CN113694110A - Incadronate disodium product and preparation method thereof - Google Patents

Incadronate disodium product and preparation method thereof Download PDF

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CN113694110A
CN113694110A CN202111022822.6A CN202111022822A CN113694110A CN 113694110 A CN113694110 A CN 113694110A CN 202111022822 A CN202111022822 A CN 202111022822A CN 113694110 A CN113694110 A CN 113694110A
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parts
plaster
medicament
disodium
water
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姜威
姜海兵
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SHENZHEN ZIFU PHARMACEUTICAL CO Ltd
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SHENZHEN ZIFU PHARMACEUTICAL CO Ltd
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • A—HUMAN NECESSITIES
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
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    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract

The invention relates to an incadronate disodium product which is prepared from the following materials in parts by weight: disodium carbendazim, radix rehmanniae preparata, dogwood, semen cuscutae, morinda officinalis, salvia miltiorrhiza, caulis spatholobi, ligusticum wallichii, hydrochlorothiazide, vitamin D, lornoxicam, auxiliary materials and water. The invention relates to an incadronate disodium product, which is added with the following traditional Chinese medicine components: the prepared rehmannia root, the dogwood, the dodder, the morinda officinalis, the salvia miltiorrhiza, the suberect spatholobus stem and the ligusticum wallichii can play a good inhibition effect on toxic and side effects caused by the disodium carbazinate, and the disodium carbazinate is attached to the surface of the bone hydroxyapatite to replace the pyrophosphate of a bone matrix and inhibit excessive bone absorption of osteoclasts, so that the bone metastasis pain can be effectively treated. In addition, lornoxicam has the functions of anti-inflammation, analgesia and antipyresis, and can inhibit hypotension caused by disodium capronate. Vitamin D and hydrochlorothiazide have inhibiting effect on adverse reaction caused by disodium caprate.

Description

Incadronate disodium product and preparation method thereof
Technical Field
The invention relates to an incadronate disodium product, in particular to an incadronate disodium product which reduces toxic and side effects by combining Chinese medicines and western medicines and a preparation method thereof.
Background
Because the disodium carbazinate is a third-generation bisphosphonate, and the bisphosphonate is an endogenous pyrophosphate analogue which is attached to the surface of the bone hydroxyapatite, the disodium carbazinate substitutes the pyrophosphate of a bone matrix and inhibits excessive bone resorption of osteoclasts, and therefore, the disodium carbazinate can effectively treat bone metastatic pain. Therefore, the disodium carbazinate is clinically used for treating pain, pathological fracture and hypercalcemia caused by malignant tumor bone metastasis.
The pharmacokinetic explanation is: the healthy adult is administrated by intravenous drip for 2 hours, the half-life periods of alpha and beta are 0.26-0.40 hour and 1.58-1.98 hour respectively, the pharmacokinetics is linear, and 55-70% of the original drug is excreted through urine 24 hours after the administration; the tumor patients drip 10.5% of the medicine which is originally excreted from the urine after 2 hours to 24 hours, and the medicine which is not excreted enters the bone tissue mostly. Animal experiments show that: after administration, the medicine is cleared from the circulatory system rapidly, is mainly distributed in bones, livers, kidneys and spleens, can be retained in bone tissues for a long time, and has a half-life period of 351 days.
Because the pharmacology is the theory of western medicine, although the maintaining time is long, the toxic and side effects are large, and other parts of the body can be damaged, for example: blood pressure lowering, acute renal insufficiency, hypocalcemia, heart disease, etc.
In order to maintain the pharmacology of the disodium incadronate for treating bone metastasis pain, reduce the adverse reaction of the disodium incadronate on the body and improve the drug effect, a disodium incadronate product combining Chinese and western medicines and a preparation method thereof are urgently needed at present.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a disodium incadronate product which can maintain the pharmacology of treating bone metastasis pain by disodium incadronate, reduce the adverse reaction of the disodium incadronate product on the body and improve the drug effect, and the combination of Chinese and western medicines and a preparation method thereof are urgently needed at present.
The invention relates to an incadronate disodium product which is characterized by comprising the following materials in parts by weight:
0.001-0.02 parts of dicamba disodium phosphate; 4-10 parts of prepared rhizome of rehmannia; 9-12 parts of dogwood; 12-16 parts of semen cuscutae; 9-12 parts of morinda officinalis; 3-8 parts of salvia miltiorrhiza; 5-10 parts of caulis spatholobi; 4-10 parts of ligusticum wallichii; 0.002-0.005 part of hydrochlorothiazide; 0.00003-0.005 part of vitamin D; 0.001-0.01 part of lornoxicam; 60-100 parts of auxiliary materials; 100 portions of water and 800 portions of water;
the invention relates to an incadronate disodium product, wherein 0.001-0.018 parts of incadronate disodium is prepared; 5-8 parts of prepared rhizome of rehmannia; 10-12 parts of dogwood; 13-15 parts of semen cuscutae; 10-11 parts of morinda officinalis; 4-6 parts of salvia miltiorrhiza; 6-8 parts of caulis spatholobi; 6-9 parts of ligusticum wallichii; 0.002-0.005 part of hydrochlorothiazide; 0.001-0.003 part of vitamin D; 100 parts of auxiliary materials; 200 portions of water and 700 portions of water;
the invention relates to a disodium incadronate product, wherein 0.008 part of disodium incadronate is prepared; 5 parts of prepared rhizome of rehmannia; 11 parts of dogwood; 12 parts of semen cuscutae; 10 parts of morinda officinalis; 5 parts of salvia miltiorrhiza; 6 parts of caulis spatholobi; 6 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam; 90 parts of auxiliary materials; 600 parts of water;
the invention relates to an incadronate disodium product, wherein the auxiliary material comprises the following materials in parts by weight: 50-70 parts of sesame oil; 40-60 parts of red lead.
The invention relates to an incadronate disodium product, wherein the auxiliary material comprises the following materials in parts by weight: 60 parts of sesame oil; 30 parts of red lead.
The invention relates to a preparation method of an incadronate disodium product, which comprises the following steps:
step one, preparing a first medicament and a first steaming liquid medicine: placing the dogwood, the dodder and the ligusticum chuanxiong hort above a steaming drawer of a steamer, placing water with the weight of 20.7 times of that of the dogwood below the steaming drawer of the steamer for steaming, steaming for 2.5 hours by strong fire, then steaming for 2 hours by slow fire, extinguishing and stewing for 6 hours after the dogwood skin turns purple black, filtering the medicinal materials, drying and grinding the medicinal materials into fine powder to prepare a first medicament, and collecting the water below the steaming drawer in the steamer after steaming as first steaming liquid medicine;
step two, preparing a second medicament: pulverizing radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, placing oleum Sesami into a pot, heating to 200 deg.C, adding pulverized radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, stirring until the surface of radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi is dark brown and the interior is brown, adding the first steamed liquid medicine, standing in shade for 48 hr, stirring once every 3 hr for 35 circles each time, and separating the upper layer oil to obtain a second preparation;
step three, refining a third medicament: continuously decocting the second medicament, and reducing the temperature of the second medicament to 220 ℃ and keeping the temperature of the second medicament at 220 ℃ when the temperature of the second medicament rises to 320 ℃; when the second medicament begins to boil, oil bloom is mostly near the periphery of the pot wall, and when the oil bloom gathers towards the center of the pot, the oil in the pot is taken out to prepare a third medicament;
step four, preparing a first plaster: after the third medicament is refined, the mixture is separated from the fire, the red lead is dried and sieved by a 100-mesh sieve, 30 parts by weight of the red lead is averagely divided into 10 parts, the red lead is placed in the third medicament every 3 minutes and is continuously stirred in the same direction, and the mixture is stirred into viscous paste to prepare the first plaster;
step five, preparing a second plaster: soaking the first plaster in cold water, and changing water every day to obtain a second plaster seven days later;
step six, preparing a third plaster: and putting the second plaster into a container, melting the second plaster in a water bath or on slow fire, adding the first medicament, hydrochlorothiazide, vitamin D and lornoxicam, uniformly stirring, putting 20-40g of each part of plaster on kraft paper or plaster cloth by using a bamboo stick, finally scattering disodium caprate on the surface of the plaster, and fully mixing and absorbing for one month to prepare the third plaster.
The invention relates to an incadronate disodium product which is different from the prior art in that the incadronate disodium product of the invention is added with the following traditional Chinese medicine components: the prepared rehmannia root, the dogwood, the dodder, the morinda officinalis, the salvia miltiorrhiza, the suberect spatholobus stem and the ligusticum wallichii can play a good inhibition effect on toxic and side effects caused by the disodium carbazinate, and the disodium carbazinate is attached to the surface of the bone hydroxyapatite to replace the pyrophosphate of a bone matrix and inhibit excessive bone absorption of osteoclasts, so that the bone metastasis pain can be effectively treated. In addition, lornoxicam has the functions of anti-inflammation, analgesia and antipyresis, and can inhibit hypotension caused by disodium capronate. Vitamin D has inhibitory effect on adverse reaction caused by disodium carvachosphate. In addition, the invention can directly reach the affected part by absorbing the drug effect through the channels and collaterals and the skin of the human body in the administration form of the plaster, avoids the burden of the liver and the kidney caused by gastrointestinal absorption and blood absorption, and has better drug effect because the administration is more vertical.
Drawings
FIG. 1 is a line graph of data from a laboratory table of a disodium incadronate product of the present invention.
Detailed Description
The invention relates to an incadronate disodium product which is prepared from the following materials in parts by weight:
0.001-0.02 parts of dicamba disodium phosphate; 4-10 parts of prepared rhizome of rehmannia; 9-12 parts of dogwood; 12-16 parts of semen cuscutae; 9-12 parts of morinda officinalis; 3-8 parts of salvia miltiorrhiza; 5-10 parts of caulis spatholobi; 4-10 parts of ligusticum wallichii; 0.002-0.005 part of hydrochlorothiazide; 0.00003-0.005 part of vitamin D; 0.001-0.01 part of lornoxicam; 60-100 parts of auxiliary materials; 100 portions of water and 800 portions of water;
the invention relates to an incadronate disodium product, which is added with the following traditional Chinese medicine components: the prepared rehmannia root, the dogwood, the dodder, the morinda officinalis, the salvia miltiorrhiza, the suberect spatholobus stem and the ligusticum wallichii can play a good inhibition effect on toxic and side effects caused by the disodium carbazinate, and the disodium carbazinate is attached to the surface of the bone hydroxyapatite to replace the pyrophosphate of a bone matrix and inhibit excessive bone absorption of osteoclasts, so that the bone metastasis pain can be effectively treated. In addition, lornoxicam has the functions of anti-inflammation, analgesia and antipyresis, and can inhibit hypotension caused by disodium capronate. Vitamin D and hydrochlorothiazide have inhibiting effect on adverse reaction caused by disodium caprate.
Description of pharmacology
Prepared rhizome of rehmannia: the main functions are nourishing yin and enriching blood. It is indicated for deficiency of yin and blood, atrophy and weakness of waist and knees, fatigue, cough, steaming bone, seminal emission, metrorrhagia and metrostaxis.
Dogwood fruit: has the efficacies of tonifying liver and kidney, astringing and relieving depletion.
Dodder seed: has effects in nourishing liver and kidney, replenishing vital essence, supporting yang, and relieving diarrhea.
Morinda officinalis: has the functions of invigorating kidney yang, strengthening physique and expelling wind-damp.
Red sage root: has the effects of activating blood circulation to dissipate blood stasis, stimulating the menstrual flow to relieve pain, clearing away the heart-fire and relieving restlessness, cooling blood and eliminating carbuncle. Can be used for treating thoracic obstruction, heart pain, abdominal pain, hypochondriac pain, abdominal mass, pain due to pyretic arthralgia, vexation, insomnia, menoxenia, dysmenorrhea, amenorrhea, and pyocutaneous disease with swelling and pain.
Caulis spatholobi: has the functions of promoting blood circulation, enriching blood, regulating menstruation, relieving pain, relaxing muscles and tendons and activating collaterals. Can be used for treating menoxenia, dysmenorrhea, amenorrhea, rheumatalgia, numbness, paralysis, and sallow complexion due to blood deficiency.
Ligusticum wallichii: promoting blood circulation and qi circulation, dispelling pathogenic wind and relieving pain, and Chuan Xiong is pungent, warm, fragrant and dry, and can disperse and ascend to the vertex. It enters the blood system and goes down to reach the blood sea. Promoting blood circulation and removing blood stasis, it is suitable for various diseases due to blood stasis.
Lornoxicam: has the main functions of relieving pain and resisting inflammation, and is used for treating chronic low back pain, ankylosing spondylitis, osteoarthritis and rheumatoid arthritis.
Vitamin D: the main function is to regulate the metabolism of calcium and phosphorus in the body so as to maintain the level of calcium and phosphorus in blood, and the calcium tablet has good inhibition effect on hypocalcemia caused by the disodium caphosphate.
Hydrochlorothiazide: the method mainly inhibits the reabsorption of the front section of the distal tubule and the proximal tubule of the kidney on sodium chloride, thereby increasing Na-K exchange of the distal tubule and the collecting tube, increasing excretion of ions such as sodium, potassium, chlorine, phosphorus, magnesium and the like, and generating convulsion symptom if a human body absorbs excessive Na ions due to the Na ions in the disodium carbazinate, and the hydrochlorothiazide can excrete excessive Na ions in the human body, thereby inhibiting the side effect caused by the disodium carbazinate.
In the invention, because the disodium carbazinate mainly plays a role in effectively treating bone metastasis pain, the morinda officinalis and the semen cuscutae are combined into a monarch drug in a large proportion, the medicine can repair toxic and side effects on the kidney caused by the disodium carbazinate, and the morinda officinalis has the effect of strengthening the bones and muscles and can repair damaged bones. The prepared rhizome of rehmannia, the root of red-rooted salvia and the caulis spatholobi are taken as ministers, have the effects of promoting blood circulation, enriching blood, regulating menstruation, relieving pain, relaxing tendons and activating collaterals, and are beneficial to blood circulation of pain parts, so that the pain is relieved. The dogwood is used as an adjuvant, the dogwood has the effects of tonifying liver and kidney, astringing and relieving depletion, and can well inhibit the damage of the kidney caused by the disodium carbazinate, and the ligusticum wallichii has the effects of promoting blood circulation and promoting qi circulation, dispelling wind and relieving pain, and promoting blood circulation and removing blood stasis, can effectively inhibit heart diseases caused by the disodium carbazinate, and can also play a role in relieving pain of the pain part of a patient.
As a preferable proportioning mode: the invention relates to an incadronate disodium product which is prepared from the following materials in parts by weight: 0.001-0.018 parts of sodium dicarbamate phosphate; 5-8 parts of prepared rhizome of rehmannia; 10-12 parts of dogwood; 13-15 parts of semen cuscutae; 10-11 parts of morinda officinalis; 4-6 parts of salvia miltiorrhiza; 6-8 parts of caulis spatholobi; 6-9 parts of ligusticum wallichii; 0.002-0.004 portion of hydrochlorothiazide; 0.001-0.003 part of vitamin D; 0.001 to 0.005 portion of lornoxicam; 100 parts of auxiliary materials; 200 portions of water and 700 portions of water;
the invention can further increase the curative effect by optimizing the proportion of the components, plays a role in inhibiting bone metastasis pain caused by tumors, reduces the toxic and side effects caused by the disodium carbazinate, and can be used for patients with heart diseases and renal diseases.
As a preferable proportioning mode: the invention relates to an incadronate disodium product which is prepared from the following materials in parts by weight: 0.008 parts of dicamba disodium phosphate; 5 parts of prepared rhizome of rehmannia; 11 parts of dogwood; 12 parts of semen cuscutae; 10 parts of morinda officinalis; 5 parts of salvia miltiorrhiza; 6 parts of caulis spatholobi; 6 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam; 90 parts of auxiliary materials; and 600 parts of water.
By optimizing the group proportion, the dosage is the most balanced proportion of the disodium incadronate and the traditional Chinese medicine, so that the larger drug effect of the disodium incadronate is ensured, the drug effect of the disodium incadronate is prevented from being influenced by the combination of important parts, the toxic and side effects of the disodium incadronate are reduced to the greatest extent, and the use frequency is recommended to be once a day and once for 12 hours.
The dose of the incadronate disodium can be 10mg/70kg, and patients with different body weights can calculate according to the dose and the like.
As a preferable proportioning mode: the invention relates to an incadronate disodium product, wherein the auxiliary material comprises the following materials in parts by weight: 50-70 parts of sesame oil; 40-60 parts of red lead.
The main component of the sesame oil, namely vitamin e, has good effects of improving blood circulation and promoting metabolism, and can also make the traditional Chinese medicine exert the maximum drug property in the process of refining the traditional Chinese medicine. The red lead has the effects of protection, blocking and treatment, and the combination of the red lead and the red lead can exert the maximum drug effect.
Sesame oil: the traditional Chinese medicine holds that: the product is sweet and cool in nature and taste, and has the effects of relaxing bowel, detoxifying and promoting granulation. According to the record of the compendium of materia Medica: it has the functions of moistening dryness, detoxicating, relieving pain and eliminating swelling. "Biyu" says: "benefiting the large intestine and keeping the cell coat from falling. The raw one rubs and swells and produces baldness. The plaster is decocted by sesame oil clinically and has the functions of generating muscles, relieving pain, eliminating carbuncle and swelling and tonifying skin cracks.
Red lead: is orange red powder with certain toxicity and bright color, can be used for producing fireworks and oxidizing substances when the substance is insoluble in water, and can also be used as a common Chinese medicinal material for tranquilizing and allaying excitement, astringing and relieving pain, detoxifying and reducing swelling when being used as a medicine.
As a preferable proportioning mode: the invention relates to an incadronate disodium product, wherein the auxiliary material comprises the following materials in parts by weight: 60 parts of sesame oil; 30 parts of red lead.
The main component of the sesame oil, namely vitamin e, has good effects of improving blood circulation and promoting metabolism, and can also make the traditional Chinese medicine exert the maximum drug property in the process of refining the traditional Chinese medicine. The red lead has the effects of protection, blocking and treatment, and the combination of the red lead and the red lead can exert the maximum drug effect.
The invention relates to a preparation method of an incadronate disodium product, which comprises the following steps:
step one, preparing a first medicament and a first steaming liquid medicine: placing the dogwood, the dodder and the ligusticum chuanxiong hort above a steaming drawer of a steamer, placing water with the weight of 20.7 times of that of the dogwood below the steaming drawer of the steamer for steaming, steaming for 2.5 hours by strong fire, then steaming for 2 hours by slow fire, extinguishing and stewing for 6 hours after the dogwood skin turns purple black, filtering the medicinal materials, drying and grinding the medicinal materials into fine powder to prepare a first medicament, and collecting the water below the steaming drawer in the steamer after steaming as first steaming liquid medicine;
step two, preparing a second medicament: pulverizing radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, placing oleum Sesami into a pot, heating to 200 deg.C, adding pulverized radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, stirring until the surface of radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi is dark brown and the interior is brown, adding the first steamed liquid medicine, standing in shade for 48 hr, stirring once every 3 hr for 35 circles each time, and separating the upper layer oil to obtain a second preparation;
step three, refining a third medicament: continuously decocting the second medicament, and reducing the temperature of the second medicament to 220 ℃ and keeping the temperature of the second medicament at 220 ℃ when the temperature of the second medicament rises to 320 ℃; when the second medicament begins to boil, oil bloom is mostly near the periphery of the pot wall, and when the oil bloom gathers towards the center of the pot, the oil in the pot is taken out to prepare a third medicament;
step four, preparing a first plaster: after the third medicament is refined, the mixture is separated from the fire, the red lead is dried and sieved by a 100-mesh sieve, 30 parts by weight of the red lead is averagely divided into 10 parts, the red lead is placed in the third medicament every 3 minutes and is continuously stirred in the same direction, and the mixture is stirred into viscous paste to prepare the first plaster;
step five, preparing a second plaster: soaking the first plaster in cold water, and changing water every day to obtain a second plaster seven days later;
step six, preparing a third plaster: and putting the second plaster into a container, melting the second plaster in a water bath or on slow fire, adding the first medicament, hydrochlorothiazide, vitamin D and lornoxicam, uniformly stirring, putting 20-40g of each part of plaster on kraft paper or plaster cloth by using a bamboo stick, finally scattering disodium caprate on the surface of the plaster, and fully mixing and absorbing for one month to prepare the third plaster.
In the invention, the dogwood, the dodder and the ligusticum chuanxiong hort are steamed firstly, so that the dogwood, the dodder and the ligusticum chuanxiong hort have better drug effect; the root-shaped medicinal materials such as the rehmannia glutinosa, the morinda officinalis, the salvia miltiorrhiza and the suberect spatholobus stem are crushed and then put into sesame oil for decocting, and then medicinal oil is extracted, so that the medicinal effect of the central part of the medicinal materials can be fully exerted; then the red lead is put into the second medicament and stirred, and the medicinal oil is converted into paste, so that the paste is convenient for patients to take, and plays a role of an adhesive; then the coated plaster is put into water for soaking, toxic substance lead in the red lead is removed, and toxic and side effects caused by absorption by patients are prevented; and finally, mixing the first medicament, hydrochlorothiazide, vitamin D, lornoxicam and the paste medicament, and scattering the disodium incadronate on the surface of the paste, so that a patient can absorb the disodium incadronate firstly, and after bone pain is reduced, the drug property of the traditional Chinese medicine medicinal materials is absorbed to inhibit the toxic and side effect generated by the disodium incadronate, thereby ensuring that various crowds can use the paste, and no other side effect is generated while treating bone metastasis pain caused by tumor.
The remaining amount of the first steaming medicinal liquid depends on the sealing performance of the steamer, the heating temperature and whether water is added in the middle, and the remaining amount of the first steaming medicinal liquid after 4.5 hours of steaming is about 10-60 parts by weight.
Wherein, in the process of decocting with slow and strong fire, additional water can be added to ensure that the final first steaming liquid medicine is in the designated parts by weight.
In the third step, the temperature is usually increased to 320 ℃, then decreased to 220 ℃ for continuous heating, during or after the process, the second medicament oil bloom may gather from the periphery of the pot wall toward the center of the pot, during which a little medicinal oil can be taken out and dropped into water after the temperature is decreased to 220 ℃, and the third medicament can be prepared without being scattered into beads.
Of course, if the heating is continued at 220 degrees, the extracted medicinal oil may be dispersed in water, and if the heating is continued at 220 degrees for 5 minutes, it may be determined that the third medicinal preparation is prepared.
Wherein the step four of stirring into viscous paste comprises the following steps
The plaster is required to be as follows: the plaster is not sticky to hands and has good wire drawing effect.
Wherein the second plaster prepared in the fifth step is used for removing fire toxin, and the fire toxin is lead which is harmful to human bodies.
Wherein, the step of spreading the dicarba disodium phosphate on the surface of the plaster finally comprises the following steps:
when the third plaster is formed, disodium dicarbamate is scattered on the surface of the plaster;
of course, the dicamba disodium phosphate can be independently packaged, and when the patient needs to apply the plaster to the affected part, the patient then sprays the dicamba disodium phosphate on the surface of the plaster and applies the plaster to the affected part within 10 minutes.
Wherein the third plaster is prepared in the sixth step for coating cooling.
In the sixth step, 20-40g of plaster is taken by bamboo stick and each part of plaster is placed on kraft paper or plaster cloth, and 30g of plaster is preferably taken by each part.
Wherein, the step of melting on water bath or slow fire in the step six comprises the following steps:
the water bath comprises the following steps: placing 100 degrees of continuously heated water in a larger container, placing a smaller container on the 100 degrees of continuously heated water, wherein the smaller container is not in contact with the larger container, and placing the second plaster, the first medicament, hydrochlorothiazide, vitamin D and lornoxicam in the smaller container, thereby heating in a water bath.
The step of slow fire is as follows: placing a decocting pot on slow fire, wherein the second plaster, the first medicament, hydrochlorothiazide, vitamin D and lornoxicam are arranged in the decocting pot, melting the plaster balls on the slow fire by the method,
the water used in the method of the invention may exceed 600 parts, and the water in the steamer is only required to be 600 parts, and the water can not be added any more.
Experimental data
At present, 500 patients are randomly allocated to five groups, and 100 patients suffering from bone metastasis pain in each group are respectively treated by different medicaments, and the experimental data are as follows:
comparison group:
this group of patients adopts traditional western medicine medicament: the production enterprise comprises the following steps: hubei Gekko people drug industry, Limited liability company, product number: the national drug standard H20051176. Once a day, 8mg each time. Half a year after the drug is taken, the pain of the affected part of the patient is reduced, but the dependence is enhanced, and 80 patients can absorb the drug effect to relieve the pain. 40 patients with insomnia, 20 patients with angina pectoris, 12 patients with interstitial nephritis, and 6 patients with cholelithiasis.
The following are examples, and it should be noted that the plasters used in examples 1 to 3 were prepared by the following methods:
step one, preparing a first medicament and a first steaming liquid medicine: placing the dogwood, the dodder and the ligusticum chuanxiong hort above a steaming drawer of a steamer, placing water with the weight of 20.7 times of that of the dogwood below the steaming drawer of the steamer for steaming, steaming for 2.5 hours by strong fire, then steaming for 2 hours by slow fire, extinguishing and stewing for 6 hours after the dogwood skin turns purple black, filtering the medicinal materials, drying and grinding the medicinal materials into fine powder to prepare a first medicament, and collecting the water below the steaming drawer in the steamer after steaming as first steaming liquid medicine;
step two, preparing a second medicament: pulverizing radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, placing oleum Sesami into a pot, heating to 200 deg.C, adding pulverized radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, stirring until the surface of radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi is dark brown and the interior is brown, adding the first steamed liquid medicine, standing in shade for 48 hr, stirring once every 3 hr for 35 circles each time, and separating the upper layer oil to obtain a second preparation;
step three, refining a third medicament: continuously decocting the second medicament, and reducing the temperature of the second medicament to 220 ℃ and keeping the temperature of the second medicament at 220 ℃ when the temperature of the second medicament rises to 320 ℃; when the second medicament begins to boil, oil bloom is mostly near the periphery of the pot wall, and when the oil bloom gathers towards the center of the pot, the oil in the pot is taken out to prepare a third medicament;
step four, preparing a first plaster: after the third medicament is refined, the mixture is separated from the fire, the red lead is dried and sieved by a 100-mesh sieve, 30 parts by weight of the red lead is averagely divided into 10 parts, the red lead is placed in the third medicament every 3 minutes and is continuously stirred in the same direction, and the mixture is stirred into viscous paste to prepare the first plaster;
step five, preparing a second plaster: soaking the first plaster in cold water, and changing water every day to obtain a second plaster seven days later;
step six, preparing a third plaster: and putting the second plaster into a container, melting the second plaster in a water bath or on slow fire, adding the first medicament, hydrochlorothiazide, vitamin D and lornoxicam, uniformly stirring, putting 20-40g of each part of plaster on kraft paper or plaster cloth by using a bamboo stick, finally scattering disodium caprate on the surface of the plaster, and fully mixing and absorbing for one month to prepare the third plaster.
The preparation method of the plaster adopted in the group of example 4 was:
step one, preparing a first medicament and a first steaming liquid medicine: placing the dogwood, the dodder and the ligusticum chuanxiong hort above a steaming drawer of a steamer, placing water with the weight of 20.7 times of that of the dogwood below the steaming drawer of the steamer for steaming, steaming for 2.5 hours by strong fire, then steaming for 2 hours by slow fire, extinguishing and stewing for 6 hours after the dogwood skin turns purple black, filtering the medicinal materials, drying and grinding the medicinal materials into fine powder to prepare a first medicament, and collecting the water below the steaming drawer in the steamer after steaming as first steaming liquid medicine;
step two, preparing a second medicament: pulverizing radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, placing oleum Sesami into a pot, heating to 200 deg.C, adding pulverized radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, stirring until the surface of radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi is dark brown and the interior is brown, adding the first steamed liquid medicine, standing in shade for 48 hr, stirring once every 3 hr for 35 circles each time, and separating the upper layer oil to obtain a second preparation;
step three, refining a third medicament: continuously decocting the second medicament, and reducing the temperature of the second medicament to 220 ℃ and keeping the temperature of the second medicament at 220 ℃ when the temperature of the second medicament rises to 320 ℃; when the second medicament begins to boil, oil bloom is mostly near the periphery of the pot wall, and when the oil bloom gathers towards the center of the pot, the oil in the pot is taken out to prepare a third medicament;
step four, preparing a first plaster: after the third medicament is refined, the mixture is separated from the fire, the red lead is dried and sieved by a 100-mesh sieve, 30 parts by weight of the red lead is averagely divided into 10 parts, the red lead is placed in the third medicament every 3 minutes and is continuously stirred in the same direction, and the mixture is stirred into viscous paste to prepare the first plaster;
step five, preparing a second plaster: soaking the first plaster in cold water, and changing water every day to obtain a second plaster seven days later;
step six, preparing a third plaster: placing the second plaster in a container, melting in water bath or on slow fire, adding the first preparation, hydrochlorothiazide, vitamin D, and lornoxicam, stirring, and placing 20-40g plaster per part on kraft paper or plaster cloth with bamboo stick.
Step seven: the incadronate disodium is separately packaged in a penicillin bottle, and the incadronate disodium is uniformly spread on an affected part before the plaster is used, and then a third plaster is pasted on the affected part within 10 minutes.
Example 1:
0.008 parts of dicamba disodium phosphate; 4 parts of prepared rhizome of rehmannia; 9 parts of dogwood; 12 parts of semen cuscutae; 9 parts of morinda officinalis; 5 parts of salvia miltiorrhiza; 6 parts of caulis spatholobi; 6 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam; 90 parts of auxiliary materials; and 600 parts of water.
The plaster is stuck to the pain part before sleeping every night, the pain part of the patient is gradually relieved after the medicine is taken for half a year, and 75 patients can absorb the medicine effect to relieve the pain. 23 patients with insomnia, 12 patients with angina pectoris, 15 patients with interstitial nephritis, and 3 patients with cholelithiasis.
Example 2:
0.008 parts of dicamba disodium phosphate; 5 parts of prepared rhizome of rehmannia; 11 parts of dogwood; 12 parts of semen cuscutae; 10 parts of morinda officinalis; 3 parts of salvia miltiorrhiza; 5 parts of caulis spatholobi; 4 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam and 90 parts of auxiliary materials; and 600 parts of water.
The plaster is attached to the pain part before sleeping every night, the pain part of the patient is gradually relieved after the medicine is taken for half a year, and 74 patients can absorb the medicine effect to relieve the pain. 12 patients with insomnia, 15 patients with angina pectoris, 5 patients with interstitial nephritis, and 3 patients with cholelithiasis.
Example 3:
0.008 parts of dicamba disodium phosphate; 5 parts of prepared rhizome of rehmannia; 11 parts of dogwood; 12 parts of semen cuscutae; 10 parts of morinda officinalis; 5 parts of salvia miltiorrhiza; 6 parts of caulis spatholobi; 6 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam; 90 parts of auxiliary materials; and 600 parts of water.
The plaster is stuck to the pain part before sleeping every night, the pain part of the patient is gradually relieved after the medicine is taken for half a year, and 75 patients can absorb the medicine effect to relieve the pain. 4 patients with insomnia, 3 patients with angina pectoris, 3 patients with interstitial nephritis, and 1 patient with cholelithiasis.
Example 4:
0.008 parts of dicamba disodium phosphate; 5 parts of prepared rhizome of rehmannia; 11 parts of dogwood; 12 parts of semen cuscutae; 10 parts of morinda officinalis; 5 parts of salvia miltiorrhiza; 6 parts of caulis spatholobi; 6 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam; 90 parts of auxiliary materials; and 600 parts of water.
The patch is attached to the pain part before sleeping every night, the pain of the pain part of the patient is relieved very quickly after the drug is taken for half a year, and 95 patients can absorb the drug effect to relieve the pain. 4 patients with insomnia, 3 patients with angina pectoris, 3 patients with interstitial nephritis, and 1 patient with cholelithiasis.
The following table was prepared based on the above experimental data:
insomnia Angina pectoris Interstitial nephritis Cholelithiasis Has the drug effect
Comparison group 40 20 12 6 80
Example 1 23 12 15 3 75
Example 2 12 15 5 3 74
Example 3 4 3 3 1 75
Example 4 4 3 3 1 95
From the above experimental data, it is known that the comparative group and examples 1, 2, 3 and 4 have different drug absorption degrees, and the examples have greatly improved drug absorption degrees, and the formula and preparation method of example 4 based on the weight parts of the above medicinal materials can enable 95 patients to have drug effects and relieve pain, while example 3 has a lower drug absorption amount than example 4, but still can relieve pain by sticking one drug before sleep every night compared with the comparative group, and has a great inhibition effect on side effects.
Patient cases:
when the patient Liji, male, 56 years old, Hebei, suffered from bone metastasis pain caused by lung cancer, the comparative group of medicines were used until now, and the insomnia symptom disappeared and the angina symptom was obviously relieved after the medicine in example 3 was replaced, which indicates that the pain was obviously relieved after the plaster was applied.
In patients with pain caused by bone metastasis due to gastric cancer, Wangzhi, women, 63 years old and Heilongjiang people have used medicaments of other brands, but after the medicaments in example 4 are replaced, insomnia symptoms disappear, symptoms of angina, interstitial nephritis and cholelithiasis appearing when medicaments of other brands are used never appear, which shows that the pain can be relieved within 10 minutes, and the duration is 18-20 hours.
The above-mentioned embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solution of the present invention by those skilled in the art should fall within the protection scope defined by the claims of the present invention without departing from the spirit of the present invention.

Claims (6)

1. The incadronate disodium product is characterized by being prepared from the following materials in parts by weight:
0.001-0.02 parts of dicamba disodium phosphate; 4-10 parts of prepared rhizome of rehmannia; 9-12 parts of dogwood; 12-16 parts of semen cuscutae; 9-12 parts of morinda officinalis; 3-8 parts of salvia miltiorrhiza; 5-10 parts of caulis spatholobi; 4-10 parts of ligusticum wallichii; 0.002-0.005 part of hydrochlorothiazide; 0.00003-0.005 part of vitamin D; 0.001-0.01 part of lornoxicam; 60-100 parts of auxiliary materials; 100 portions of water and 800 portions of water.
2. The incadronate disodium product according to claim 1, characterized in that it is composed of the following materials in parts by weight: 0.001-0.018 parts of dicamba disodium phosphate; 5-8 parts of prepared rhizome of rehmannia; 10-12 parts of dogwood; 13-15 parts of semen cuscutae; 10-11 parts of morinda officinalis; 4-6 parts of salvia miltiorrhiza; 6-8 parts of caulis spatholobi; 6-9 parts of ligusticum wallichii; 0.002-0.004 portion of hydrochlorothiazide; 0.001-0.003 part of vitamin D; 0.001 to 0.005 portion of lornoxicam; 100 parts of auxiliary materials; 200 portions of water and 700 portions of water.
3. The incadronate disodium product according to claim 2, characterized in that it is composed of the following materials in parts by weight: 0.008 parts of dicamba disodium phosphate; 5 parts of prepared rhizome of rehmannia; 11 parts of dogwood; 12 parts of semen cuscutae; 10 parts of morinda officinalis; 5 parts of salvia miltiorrhiza; 6 parts of caulis spatholobi; 6 parts of ligusticum wallichii; 0.0035 parts of hydrochlorothiazide; 0.0026 parts of vitamin D; 0.005 part of lornoxicam and 90 parts of auxiliary materials; and 600 parts of water.
4. The incadronate disodium product of claim 1, wherein: the auxiliary materials comprise the following materials in parts by weight: 50-70 parts of sesame oil; 40-60 parts of red lead.
5. The incadronate disodium product of claim 4, wherein: the auxiliary materials comprise the following materials in parts by weight: 60 parts of sesame oil; 30 parts of red lead.
6. A process for the preparation of the incadronate disodium product according to any of claims 1 to 5, characterized in that it comprises the following steps:
step one, preparing a first medicament and a first steaming liquid medicine: placing the dogwood, the dodder and the ligusticum chuanxiong hort above a steaming drawer of a steamer, placing water with the weight of 20.7 times of that of the dogwood below the steaming drawer of the steamer for steaming, steaming for 2.5 hours by strong fire, then steaming for 2 hours by slow fire, extinguishing and stewing for 6 hours after the dogwood skin turns purple black, filtering the medicinal materials, drying and grinding the medicinal materials into fine powder to prepare a first medicament, and collecting the water below the steaming drawer in the steamer after steaming as first steaming liquid medicine;
step two, preparing a second medicament: pulverizing radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, placing oleum Sesami into a pot, heating to 200 deg.C, adding pulverized radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi, stirring until the surface of radix rehmanniae Preparata, radix Morindae officinalis, Saviae Miltiorrhizae radix, and caulis Spatholobi is dark brown and the interior is brown, adding the first steamed liquid medicine, standing in shade for 48 hr, stirring once every 3 hr for 35 circles each time, and separating the upper layer oil to obtain a second preparation;
step three, refining a third medicament: continuously decocting the second medicament, and reducing the temperature of the second medicament to 220 ℃ and keeping the temperature of the second medicament at 220 ℃ when the temperature of the second medicament rises to 320 ℃; when the second medicament begins to boil, oil bloom is mostly near the periphery of the pot wall, and when the oil bloom gathers towards the center of the pot, the oil in the pot is taken out to prepare a third medicament;
step four, preparing a first plaster: after the third medicament is refined, the mixture is separated from the fire, the red lead is dried and sieved by a 100-mesh sieve, 30 parts by weight of the red lead is averagely divided into 10 parts, the red lead is placed in the third medicament every 3 minutes and is continuously stirred in the same direction, and the mixture is stirred into viscous paste to prepare the first plaster;
step five, preparing a second plaster: soaking the first plaster in cold water, and changing water every day to obtain a second plaster seven days later;
step six, preparing a third plaster: and putting the second plaster into a container, melting the second plaster in a water bath or on slow fire, adding the first medicament, hydrochlorothiazide, vitamin D and lornoxicam, uniformly stirring, putting 20-40g of each part of plaster on kraft paper or plaster cloth by using a bamboo stick, finally scattering disodium caprate on the surface of the plaster, and fully mixing and absorbing for one month to prepare the third plaster.
CN202111022822.6A 2021-09-01 2021-09-01 Incadronate disodium product and preparation method thereof Pending CN113694110A (en)

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CN1633300A (en) * 2002-02-14 2005-06-29 山之内制药株式会社 Percutaneous preparations
CN102357235A (en) * 2011-10-21 2012-02-22 于明儒 Pasty pharmaceutical composition and preparation method thereof
CN104491819A (en) * 2015-01-05 2015-04-08 李旭振 Traditional Chinese medicine plaster for treating fracture and tendon injury and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1253815A (en) * 1999-11-24 2000-05-24 刘思宁 Preparation for external application for curing hypertension and hyperlipemia and its preparation method
CN1633300A (en) * 2002-02-14 2005-06-29 山之内制药株式会社 Percutaneous preparations
CN102357235A (en) * 2011-10-21 2012-02-22 于明儒 Pasty pharmaceutical composition and preparation method thereof
CN104491819A (en) * 2015-01-05 2015-04-08 李旭振 Traditional Chinese medicine plaster for treating fracture and tendon injury and preparation method thereof

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王文萍 主编: "《实用肿瘤转移学》", 31 March 2003, 辽宁科学技术出版社 *

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Application publication date: 20211126