Summary of the invention
The object of the invention is intended to overcome the defective of prior art, provide a kind of and have no side effect, fat-reducing effect obviously and the pharmaceutical composition that is used for weight-reducing massage of cost.
The pharmaceutical composition that is used for weight-reducing massage of the present invention is made up of the Chinese crude drug of following composition by weight: Ramulus Cinnamomi 8-16%, Rhizoma Chuanxiong 4-14%, Pericarpium Zanthoxyli 4-14%, Semen Cassiae 8-16%, Rhizoma Alismatis 4-14%, Radix Arnebiae (Radix Lithospermi) 4-14%, old ginger 32-40%.
The described pharmaceutical composition that is used for weight-reducing massage, the method for preparing of its unguentum is:
A. Ramulus Cinnamomi, Rhizoma Chuanxiong, Pericarpium Zanthoxyli extract volatile oil with steam distillation, and it is subsequent use to separate volatile oil, the decocting residual liquid;
B. with step a gained residual liquid and Semen Cassiae, Rhizoma Alismatis and Rhizoma Zingiberis Recens with decocting at least 3 times, each 45-90 minute, filter, merging filtrate, centrifugal, supernatant concentration to thick paste shape extractum, subsequent use;
C. white vaseline, stearic acid, lanoline, glyceryl monostearate are merged the heating in water bath fusion, the adding Radix Arnebiae (Radix Lithospermi) is fried gets 1-3min, and filtered while hot is incubated 75-85 ℃, adds azone dissolving mixing;
D. get the extractum and the glycerol that are equivalent to substrate weight 30%, water, tween 80, heating in water bath are to 75-85 ℃, and mixing adds water with oil phase while stirring, is stirred to coldly, promptly gets.
The described supernatant concentration that is used for the preparation of drug combination method step b of weight-reducing massage is concentrated into medical material: thick paste=1: 0.6-0.95.
The pharmaceutical composition that is used for weight-reducing massage of the present invention can add substrates with different according to the different dosage form of preparation of pharmaceutical compositions, when the preparation unguentum, can add mastic medicines such as white vaseline, stearic acid, lanoline, glyceryl monostearate substrate commonly used.
The pharmaceutical composition that is used for weight-reducing massage of the present invention the position massage of needs fat-reducing 20-30 minute, is smeared pharmaceutical composition of the present invention earlier in use then, wipes to local skin warm for degree gets final product, once-a-day.Massage through spleen reinforcing, clearing stomach, clear small intestinal, clear large intestine, rub in Ban Men, the fortune Eight Diagrams etc. and regulate functions; Through opening circumpolar constellation template, the abdomen that rubs, rubbing the middle part of gastric cavity that rubs, rub umbilicus and Tianshu, regulate the conception vessel of the moon of total arbitrary bodies by rubbing moisture, Qihai, Tianshu, Slippery Flesh Gate, Wailing etc.; Through chiropractic, by the positive governor vessel of rubbing adjusting governor the whole bodys such as Pishu, bl; Through rubbing the Testudinis tail, push away seven joint bones, wiping maneuvers such as lumbosacral region and further regulate whole body internal organs QI and blood, promote each metabolism links such as lipid metabolism of patient, thereby reach the effect of fat-reducing.Massaging ointment for losing weight uses as the massage medium; Not only can protect skin; And make medicine get into body through transdermal; Can the toxic and side effects of medicine in use for oral administration be reduced to bottom line, can when increasing fat-reducing effect, not influence patient's daily life and work, for the Chinese medicine fat-reducing provides a new route of administration.
The pharmaceutical composition that is used for weight-reducing massage of the present invention, in its prescription, Ramulus Cinnamomi Xin Ganwen, GUIXIN, lung, urinary bladder channel; The warming YANG activating QI, but both warming YANG to reduce phlegm, again can activating QI with diuretic, be monarch drug; Can make the spleen sun healthy and vigorous, water damp-phlegm drink is from removing, and modern pharmacological research shows: contain compositions such as cinnamic aldehyde in the Ramulus Cinnamomi Volatile oil, but sedation and analgesia not only; The nervous system regulation function can also be regulated blood circulation, improves coronary flow.Rhizoma Alismatis, Semen Cassiae are minister.Rhizoma Alismatis is sweet light cold in nature; Return kidney, urinary bladder channel; Except that containing certain protein, aminoacid, metallic element K, Na, Mg, Ca, Fe, Mn, Cu, Zn etc.; Compositions such as Rhizoma Alismatis terpene alcohol wherein have good effect for reducing fat, and it can reduce the content of fat index and serum triglycerides around experimental obese rat Body Mass Index, uterus and the testis, also have the effect of the immunity regulated, blood sugar regulation and blood pressure; Semen Cassiae sweetness and bitterness is slightly cold, and returns liver, large intestine channel, and Semen Cassiae contains materials such as chrysophanol, emodin, not only can strengthen the fat-reducing and antihyperglycemic of Semen Cassiae, can also regulate immune system and antibiotic; The merit of playing the spleen strengthening and damp drying, consumer product dredge stasis is altogether share in medicine-feeding, and the heresy of turbid yins such as guiding water is wet, phlegm retention is by going out down.Help with the Rhizoma Chuanxiong blood circulation promoting and blood stasis dispelling again, strengthen the power of the consumer product dredge stasis of prodrug, Rhizoma Chuanxiong can not only improve the heart, cerebral circulation, the effect that also the sliding flesh of central nervous system's peace is had two-ways regulation.The Radix Arnebiae (Radix Lithospermi) removing heat from blood and promoting blood circulation, the detoxifcation rash can be protected skin, and external can antibiotic, blood sugar lowering, and the antiinflammatory antiallergic action avoid the zest of medicine, and its color is purplish red, can regulate the color of plaster, and the patient is taken like a shot.Pericarpium Zanthoxyli is hot, nature and flavor fragrance, and warming middle-JIAO to relieve pain, killing parasites for relieving itching not only can be strengthened the warming YANG and strengthening the spleen effect, can protect the liver, antidiarrheal, antiulcer, antibiotic, to the effect that intestinal tube has two-ways regulation, can also regulate the flavor of the fragrance of medicine.Old ginger both can increase the osmotic absorption of medicine for making, and can regulate the nature and flavor of medicine again, the ability antiinflammatory, and microcirculation improvement, the abnormal smells from the patient of adjusting ointment lets the patient feel that fragrance is comfortable.The present invention one is through effecting a permanent cure, i.e. warming YANG and strengthening the spleen makes the source of the no hair growth promoting of water damp-phlegm drink; The 2nd, through taking stopgap measures, promptly reduce phlegm, dehumidifying, blood stasis dispelling, the heresy of turbid yins such as water is wet, the expectorant stasis of blood is dispeled through different approaches such as temperatureization, intestinal stasis relieving.Because administering mode of the present invention is through the maneuver Transdermal absorption,, can play the effect of medicine treating both the principal and secondary aspects of a disease again so both avoided taking for a long time the unfavorable factor of slimming medicine; Neither influence patient's daily life, can reach the purpose of Weight-reducing and lipid-lowering again, and expense is cheaper, in being accepted by consumer.In the prescription of the present invention; Contain a large amount of polysaccharide, aminoacid and trace element,, can not cause damage local skin and subcutaneous tissue through the mode of Transdermal absorption; Wherein most of medicine not only has fat-reducing and antihyperglycemic, also has the function of systems such as regulating nerve, blood, immunity, digestion.Radix Arnebiae (Radix Lithospermi) also has special skin care effect, can the zest of medicine to skin be reduced as far as possible.Above medicine is processed extractum, fits to add substrate such as white vaseline, stearic acid, lanoline, azone, glycerol, tween 80, glyceryl monostearate, and purpose is the Transdermal absorption effect that increases extractum.Dosage form is the O/W non-greasy, is prone to dispel, and further increases Absorption.
Pharmaceutical composition of the present invention, through toxicological study:
1, skin acute toxicity test
Get body weight 12 of the white big ear rabbits of 2.1-2.4Kg, the male and female dual-purpose is divided into 3 groups at random; 24h takes off the hair of tame rabbit back spinal column both sides with depilatory before the administration, and the depilation scope is equivalent to about 10% of body surface area, and first group is weight-reducing massage pharmaceutical composition low dose group; The massaging ointment for losing weight 2.5g of the clinical consumption that will be equivalent to be grown up evenly is coated on tame rabbit back depilation district, and covers with gauze; Medical rubber cream is fixed, and behind the lasting 24h, removes residual massage cream with warm water.Second group is the massaging ointment for losing weight high dose group, gives massage cream 5g, and the 3rd group is matched group, gives reference substance 5g, and reference substance is medical ventolin 50g, and refined edible oil 10g stirs.Method is all with the massaging ointment for losing weight low dose group.Behavioral activity, fur gloss, diet, eye and mucosa, breathing, body weight and death condition etc. to rabbit are observed 7d continuously, and the result does not find any toxic reaction.No. 16, reuse sterilization syringe needle is drawn " # " word cut with depilation district, tame rabbit back spinal column both sides sterilization skin, and cut is each about 2cm anyhow, and the degree of being with the oozing of blood is coated massage cream scratching skin part immediately, and observation index is the same, and with the matched group comparison.Massage cream time spent outside low dosage and high dose does not have influence to behavior, activity, fur gloss, diet, eye and mucosa, breathing, the body weight of intact skin rabbit and damaged skin rabbit as a result; Successively observe no rabbit death in the 14d, any acute toxic reaction do not occur.
2, massaging ointment for losing weight skin irritation test
(1) single administration skin irritation test
Get body weight and be 6 of the white big ear rabbits of 2.1-2.4Kg, the male and female dual-purpose is divided into 2 groups at random, and 3 every group, wherein one group is intact skin, and another group is damaged skin.24h takes off the hair of tame rabbit back spinal column both sides with depilatory before the administration, the about 50cm of the depilation every side of area
2The damaged skin group is with No. 16 sterilization syringe needles position sterilization skin standardized " # " word cut that will lose hair or feathers, and cut is each about 2cm anyhow, the degree of being with the oozing of blood, left and right sides skin injury degree unanimity.Two groups of rabbit left dorsal all apply massaging ointment for losing weight 3g, and the right side back of the body all applies reference substance 3g, and reference substance is medical ventolin 50g; Refined edible oil 10g stirs and get, applies then to cover with gauze; Reuse medical rubber cream is fixed, and continues to use the warm water cleaning medicine after 24 hours; Position 1h, 24h, 48h, the reaction of 72h skin irritation are smeared in observation, carry out skin irritation reaction scoring and intensity evaluation by table 2,3, and the result shows; Single administration is to rabbit intact skin and the equal nonirritant of damaged skin.
(2) multiple dosing skin irritation test
Rabbit is selected for use, grouping, QUMAO and damaged method be with an administration skin irritation test.Two groups of rabbit left dorsal all apply massage cream 3g, and the right side back of the body all applies reference substance 3g, and fixing means is tested with skin irritation.Continuous 7 days, behind last administration 24h, use the warm water cleaning medicine, observe and smear position 1h, 24h, 48h, the reaction of 72h skin irritation.IR is marked, intensity evaluation is the same, and the result shows: multiple dosing is to rabbit intact skin and the equal nonirritant of damaged skin.
3, skin allergy test
Get body weight and be 30 of the Cavia porcelluss of 220-250g, be divided into 3 groups at random, 10 every group, male and female half and half set up massaging ointment for losing weight test group, blank group and positive controls separately.24h takes off the hair of guinea pig back spinal column both sides with depilatory before the administration, the every side 3 * 3cm of depilation area
2The depilation district applies massage cream 0.2g on the left of every Cavia porcellus of experimental group, and covers with gauze, and reuse medical rubber cream is fixed, and dismantles in lasting 6 hours.The 7th day and the 14th day in kind respectively repeats once, and the blank group applies normal saline 0.2ml, positive controls coating 0.1%2,4-dinitrochlorobenzene 0.2ml, the same experimental group of method.After the last administration the 14th day, depilation district repaste applied massage cream 0.2g to every Cavia porcellus of experimental group on the right side, fixes with method, removes covering behind the 6h, observes at once, observes the skin allergy situation once more respectively at 24h, 48h, 72h then.Blank group and positive controls give normal saline 0.2ml, 0.1%2,4-dinitrochlorobenzene 0.2ml, the same experimental group of method respectively.
The irritated number of animals ÷ animal subject number of sensitization rate (%)=generation * 100%
The result shows that experimental group, blank control group all do not make guinea pig skin anaphylaxiss such as erythema, edema occur, and the sensitization rate is 0%, and positive controls sensitization rate is 100%.Show that massaging ointment for losing weight does not have sensitization to guinea pig skin, 2, the 4-dinitrochlorobenzene has extremely sensitization to guinea pig skin.
Above experimental result shows that massaging ointment for losing weight spreads on and all do not cause acute toxic reaction on rabbit intact skin and the damaged skin outward; Single administration and multiple dosing are to rabbit intact skin and the equal nonirritant of damaged skin; First sensitization contact with excite sensitization that guinea pig skin is not all had sensitization.
4, clinical trial
The patient is divided into three groups, a maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group, pushes away rub group and blank control group, through t check, three groups of case body weight, height, course of disease there was no significant difference (being P>0.05)
In the therapeutic process; The massaging ointment for losing weight that a maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group adopts is the made weight-reducing massage pharmaceutical composition of the present invention, and each treatment is about totally 40 minutes, ADT 1 time; 15 times is 1 course of treatment; All measure and write down index of correlation when finish each course of treatment, carry out next one course of treatment after the week of having a rest, add up curative effect after 3 courses of treatment.The massage group adopts massage operation sequence and the maneuver identical with test group.The massaging ointment for losing weight that uses in the therapeutic process changes Johnson & Johnson's baby oil into, and the course of treatment and index detect and the same test group of recording method.Blank control group is not done other special treatment, but follows up a case by regular visits to once in 30 days, presses the method detection record index of correlation of the massage group of test group.
Three groups of cases are all issued the equal corresponding form of planting of every 418KJ heat energy when first visit, and church's patient's food and momental heat energy conversion method, calculate logical diet amount, quantity of motion etc. according to different patients' concrete condition help.Regularly hold fat health knowledge lecture, guarantee that every patient participates in the number of times at least 2 times of attending a lecture, to reduce the influence that extraneous factor is brought clinical research.
The variation of three groups of patient's clinical symptoms average product score values is compared:
Compare no significant difference (P>0.05) between the clinical symptoms average product score value group before a maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group, massage group, three groups of treatments of blank control group, have comparability.Compare a maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group and massage group no significant difference (P>0.05), a maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group and blank control group no significant difference (P>0.05), massage group and blank control group no significant difference (P>0.05) before the treatment.Three groups the clinical symptoms no significant difference before treatment is described, is had comparability.A maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group, massage group, the preceding clinical symptoms average product score value that reaches after treating of three groups of treatments of blank control group compare, and except that the blank group, all before treating, decrease after all the other two groups clinical symptoms integrated value treatments.The treatment back is relatively preceding with treatment, blank group no significant difference (P>0.05), and a maneuver of massage by rubbing the affected part with ointment for treating arthralgia and skin disease group has significant difference (P<0.01); The massage group has notable difference (P<0.05).In the therapeutic process, the property a crossed appetite appears in indivedual infants to be increased, and continues promptly to recover about a week normal, does not find other untoward reaction.
The specific embodiment
Below in conjunction with embodiment the present invention is done further description, but be not limited to embodiment.
Embodiment 1
The pharmaceutical composition that is used for weight-reducing massage of the present invention is made up of the Chinese crude drug of following composition by weight: Ramulus Cinnamomi 12.2%, Rhizoma Chuanxiong 9.76%; Pericarpium Zanthoxyli 9.76%, Semen Cassiae 12.2%, Rhizoma Alismatis 9.76%; Radix Arnebiae (Radix Lithospermi) 9.76%; Old ginger 36.56% adds substrate and prepares massage cream, and described substrate is mastic medicines such as white vaseline, stearic acid, lanoline, glyceryl monostearate substrate commonly used.
Embodiment 2
The bright described pharmaceutical composition that is used for weight-reducing massage, form by the Chinese crude drug of following composition by weight: Ramulus Cinnamomi 8%, Rhizoma Chuanxiong 4%, Pericarpium Zanthoxyli 14%, Semen Cassiae 16%, Rhizoma Alismatis 4%, Radix Arnebiae (Radix Lithospermi) 14%, old ginger 40% adds substrate and prepares massage cream.Described substrate is mastic medicines such as white vaseline, stearic acid, lanoline, glyceryl monostearate substrate commonly used.
Embodiment 3
The bright described pharmaceutical composition that is used for weight-reducing massage is made up of the Chinese crude drug of following composition by weight: Ramulus Cinnamomi 16%, Rhizoma Chuanxiong 14%, Pericarpium Zanthoxyli 12%, Semen Cassiae 8%, Rhizoma Alismatis 14%, Radix Arnebiae (Radix Lithospermi) 4%, the substrate of old ginger 32% and surplus.Described substrate is mastic medicines such as white vaseline, stearic acid, lanoline, glyceryl monostearate substrate commonly used.
Embodiment 4
The bright described pharmaceutical composition that is used for weight-reducing massage is made up of the Chinese crude drug of following composition by weight: Ramulus Cinnamomi 16%, Rhizoma Chuanxiong 14%, Pericarpium Zanthoxyli 4%, Semen Cassiae 8%, Rhizoma Alismatis 14%, Radix Arnebiae (Radix Lithospermi) 4%, the substrate of old ginger 40% and surplus.Described substrate is mastic medicines such as white vaseline, stearic acid, lanoline, glyceryl monostearate substrate commonly used.
Embodiment 5
The pharmaceutical composition that is used for weight-reducing massage of the present invention, the method for preparing of its unguentum is: the pharmaceutical composition of arbitrary proportioning among the embodiment 1,2,3 is followed these steps to preparation get:
A. Ramulus Cinnamomi, Rhizoma Chuanxiong, Pericarpium Zanthoxyli extract volatile oil with steam distillation, and it is subsequent use to separate volatile oil, the decocting residual liquid;
B. with step a gained residual liquid and Semen Cassiae, Rhizoma Alismatis and Rhizoma Zingiberis Recens with decocting 3 times, each 60 minutes, filter, merge filtrating 3 times, centrifugal, supernatant concentration to thick paste shape, medical material: thick paste=1: 0.85, subsequent use;
C. white vaseline, stearic acid, lanoline, glyceryl monostearate are merged the heating in water bath fusion, add fried 2mi n, the filtered through gauze while hot of getting of Radix Arnebiae (Radix Lithospermi); Be incubated 75-85 ℃, add azone dissolving mixing;
D. get the extractum and the glycerol that are equivalent to substrate weight 30%, water, tween 80, heating in water bath are to 75-85 ℃, and mixing adds water with oil phase while stirring, is stirred to coldly, promptly gets.
Embodiment 6
A. Ramulus Cinnamomi, Rhizoma Chuanxiong, Pericarpium Zanthoxyli extract volatile oil with steam distillation, and it is subsequent use to separate volatile oil, the decocting residual liquid;
B. with step a gained residual liquid and Semen Cassiae, Rhizoma Alismatis and Rhizoma Zingiberis Recens with decocting at least 3 times, each 45 minutes, filter, merging filtrate, centrifugal, supernatant concentration to thick paste shape extractum, subsequent use;
C. white vaseline, stearic acid, lanoline, glyceryl monostearate are merged the heating in water bath fusion, the adding Radix Arnebiae (Radix Lithospermi) is fried gets 3min, and filtered while hot is incubated 85 ℃, adds azone dissolving mixing;
D. get the extractum and the glycerol that are equivalent to substrate weight 30%, water, tween 80, heating in water bath to 85 ℃, mixing adds water with oil phase while stirring, is stirred to coldly, promptly gets.
The described supernatant concentration that is used for the preparation of drug combination method step b of weight-reducing massage is concentrated into medical material: thick paste=1: 0.6.
Embodiment 7
A. Ramulus Cinnamomi, Rhizoma Chuanxiong, Pericarpium Zanthoxyli extract volatile oil with steam distillation, and it is subsequent use to separate volatile oil, the decocting residual liquid;
B. with step a gained residual liquid and Semen Cassiae, Rhizoma Alismatis and Rhizoma Zingiberis Recens with decocting at least 3 times, each 90 minutes, filter, merging filtrate, centrifugal, supernatant concentration to thick paste shape extractum, subsequent use;
C. white vaseline, stearic acid, lanoline, glyceryl monostearate are merged the heating in water bath fusion, the adding Radix Arnebiae (Radix Lithospermi) is fried gets 1min, and filtered while hot is incubated 75 ℃, adds azone dissolving mixing;
D. get the extractum and the glycerol that are equivalent to substrate weight 30%, water, tween 80, heating in water bath to 75 ℃, mixing adds water with oil phase while stirring, is stirred to coldly, promptly gets.
The described supernatant concentration that is used for the preparation of drug combination method step b of weight-reducing massage is concentrated into medical material: thick paste=1: 0.95.