CN107898924B - Chinese herbal medicine for treating osteoporosis and preparation method of gel patch thereof - Google Patents
Chinese herbal medicine for treating osteoporosis and preparation method of gel patch thereof Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/11—Pteridophyta or Filicophyta (ferns)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/254—Acanthopanax or Eleutherococcus
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention discloses a Chinese herbal medicine for treating osteoporosis, which comprises the following components in parts by mass: 6-15 parts of rhizoma drynariae, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry. The preparation method of the gel patch comprises the steps of extracting the Chinese herbal medicines with ethanol under reflux to obtain an extract; mixing the extract with medicinal adjuvants, stirring, coating, cutting, and standing. The gel patch has the effects of nourishing liver and kidney, replenishing essence and generating marrow, removing blood stasis and dredging collaterals, and strengthening tendons and bones, the active ingredients of the medicine are transdermally absorbed by the Shenque point of a patient, and the gel patch plays a role in preventing and treating osteoporosis through ways of promoting osteoblast differentiation and proliferation, inhibiting osteoclast formation and the like. The gel patch has the characteristics of convenient use, safety, reliability, long-acting slow release and administration frequency reduction, and provides a new way for preventing and treating osteoporosis.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a Chinese herbal medicine for treating osteoporosis, and a preparation method of a Chinese herbal medicine gel patch for treating osteoporosis.
Background
Osteoporosis (OP) is caused by a variety of causes, and is a systemic metabolic bone disease characterized by decreased bone mass, decreased bone density, deterioration of damaged bone microarchitectures, increased bone fragility, and susceptibility to bone fracture. OP is mainly divided into three categories of postmenopausal osteoporosis, senile osteoporosis and idiopathic osteoporosis, wherein the postmenopausal osteoporosis and senile osteoporosis are mainly encountered by the elderly and postmenopausal women, and other age groups also have diseases; idiopathic osteoporosis is most common in pregnant and lactating women or the adolescent population. The occurrence of OP is related to disease factors, endocrine factors, nutritional status, physical factors, pharmaceutical factors, lifestyle and the like, but specific causes of OP are not clear at present, such as (i) disease factors: osteoporosis can be caused to a certain extent by diseases such as diabetes, adenohypophysis hypofunction and hyperthyroidism; endocrine factors: the decrease of sex hormone secretion ability in the body of the old people can gradually cause the secretion imbalance of Calcitonin (CT), parathyroid hormone (PTH) and 1, 25-dihydroxyvitamin D3, thereby causing the disorder of bone metabolism and the loss of bone; ③ nutrient factors: because the digestion and absorption functions of the body are weakened, the insufficient intake of various nutrient elements such as protein, calcium, phosphorus, vitamins, trace elements and the like can be caused, and the integrity and the strength of bones are influenced; physical factors: the reduction of the exercise amount and the exercise intensity of the human body reduces the blood flow in bones, reduces the stimulation of muscle strength and mechanical stress to cause the slow bone formation and the reduction of the bone mass, and is easy to cause fracture; medicine factors: some drugs, such as glucocorticoids, immunosuppressants, heparin, anticonvulsants, aluminum-containing antacids, etc., can cause loss of bone mass and a decrease in bone density after entering the body.
OP is clinically manifested primarily as pain, spinal deformity, stature shortening and fracture, with osteoporotic fractures being the greatest hazard. Serious osteoporosis bone pain can affect the daily life, diet, sleep and the like of a patient, often make the patient have irregular life, the teeth fall off early and the patient does not think of diet, and further cause the further deterioration of the health condition; the osteoporosis patient is easy to fracture, namely the fracture can be caused by slight external force such as cough, turning over and the like, particularly when the thoracic vertebra and the lumbar vertebra generate compression fracture, the retroflexion of the vertebra and the thoracic deformity can be forced to cause the rapid reduction of vital capacity and maximum ventilation volume, so that symptoms such as chest distress, short breath, dyspnea and the like are caused and related complications are caused; in addition, the fracture of the old can also cause or aggravate cardiovascular and cerebrovascular complications, cause various complications such as pulmonary infection, bedsore and the like, seriously harm the health and the life quality of the old and even endanger the life. Therefore, the osteoporosis is extremely harmful, the life quality of patients is greatly reduced, the death rate of old people is increased, and heavy economic burden and pressure are brought to families and society (such as medical insurance systems). According to statistics, the total prevalence rate of osteoporosis of people over 40 years old in China is 13.2%; in the population of 60-69 years old, the incidence rate of osteoporosis of the old female reaches 50% -70%, and the incidence rate of osteoporosis of the old male reaches 30%; OP has become an increasingly serious public health problem, which is very unfavorable for the rapid development of our country's society and economy!
At present, modern medicine mainly adopts oral medication therapy for OP, such as oral administration of bisphosphates, calcium agents, vitamin D, calcitonin, estrogen and other medicines, and although the medicines can effectively improve bone mass and reduce the risk of fracture, long-term administration of chemical medicines not only can increase the burden of liver and kidney, but also can stimulate gastrointestinal tract and other serious adverse reactions. For example, long-term administration of bisphosphonates can cause upper gastrointestinal ulcers and increase the risk of esophageal cancer; hormone drugs are easy to cause endocrine imbalance after being taken for a long time, so that the risk of breast cancer and endometrial cancer is increased; excessive calcium is easy to cause hypercalcemia and cause renal calculus; therefore, the oral chemical drugs have the disadvantages of more adverse reactions, heavy burden on liver and kidney, poor tolerance of patients, poor long-term treatment effect and the like, and are not beneficial to the effective treatment of OP. In the traditional Chinese medicine, OP belongs to the categories of 'bone atrophy', 'bone withering' and 'bone impediment', and is considered to have relations with kidney, liver, spleen, blood stasis and the like, wherein deficiency of kidney essence is the main cause of disease, and has important relations with liver deficiency, spleen deficiency and blood stasis, so that the traditional Chinese medicine is mainly used for clinically nourishing liver and kidney, regulating and tonifying spleen and stomach, and activating blood and dissolving stasis. However, clinically, the main method for treating OP by Chinese herbal medicines is oral administration, and the common dosage forms are decoction (including formula granules and tea), granules, capsules (including soft capsules), concentrated pills, big honeyed pills, tablets and the like, and the oral administration dosage forms have some defects, such as: the traditional decoction has the problems of poor taste, inconvenience in use and the like, and the water content of the decoction is high, so that the life quality of the old is seriously influenced due to increase of urine volume and acceleration of urination frequency of the old, and the kidney burden is increased; secondly, the granules are mostly sugar (sucrose) -containing granules, which not only cause the disadvantages of blood sugar rise, gastrointestinal tract stimulation and the like, but also cause the increase of urine volume and urination frequency to influence daily life; solid preparations such as capsules (including soft capsules), concentrated pills, tablets and the like cause more water drinking and difficult medicine swallowing to cause difficult medicine taking because the water drinking and medicine swallowing actions of the old are often inconsistent; fourthly, big honeyed pills need to be chewed and bitten when being taken, but old people have the problems of insufficient chewing due to the reduced chewing force of oral muscles, large broken pills and easy stimulation to throats when being swallowed, causing nausea and vomiting, and the like; in addition, the old people often forget to take the medicine, take the medicine for many times and take the wrong medicine due to the hypomnesis of the old people, so that the long-term curative effect of the medicine is influenced to a certain extent and the potential harm is brought to patients. The transdermal drug delivery preparation is a novel drug delivery method, can avoid the bad taste and liver first-pass effect of oral drugs, avoid the bad stimulation of the drugs to the gastrointestinal tract, reduce the drug delivery times, be convenient to use, have long drug action time and no pain, and meet the drug characteristics that the old people are difficult to take the drugs orally and fear injection. The transdermal drug delivery preparation is an ideal drug delivery way for the elderly, and at present, the transdermal drug delivery preparation for treating OP in China is still blank. Because the Chinese herbal medicine has the characteristics of natural acquisition of active ingredients of the medicine, low or no toxic and side effect, wide action target and the like, and conforms to the multi-level characteristic of OP pathogenesis, the research and development of the high-efficiency Chinese herbal medicine transdermal drug delivery preparation for OP treatment have greater scientific significance and clinical value.
Disclosure of Invention
The invention aims to provide a Chinese herbal medicine for treating osteoporosis, and solves the problems of great toxic and side effects, heavy kidney burden, poor long-term curative effect, low tolerance of patients and the like of chemical medicines for treating osteoporosis.
Another object of the present invention is to provide a method for preparing a herbal gel patch for treating osteoporosis.
The technical scheme adopted by the invention is that the Chinese herbal medicine for treating osteoporosis consists of the following components in parts by mass: 6-15 parts of rhizoma drynariae, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry.
According to another technical scheme, the preparation method of the Chinese herbal medicine gel patch for treating osteoporosis comprises the following steps:
step 1, weighing and pretreating Chinese herbal medicines
Step 1.1, weighing 6-15 parts of drynaria baronii, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry according to parts by mass;
step 1.2, mixing the 7 medicines in the step 1.1, adding the mixture into an ethanol solution for soaking and reflux extraction for one time to obtain a primary extracting solution and dregs of a decoction, wherein the primary extracting solution is used for later use;
step 1.3, adding the dregs of a decoction obtained in the step 1.2 into an ethanol solution again, performing reflux extraction twice to obtain a secondary extracting solution and a third extracting solution, mixing the first, second and third extracting solutions, and recovering ethanol under reduced pressure until no alcohol smell exists to obtain an extract for later use;
step 2, preparing gel paste
Step 2.1, weighing and uniformly mixing sodium polyacrylate ViscomateNP-800, sodium polyacrylate ViscomateNP-700, aluminum glycinate, ethylene diamine tetraacetic acid disodium and titanium dioxide, then adding into glycerol, and stirring under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
step 2.2, sequentially weighing polyvinylpyrrolidone K-90 and tartaric acid, adding the polyvinylpyrrolidone K-90 and the tartaric acid into purified water, and stirring the mixture until the polyvinylpyrrolidone K-90 and the tartaric acid are fully dissolved to obtain a phase II for later use;
step 2.3, weighing the preservative, adding the preservative into the ethanol solution, and stirring until the preservative is dissolved to obtain a phase III for later use;
step 2.4, weighing laurocapram, sequentially adding laurocapram, the phase III in the step 2.3, the phase II in the step 2.2 and the extract in the step 1 into the phase I in the step 2.1, and stirring for 10-15 min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste;
and 3, transferring the gel paste obtained in the step 2 to a coating cutting machine, and standing the obtained semi-finished product after coating and cutting to obtain the gel patch.
The present invention is also characterized in that,
the addition amount of the ethanol solution in the step 1.2 is 6-8 times of the total mass of the 7 medicinal materials in the step 1.1, the volume fraction of the ethanol solution is 75-85%, the soaking time is 45min, and the reflux extraction time is 60 min.
The addition amount of the ethanol solution in the step 1.3 is 6-8 times of the total mass of the 7 medicinal materials in the step 1.1, the volume fraction of the ethanol solution is 45-65%, and the reflux extraction time is 45min each time.
In the step 2.1, the mass part ratio of sodium polyacrylate ViscomateNP-800, sodium polyacrylate ViscomateNP-700, aluminum glycinate, disodium ethylene diamine tetraacetate, titanium dioxide and glycerol is 0.5-2.5: 0.25-0.65: 0.05-0.11: 3-8: 45-60, wherein the titanium dioxide can be replaced by ceramic powder or kaolin; the stirring time was 10 min.
In the step 2.2, the mass part ratio of the polyvinylpyrrolidone K-90 to the tartaric acid to the purified water is 6-12: 0.25-0.65: 40-60, and the polyvinylpyrrolidone K-90 can be replaced by polyvinylpyrrolidone K-120.
In the step 2.2, the mass part ratio of the preservative to the ethanol solution is 0.25-0.35: 2-4, and the volume fraction of the ethanol solution is 95%; wherein the preservative is a mixture of ethylparaben and butylparaben in a mass ratio of 4: 1.
In the step 2.4, the mass part ratio of the laurocapram to the extract in the step 1 is 2-8: 25-35,
the standing in the step 3 is divided into two times:
standing for 72 hours at the temperature of 35-40 ℃ and the humidity of 40-50% for the first time;
the secondary standing temperature is 30-35 ℃, the humidity is 60-70 percent, and the time is 48 hours.
The gel patch of the invention has the beneficial effects that:
a) the gel patch is prepared by adopting modern preparation technology according to the theoretical discussion of the traditional Chinese medicine on osteoporosis, the physiological characteristics and the medication habit of the elderly, and the combination of the traditional Chinese medicine pharmacological research result and the clinical medication curative effect verification selection medicine prescription. The gel patch has the effects of nourishing liver and kidney, replenishing essence and generating marrow, removing blood stasis and dredging collaterals, and strengthening tendons and bones, and has exact treatment effect on osteoporosis by promoting osteoblast differentiation and proliferation, inhibiting osteoclast formation, promoting mesenchymal stem cell proliferation and differentiation into osteoblasts and the like;
b) the gel patch is a Chinese herbal medicine external patch, is green and natural, safe and nontoxic, is convenient to use, has high patient compliance, can be used for a long time, and has exact prevention and treatment effects on osteoporosis. The invention solves the defects of heavy burden of liver and kidney, great toxic and side effects, poor long-term treatment effect, low tolerance degree of patients and the like existing in the process of clinically treating osteoporosis by taking the oral chemical medicine; solves the defects that the oral Chinese herbal medicine liquid preparation such as decoction (containing formula granules and tea) has poor taste and large dosage, increases the urination frequency and kidney burden of the old and further influences the life quality; the defect that the swallowing of the medicine is difficult due to the inconsistent actions of drinking water and swallowing the medicine when the old orally take the Chinese herbal medicine solid preparation is overcome; also solves the defects that the old people often forget to take the medicine, take more medicines and take wrong medicines due to hypomnesis.
Detailed Description
The present invention will be described in detail below with reference to specific embodiments.
The Chinese herbal medicine for treating osteoporosis consists of the following components in parts by mass: 6-15 parts of rhizoma drynariae, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry.
The preparation method of the Chinese herbal medicine gel patch for treating osteoporosis is characterized by comprising the following steps of:
step 1, weighing and pretreating Chinese herbal medicines
Step 1.1, weighing 6-15 parts of drynaria baronii, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry according to parts by mass;
step 1.2, mixing the 7 medicines in the step 1.1, adding the mixture into an ethanol solution for soaking and reflux extraction for one time to obtain a primary extracting solution and dregs of a decoction, wherein the primary extracting solution is used for later use; wherein the addition amount of the ethanol solution is 6-8 times of the total mass of the 7 medicinal materials, the volume fraction of the ethanol solution is 75-85%, the soaking time is 45min, and the reflux extraction time is 60 min.
Step 1.3, adding the dregs of a decoction obtained in the step 1.2 into an ethanol solution again, performing reflux extraction twice to obtain a secondary extracting solution and a third extracting solution, mixing the first, second and third extracting solutions, and recovering ethanol under reduced pressure until no alcohol smell exists to obtain an extract for later use; wherein the addition amount of the ethanol solution is 6-8 times of the total mass of the 7 medicinal materials, the volume fraction of the ethanol solution is 45-65%, and the reflux extraction time is 45min each time.
Step 2, preparing gel paste
Step 2.1, weighing 0.5-2.5 parts by weight of sodium polyacrylate ViscomateNP-800, 0.5-2.5 parts by weight of sodium polyacrylate ViscomateNP-700, 0.25-0.65 part by weight of aluminum glycinate, 0.05-0.11 part by weight of disodium ethylenediamine tetraacetate, and 3-8 parts by weight of titanium dioxide or ceramic powder or kaolin, uniformly mixing, adding into 45-60 parts by weight of glycerol, and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
step 2.2, weighing 6-12 parts by weight of polyvinylpyrrolidone K-90 or K-120 and 0.25-0.65 part by weight of tartaric acid, adding into 40-60 parts by weight of purified water, and stirring until the materials are fully dissolved to obtain a phase II for later use;
step 2.3, weighing 0.25-0.35 parts by weight of preservative, adding into 2-4 parts by weight of 95% ethanol, and stirring until the materials are dissolved to obtain a phase III for later use; wherein the preservative is a mixture of ethylparaben and butylparaben in a mass ratio of 4: 1;
step 2.4, weighing 2-8 parts by weight of laurocapram and 25-35 parts by weight of the extract in the step 1, sequentially adding laurocapram, the phase III in the step 2.3, the phase II in the step 2.2 and the extract into the phase I in the step 2.1, and stirring for 10-15 min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste for later use;
step 3, transferring the gel paste obtained in the step 2 to a coating cutting machine, coating and cutting, placing the obtained semi-finished product at the temperature of 35-40 ℃ and the humidity of 40-50%, and standing for 72 hours; then standing for 48 hours under the conditions of humidity of 60-70% and temperature of 30-35 ℃ to obtain the required gel patch.
The external gel patch is prepared on the basis of the traditional Chinese medicine theory, according to the pathogenesis and mechanism of osteoporosis and the physiological characteristics and medication habits of the body of the old, and combining the traditional Chinese medicine pharmacology and the clinical medication curative effect verification experience to select a medicine formula, and then adopting the modern preparation technology; the invention exerts the effects of nourishing liver and kidney, replenishing essence and generating marrow, removing blood stasis and dredging collaterals and strengthening muscles and bones through external transdermal administration, and has exact treatment effect on osteoporosis through the ways of promoting osteoblast differentiation and proliferation, inhibiting the formation of osteoclasts, promoting the proliferation of mesenchymal stem cells and differentiating the mesenchymal stem cells into osteoblasts and the like. The gel patch is a Chinese herbal medicine external patch, has the characteristics of greenness, naturalness, safety, no toxicity, convenient use, long-acting slow release and reduction of administration times, thus conforming to the medication habits and characteristics of the old, having high patient compliance and laying a good foundation for the effective prevention and treatment of osteoporosis.
The invention adopts the compatibility of drynaria rhizome, acanthopanax root, rhizoma polygonati, epimedium, achyranthes root, suberect spatholobus stem and mulberry. The Shenjiang has the effects of tonifying kidney, strengthening bone, relieving pain and reuniting bones and muscles, can be used for treating lumbago due to weak bones, traumatic injury, contusion, fracture of bones and muscles, tinnitus, deafness, tooth looseness and the like, and modern pharmacological research shows that the Shenjiang has the effects of promoting the absorption of bones to calcium and improving the levels of blood calcium and blood phosphorus of organisms, and can also promote the proliferation of osteoblasts and inhibit the activity of osteoclasts so as to promote bone calcification and bone formation; acanthopanax has the effects of tonifying qi and kidney, strengthening bone and waist, promoting blood circulation and removing obstruction in channels, dispelling wind and removing dampness, and can be used for treating wind-cold-dampness arthralgia, lumbago and knee pain, flaccidity of bones and muscles, asthenia and weakness, bradykinesia, traumatic injury and the like; rhizoma Polygonati has effects of nourishing yin and moistening lung, invigorating qi and invigorating spleen and kidney, and can supplement essence and marrow, strengthen bone and brain by invigorating lung, spleen and kidney, and modern research shows that rhizoma Polygonati has effects of delaying aging, resisting oxidation, relieving fatigue, improving and improving memory; the herba epimedii has the effects of tonifying kidney yang, strengthening bones and muscles and dispelling wind-damp, can be used for treating flaccidity and flaccidity of bones and muscles, rheumatic arthralgia, spasm and numbness of limbs and the like, and modern pharmacological research shows that the herba epimedii has the activity of inhibiting osteoclast activation and proliferation and promoting osteoblast differentiation and can also promote bone calcification to prevent osteoporosis; achyranthes root has the effects of promoting blood circulation to remove blood stasis, tonifying liver and kidney, strengthening muscles and bones, inducing diuresis for treating stranguria, and guiding blood and fire to descend, can be used for traumatic injury, soreness and pain of waist and knees, weakness of bones and muscles, stranguria, edema, toothache and the like, and modern researches show that achyranthes root has the effects of resisting aging, easing pain and resisting inflammation, and can also improve the contents of bone calcium and bone phosphorus to promote the growth and development of bones; caulis Spatholobi has effects of promoting blood circulation, replenishing blood, relieving rigidity of muscles and activating collaterals, and can be used for treating menoxenia, rheumatalgia, numbness paralysis and blood deficiency chlorosis etc., modern research shows that caulis Spatholobi has pharmacological effects of improving hematopoiesis, resisting inflammation, resisting thrombi, regulating immunity, resisting tumor, resisting radiation, resisting oxidation and promoting liver cell regeneration etc.; mulberry has the efficacies of tonifying liver and kidney, nourishing yin, promoting the production of body fluid, and relaxing bowel, and can be used for treating liver and kidney yin deficiency, diabetes, constipation, dark eye tinnitus, scrofula, joint discomfort and the like. The Chinese herbal medicine composition has the effects of nourishing liver and kidney, replenishing essence and generating marrow, removing blood stasis and dredging collaterals and strengthening muscles and bones in a value range, and has exact treatment effect on osteoporosis by promoting osteoblast differentiation and proliferation, inhibiting the formation of osteoclasts, promoting the proliferation of mesenchymal stem cells and differentiating the mesenchymal stem cells into osteoblasts and the like.
The preparation method of the gel patch adopts the water-soluble medical polymer auxiliary material with good biocompatibility with skin, and the gel patch is formed by forming a space three-dimensional network structure through cross-linking among polymers, thereby not only ensuring that the gel patch has no stimulation and no allergy to the skin, but also having the characteristics of large drug-loading rate, high drug transdermal absorption efficiency, lasting drug release time, reduced drug administration times, and increased drug comfort and convenience, therefore, compared with the traditional patch obtained by other preparation methods, the gel patch has better curative effect, and particularly conforms to the drug administration habits and characteristics of the old.
Example 1
Step 1: weighing 15 parts of drynaria baronii (1500g), 9 parts of acanthopanax (900g), 15 parts of rhizoma polygonati (1500g), 6 parts of herba epimedii (600g), 10 parts of radix achyranthis bidentatae (1000g), 9 parts of caulis spatholobi (900g) and 9 parts of mulberry (900g), mixing 7 medicinal materials, adding 8 times of 75% ethanol, soaking for 45 minutes, performing reflux extraction for 60 minutes, extracting for 1 time, and keeping an extracting solution for later use; adding 6 times of 65% ethanol into the residue, reflux-extracting for 2 times, each for 45min, mixing the 3 extractive solutions, and recovering ethanol under reduced pressure to obtain extract;
step 2: weighing 0.5 part of sodium polyacrylate ViscomateNP-800(50g), 2.5 parts of ViscomateNP-700(250g), 0.65 part of aluminum glycinate (65g), 0.11 part of disodium ethylene diamine tetraacetate (11g) and 3 parts of titanium dioxide or ceramic powder or kaolin (300g), uniformly mixing, adding into 45 parts of glycerol (4500g), and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
and step 3: weighing 6 parts of polyvinylpyrrolidone K-120(600g) and 0.65 part of tartaric acid (65g), adding into 40 parts of purified water (4000g), and stirring until the materials are fully dissolved to obtain a phase II for later use;
and 4, step 4: weighing 0.25 part of preservative (a 4:1 mixture of ethylparaben and butylparaben) (25g), adding into 2 parts of 95% ethanol (200g), and stirring until the materials are dissolved to obtain phase III for later use;
and 5: weighing 8 parts of laurocapram (800g) and 25 parts of the extract (2500g) obtained in the step 1, sequentially adding laurocapram, the phase III in the step 4, the phase II in the step 3 and the extract into the phase I in the step 2, and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste for later use;
step 6: transferring the gel paste obtained in the step 5 to a coating cutting machine, coating and cutting, placing the obtained semi-finished product at the temperature of 35 ℃ and the humidity of 40%, and standing for 72 h; standing at 30 deg.C and humidity of 60% for 48 hr to obtain external gel patch.
Example 2
Step 1: weighing 6 parts of drynaria baronii (600g), 15 parts of acanthopanax (1500g), 9 parts of rhizoma polygonati (900g), 15 parts of herba epimedii (1500g), 5 parts of radix achyranthis bidentatae (500g), 15 parts of caulis spatholobi (1500g) and 15 parts of mulberry (1500g), mixing 7 medicinal materials, adding 85% ethanol in an amount which is 6 times that of the medicinal materials, soaking for 45 minutes, performing reflux extraction for 60 minutes, extracting for 1 time, and keeping an extracting solution for later use; adding 8 times of 45% ethanol into the residue, reflux-extracting for 2 times (45 min each time), mixing the 3 extractive solutions, and recovering ethanol under reduced pressure to obtain extract;
step 2: weighing 2.5 parts of sodium polyacrylate ViscomateNP-800(250g), 0.5 part of ViscomateNP-700(50g), 0.25 part of aluminum glycinate (25g), 0.05 part of disodium ethylene diamine tetraacetate (5g) and 8 parts of titanium dioxide or ceramic powder or kaolin (800g), uniformly mixing, adding into 60 parts of glycerol (6000g), and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
and step 3: weighing 12 parts of polyvinylpyrrolidone K-90(1200g) and 0.25 part of tartaric acid (25g), adding into 60 parts of purified water (6000g), and stirring until the materials are fully dissolved to obtain a phase II for later use;
and 4, step 4: weighing 0.35 part of preservative (a 4:1 mixture of ethylparaben and butylparaben) (35g), adding into 4 parts of 95% ethanol (400g), and stirring until the materials are dissolved to obtain phase III for later use;
and 5: weighing 2 parts of laurocapram (200g) and 35 parts of the extract (3500g) obtained in the step 1, sequentially adding laurocapram, the phase III in the step 4, the phase II in the step 3 and the extract into the phase I in the step 2, and stirring for 15min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste for later use;
step 6: transferring the gel paste obtained in the step 5 to a coating cutting machine, coating and cutting, placing the obtained semi-finished product at the temperature of 36 ℃ and the humidity of 42%, and standing for 72 h; and standing for 48h under the conditions of the humidity of 62% and the temperature of 31 ℃ to obtain the external gel patch.
Example 3
Step 1: weighing 10 parts of drynaria baronii (1000g), 12 parts of acanthopanax senticosus (1200g), 12 parts of rhizoma polygonati (1200g), 10 parts of herba epimedii (1000g), 10 parts of achyranthes bidentata (1000g), 12 parts of caulis spatholobi (1200g) and 12 parts of mulberry (1200g), mixing 7 medicinal materials, adding 7 times of 80% ethanol, soaking for 45 minutes, performing reflux extraction for 60 minutes, extracting for 1 time, and keeping an extracting solution for later use; adding 55% ethanol 7 times the amount of the residue, reflux-extracting for 2 times (45 min each time), mixing the 3 extractive solutions, and recovering ethanol under reduced pressure to obtain extract;
step 2: weighing 1.5 parts of sodium polyacrylate ViscomateNP-800(150g), 2.0 parts of ViscomateNP-700(200g), 0.45 part of aluminum glycinate (45g), 0.08 part of disodium ethylene diamine tetraacetate (8g) and 5 parts of titanium dioxide or ceramic powder or kaolin (500g), uniformly mixing, adding into 55 parts of glycerol (5500g), and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
and step 3: weighing 9 parts of polyvinylpyrrolidone K-90(900g) and 0.45 part of tartaric acid (45g), adding into 50 parts of purified water (5000g), and stirring until the materials are fully dissolved to obtain a phase II for later use;
and 4, step 4: weighing 0.3 part of preservative (a 4:1 mixture of ethylparaben and butylparaben) (30g), adding into 3 parts of 95% ethanol (300g), and stirring until the materials are dissolved to obtain phase III for later use;
and 5: weighing 5 parts of laurocapram (500g) and 30 parts of the extract (3000g) obtained in the step 1, sequentially adding laurocapram, the phase III in the step 4, the phase II in the step 3 and the extract into the phase I in the step 2, and stirring for 12min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste for later use;
step 6: transferring the gel paste obtained in the step 5 to a coating cutting machine, coating and cutting, placing the obtained semi-finished product at the temperature of 37 ℃ and the humidity of 44%, and standing for 72 h; and standing for 48h under the conditions of 64% of humidity and 32 ℃ to obtain the external gel patch.
Example 4
Step 1: weighing 12 parts of drynaria baronii (1200g), 12 parts of acanthopanax (1200g), 12 parts of rhizoma polygonati (1200g), 10 parts of herba epimedii (1000g), 10 parts of radix achyranthis bidentatae (1000g), 10 parts of caulis spatholobi (1000g) and 10 parts of mulberry (1000g), mixing 7 medicinal materials, adding 8 times of 85% ethanol, soaking for 45 minutes, performing reflux extraction for 60 minutes, extracting for 1 time, and keeping an extracting solution for later use; adding 8 times of 50% ethanol into the residue, reflux-extracting for 2 times (45 min each time), mixing the 3 extractive solutions, and recovering ethanol under reduced pressure to obtain extract;
step 2: weighing 1.5 parts of sodium polyacrylate ViscomateNP-800(150g), 1.5 parts of ViscomateNP-700(150g), 0.45 part of aluminum glycinate (45g), 0.09 part of disodium ethylene diamine tetraacetate (9g) and 4 parts of titanium dioxide or ceramic powder or kaolin (400g), uniformly mixing, adding into 55 parts of glycerol (5500g), and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
and step 3: weighing 9 parts of polyvinylpyrrolidone K-120(900g) and 0.45 part of tartaric acid (45g), adding into 50 parts of purified water (5000g), and stirring until the materials are fully dissolved to obtain a phase II for later use;
and 4, step 4: weighing 0.3 part of preservative (a 4:1 mixture of ethylparaben and butylparaben) (30g), adding into 3 parts of 95% ethanol (300g), and stirring until the materials are dissolved to obtain phase III for later use;
and 5: weighing 5 parts of laurocapram (500g) and 35 parts of the extract (3500g) obtained in the step 1, sequentially adding laurocapram, the phase III obtained in the step 4, the phase II obtained in the step 3 and the extract into the phase I obtained in the step 2, and stirring for 15min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste for later use;
step 6: transferring the gel paste obtained in the step 5 to a coating cutting machine, coating and cutting, placing the obtained semi-finished product at the temperature of 38 ℃ and the humidity of 48%, and standing for 72 h; and standing for 48h under the conditions of 68% of humidity and 34 ℃ to obtain the external gel patch.
Example 5
Step 1: weighing 15 parts of drynaria baronii (1000g), 10 parts of acanthopanax (1000g), 10 parts of rhizoma polygonati (1000g), 15 parts of herba epimedii (1500g), 5 parts of radix achyranthis bidentatae (500g), 10 parts of caulis spatholobi (1000g) and 15 parts of mulberry (1500g), mixing 7 medicinal materials, adding 8 times of 80% ethanol, soaking for 45 minutes, performing reflux extraction for 60 minutes, extracting for 1 time, and keeping an extracting solution for later use; adding 55% ethanol 7 times the amount of the residue, reflux-extracting for 2 times (45 min each time), mixing the 3 extractive solutions, and recovering ethanol under reduced pressure to obtain extract;
step 2: weighing 2.0 parts of sodium polyacrylate ViscomateNP-800(200g), 2.0 parts of ViscomateNP-700(200g), 0.55 part of aluminum glycinate (55g), 0.1 part of disodium ethylene diamine tetraacetate (10g) and 6 parts of titanium dioxide or ceramic powder or kaolin (600g), uniformly mixing, adding into 55 parts of glycerol (5500g), and stirring for 10min under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
and step 3: weighing 8 parts of polyvinylpyrrolidone K-120(800g) and 0.55 part of tartaric acid (55g), adding into 50 parts of purified water (5000g), and stirring until the materials are fully dissolved to obtain a phase II for later use;
and 4, step 4: weighing 0.25 part of preservative (a 4:1 mixture of ethylparaben and butylparaben) (25g), adding into 2 parts of 95% ethanol (200g), and stirring until the materials are dissolved to obtain phase III for later use;
and 5: weighing 6 parts of laurocapram (600g) and 30 parts of the extract (3000g) obtained in the step 1, sequentially adding laurocapram, the phase III obtained in the step 4, the phase II obtained in the step 3 and the extract into the phase I obtained in the step 2, and stirring for 12min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste for later use;
step 6: transferring the gel paste obtained in the step 5 to a coating cutting machine, coating and cutting, placing the obtained semi-finished product at the temperature of 40 ℃ and the humidity of 50%, and standing for 72 h; standing at 35 deg.C and 70% humidity for 48 hr to obtain external gel patch.
1. Patient data
According to the clinical research guidelines for treating osteoporosis by using new traditional Chinese medicines, the density of the lumbar vertebrae detected by a bone densitometer meets the diagnosis standard for osteoporosis suggestion of Chinese (draft II); the essential symptoms are pain in the waist and back or pain in bones of the limbs, and the secondary symptoms are soreness and weakness of the waist and knees, numbness of limbs, cold body and cold limbs. Exclusion criteria: treating patients who have taken drugs affecting bone metabolism in the early stage; patients with diseases affecting bone metabolism such as diabetes, hyperthyroidism and thyroid gland, and chronic liver, kidney and breast diseases; inadequate medication prescribes a course of treatment or discontinuation of treatment for the patient for the reason.
According to the above criteria, 19 OP patients were selected, 10 male and 9 female, and the patients were aged 48-70 years.
2. Treatment methods and criteria for efficacy
The invention selects the Shenque point as the administration position according to the theory that the navel patient moves qi between the kidneys, the qi is passed through all vessels, and the viscera is distributed to the five zang organs and the six fu organs to be the root of life, and the theory that the medicament enters from the navel and does not have difference with the entrance in the parallel literature. The patch is applied to the Shenque acupoint (navel part) of a patient, the patch is replaced for 1 time every 2 days, 6 months are taken as 1 treatment course, and after 1 treatment course, the bone density is measured and the pain relieving condition is evaluated. Grading criteria for pain were: grade 0 indicates no pain; grade 1 indicates pain when attention is focused; grade 2 indicates pain sensation during distraction; grade 3 indicates nighttime wakefulness affecting sleep.
The evaluation criteria of the curative effect are as follows: the method has the following advantages: pain is reduced by 2 or more than 3 grades or pain is disappeared, and bone density is increased>0.05g/cm2(ii) a Secondly, the method is effective: pain reduction of grade 1, or increased bone density<0.05g/cm2(ii) a ③ invalid: there was no improvement in pain and no improvement in bone density compared to before treatment.
3. Therapeutic results
After 1 treatment course, the medicine has 16 cases of obvious effect, and the obvious effect rate is 84.21 percent; the effective amount is 3 cases, accounting for 15.79%; invalid 0 case; the total effective rate is 100%. The patient reflects that the product of the invention is comfortable and convenient to use, does not influence life, does not have hair plucking and pain feeling when being taken off, does not have adverse reaction in the treatment process, and simultaneously improves the functions of spleen and stomach and relieves the problem of constipation, so the patient is willing to accept the treatment of the product.
Claims (4)
1. The Chinese herbal medicine for treating osteoporosis is characterized by comprising the following components in parts by mass: 6-15 parts of rhizoma drynariae, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry.
2. The method of making a herbal gel patch for the treatment of osteoporosis of claim 1, comprising the steps of:
step 1, weighing and pretreating Chinese herbal medicines
Step 1.1, weighing 6-15 parts of drynaria baronii, 9-15 parts of acanthopanax, 9-15 parts of rhizoma polygonati, 6-15 parts of herba epimedii, 5-15 parts of radix achyranthis bidentatae, 9-15 parts of caulis spatholobi and 9-15 parts of mulberry according to parts by mass;
step 1.2, mixing the 7 medicines in the step 1.1, adding the mixture into an ethanol solution for soaking and reflux extraction for one time to obtain a primary extracting solution and dregs of a decoction, wherein the primary extracting solution is used for later use;
the adding amount of the ethanol solution in the step 1.2 is 6-8 times of the total mass of the 7 medicinal materials in the step 1.1, the volume fraction of the ethanol solution is 75-85%, the soaking time is 45min, and the reflux extraction time is 60 min;
step 1.3, adding the dregs of a decoction obtained in the step 1.2 into an ethanol solution again, performing reflux extraction twice to obtain a secondary extracting solution and a third extracting solution, mixing the first, second and third extracting solutions, and recovering ethanol under reduced pressure until no alcohol smell exists to obtain an extract for later use;
the addition amount of the ethanol solution in the step 1.3 is 6-8 times of the total mass of the 7 medicinal materials in the step 1.1, the volume fraction of the ethanol solution is 45-65%, and the reflux extraction time is 45min each time;
step 2, preparing gel paste
Step 2.1, weighing sodium polyacrylate ViscomateNP-800, sodium polyacrylate ViscomateNP-700, aluminum glycinate, ethylene diamine tetraacetic acid disodium and titanium dioxide or ceramic powder or kaolin, uniformly mixing, adding into glycerol, and stirring under the condition that the vacuum degree is-0.07 MPa to obtain a phase I for later use;
step 2.2, sequentially weighing polyvinylpyrrolidone K-90 or polyvinylpyrrolidone K-120 and tartaric acid, adding the polyvinylpyrrolidone K-90 or polyvinylpyrrolidone K-120 and tartaric acid into purified water, and stirring the mixture until the polyvinylpyrrolidone K-90 or polyvinylpyrrolidone K-120 and tartaric acid are fully dissolved to obtain a phase II for later use;
the mass part ratio of the polyvinylpyrrolidone K-90 or the polyvinylpyrrolidone K-120 to the tartaric acid to the purified water is 6-12: 0.25-0.65: 40-60;
step 2.3, weighing the preservative, adding the preservative into the ethanol solution, and stirring until the preservative is dissolved to obtain a phase III for later use;
the mass part ratio of the preservative to the ethanol solution is 0.25-0.35: 2-4, and the volume fraction of the ethanol solution is 95%; wherein the preservative is a mixture of ethylparaben and butylparaben in a mass ratio of 4: 1;
step 2.4, weighing laurocapram, sequentially adding laurocapram, the phase III in the step 2.3, the phase II in the step 2.2 and the extract in the step 1 into the phase I in the step 2.1, and stirring for 10-15 min under the condition that the vacuum degree is-0.07 MPa to obtain a gel paste;
step 3, transferring the gel paste obtained in the step 2 to a coating cutting machine, and standing the obtained semi-finished product after coating and cutting to obtain the gel patch;
the standing in the step 3 is divided into two times: standing for 72 hours at the temperature of 35-40 ℃ and the humidity of 40-50% for the first time; the secondary standing temperature is 30-35 ℃, the humidity is 60-70 percent, and the time is 48 hours.
3. The preparation method of the Chinese herbal medicine gel patch for treating osteoporosis of claim 2, wherein the mass part ratio of the sodium polyacrylate ViscomateNP-800, the sodium polyacrylate ViscomateNP-700, the aluminum glycinate, the disodium ethylene diamine tetraacetate, the titanium dioxide or the ceramic powder or the kaolin and the glycerol in the step 2.1 is 0.5-2.5: 0.25-0.65: 0.05-0.11: 3-8: 45-60, and the stirring time is 10 min.
4. The preparation method of the Chinese herbal medicine gel patch for treating osteoporosis of claim 2, wherein the mass part ratio of the laurocapram to the extract in the step 1 in the step 2.4 is 2-8: 25-35.
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| KR101152753B1 (en) * | 2011-12-30 | 2012-06-18 | 신준식 | Pharmaceutical composition for preventing and treating of metabolic bone disease comprising the harpagophytum |
| CN105148137A (en) * | 2015-08-21 | 2015-12-16 | 山西丰源药业有限公司 | Externally-applied Chinese herbal medicine for treating prostatic hyperplasia |
| CN105434654A (en) * | 2014-09-29 | 2016-03-30 | 熊玮 | Kidney-tonifying and bone-strengthening soup for treating osteoporosis |
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| KR101152753B1 (en) * | 2011-12-30 | 2012-06-18 | 신준식 | Pharmaceutical composition for preventing and treating of metabolic bone disease comprising the harpagophytum |
| CN105434654A (en) * | 2014-09-29 | 2016-03-30 | 熊玮 | Kidney-tonifying and bone-strengthening soup for treating osteoporosis |
| CN105148137A (en) * | 2015-08-21 | 2015-12-16 | 山西丰源药业有限公司 | Externally-applied Chinese herbal medicine for treating prostatic hyperplasia |
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