CN108703946A - A kind of transdermal absorption formulation for treating diabete peripheral herve pain - Google Patents
A kind of transdermal absorption formulation for treating diabete peripheral herve pain Download PDFInfo
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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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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Abstract
The invention belongs to chemical medicine fields, and in particular to a kind of transdermal absorption formulation for treating diabete peripheral herve pain.The transdermal absorption formulation is made of gamma-aminobutyric acid analog class antalgesic and three carbonyl nitrogen-containing compound of small molecule, and the pharmaceutic adjuvant of preparation is card pool nurse 940, glycerine, Tween 80, triethanolamine, Laurocapram and distilled water.Above-mentioned transdermal absorption formulation topical administration has notable analgesic effect to diabete peripheral herve pain.And the dosage of gamma-aminobutyric acid analog class antalgesic can be reduced.
Description
Technical field
The invention belongs to chemical medicine fields, and in particular to a kind of Transdermal absorption system for treating diabete peripheral herve pain
Agent.
Background technology
Diabetes are a kind of metabolic diseases characterized by blood glucose rise.The disease and cardiovascular and cerebrovascular disease, tumour are mesh
The preceding three big major chronic illnesses for threatening human health.In recent years, with the improvement of living standards, the accelerating rhythm of life etc.,
Apparent ascendant trend is also presented in diabetes morbidity, and incidence has been up to 12% at present；And prediabetes crowd is also increasingly huge
Greatly.And glycemic control needs Long-term taking medicine.
Diabete peripheral herve pain is one of major complications of diabetes, and patients account for about diabetes total number of persons
7.5~24%.Early in 19th century mid-term, American-European countries has been noted that the high phenomenon of diabetic's peripheral neuralgia incidence.
Diabete peripheral herve pain pathogenesis it is not immediately clear that supposition may be with metabolic disorder caused by hyperglycemia, neurotrophy
Blood vessel hypoxic-ischemic, neurotrophic factor are reduced and the collective effect of many factors such as role of autoimmune factors is related.Diabetes week
Neuralgia patient is enclosed often to show as limbs pain, feel decline, is numb, scorching hot, ice-cold etc., can also appear as spontaneous pain,
Allodynia.Abnormal sensory includes numb, ant walks, worm climbs, generate heat, electric shock sample is felt etc., and paralgesia is from distal end toe uplink
Reachable above-knee, patient wears socks and wears gloves sample feeling.The serious case of sensory disturbance may occur in which that joint of lower extremity is sick and foot is burst
Ulcer generally requires amputation when being developed to diabetic foot ulcer, seriously affects patients ' life quality.In China, Diabetic Peripheral god
Dysmenorrhoea patient accounts for the 85% of diabetes total number of persons, and pain seriously affects the quality of life of patient, and lethality of disabling is higher.
Since its pathogenic factor and mechanism is not still fully aware of, clinical treatment can only anti symptom treatment.At present clinically to sugar
The treatment of the sick peripheral neuralgia of urine is general by the way of glycemic control Combinated easing pain agent.Wherein analgesic includes opiates town
Pain medicine, tricyclic antidepressant, selective serotonin and norepinephrine reuptake inhibitors, γ-aminobutyric acid are similar
Object etc..Wherein there are tolerance, drug withdrawal syndrome and abuse risks for opium kind analgesics.Tricyclic antidepressant early in
Have been used within 1977 neuralgic treatment, mechanism is to block sodium channel, calcium channel, increases monoamine release and blocks NDMA
Receptor.But since side effect (such as drowsiness, orthostatic hypotension, anticholinergic side reaction) is strong and incidence is high, patient
It is difficult to be resistant to and limit application.Selective serotonin and norepinephrine reuptake inhibitors such as Duloxetine are to nerve
Pain is also effective, but it is also not satisfactory that effect is used alone.Gamma-aminobutyric acid analog is mainly Pregabalin, Gabapentin.
Gabapentin tests table by mitigating pain with voltage-gated calcium channel in conjunction with blocking primary afferent neuron to depolarize
It is bright its to treatment diabete peripheral herve pain it is more effective compared with other neuralgias；Pregabalin is the homologous chemical combination of Gabapentin
Object is particularly effective diabete peripheral herve pain and postherpetic neuralgia.Both the above curative effect of medication is high, side effect is low,
Potential applicability in clinical practice is wide, but expensive, cannot function as a line routine administration.Clinical diabete peripheral herve pain is controlled at present
Treatment scheme is mostly Duloxetine exclusive use or Pregabalin, Duloxetine joint plus spray fourth use.
Has the treatment that a small number of external preparations are approved for diabete peripheral herve pain at present.The theory of local application is excellent
Gesture is to reduce side effect, and the interaction between no drug is not usually required to dose titration.As supervised by U.S.'s food and medicine
The agent of lidocaine lagging, capsaicin ointment, the isosorbide dinitrate spray etc. that management board's approval lists.
Invention content
For the existing existing above problem, the object of the present invention is to provide a kind of diabete peripheral herve pains for the treatment of
Transdermal absorption formulation.Unresolved above-mentioned technical problem, the technical solution adopted by the present invention are as follows：
A kind of transdermal absorption formulation for treating diabete peripheral herve pain, by gamma-aminobutyric acid analog, the change being shown below
Close object（I）It is made with pharmaceutic adjuvant：
The compound（I）Middle R is one kind in H, methyl, ethyl；The gamma-aminobutyric acid analog is Pregabalin, adds
Bar spray fourth in one kind.
Preferably, the gamma-aminobutyric acid analog is Pregabalin, the compound（I）Middle R is H.
Preferably, the gamma-aminobutyric acid analog is Pregabalin, the compound（I）Middle R is methyl.
Preferably, the gamma-aminobutyric acid analog is Pregabalin, the compound（I）Middle R is ethyl.
Preferably, the gamma-aminobutyric acid analog is Gabapentin, the compound（I）Middle R is H.
Preferably, when the compound（I）When middle R is H, the gamma-aminobutyric acid analog and compound
（I）Weight part ratio be 6~9 parts by weight of gamma-aminobutyric acid analog, compound（I）1 parts by weight；
It is further preferred that the gamma-aminobutyric acid analog and compound（I）Weight part ratio be γ-aminobutyric acid it is similar
9 parts by weight of object, compound（I）1 parts by weight.
The scheme further preferred as another, the gamma-aminobutyric acid analog and compound（I）Weight part ratio
For 7 parts by weight of gamma-aminobutyric acid analog, compound（I）1 parts by weight.
For the transdermal absorption formulation of above-mentioned treatment diabete peripheral herve pain, the dosage form of the transdermal absorption formulation is preferred
For gelling agent, the pharmaceutic adjuvant includes card pool nurse 940, glycerine, Tween 80, triethanolamine and distilled water.
Further, the pharmaceutic adjuvant further includes Laurocapram.
Wherein, work as compound（I）When middle R is H, methyl, ethyl, compound（I）Structural formula respectively as following formula I A, IB,
Shown in IC：
Wherein compound（IA）Preparation method disclosed in the patent documents such as CN200710036109.0；Compound（IB）,
Compound（IC）Respectively compound（IA）Dimethyl ester and diethylester, can be in compound（IA）On the basis of by with methanol,
Ethanol synthesis is formed.To those skilled in the art, esterification belongs to typical organic synthesis, reference can be made to magnifying
State writes what Chemical Industry Press published for 2014《Fine organism unit reaction synthetic technology handbook》.
In a preferred scheme, the transdermal absorption formulation of the treatment diabete peripheral herve pain is by compound
（IA）, Pregabalin, card pool nurse 940, glycerine, Tween 80, triethanolamine, Laurocapram and distilled water be made, specific prescription
It is as follows：Pregabalin 70g, compound（IA）10g, 940 21g of card pool nurse, glycerine 78g, Tween 80 21g triethanolamines 32g, the moon
Osmanthus Azone 7g and distilled water 1261g.Specific preparation method is as follows：It takes recipe quantity Acritamer 940 to add 1029g distilled water, stands
Make fully to be swollen overnight；The grinding of recipe quantity glycerine, which is added, makes wetting, and recipe quantity triethanolamine is added to be ground into clear gel matrix.It takes
Surplus distilled water, recipe quantity Tween 80, Laurocapram, compound（IA）, Pregabalin stirring, be added gel-type vehicle in 60~
90 revs/min are stirred 5~20 minutes, and cream pipe is distributed into.
In another preferred scheme, the transdermal absorption formulation of the treatment diabete peripheral herve pain is by compound
（IA）, Gabapentin, card pool nurse 940, glycerine, Tween 80, triethanolamine, Laurocapram and distilled water be made, specific prescription
It is as follows：Gabapentin 90g, compound（IA）10g, 940 21g of card pool nurse, glycerine 78g, Tween 80 21g triethanolamines 32g, the moon
Osmanthus Azone 7g and distilled water 1241g.Specific preparation method is as follows：It takes recipe quantity Acritamer 940 to add 1029g distilled water, stands
Make fully to be swollen overnight；The grinding of recipe quantity glycerine, which is added, makes wetting, and recipe quantity triethanolamine is added to be ground into clear gel matrix.It takes
Surplus distilled water, recipe quantity Tween 80, Laurocapram, compound（IA）, Gabapentin stirring, be added gel-type vehicle in 60~
90 revs/min are stirred 5~20 minutes, and cream pipe is distributed into.
Above-mentioned Pregabalin English entitled Pregabalin, the entitled Gabapentin of Gabapentin English.
The transdermal absorption formulation of above-mentioned treatment diabete peripheral herve pain is applied to illing skin such as forearm or shank position.
Human administration's dosage is calculated by 60kg weight, is calculated with Pregabalin or Gabapentin, and daily dosage is 100 mg~200mg.
The dosage that Pregabalin or Gabapentin can be significantly reduced to be conducive to control drug use cost, and avoids drug oral
The harmful effect to gastrointestinal tract and liver is administered.Patient can feed protein-contng foodstuffs according to conventional in drug administration process.But it should
It avoids being administered at skin injury, to prevent drug from generating stimulation to damaged skin.Inventor by experimental studies have found that, chemical combination
Object（I）Combine topical administration with Pregabalin or Gabapentin and Pregabalin is better than to the therapeutic effect of diabete peripheral herve pain
Or Gabapentin independent medication, and the safety of topical administration is better than traditional Oral administration.
Specific implementation mode
Below with reference to the detailed explanation present invention of specific embodiment, following embodiment is only for technical scheme of the present invention
It is explained, the present invention is not limited to following embodiments.
The gelling agent of 1 anti-diabetic peripheral neuralgia of embodiment and its preparation
Gelling agent prescription：Pregabalin 70g, compound（IA）10g, 940 21g of card pool nurse, glycerine 78g, tri- second of Tween 80 21g
Hydramine 32g, Laurocapram 7g and distilled water 1261g.
Preparation method：Recipe quantity Acritamer 940 is taken to add 1029g distilled water, standing overnight makes fully to be swollen；Recipe quantity is added
Glycerine grinding makes wetting, and recipe quantity triethanolamine is added to be ground into clear gel matrix.Remainder amount distilled water, recipe quantity Tween 80,
Laurocapram, compound（IA）, Pregabalin stirring, be added gel-type vehicle in 90 revs/min stir 8 minutes, packing is used as medicine
With ointment tube to obtain the final product.
The gelling agent of 2 anti-diabetic peripheral neuralgia of embodiment and its preparation
Gelling agent prescription：Gabapentin 90g, compound（IA）10g, 940 21g of card pool nurse, glycerine 78g, tri- second of Tween 80 21g
Hydramine 32g, Laurocapram 7g and distilled water 1241g.
Preparation method：Recipe quantity Acritamer 940 is taken to add 1029g distilled water, standing overnight makes fully to be swollen；Recipe quantity is added
Glycerine grinding makes wetting, and recipe quantity triethanolamine is added to be ground into clear gel matrix.Remainder amount distilled water, recipe quantity Tween 80,
Laurocapram, compound（IA）, Gabapentin stirring, be added gel-type vehicle in 60 revs/min stir 12 minutes, packing is used as medicine
With ointment tube.
The Effect tests of 3 anti-diabetic peripheral neuralgia prescription of embodiment
Healthy male SD rat, 190~200g of weight are raised in the laboratories SPF.Streptozotocin uses sodium citrate buffer solution
Dissolving, matching while using.Rat Fast every rats by intraperitoneal injection streptozotocin 12mg after 24 hours.After streptozotocin injection
It 14th day, takes diabetes rat to measure rat using hot plate method and occurs the time of reactions such as licking foot, shout, jump, that is, before being administered
Pyrocondensation foot incubation period, hot plate temperature are 51-52 DEG C.Every rat replication 3 times is spaced 15 minutes between measuring twice, takes 3
The mean value of secondary measurement result represents pyrocondensation sufficient incubation period before the administration of the rat.
The 15th day after streptozotocin injection, rat is randomly divided into 6 groups, every group 6, rat back shaving, in shaving
Smear administration in region：
Model group smears physiological saline, one time a day successive administration 7 days；
Dimethyl sulfoxide (DMSO) is added in Pregabalin by Pregabalin group, and every rat is smeared every time gives Pregabalin 2.1mg, daily
It is administered once, successive administration 7 days；
Dimethyl sulfoxide (DMSO) is added in Gabapentin by Gabapentin group, and every rat is smeared every time gives Gabapentin 2.7mg, daily
It is administered once, successive administration 7 days；
Compound（IA）Group is by compound（IA）Dimethyl sulfoxide (DMSO) is added, every rat is smeared every time gives compound（IA）
0.3mg is administered daily 1 time, successive administration 7 days；
Pregabalin+compound（IA）Group is by Pregabalin and compound（IA）According to weight ratio 7:Dimethyl is added in 1 ratio
Sulfoxide is smeared administration, is administered daily 1 time, successive administration 7 days, calculating each dosage of every rat with Pregabalin is
2.1mg。
Gabapentin+compound（IA）Group is by Gabapentin and compound（IA）According to weight ratio 9:1 ratio is added two
Methyl sulfoxide smears administration, is administered daily 1 time, successive administration 7 days, each dosage of every rat is calculated with Gabapentin
For 2.7mg.
Last dose next day uses hot plate method to measure rat and occurs the time of reactions such as licking foot, shout, jump, i.e., again
Pyrocondensation foot incubation period after administration, hot plate temperature are 51-52 DEG C.Every rat replication 3 times is spaced 15 points between measuring twice
Clock, pyrocondensation foot incubation period after taking the mean value of 3 measurement results to represent the administration of the rat.
Improve percentage in the threshold of pain that every rat is calculated according to following formula：Improve percentage in the threshold of pain（%）=1-（Before administration
Pyrocondensation sufficient incubation period after pyrocondensation foot incubation period-administration）Pyrocondensation sufficient incubation period before/administration.
Pyrocondensation sufficient incubation period and the threshold of pain are improved percentage and are compared before each group rat is administered using statistical software, after administration
Compared with comparison among groups are examined using t, P<0.05 is considered as significant difference.
Pyrocondensation foot latency result see the table below before the administration of each group rat, after administration
In table：* it indicates：The P< compared with model group;0.01；# is indicated：Pregabalin+compound（IA）Group is compared with Pregabalin group
Or Gabapentin+compound（IA）Group P< compared with Gabapentin group;0.01.
By result as it can be seen that the preceding each group rat pyrocondensation of administration sufficient incubation period is without significant difference.Compound is removed after administration（IA）Group
Outside, the pyrocondensation of other each groups sufficient incubation period and the threshold of pain improve percentage and are all remarkably higher than model group（P<0.01）.Wherein, Puri bar
Woods+compound（IA）Group and Gabapentin+compound（IA）Percentage point is improved in pyrocondensation sufficient incubation period and the threshold of pain after the administration of group
It is not significantly higher than Pregabalin group and Gabapentin group（P<0.01）.As it can be seen that compound（IA）The indices of group and model group
No difference of science of statistics, but compound（IA）Combine topical administration with Pregabalin or Gabapentin, is remarkably improved the latter to sugar
The threshold of pain of the sick peripheral neuralgia rat model of urine, improves its analgesic effect.
Above example gives example displaying to the effect of the present invention.But above-described embodiment is only used for explaining the present invention,
Not for restriction protection scope of the present invention.To those skilled in the art, in compound（IA）Structure and activity
Under the premise of disclosed, compound（IA）Analog or its ester, salt after substituent group variation etc. are such as compound（IB）, compound（IC）
Have and compound（IA）Similar activity is can be with rational expectation, and can pass through limited trials confirmation.
Claims (10)
1. a kind of transdermal absorption formulation for treating diabete peripheral herve pain, which is characterized in that by gamma-aminobutyric acid analog,
The compound being shown below（I）It is made with pharmaceutic adjuvant：
The compound（I）Middle R is one kind in H, methyl, ethyl；The gamma-aminobutyric acid analog is Pregabalin, adds
Bar spray fourth in one kind.
2. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 1, which is characterized in that described
Gamma-aminobutyric acid analog is Pregabalin, the compound（I）Middle R is H.
3. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 1, which is characterized in that described
Gamma-aminobutyric acid analog is Pregabalin, the compound（I）Middle R is methyl.
4. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 1, which is characterized in that described
Gamma-aminobutyric acid analog is Pregabalin, the compound（I）Middle R is ethyl.
5. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 1, which is characterized in that described
Gamma-aminobutyric acid analog is Gabapentin, the compound（I）Middle R is H.
6. the transdermal absorption formulation of the treatment diabete peripheral herve pain according to claim 2 and 5, which is characterized in that institute
State gamma-aminobutyric acid analog and compound（I）Weight part ratio be 6~9 parts by weight of gamma-aminobutyric acid analog, compound
（I）1 parts by weight.
7. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 6, which is characterized in that described
Gamma-aminobutyric acid analog and compound（I）Weight part ratio be 9 parts by weight of gamma-aminobutyric acid analog, compound（I）1 weight
Measure part.
8. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 6, which is characterized in that described
Gamma-aminobutyric acid analog and compound（I）Weight part ratio be 7 parts by weight of gamma-aminobutyric acid analog, compound（I）1 weight
Measure part.
9. according to the transdermal absorption formulation of the treatment diabete peripheral herve pain described in claim 6 to 8, which is characterized in that institute
State transdermal absorption formulation dosage form be gelling agent, the pharmaceutic adjuvant include card pool nurse 940, glycerine, Tween 80, triethanolamine and
Distilled water.
10. the transdermal absorption formulation for the treatment of diabete peripheral herve pain according to claim 9, which is characterized in that described
Pharmaceutic adjuvant further includes Laurocapram.
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|---|---|---|---|---|
| CN109498611A (en) * | 2019-01-15 | 2019-03-22 | 张惊宇 | A kind of drug and application thereof for treating diabete peripheral herve pain |
| CN109498611B (en) * | 2019-01-15 | 2020-09-01 | 张惊宇 | Medicine for treating diabetic peripheral neuralgia and application thereof |
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| CN108703946B (en) | 2019-04-12 |
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