sleep quality.
Claims (10)
1. the Traditional Chinese medicine gel cream of an acupoint application treatment insomnia, be made up of backing layer, ointment-containing body layer and lid lining, it is characterized in that: ointment-containing body layer is made up of the raw material of following parts by weight: drug extract 2 ~ 10 parts, framework material 8 ~ 15 parts, sticker 3 ~ 7 parts, wetting agent 15 ~ 22 parts, filler 3 ~ 8 parts, cross-linking agent 1 ~ 2 part, cross-linking regulator 1 ~ 2 part, transdermal enhancer 0.5 ~ 2 part; Described drug extract is extracted by following raw material and makes: Radix Astragali Preparata 40 ~ 120 parts, Radix Codonopsis 10 ~ 30 parts, Radix Angelicae Sinensis 10 ~ 30 parts, Rhizoma Chuanxiong 40 ~ 120 parts, Semen Platycladi 10 ~ 30 parts, Semen Ziziphi Spinosae 10 ~ 30 parts, Radix Polygalae (system) 10 ~ 30 parts, Fructus Schisandrae Chinensis (steaming) 10 ~ 30 parts, Cortex Cinnamomi 10 ~ 30 parts, 80 ~ 240 parts, Poria, Pinellia leaven 40 ~ 120 parts, 12 ~ 36 parts, Cinnabaris, Radix Glycyrrhizae Preparata 5 ~ 20 parts.
2. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, it is characterized in that: ointment-containing body layer is made up of following raw material by weight: drug extract 3 parts, framework material 12 parts, sticker 6 parts, wetting agent 20 parts, filler 5 parts, cross-linking agent 1 part, cross-linking regulator 1 part, transdermal enhancer 1.5 parts; Drug extract is extracted by following raw material and makes: Radix Astragali Preparata 40 parts, Radix Codonopsis 10 parts, Radix Angelicae Sinensis 10 parts, Rhizoma Chuanxiong 40 parts, Semen Platycladi 10 parts, Semen Ziziphi Spinosae 10 parts, Radix Polygalae (system) 10 parts, Fructus Schisandrae Chinensis (steaming) 10 parts, Cortex Cinnamomi 10 parts, 80 parts, Poria, Pinellia leaven 40 parts, 12 parts, Cinnabaris, Radix Glycyrrhizae Preparata 5 parts.
3. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described framework material is selected from the one in sodium carboxymethyl cellulose, gelatin, Resina persicae or corn starch.
4. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described sticker is selected from the one in sodium alginate, methylcellulose, polyacrylic acid or sodium polyacrylate.
5. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described wetting agent is selected from the one in glycerol, Polyethylene Glycol or sorbitol.
6. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described filler is selected from the one in Kaolin, micropowder silica gel or titanium dioxide.
7. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described cross-linking agent is selected from the one in aluminum chloride or dihydroxyaluminum aminoacetate.
8. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described crosslinking accelerator is selected from the one in EDTA-2Na, hydroxyl succinic acid or citric acid.
9. the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: described transdermal enhancer is selected from the one in azone, propylene glycol, Mentholum or Borneolum Syntheticum.
10. the preparation method of the Traditional Chinese medicine gel cream of acupoint application treatment insomnia according to claim 1, is characterized in that: comprise the following steps:
Step 1, prepared by drug extract: get Rhizoma Chuanxiong, Semen Platycladi, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis (steaming), Cortex Cinnamomi, Cinnabaris, under vacuum 60 ~ 80 DEG C stifling after, with 60% ~ 90% alcohol reflux, filter, obtain filtrate I, again by Radix Astragali Preparata, Radix Codonopsis, Radix Angelicae Sinensis, Radix Polygalae (system), Poria, Pinellia leaven, after Radix Glycyrrhizae Preparata is placed in 95% alcohol vapour infiltration 2 ~ 4h, pulverize, decoct with water, decocting liquid filters, obtain filtrate II, merging filtrate I and filtrate II, washed with water by macroporous adsorptive resins, eluent discards, use 50% ~ 90% ethanol elution again, collect ethanol elution, drug extract is obtained through vacuum concentration,
Step 2, matrix composition: by framework material with after 2/3 weight wetting agent moistening, mix with filler, cross-linking agent, add the water with wetting agent identical weight, heated and stirred evenly obtains sol solutions I under 40 ~ 60 DEG C of conditions; By sticker with after the moistening of residue wetting agent, then add cross-linking agent and crosslinking accelerator, under 50 ~ 70 DEG C of conditions, heated and stirred evenly obtains sol solutions II; Added in sol solutions I by sol solutions II, mix homogeneously obtains bare substrate again;
Step 3, added in step 2 gained bare substrate together with step 1 gained extractum by transdermal enhancer, coat on back lining materials after stirring, close the lid lining, cutting, and packaging, obtains gel cream.
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| CN106039265A (en) * | 2016-07-14 | 2016-10-26 | 郑州五行舒体商贸有限公司 | Regular nourishing herbal membrane |
| CN106038723A (en) * | 2016-06-28 | 2016-10-26 | 郑胜 | Traditional Chinese medicine gel ointment for treating knee osteoarthritis and preparation method thereof |
| CN106310509A (en) * | 2016-08-28 | 2017-01-11 | 贵州苗老吉药业有限公司 | Yongquan acupoint plaster |
| CN107875256A (en) * | 2017-11-22 | 2018-04-06 | 广西中医药大学 | A kind of strong medicine point-application drug paste for the treatment of of insomnia patients and preparation method thereof |
| CN107890252A (en) * | 2017-12-15 | 2018-04-10 | 长沙拓扑陆川新材料科技有限公司 | A kind of latex pillow |
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Application publication date: 20151223 |