CN105770803A - Gel paste preparation for treating osteoarthritis and preparation method thereof - Google Patents

Gel paste preparation for treating osteoarthritis and preparation method thereof Download PDF

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Publication number
CN105770803A
CN105770803A CN201610145417.6A CN201610145417A CN105770803A CN 105770803 A CN105770803 A CN 105770803A CN 201610145417 A CN201610145417 A CN 201610145417A CN 105770803 A CN105770803 A CN 105770803A
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radix
add
fructus
gel ointment
rhizoma
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CN105770803B (en
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韩清民
吴雪茹
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Affiliated Orthopedic Hospital Of Guangzhou University Of Traditional Chinese Medicine
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Affiliated Orthopedic Hospital Of Guangzhou University Of Traditional Chinese Medicine
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
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Abstract

The invention relates to a gel paste preparation for treating osteoarthritis and a preparation method thereof. The active ingredient of the gel paste preparation is prepared from the following raw materials: fructus psoraleae, astragalus membranaceus, bidentate achyranthes root, teasel root, eucommia bark, rhizoma drynariae, pawpaw, suberect spatholobus stem, shinyleaf pricklyash root, frankincense, myrrh, paniculate swallowwort root, cortex phellodendri amurensis, rheum officinale, dried ginger, safflower carthamus, asarum, chillies, camphor, borneol, menthol, methyl salicylate and turpentine oil. The invention further provides the preparation method for the gel paste preparation. The gel paste preparation provided by the invention is accurate in treatment effect, high in safety, convenient to use and low in cost, has no side effect, and has a better effect than that in the prior art in the aspect of treating various types of arthritis and arthropathy of muscles and bones caused by blocking merdian and collateral channels by wind cold dampness.

Description

A kind of gel ointment treating osteoarthritis and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of gel ointment treating osteoarthritis and preparation method thereof.
Background technology
Osteoarthritis (osteoarthritis, OA) also known as proliferative arthritis, hypertrophiarthritis, senile arthritis, osteoarthritis, chondromalacic arthrosis etc., it is under the combined effect of mechanics factor and biological factor, cause chondrocyte, extracellular matrix, subchondral bone three degraded and synthesize that unbalance one is chronic, progressivity joint disease, is the commonly encountered diseases in a kind of mid-aged population, frequently-occurring disease.The pathological change of osteoarthritis is with the degeneration of articular cartilage and Secondary cases hyperosteogeny for core.It can be secondary to traumatic arthritis, arthritis deformans.Primary disease is apt to occur in many joints big, movable of bearing a heavy burden, such as knee joint, spinal column, hip etc..The traditional Chinese medical science thinks that primary disease belongs to the category of " rheumatism involving the bone " more.Primary disease is many to be caused due to caused by liver and kidney deficiency and chronic strain.Blood stored in the liver, blood nourishing muscle and tendon, therefore the tissue connected with the liver being tendon.The main storage vital essence of kidney, bone marrow is born in vital essence, therefore the tissue connected with the kidney being bone.All muscle persons, come under joint, and muscle can retrain joint.Due to caused by liver and kidney deficiency after the middle age, deficiency of the liver is blood failing to nourish tendons then, and muscle can not maintain the relaxation of joint, and sliding profit is lost in joint, suffers from a deficiency of the kidney and marrow subtracts, and causes muscles and bones all to be become homeless foster.Overworked, to accumulate over a long period, muscles and bones is impaired, and battalion defends imbalance, QI and blood being obstructed, and passages through which vital energy circulates stagnates, and muscles and bones is lost and supported, it is possible to cause raw primary disease.The generation of Primary Osteoarthritis, the age being as people increases, and articular cartilage becomes fragile, and destroying occurs because bearing differential pressure in cartilage, and adds the activity that upper joint is too much, and the lumbar vertebra that osteoarthritis, joint of the lower extremity and spinal column easily occur is common.Post-traumatic arthritis, can cause the infringement of cartilage because of wound, deformity and disease, with the passing of time cause primary disease.Articular cartilage is due to age growth, wound, deformity etc., cartilage wear, and subchondral bone appears, and in ivory bones, forms the cartilage circle of thickness at joint margins, by os endochondrale, forms hyperosteogeny；Joint capsule produces fibre modification and thickens, the activity in restriction joint, and periarticular muscle produces protectiveness spasm because of pain, makes joint motion be further affected by restriction, adds degeneration process, and fibrous ankylosis occurs in joint.
Osteoarthritis cardinal symptom is arthralgia, and early stage is passivity, increases the weight of gradually later, may occur in which typical " rest pain " and " morning is stiff ", pain when patient can feel static, namely to be in certain position excessively of a specified duration in joint, or when getting up in the morning, feel that arthralgia is with stiff；Pain relief after activity after a while；Such as hyperactivity, produce again pain because of joint-friction.Visible diseased joints swelling during physical examination, amyotrophy, can there is cartilage friction sound when joint is actively or passively movable, have joint motion in various degree limited and muscle spasm about.
In treatment, theoretical according to the traditional Chinese medical science " kidney governing bones ", at present for the Chinese traditional treatment of primary disease, it mostly is kidney treating therapy and treats.For deficiency of both the liver and kidney patient, the rule for the treatment of should nourishing the liver and kidney.For chronic strain patient, early stage deficient qi and blood, control with rich in nutrition；The person that occurs deficiency of the liver and kindey late period, if deficiency of the kidney yin person, should nourishing kidney yin, if insufficiency of kidney-YANG person, easy warming and recuperating the kidney-YANG.
Chinese Traditional Medicine shows big advantage in preventing and treating osteoarthritis, and theory of Chinese medical science is thought, osteoarthritis belongs to Chinese medicine " arthromyodynia " category, specifically includes rheumatism involving the bone, muscular rheumatism, BI-syndrome involved the muscle, BI-syndrome related to skin etc..Knee osteoarthritis is included into " rheumatism involving the bone " category more and carries out determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs by modern many doctors.Inventor is through clinical practice for many years, in conjunction with existing clinic and scientific achievement, by the many factors such as the cause of disease of knee osteoarthritis, pathogenesis and Clinical symptoms and Coryza Treated by Syndrome Differentiation effect are comprehensively analyzed, think: " muscular rheumatism " is the only stage which must be passed by that kneecap joint occurs in evolution, and " rheumatism involving the bone " is the extension of " muscular rheumatism " evolution！Therefore, again examine the pathologic basis of knee osteoarthritis from " muscular rheumatism " angle closely, and effectively treat, lapsing to of accurate assurance knee osteoarthritis, and enrich osteoarthritis Syndrome Differentiation System further, effectively instruct osteoarthritis clinical practice.
Summary of the invention
It is an object of the invention to provide a kind of gel ointment treating osteoarthritis；
The preparation method that it is a further object of the present invention to provide a kind of gel ointment treating osteoarthritis.
It is an object of the invention to by following technical scheme realization:
The gel ointment for the treatment of osteoarthritis of the present invention, is prepared by what the raw material of weight portion was prepared from: active ingredient compositions 1-10 part, adjuvant 300-600 part.
Described adjuvant is made up of following raw material:
Carbomer, triethanolamine, azone, tween 80, glycerol, sodium polyacrylate, Kaolin, dihydroxyaluminum aminoacetate, disodiumedetate, tartaric acid.
Described adjuvant weight proportion is as follows:
Carbomer 1-10 part, triethanolamine 5-15 part, azone 1-10 part, tween 80 5-15 part, glycerol 400-500 part, sodium polyacrylate 20-100 part, Kaolin 20-100 part, dihydroxyaluminum aminoacetate 1-10 part, disodiumedetate 0.5-20 part, tartaric acid 0.5-20 part.
The preparation method that another aspect of the present invention there is provided inventive gel unguentum, comprises the following steps:
(1) Camphora, Borneolum Syntheticum, Mentholum, methyl salicylate, Oleum Terebinthinae being mixed with azone and make dissolving, add tween 80, stir, mixture is standby；
(2) taking carbomer, to add 300-400 part purified water swelling overnight, adds triethanolamine furnishing gel, obtains substrate I；
(3) take glycerol and add sodium polyacrylate, Kaolin, dihydroxyaluminum aminoacetate, disodiumedetate, stir, obtain substrate II；
(4) in substrate II, add active ingredient compositions and step (1) described mixture, stir；Add tartaric acid, stir；Continuously add matrix I, stir into viscosity creme, coating, shear, curing molding, to obtain final product.
Camphora described in step (1), Borneolum Syntheticum, Mentholum, methyl salicylate, Oleum Terebinthinae weight be: Camphora 15-25 part, Borneolum Syntheticum 5-15 part, Mentholum 5-15 part, methyl salicylate 5-15 part, Oleum Terebinthinae 5-15.
Active ingredient compositions described in step (4) is prepared from Fructus Psoraleae, the Radix Astragali, Radix Achyranthis Bidentatae, Radix Dipsaci, the Cortex Eucommiae, Rhizoma Drynariae, Fructus Chaenomelis, Caulis Spatholobi, Radix Zanthoxyli, Olibanum, Myrrha, Radix Cynanchi Paniculati, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Flos Carthami, Herba Asari, Fructus Capsici by following raw material of Chinese medicine.
Described active ingredient compositions is prepared from by by following steps:
1) Radix Astragali, Radix Dipsaci, Rhizoma Drynariae, Radix Cynanchi Paniculati, Flos Carthami powder make active components A；
2) Fructus Psoraleae, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Chaenomelis, Caulis Spatholobi, Radix Zanthoxyli, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Herba Asari, Fructus Capsici make active component B；
3) active component C made by Olibanum, Myrrha；
4) active components A, B, C mix homogeneously, to obtain final product.
Described active components A is broken into fine powder is prepared from by the Radix Astragali, Radix Dipsaci, Rhizoma Drynariae, Radix Cynanchi Paniculati, Flos Carthami powder.
Described active component B is prepared: take Fructus Psoraleae, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Chaenomelis, Caulis Spatholobi, Radix Zanthoxyli, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Herba Asari, Fructus Capsici add 4-8 times amount 70% alcohol heating reflux extract 1-3 time, each 1-3 hour, collecting decoction, filter, filtrate is condensed into clear paste, to obtain final product.
Described active component C is prepared: is added ethanol by Olibanum, Myrrha and dissolves, filters, to obtain final product.
The described raw material of Chinese medicine proportioning preparing active ingredient compositions is:
Fructus Psoraleae 15-25 part, Radix Achyranthis Bidentatae 10-20 part, Cortex Eucommiae 5-15 part, Fructus Chaenomelis 10-20 part, Caulis Spatholobi 5-15 part, Radix Zanthoxyli 5-15 part, Cortex Phellodendri 10-20 part, Radix Et Rhizoma Rhei 5-15 part, Rhizoma Zingiberis 1-10 part, Herba Asari 10-20 part, Fructus Capsici 1-10 part；
Radix Astragali 15-25 part, Radix Dipsaci 10-20 part, Rhizoma Drynariae 5-15 part, Radix Cynanchi Paniculati 5-15 part, Flos Carthami 1-10 part；
Olibanum 5-15 part, Myrrha 5-15 part.
The following is the crude drug source of Chinese medicine of the present invention:
Fructus Psoraleae, the dry mature fruit of legumes psoraleae PsoraleacorylifoliaL..[nature and flavor] are pungent, bitter, temperature.[return through] returns kidney, spleen channel.[function cures mainly] warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI, antidiarrheal.For impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffer from a deficiency of the kidney and breathe heavily, Diarrhoea；External curing vitiligo, alopecia areata.
The Radix Astragali, leguminous plant Radix Astagali Astragalusmembranaceus(Fisch.) Bge.var.mongholicus(Bge.) Hsiao or Radix Astragali Astragalusmembranaceus(Fisch.) dry root of Bge..[nature and flavor] are sweet, temperature.[return through] returns lung, spleen channel.[function cures mainly] invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and bursts for a long time and does not hold back, and blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst；Chronic nephritis proteinuria, diabetes.
Radix Achyranthis Bidentatae, the dry root of amaranthaceous plant Radix Achyranthis Bidentatae AchyranthesbidentataBlume..[nature and flavor] are bitter, sour, flat.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, eliminating blood stasis and inducing menstruation, conducting blood to flow downwards.For soreness of waist and knee joint, muscles and bones is unable, amenorrhea lump in the abdomen, dizziness due to hyperactivity of liver-YANG.
Radix Dipsaci, Dipsacaceae plant Radix Dipsaci DipsacusasperoidesC.Y.ChengetT.M.Ai(or DipsacusasperWall) dry root.[nature and flavor] are bitter, pungent, tepor.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, continuous injured, only metrorrhagia.For soreness of the waist and knees, rheumatic arthralgia, metrorrhagia, vaginal bleeding during pregnancy, injury from falling down.Prepared RADIX DIPSACI with yellow rice wine is used for rheumatic arthralgia, injury from falling down.Prepared RADIX DIPSACI with salt solution is used for soreness of the waist and knees.
The Cortex Eucommiae, the dry bark of Eucommiaceae plant Cortex Eucommiae EucommiaulmoidesOliv..[nature and flavor] are sweet, temperature.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, antiabortive.For lumbago due to renal deficiency, muscles and bones is unable, blood leaking in gestation, frequent fetal movement；Hypertension.
Rhizoma Drynariae, Plants of Polypodiaceae Mongolian oak Herba pteridii latiusculi Drynariafortunei(Kunze) dry rhizome of J.Sm..[nature and flavor] are bitter, temperature.[return through] returns kidney, Liver Channel.[function cures mainly] the kidney invigorating bone strengthening, continues and hinders pain relieving.For lumbago due to renal deficiency, Hiccough and deaf, odontoseisis, falling winks frustrates, injured bone；External treatment alopecia areata, vitiligo.
Fructus Chaenomelis, rosaceous plant chaenomeles lagenaria Chaenomelesspeciosa(Sweet) the dry almost ripe fruit of Nakai.[nature and flavor] acid, temperature.[return through] returns liver, spleen channel.[function cures mainly] suppressing the hyperactive liver relaxing muscles and tendons, stomach function regulating removing dampness.For arthralgia chiefly caused by damp pathogen contracture, waist knee joint acid weight pain, convulsion of vomiting and diarrhoea, beriberi edema.
Caulis Spatholobi, the dry rattan of leguminous plant spatholobus suberectus (Caulis Sargentodoxae, Radix seu Caulis Verntilaginis Leiocarpae, SANYE Caulis Spatholobi, nine layers of wind) SpatholobussuberectusDunn.[nature and flavor] are bitter, sweet, temperature.[return through] returns liver, kidney channel.[function cures mainly] enriches blood, and invigorates blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia.
Radix Zanthoxyli, rutaceae Radix Zanthoxyli Zanthoxylumnitidum(Roxb.) dry root of DC..[nature and flavor] are bitter, pungent, flat；Slightly poisonous.[return through] returns liver, stomach warp.[function cures mainly] promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, dispelling wind and removing obstruction in the collateral.The traumatic injury that causes for qi depression to blood stasis, rheumatic arthralgia, stomachache, toothache, venom；The burning hot wound of external treatment soup.
Olibanum, Burseraceae Boswellia carterii platymiscium Boswellia carterii BoswelliacarteriiBirdw. [B.sacraFluek.], medicine glue XIANGSHU B.bhawdajianaBirdw. and wild Boswellia carterii B.neglectaM.Moore etc., be used as medicine with the oleo-gum-resin that its trunk skin zone wound oozes out.[nature and flavor] are pungent, bitter, temperature.[function cures mainly] promoting blood circulation and stopping pain.For all pains of trusted subordinate, muscle arteries and veins contracture, traumatic injury, sore, carbuncle and painful swelling；Externally used detumescence granulation promoting.
Myrrha, Burseraceae bdellium plant myrrh CommiphoramyrrhaEngl. [C.molmolEngl.] and belong to the oleo-gum-resin that the trunk skin zone of his kind of plant oozes out together.[nature and flavor] are bitter, flat.[function cures mainly] eliminating stasis to stop pain, externally used detumescence granulation promoting.Swell and ache for traumatic injury congestion, ulcer sore pain, all pains of chest and abdomen；External is controlled the open sore part and is not restrained for a long time.
Radix Cynanchi Paniculati, trailing plants section Cynanchum plant Radix Cynanchi Paniculati Cynanchumpaniculatum(Bge.) the dry root and rhizome of Kitag..[nature and flavor] are pungent, temperature.[return through] returns liver, stomach warp.[function cures mainly] dispels the wind removing dampness, antalgesic-antipruritic.For rheumatic arthralgia, distension of having a stomachache, toothache, lumbago, injury from falling down, urticaria, eczema.
Cortex Phellodendri, the dry bark of rutaceae wampee PhellodendronchinenseSchneid..[nature and flavor] are bitter, cold.[return through] returns kidney, bladder warp.[function cures mainly] heat clearing and damp drying, pathogenic fire purging is except steaming, detoxification sore treatment.For damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity { is warded off }, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema pruritus.Stir-baked CORTEX PHELLODENDRI with salt solution nourishing YIN to lower pathogenic fire.For hyperactivity of fire caused by deficiency of YIN, night sweat hectic fever due to YIN-deficiency.
Radix Et Rhizoma Rhei, for polygonum rheum palmatum RheumpalmatumL., Rheum tanguticum RheumtanguticumMaxim.exBalf.Or Rheum officinale RheumofficinaleBaill.Dry root and rhizome.[nature and flavor] are bitter, cold.[return through] returns spleen, stomach, large intestine, liver, pericardium channel.[function cures mainly] purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation.For excess-heat constipation, stagnant stomachache, dysentery is not well, jaundice due to damp-heat, and heat in blood tells nosebleed, conjunctival congestion, pharyngeal swelling, abdominalgia with intestinal abscess, carbuncle furuncle, blood stasis amenorrhea, traumatic injury, external treatment burn due to hot liquid or fire；Upper gastrointestinal hemorrhage.
Rhizoma Zingiberis, the dry rhizome of zingiber ZingiberofficinaleRosc..[nature and flavor] are pungent, hot.[return through] returns spleen, stomach, kidney, the heart, lung meridian.[function cures mainly] Rhizoma Zingiberis warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant.For coldness and pain in the epigastrium, vomiting is had loose bowels, and cold extremities faint pulse, phlegm retention is breathed with cough.
Flos Carthami, the dried floral of feverfew Flos Carthami CarthamustinctoriusL..[nature and flavor] are pungent, temperature.[return through] GUIXIN, Liver Channel.[function cures mainly] promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.For amenorrhea, dysmenorrhea, lochia, lump in the abdomen mass in the abdomen, injury from falling down, skin infection swells and ache.
Herba Asari, aristolochiaceae plant Herba Asari AsarumheterotropoidesFr.Schmidtvar.mandshuricum(Maxim.) the dry herb of Kitag., Seoul Herba Asari AsarumsieboldiiMiq.var.seoulenseNakai or China Herba Asari AsarumsieboldiiMiq..[nature and flavor] are pungent, temperature.[return through] GUIXIN, lung, kidney channel.[function cures mainly] expelling wind and cold, sensible pain relieving, warming the lung to resolve fluid-retention.For anemofrigid cold, headache, toothache, nasal sinusitis of having a stuffy nose, rheumatic arthralgia, phlegm retention is breathed with cough.
Fructus Capsici, Solanaceae capsicum plants Fructus Capsici CapsicumfrutescensL. [C.annuumL.], it is used as medicine with fruit, root and stem branch.[nature and flavor] really: pungent, hot.[function cures mainly] really: warming spleen and stomach for dispelling cold, invigorating the stomach and promoting digestion.For cold syndrome of the stomach pain, flatulence, dyspepsia；External treating chilblain, rheumatalgia, lumbago.Root: promoting blood circulation and detumescence.External treating chilblain.
Camphora, for Lauraceae cinnamon Camphor tree Cinnamomumcamphora(L.) Presl., with root, branch, leaf and waste wood through distilling the crystalline particulate of gained.[nature and flavor] are pungent, temperature.[function cures mainly] sensible ward off dirty, warming middle-JIAO to relieve pain, dampness removing parasite killing.Vomit and diarrhoea for cold-damp, stomach abdomen pain；Scabies is controlled in external, tinea, dental caries are had a pain.
Borneolum Syntheticum, for the processed goods of Spore density Borneolum Syntheticum resin, or is processed into product for what Camphora, Lignum Pini Nodi wet goods chemically synthesized.[nature and flavor] work hard, cool.[return through] enters the heart, lung meridian.[function cures mainly] leads to all keys, dissipates stagnated fire, removing nebula improving eyesight, reducing swelling and alleviating pain.Controlling apoplexy locked mouth, calentura coma, infantile convulsion expectorant fan, deafness with qi stagnation, sore throat, aphtha, otitis media, carbuncle, hemorrhoid, order is nebula film also, enterobiasis.
Mentholum, for a kind of saturated cyclic alcohol obtained in Oleum menthae.[function cures mainly] aromatic drug, remedium corrigens and carminative.Can be used for skin or mucosa produces refrigerant sense to alleviate discomfort and pain.
Inventive formulation is rationally innovated, Fructus Psoraleae reinforcing the kidney and supporting YANG in side, Radix Astragali tonifying Qi and lifting yang；Radix Achyranthis Bidentatae, Radix Dipsaci, the Cortex Eucommiae, Rhizoma Drynariae invigorating the liver and kidney, bone and muscle strengthening, Fructus Chaenomelis, Caulis Spatholobi relaxing muscles and tendons and activating QI and blood in the collateral, Radix Zanthoxyli dispelling wind and removing obstruction in the collateral, promoting the circulation of QI to relieve pain, Olibanum, Myrrha promoting blood circulation and stopping pain, Radix Cynanchi Paniculati dispels the wind removing dampness；Cortex Phellodendri heat clearing and damp drying, Radix Et Rhizoma Rhei clearing away heat-damp and promoting diuresis, blood circulation promoting and blood stasis dispelling；Rhizoma Zingiberis warming spleen and stomach for dispelling cold, recuperating depleted YANG are promoted blood circulation, Flos Carthami stasis-dispelling and pain-killing;Herba Asari expelling wind and cold, sensible pain relieving；Fructus Capsici warming spleen and stomach for dispelling cold.Being aided with Camphora, Borneolum Syntheticum, Mentholum, not only increase transmitance, and this three taste is also Chinese crude drug, the sensible pain relieving of Camphora, Borneolum Syntheticum, Mentholum alleviates uncomfortable and pain.Full side gathers the effect of dispelling cold by warming the meridian, promoting blood circulation and stopping pain, channels sootheing and network vessel quickening, damp eliminating detumescence, bone and muscle strengthening altogether.For treating various arthritis and the arthrosis that the wet impatency meridians of wind and cold cause, disease sees joint, myalgia, obtains Wen Ze and subtracts, and meets cold rnning weight, or companion see swelling, stiff, weigh, numb, joint stuffiness person；The bones and muscles pain that chronic strain causes, weak, cramp etc.；Traumatic injury, fracture dislocation middle and late stage limbs swell and ache and dysfunction.
A kind of Chinese medicine composition treating osteoarthritis provided by the invention has the advantage that
1, gel ointment provided by the invention is safe and effective, for treating various arthritis and the muscles and bones arthrosis that the wet impatency meridians of wind and cold cause, disease sees joint, myalgia, obtains Wen Ze and subtracts, meet cold rnning weight, or companion see swelling, stiff, weigh, numb, joint stuffiness person；The bones and muscles pain that chronic strain causes, weak, cramp etc.；Traumatic injury, fracture dislocation middle and late stage limbs swell and ache and dysfunction.
2, the total effective rate of compositions provided by the invention treatment pain is 97%, and the total effective rate for the treatment of swelling is 95.3%, and the total effective rate eliminating ecchymosis is 94.2%, and treatment osteoarthritis is evident in efficacy.
3, Traditional Chinese medicine composition formula of the present invention is rationally innovated, and production cost is low, technique is simple.
Detailed description of the invention
Further illustrate the present invention by the examples below.It should be understood that embodiments of the invention are an illustration for the present invention rather than limitation of the present invention.The simple modifications that the present invention is carried out by the essence according to the present invention broadly falls into the scope of protection of present invention.Except as otherwise noted, the percent of the amount of alcohol in the present invention is percentage by volume, and v/v represents the volume ratio of solution.
Embodiment 1
Active ingredient compositions is formed by active components A, active component B, active component C in combination, and the preparation method of each active component is:
Active components A: weigh Fructus Psoraleae 1.5kg, Radix Achyranthis Bidentatae 1kg, Cortex Eucommiae 0.5kg, Fructus Chaenomelis 1kg, Caulis Spatholobi 0.5kg, Radix Zanthoxyli 0.5kg, Cortex Phellodendri 1kg, Radix Et Rhizoma Rhei 0.5kg, Rhizoma Zingiberis 0.1kg, Herba Asari 1kg, Fructus Capsici 0.1kg, add 4 times amount 70% alcohol heating reflux and extract 3 times, each 1 hour, collecting decoction, filter, filtrate is condensed into clear paste, standby.
Active component B: Radix Astragali 1.5kg, Radix Dipsaci 1kg, Rhizoma Drynariae 0.5kg, Radix Cynanchi Paniculati 0.5kg, Flos Carthami 0.1kg is ground into fine powder, standby；
Active component C: take Olibanum 0.5kg, Myrrha 0.5kg, adds ethanol and dissolves, filter, and filtrate is standby；
The preparation method of gel ointment, comprises the following steps:
(1), by Camphora 1.5kg, Borneolum Syntheticum 0.5kg, Mentholum 0.5kg, methyl salicylate 0.5kg, Oleum Terebinthinae 0.5kg with azone 0.1kg mixing and make dissolving, add tween 80 0.5kg, stir, mixture is standby；
(2), taking carbomer 0.1kg, to add 30kg purified water swelling overnight, adds triethanolamine 0.5kg furnishing gel, obtains substrate I；
(3), take 40kg glycerol addition sodium polyacrylate 2kg, Kaolin 2kg, dihydroxyaluminum aminoacetate 0.1kg, disodiumedetate 0.05kg, stir, obtain substrate II；
(4), in substrate II, add mixture of active principles and step (1) described mixture, stir；Add tartaric acid 0.05kg, stir；Continuously add matrix I, stir into viscosity creme.Coating, shears, curing molding, to obtain final product.
Embodiment 2
Active ingredient compositions is formed by active components A, active component B, active component C in combination, and the preparation method of each active component is:
Active components A: weigh Fructus Psoraleae 2.5kg, Radix Achyranthis Bidentatae 2kg, Cortex Eucommiae 1.5kg, Fructus Chaenomelis 2kg, Caulis Spatholobi 1.5kg, Radix Zanthoxyli 1.5kg, Cortex Phellodendri 2kg, Radix Et Rhizoma Rhei 1.5kg, Rhizoma Zingiberis 1kg, Herba Asari 2kg, Fructus Capsici 1kg, add 8 times amount 70% alcohol heating reflux and extract 1 time, 1 time 3 hours, collecting decoction, filter, filtrate is condensed into clear paste, standby.
Active component B: Radix Astragali 2.5kg, Radix Dipsaci 2kg, Rhizoma Drynariae 1.5kg, Radix Cynanchi Paniculati 1.5kg, Flos Carthami 1kg is ground into fine powder, standby；
Active component C: take Olibanum 1.5kg, Myrrha 1.5kg, adds ethanol and dissolves, filter, and filtrate is standby.
The preparation method of gel ointment, comprises the following steps:
(1), by Camphora 2.5kg, Borneolum Syntheticum 1.5kg, Mentholum 1.5kg, methyl salicylate 1.5kg, Oleum Terebinthinae 1.5kg.Mixing with azone 1kg and make dissolving, add tween 80 1.5kg, stir, mixture is standby；
(2), taking carbomer 1kg, to add 40kg purified water swelling overnight, adds triethanolamine 1.5kg furnishing gel, obtains substrate I；
(3), take 50kg glycerol addition sodium polyacrylate 10kg, Kaolin 10kg, dihydroxyaluminum aminoacetate 1kg, disodiumedetate 2kg, stir, obtain substrate II；
(4), in substrate II, add mixture of active principles and step (1) described mixture, stir；Add tartaric acid 2kg, stir；Continuously add matrix I, stir into viscosity creme.Coating, shears, curing molding, to obtain final product.
Embodiment 3
Active ingredient compositions is formed by active components A, active component B, active component C in combination, and the preparation method of each active component is:
Active components A: weigh Fructus Psoraleae 2kg, Radix Achyranthis Bidentatae 1.5kg, Cortex Eucommiae 1kg, Fructus Chaenomelis 1.5kg, Caulis Spatholobi 1kg, Radix Zanthoxyli 1kg, Cortex Phellodendri 1.5kg, Radix Et Rhizoma Rhei 1kg, Rhizoma Zingiberis 0.5kg, Herba Asari 1.5kg, Fructus Capsici 0.5kg, add 6 times amount 70% alcohol heating reflux and extract 2 times, each 2 hours, collecting decoction, filter, filtrate is condensed into clear paste, standby.
Active component B: Radix Astragali 2kg, Radix Dipsaci 1.5kg, Rhizoma Drynariae 1kg, Radix Cynanchi Paniculati 1kg, Flos Carthami 0.5kg, it is ground into fine powder, standby；
Active component C: take Olibanum 1kg, Myrrha 1kg, adds ethanol and dissolves, filter, and filtrate is standby；
The preparation method that another aspect of the present invention there is provided inventive gel unguentum, comprises the following steps:
(1), by Camphora 2kg, Borneolum Syntheticum 1kg, Mentholum 1kg, methyl salicylate 1kg, Oleum Terebinthinae 1kg with azone 0.5kg mixing and make dissolving, add tween 80 1kg, stir, mixture is standby；
(2), taking carbomer 0.5kg, to add 35kg purified water swelling overnight, adds triethanolamine 1kg furnishing gel, obtains substrate I；
(3), take 45kg glycerol addition sodium polyacrylate 5kg, Kaolin 5kg, dihydroxyaluminum aminoacetate 0.5kg, disodiumedetate 1kg, stir, obtain substrate II；
(4), in substrate II, add mixture of active principles and step (1) described mixture, stir；Add tartaric acid 1kg, stir；Continuously add matrix I, stir into viscosity creme.Coating, shears, curing molding, to obtain final product.
Clinical trial is summed up
1. object of study observes case is totally 200 patients treated in my institute in February, 2013 to June, adopts the form of application therapy to use in therapeutic room these 200 patients.Wherein male 69 examples, female 131 example, the age is between 3～89 years old；Pain and swelling ecchymosis 131 example that wherein osteoarthritis causes, pain and swelling ecchymosis 62 example that soft tissue injury causes, pain and swelling ecchymosis 7 example that fracture causes.
Therapeutic Method: adopting gel ointment described in the embodiment of the present invention 3 to stick affected part, often patch uses 24 hours, treats 2 weeks.
Criterion of therapeutical effect and therapeutic outcome
3.1 criterions of therapeutical effect are formulated with reference to " new Chinese medicine guideline of clinical investigations ".
Clinical recovery: arthralgia disappears substantially, walking is normal, and daily life is unaffected, and joint is without swelling, ecchymosis；
Effective: arthralgia substantially alleviates, accidental or have mild pain, it is possible to tolerance, daily life is normal, and joint is without swelling, ecchymosis；
Effective: the symptom of patient has and to a certain degree takes a turn for the better, but still has pain, swelling, ecchymosis, and clinical symptoms alleviates before relatively treating；
Invalid: before and after treatment, clinic is not improved, even increase the weight of.
The symptoms such as the pain in the above patient affected part of therapeutic outcome, swelling, ecchymosis all obtain improvement in various degree, and do not find the anaphylaxiss such as erythra, pruritus, erythema, foaming during use, also without receiving untoward reaction report.Its therapeutic outcome such as following table:
Table 1: the impact (n=200) on affected part pain
Number of cases Recovery from illness Effective Effectively Invalid Total effective rate
Treatment pain 200 32 105 52 6 97%
Table 2: the impact (n=194) on affected part swelling
Table 3: eliminate the impact (n=69) of affected part ecchymosis
Number of cases Recovery from illness Effective Effectively Invalid Total effective rate
Eliminate ecchymosis 69 20 30 15 4 94.2%
From table 1-3: the total effective rate of inventive gel unguentum treatment pain is 97%, and the total effective rate for the treatment of swelling is 95.3%, and the total effective rate eliminating ecchymosis is 94.2%, and treatment osteoarthritis is evident in efficacy.
Animal acute toxicity test
One, experiment material
1, trial drug
Gel ointment, bare substrate described in the embodiment of the present invention 1.
2, experimental animal
SD rat (quality certification SCXK(Guangdong) 2008-0002)；Being thered is provided by Guangdong Medical Lab Animal Center, meet SPF grade standard, normal raising quarantine supplied examination after 3 days.
3, experimental condition
Experimental animal occupancy permit number: SYXK(Guangdong) 2012-0125.Laboratory temperature is constant, room temperature 23-25 DEG C；Relative humidity 40-70%；15-20 time/h of ventilation volume；Illuminate 12 hours light and shades alternately.Raise with full nutrition standard recipe feedstuff.
Two, test method and result
1, test packet
Matched group: smear substrate
Test group: smear the embodiment of the present invention 1 gel ointment
2, test method
Take SD rat 40, body weight 180-220g, male and female half and half, before experiment, slough rat back spinal column diamond wool with 8% sodium sulfide.Depilation area is about 5cm × 8cm, checks that whether skin of unhairing is injured because of unhairing after unhairing 24h.
Wherein will be randomly divided into 2 groups by 20 intact rats of skin, often group 10, i.e. matched group and test group, empirically it is grouped and medicaments uniformity is applied in depilation district, and fixed with nonirritant gauze, carry out second time administration, every animal sub-cage rearing after 8 hours in the same way；
Another 20 rats wipe depilation district epidermis with No. 0 sand paper at intact skin, and with oozing of blood for degree, packet and dosage are with intact skin acute toxicity test group.Each group washes away the medicine smeared or substrate after smearing 24h with warm water, and in removing after test medicine 1,24,48, the body weight observing and recording rat every day in 72 hours to the 14th day, systemic toxicity profiles performance and the death condition such as the change of skin, hair, eyes and mucosa and breathing, central nervous system, extremity activity, if meeting dead animal, perform an autopsy on sb. and perusal, when naked eyes lesions visible, then carry out histopathologic examination.
2, experimental result
Rat skin is after smearing gel ointment, and administration group rat no abnormality seen reacts, and its diet, defecation, behavioral activity, body weight etc. are all normal, hair and mucosa also no abnormality seen, compared with matched group, there are no any difference.Wherein intact skin group rat skin is all without erythema, without edema, also without dead；In damaged skin group, when 48h, there is mild redness at rat skin cut place, and during to 14d, redness is wholly absent, and hair growth is normal, without dead, with matched group indifference.Test group dosage is 51.6g crude drug/kg/d, the gel ointment (specification: 5.56g crude drug/patch) of this treatment osteoarthritis, adult clinical every day 1 time, one time 1 patch, namely maximum dosage every day is 5.56g crude drug/d, to be grown up, body weight 60kg calculates, and average dosage is 0.0927g crude drug/kg/d.Then in this experiment, dosage every day of SD rat (average weight is counted with 200g) admits 557 times of consumption for Lincheng, and the gel ointment safety of prompting clinical treatment osteoarthritis is higher.Result is in Table 4.
The administration acute toxicity test of osteoarthritis gel ointment rat skin treated by table 4
As shown in Table 4, give the local skin medication of this high concentration of rat, 51.6g crude drug/kg/d, it it is 557 times of clinical Coming-of-Age Day usual amounts, Continuous Observation 14 days, each treated animal general reaction, ingest, drink water all normal, without dead, it was shown that the present invention treats the gel ointment of osteoarthritis and has good safety.
Although, above use generality explanation, detailed description of the invention and test, the present invention is described in detail, but on basis of the present invention, it is possible to it is made some modifications or improvements, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to the scope of protection of present invention.

Claims (10)

1. the gel ointment treating osteoarthritis, it is characterised in that be prepared by that the raw material of weight portion is processed to be prepared from: active ingredient compositions 1-10 part, adjuvant 300-600 part；
Described adjuvant is made up of following raw material:
Carbomer, triethanolamine, azone, tween 80, glycerol, sodium polyacrylate, Kaolin, dihydroxyaluminum aminoacetate, disodiumedetate, tartaric acid.
2. the gel ointment of the treatment osteoarthritis described in claim 1, it is characterised in that described adjuvant weight proportion is as follows:
Carbomer 1-10 part, triethanolamine 5-15 part, azone 1-10 part, tween 80 5-15 part, glycerol 400-500 part, sodium polyacrylate 20-100 part, Kaolin 20-100 part, dihydroxyaluminum aminoacetate 1-10 part, disodiumedetate 0.5-20 part, tartaric acid 0.5-20 part.
3. the gel ointment treating osteoarthritis, it is characterised in that its preparation method comprises the following steps:
(1) Camphora, Borneolum Syntheticum, Mentholum, methyl salicylate, Oleum Terebinthinae being mixed with azone and make dissolving, add tween 80, stir, mixture is standby；
(2) taking carbomer, to add 300-400 part purified water swelling overnight, adds triethanolamine furnishing gel, obtains substrate I；
(3) take glycerol and add sodium polyacrylate, Kaolin, dihydroxyaluminum aminoacetate, disodiumedetate, stir, obtain substrate II；
(4) in substrate II, add active ingredient compositions and step (1) described mixture, stir；Add tartaric acid, stir；Continuously add matrix I, stir into viscosity creme, coating, shear, curing molding, to obtain final product.
4. the gel ointment of the treatment osteoarthritis described in claim 3, it is characterized in that the Camphora described in step (1), Borneolum Syntheticum, Mentholum, methyl salicylate, Oleum Terebinthinae weight are: Camphora 15-25 part, Borneolum Syntheticum 5-15 part, Mentholum 5-15 part, methyl salicylate 5-15 part, Oleum Terebinthinae 5-15.
5. the gel ointment of the treatment osteoarthritis described in claim 3, it is characterised in that the active ingredient compositions described in step (4) is prepared from by following raw material of Chinese medicine: Fructus Psoraleae, the Radix Astragali, Radix Achyranthis Bidentatae, Radix Dipsaci, the Cortex Eucommiae, Rhizoma Drynariae, Fructus Chaenomelis, Caulis Spatholobi, Radix Zanthoxyli, Olibanum, Myrrha, Radix Cynanchi Paniculati, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Flos Carthami, Herba Asari, Fructus Capsici.
6. the gel ointment of the treatment osteoarthritis described in claim 5, it is characterised in that described active ingredient compositions is prepared from by following steps:
1) Radix Astragali, Radix Dipsaci, Rhizoma Drynariae, Radix Cynanchi Paniculati, Flos Carthami make active components A；
2) Fructus Psoraleae, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Chaenomelis, Caulis Spatholobi, Radix Zanthoxyli, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Herba Asari, Fructus Capsici make active component B；
3) active component C made by Olibanum, Myrrha；
4) active components A, B, C mix homogeneously, to obtain final product.
7. the gel ointment of the treatment osteoarthritis described in claim 6, it is characterised in that described active components A is broken into fine powder is prepared from by the Radix Astragali, Radix Dipsaci, Rhizoma Drynariae, Radix Cynanchi Paniculati, Flos Carthami powder.
8. the gel ointment of the treatment osteoarthritis described in claim 7, it is characterized in that described active component B is prepared from by following steps: take Fructus Psoraleae, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Chaenomelis, Caulis Spatholobi, Radix Zanthoxyli, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Herba Asari, Fructus Capsici add 4-8 times amount 70% alcohol heating reflux extract 1-3 time, each 1-3 hour, collecting decoction, filter, filtrate is condensed into clear paste, to obtain final product.
9. the gel ointment of the treatment osteoarthritis described in claim 7, it is characterised in that described active component C is prepared from by following steps: added ethanol by Olibanum, Myrrha and dissolve, filter, to obtain final product.
10. the gel ointment of the treatment osteoarthritis described in claim 6, it is characterised in that described prepare active ingredient compositions raw material of Chinese medicine proportioning be:
Fructus Psoraleae 15-25 part, Radix Achyranthis Bidentatae 10-20 part, Cortex Eucommiae 5-15 part, Fructus Chaenomelis 10-20 part, Caulis Spatholobi 5-15 part, Radix Zanthoxyli 5-15 part, Cortex Phellodendri 10-20 part, Radix Et Rhizoma Rhei 5-15 part, Rhizoma Zingiberis 1-10 part, Herba Asari 10-20 part, Fructus Capsici 1-10 part；
Radix Astragali 15-25 part, Radix Dipsaci 10-20 part, Rhizoma Drynariae 5-15 part, Radix Cynanchi Paniculati 5-15 part, Flos Carthami 1-10 part；
Olibanum 5-15 part, Myrrha 5-15 part.
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CN106880701A (en) * 2017-03-30 2017-06-23 贵阳中医学院 A kind of compound osteitis bar cloth pastes the preparation method of Chinese medical concrete
CN107320442A (en) * 2017-06-27 2017-11-07 广州中医药大学附属骨伤科医院 Chinese medicine external gel and preparation method thereof
CN108969619A (en) * 2018-09-10 2018-12-11 穆艳华 One analgesic bone cold compress gel and preparation method thereof
CN109331159A (en) * 2018-11-15 2019-02-15 谈宗华 A kind of gel emplastrum and preparation method thereof for treating dysmenorrhea

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CN1872275A (en) * 2006-04-17 2006-12-06 韩贤哲 Medication for treating diseases of orthopaedics, and preparation method
CN104324343A (en) * 2014-09-09 2015-02-04 韩世昌 Traditional Chinese medicinal ointment for treating femoral head necrosis, and preparation method thereof
CN104984310A (en) * 2015-08-07 2015-10-21 韩清民 Traditional Chinese medicine composition for treating osteoarthritis and preparation method thereof

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CN1872275A (en) * 2006-04-17 2006-12-06 韩贤哲 Medication for treating diseases of orthopaedics, and preparation method
CN104324343A (en) * 2014-09-09 2015-02-04 韩世昌 Traditional Chinese medicinal ointment for treating femoral head necrosis, and preparation method thereof
CN104984310A (en) * 2015-08-07 2015-10-21 韩清民 Traditional Chinese medicine composition for treating osteoarthritis and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106880701A (en) * 2017-03-30 2017-06-23 贵阳中医学院 A kind of compound osteitis bar cloth pastes the preparation method of Chinese medical concrete
CN106880701B (en) * 2017-03-30 2020-08-25 贵阳中医学院 Preparation method of compound traditional Chinese medicine plaster for treating osteitis
CN107320442A (en) * 2017-06-27 2017-11-07 广州中医药大学附属骨伤科医院 Chinese medicine external gel and preparation method thereof
CN107320442B (en) * 2017-06-27 2021-02-26 广州中医药大学附属骨伤科医院 Traditional Chinese medicine external gel and preparation method thereof
CN108969619A (en) * 2018-09-10 2018-12-11 穆艳华 One analgesic bone cold compress gel and preparation method thereof
CN109331159A (en) * 2018-11-15 2019-02-15 谈宗华 A kind of gel emplastrum and preparation method thereof for treating dysmenorrhea

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