CN103735620A - Nano-emulsion in-situ gel for treating haemorrhoids - Google Patents
Nano-emulsion in-situ gel for treating haemorrhoids Download PDFInfo
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Abstract
The invention relates to nano-emulsion in-situ gel for treating haemorrhoids. The gel comprises the following components by weight: 30-100g of sophora flavescens, 30-120g of salviae miltiorrhizae, 30-100g of wild chrysanthemum, 1-8g of borneol, 1-8g of menthol, 30-160g of polyoxyethylated castor oil, 10-80g of absolute ethyl alcohol, 5-60g of isopropyl myristate, 60-160g of poloxamer 407, and 5-80g of poloxamer 188. The nano-emulsion in-situ gel can infiltrate into a mucous membrane to play the effects of clearing heat, removing toxicity, drying dampness, relieving itching, activating blood circulation to remove stasis, diminishing edema and relieving pain, and can be used for promoting local blood circulation, and improving nutrition of peripheral tissues to achieve the aims of diminishing edema and inflammation, and relieving pain.
Description
Technical field
The present invention relates to a kind of nano-emulsion situ-gel for the treatment of hemorrhoid, belong to technical field of Chinese medicines.
Background technology
Hemorrhoid are mainly under rectum end mucosa, anal canal and the subcutaneous venous plexus of anus edge expands, varicose forms soft vein group; Or anus edge pleat chafing, hypertrophy, connective tissue proliferation; Or anal veins breaks, the stagnant formation thrombosis of the blood stasis of blood.According to interrelated data, show, the sickness rate of anorectal disease is 59.1%, and hemorrhoid account for 87.25% of all recial diseases, accounting for 52.19% of all anal and intestinal diseases, is a kind of Multiple Chronic disease, drags and does not control for a long time, can cause anemia, incarceration, necrosis and infection etc., aggravate the pain and the state of an illness.At present, doctor trained in Western medicine adopts operation method to the treatment of hemorrhoid more, and postoperative nursing adopts hormone and analgesic more, and these medicines have more side effect.Chinese medicine preparation treatment hemorrhoid are little, evident in efficacy and be subject to numerous doctors and patients' favor with its side effect, but it still has many deficiencies, as too frequent in medication, have certain zest etc.The conventional Chinese medicine for external application of clinical treatment hemorrhoid mainly contains lotion, suppository, gel etc. at present, and lotion is of short duration action time, and medication is too frequent, and irritant, to patient, brings inconvenience; Traditional suppository, with solid form administration, melts or softens in tract, not only uses inconvenience, also may slip into rectum bottom and cause the first pass effect of medicine, and because water sorption causes patient's discomfort, reduce compliance; Gel can improve patient's compliance, and the certain bioadhesive of tool, can avoid the first pass effect of medicine, but dosage is wayward, uses inconvenience.Therefore, the medicine for the treatment of hemorrhoid being improved is current technical problem urgently to be resolved hurrily.
Summary of the invention
For above-mentioned situation, for overcoming the defect of prior art, the present invention's object is just to provide a kind of nano-emulsion situ-gel for the treatment of hemorrhoid, can effectively treat anus edge pleat chafing, hypertrophy, connective tissue proliferation and the hemorrhoids disease such as anal veins breaks, the stagnant formation thrombosis of the blood stasis of blood etc. causes anemia, incarceration, necrosis and infection.
The technical scheme that the present invention solves is, treat a nano-emulsion situ-gel for hemorrhoid, by following weighing scale: Radix Sophorae Flavescentis 30-100g, Radix Salviae Miltiorrhizae 30-120g, Flos Chrysanthemi Indici 30-100g, Borneolum Syntheticum 1-8g, Mentholum 1-8g, polyoxyethylene castor oil 30-160g, dehydrated alcohol 10-80g, isopropyl myristate 5-60g, poloxamer188 60-160g and PLURONICS F87 5-80g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
Nano-emulsion situ-gel of the present invention is by ingredients such as Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis, Flos Chrysanthemi Indici, Borneolum Syntheticum, Mentholums.Take Radix Salviae Miltiorrhizae as monarch, bitter and be slightly cold in side, can blood circulation promoting and blood stasis dispelling, again can removing heat from blood eliminating carbuncle and control skin infection and swell and ache; Take the Radix Sophorae Flavescentis of bitter cold, toil and the Flos Chrysanthemi Indici being slightly cold as minister, heat-clearing and toxic substances removing, dampness, reducing swelling and alleviating pain, killing parasites for relieving itching.Assistant is with Borneolum Syntheticum, Mentholum, wind-dispelling heat-dissipating, promoting the circulation of QI pain relieving.Four medicines share the merit of playing altogether heat-clearing and toxic substances removing, dampness removing to stop itchin, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain.
In addition, the present invention makes nano-emulsion situ-gel according to certain technique, belongs to mucosal drug delivery system, and tool nano-emulsion and in-situ gel two-fold advantage not only can improve dissolubility, the percutaneous rate of medicine, and targeting can also reduce the zest of medicine; To occur to change mutually at agents area immediately after solution state administration, the non-chemically crosslinked semi-solid preparation forming, particularly mucous membrane tissue affinity is strong with agents area, holdup time is long, can significantly improve curative effect, increase patient's compliance, and prepare simple, easy to use, dosage and be easy to the advantages such as control.
The specific embodiment
Below in conjunction with embodiment, the specific embodiment of the present invention is elaborated.
Embodiment 1
The nano-emulsion situ-gel of the treatment hemorrhoid of the present embodiment, by following weighing scale: Radix Sophorae Flavescentis 65g, Radix Salviae Miltiorrhizae 110g, Flos Chrysanthemi Indici 65g, Borneolum Syntheticum 1.7g, Mentholum 3.6g, polyoxyethylene castor oil 100g, dehydrated alcohol 40g, isopropyl myristate 10g, poloxamer188 120g and PLURONICS F87 24g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
Embodiment 2
The nano-emulsion situ-gel of the treatment hemorrhoid of the present embodiment, by following weighing scale: Radix Sophorae Flavescentis 30g, Radix Salviae Miltiorrhizae 30g, Flos Chrysanthemi Indici 100g, Borneolum Syntheticum 8g, Mentholum 1g, polyoxyethylene castor oil 160g, dehydrated alcohol 10g, isopropyl myristate 60g, poloxamer188 60g and PLURONICS F87 5g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
Embodiment 3
The nano-emulsion situ-gel of the treatment hemorrhoid of the present embodiment, by following weighing scale: Radix Sophorae Flavescentis 100g, Radix Salviae Miltiorrhizae 120g, Flos Chrysanthemi Indici 30g, Borneolum Syntheticum 1g, Mentholum 8g, polyoxyethylene castor oil 30g, dehydrated alcohol 80g, isopropyl myristate 5g, poloxamer188 160g and PLURONICS F87 80g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
Effective combination of medicine of the present invention, supports mutually, has the effect of heat-clearing and toxic substances removing, dampness removing to stop itchin, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, is effective to treat hemorrhoid, and has obtained useful technique effect through clinical experiment, and relevant clinical data is as follows:
1 clinical data
1.1 select the standard of case to observe case totally 60 examples, and single-blind randomized is divided into 2 groups for the treatment of group, matched groups, every group of each 30 examples.Male 21 examples in treatment group, female's 9 examples, 20～75 years old age, average 61.7 years old, the course of disease 15 days-20 years, this time morbidity is the longest is 12d, the shortest is 2d, internal hemorrhoid 8 examples, external hemorrhoid 18 examples, mixed hemorrhoid 4 examples.Matched group 30 examples, male 20 examples, female's 10 examples, age 20-68 year, average 41 years old, internal hemorrhoid 6 examples, external hemorrhoid 18 examples, mixed hemorrhoid 6 examples.Two groups at aspects such as sex, age, the course of disease and type distribution all without significant difference, there is comparability (P>0.05).
1.2 diagnostic criteria
Inclusive criteria: all cases meet the Chinese medicine industry standard > > of the < < People's Republic of China (PRC) that State Administration of Traditional Chinese Medicine promulgates.Traditional Chinese medical science anorectal section disease Standardization of diagnosis and curative effect, signature Informed Consent Form.
Exclusion standard: I degree internal hemorrhoid; Gestation and women breast-feeding their children; Suffer from the vitals disease psychiatric patients such as serious heart and brain Liver and kidney; Suffers from anal fistula proctoptosis rectal polyp anal papilla tumor, other anal and intestinal diseases such as colorectal carcinoma, colitis; Meet above-mentioned diagnostic criteria but the person that needs operative treatment.
2 therapeutic schemes
2.1 matched groups are used Moschus ZHICHUANG GAO.Before each medication, all clean affected part, plug anus, each 1, every day 2 times, use just before going to bed or after an action of the bowels, treat altogether 2 weeks.
2.2 treatment groups are used nano-emulsion situ-gel of the present invention.Before each medication, all clean affected part, inject rectum, each 5ml, every day 2 times, is used just before going to bed or after an action of the bowels, treats altogether 2 weeks.
3 observation index and statistical method
3.1 observation index
3.1.1 health giving quality index
3.1.1.1 0 point of pain measurement: disappear without pain after pain or treatment; 2 points: during defecation, occasionally have pain; 4 points: pain is intermittent, can tolerate; 6 points: pain is persistence, endurable, needs analgesic.
3.1.1.2 0 point of external hemorrhoid swelling: without edema redness; 2 points: edema; 4 points: redness; 6 points: external hemorrhoid surface is red and swollen rotten to the corn.
3.1.1.3 deviate from 0 point: without swollen thing, deviate from or treat afterwards to disappear; 2 points: swollen thing is deviate from anus external enwergy self-resetting after an action of the bowels; 4 points: the rear or hand rest reset of deviating to need to have a rest when defecation or increase abdominal pressure; 6 points: the thing generation strangulation incarceration of deviating to swell, can not reset.
3.1.1.4 0 point of rectal tenesmus: anus is without falling inflation; 2 points: occasionally there is sensation of fullness in anus, just obviously front; 4 points: in anus, distension is obvious, is persistence; 6 points: the interior falling inflation sense of anus is heavier, desiring defecation constantly, wants just not understand.
3.1.1.5 have blood in stool 0 point: without having blood in stool or having blood in stool, stop; 2 points: have blood in stool and obviously reduce, the paper of occasionally having illicit sexual relations; 4 points: the minimizing of having blood in stool,, there is stool band blood in time or bleeds; 6 points: have blood in stool and have no minimizing, time has just, time penetrate blood.
3.1.1.6 blood stasis surface mucous changes 0 point: mucosa recovers normal or mild fibrosis; 2 points: mucosa mild hyperaemia; 4 points: mucosa hyperemia, fibrosis hypertrophy, but without erosion and petechia; 6 points: mucosal erosion, petechia.
3.1.2 the general health check-up project of safety indexes (body temperature, blood pressure, breathing, pulse), hematuria stool routine, darling renal function inspections etc., to begin a project all before medication and clinical research finishes rear each inspection once, observe untoward reaction at any time.
3.2 statistical method total datas are all through SPSS10.0 software processes, and measurement data adopts mean ± standard deviation, and (enumeration data adopts chi-square criterion for x ± s) represent, measurement data employing t check, and ranked data are checked with Ridit.
4 criterions of therapeutical effect and therapeutic outcome
4.1 criterions of therapeutical effect: evaluation of clinical curative effect is with reference to < < traditional Chinese medical science disease Standardization of diagnosis and curative effect > >;
Cure: symptom and sign disappears or substantially disappears;
Take a turn for the better: symptom and sign obviously improves;
Do not heal: symptom and sign has no improvement;
The comparison of 4.2 liang of group patient curative effects, in Table 1.
Table 1 liang group patient curative effect comparison
| Group | Cure | Take a turn for the better | Do not heal | Total effective rate |
| Treatment group (30) | 17 | 10 | 3 | 90.00% |
| Matched group (30) | 10 | 12 | 8 | 73.33% |
As seen from Table 1, in the routine patient for the treatment of group 30, cure 17 examples, effective 10 examples, invalid 3 examples, total effective rate is 90.00%; In the routine patient of matched group 30, cure 10 examples, effective 12 examples, invalid 8 examples, total effective rate is 73.33%.Through Ridit check, U=2.01, P=0.04, P<0.05, two groups of total effects comparing difference statistical significances.
Symptom score comparison before and after 4.3 liang of group patient treatments, in Table 2.
Symptom score comparison before and after table 2 liang group patient treatment (point, x ± s)
Note: compared with before the treatment of this group, * P < 0.05; * P < 0.01; Compared with after treatment of control group, △ P < 0.01.
As seen from Table 2, after two groups of treatments, before treatment, compare pain, have blood in stool, swelling, deviate from, blood stasis surface mucous changes symptom all obvious change (P < 0.05; P < 0.01); Pain after treatment group treatment, have blood in stool, swelling, deviate from, blood stasis surface mucous changes symptom score and matched group comparing difference has statistical significance (P < 0.01).
4.3 safety indexes are observed two groups of front and back of this clinical observation treatment general health check-up project of patient, the inspection of hematuria stool routine, cardiac inspection etc. and are had no significant change.Two groups of patients do not find the untoward reaction such as causalgia, pruritus, and through t check, before and after two groups of treatments, hepatic and renal function and routine blood test index of correlation are all without significant difference, and P>0.05, all has no significant effect hepatic and renal function and hemogram during pointing out two groups of medications.
Nano-emulsion situ-gel of the present invention is by ingredients such as Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis, Flos Chrysanthemi Indici, Borneolum Syntheticum, Mentholums.Take Radix Salviae Miltiorrhizae as monarch, bitter and be slightly cold in side, can blood circulation promoting and blood stasis dispelling, again can removing heat from blood eliminating carbuncle and control skin infection and swell and ache; Take the Radix Sophorae Flavescentis of bitter cold, toil and the Flos Chrysanthemi Indici being slightly cold as minister, heat-clearing and toxic substances removing, dampness, reducing swelling and alleviating pain, killing parasites for relieving itching.Assistant is with Borneolum Syntheticum, Mentholum, wind-dispelling heat-dissipating, promoting the circulation of QI pain relieving.Four medicines share the merit of playing altogether heat-clearing and toxic substances removing, dampness removing to stop itchin, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain.
The present invention makes nano-emulsion situ-gel according to certain technique, belongs to mucosal drug delivery system, and tool nano-emulsion and in-situ gel two-fold advantage not only can improve dissolubility, the percutaneous rate of medicine, and targeting can also reduce the zest of medicine; To occur to change mutually at agents area immediately after solution state administration, the non-chemically crosslinked semi-solid preparation forming, particularly mucous membrane tissue affinity is strong with agents area, holdup time is long, can significantly improve curative effect, increase patient's compliance, and prepare simple, easy to use, dosage and be easy to the advantages such as control.
Conclusion
By clearly surface of above-mentioned data, nano-emulsion situ-gel of the present invention not only can penetrate mucosa heat-clearing and toxic substances removing, dampness removing to stop itchin, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain; And can promote local blood circulation, and improve surrounding tissue nutrition, reach detumescence, antiinflammatory and analgesic object.The present invention fills a prescription rigorous, easy to use, curative effect is certain, pain after hemorrhoid patients is used, have blood in stool, swelling, deviate from, the symptom such as blood stasis surface mucous change all has clear improvement, and there is not side effect, hepatic and renal function, blood, urine, excrement etc. are all had no significant effect, and are the innovations on medicine for treaching hemorrhoie, have good economic and social benefit.
Claims (4)
1. treat the nano-emulsion situ-gel of hemorrhoid for one kind, it is characterized in that, by following weighing scale: Radix Sophorae Flavescentis 30-100g, Radix Salviae Miltiorrhizae 30-120g, Flos Chrysanthemi Indici 30-100g, Borneolum Syntheticum 1-8g, Mentholum 1-8g, polyoxyethylene castor oil 30-160g, dehydrated alcohol 10-80g, isopropyl myristate 5-60g, poloxamer188 60-160g and PLURONICS F87 5-80g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
2. the nano-emulsion situ-gel for the treatment of hemorrhoid according to claim 1, it is characterized in that, by following weighing scale: Radix Sophorae Flavescentis 65g, Radix Salviae Miltiorrhizae 110g, Flos Chrysanthemi Indici 65g, Borneolum Syntheticum 1.7g, Mentholum 3.6g, polyoxyethylene castor oil 100g, dehydrated alcohol 40g, isopropyl myristate 10g, poloxamer188 120g and PLURONICS F87 24g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
3. the nano-emulsion situ-gel for the treatment of hemorrhoid according to claim 1, it is characterized in that, by following weighing scale: Radix Sophorae Flavescentis 30g, Radix Salviae Miltiorrhizae 30g, Flos Chrysanthemi Indici 100g, Borneolum Syntheticum 8g, Mentholum 1g, polyoxyethylene castor oil 160g, dehydrated alcohol 10g, isopropyl myristate 60g, poloxamer188 60g and PLURONICS F87 5g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
4. the nano-emulsion situ-gel for the treatment of hemorrhoid according to claim 1, it is characterized in that, by following weighing scale: Radix Sophorae Flavescentis 100g, Radix Salviae Miltiorrhizae 120g, Flos Chrysanthemi Indici 30g, Borneolum Syntheticum 1g, Mentholum 8g, polyoxyethylene castor oil 30g, dehydrated alcohol 80g, isopropyl myristate 5g, poloxamer188 160g and PLURONICS F87 80g form; Wherein,
Flos Chrysanthemi Indici is added at every turn to the water of 14 times of Flos Chrysanthemi Indici weight, vapor distillation 4h, extracts to such an extent that Flos Chrysanthemi Indici volatile oil is standby, filters, and obtains water extraction liquid; Flos Chrysanthemi Indici medicinal residues are added to the ethanol of the mass fraction 50% of 14 times of Flos Chrysanthemi Indici weight, reflux, extract, 2 times, each 1h, merge alcohol extract, decompression recycling ethanol, merges with water extraction liquid, concentrated, adjust pH to 5, through AB-8 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 4BV eluting of mass fraction 50%, elution flow rate 2BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Flos Chrysanthemi Indici extract;
Radix Salviae Miltiorrhizae is added at every turn to the ethanol of the mass fraction 30% of 11 times of Radix Salviae Miltiorrhizae weight, reflux, extract, 3 times, each 0.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through D101 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 3.3BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Salviae Miltiorrhizae extract;
Radix Sophorae Flavescentis is added at every turn to the ethanol of the mass fraction 70% of 8 times of Radix Sophorae Flavescentis weight, reflux, extract, 3 times, each 1.5h, merge alcohol extract, decompression recycling ethanol, concentrated, through SP825 absorption with macroporous adsorbent resin, with the remove impurity of 2BV pure water eluting, with the ethanol 12BV eluting of mass fraction 50%, elution flow rate 1BV/h, eluent is concentrated, drying under reduced pressure becomes dry extract, pulverizes, and obtains Radix Sophorae Flavescentis extract;
The Flos Chrysanthemi Indici volatile oil of Borneolum Syntheticum, Mentholum, isopropyl myristate, extraction is put in dry beaker, and mix homogeneously, as oil phase; By polyoxyethylene castor oil, dehydrated alcohol, to put in dry beaker, mix homogeneously, as mixed surfactant; Radix Sophorae Flavescentis extract, Flos Chrysanthemi Indici extract, Radix Salviae Miltiorrhizae extract are placed in to purified water and dissolve, ultrasonic dispersion 40min, as water; Mixed surfactant is mixed homogeneously with oil phase, then add water, constantly stir, mend and add water to 1000g, obtain nano-emulsion;
Poloxamer188, PLURONICS F87 are added in the nano-emulsion of continuous stirring, be uniformly dispersed, swellingly mix completely in 4 ℃.
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| CN108743465A (en) * | 2018-06-08 | 2018-11-06 | 苏州思源天然产物研发有限公司 | Traditional Chinese medicine gel composition and its preparation method and application |
| CN110123925A (en) * | 2019-06-27 | 2019-08-16 | 河南中医药大学 | It is a kind of to treat hydrocephalic nasal nanometer emulsion in-situ gel and preparation method thereof |
| CN110693832A (en) * | 2019-10-12 | 2020-01-17 | 嘉应学院 | Cinnamomum camphora extract microemulsion gel and preparation method thereof |
| CN114452318A (en) * | 2022-02-22 | 2022-05-10 | 威高(北京)医疗科技有限公司 | Anti-inflammatory traditional Chinese medicine composition for sanitary products and preparation method and application thereof |
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| CN108743465A (en) * | 2018-06-08 | 2018-11-06 | 苏州思源天然产物研发有限公司 | Traditional Chinese medicine gel composition and its preparation method and application |
| CN110123925A (en) * | 2019-06-27 | 2019-08-16 | 河南中医药大学 | It is a kind of to treat hydrocephalic nasal nanometer emulsion in-situ gel and preparation method thereof |
| CN110693832A (en) * | 2019-10-12 | 2020-01-17 | 嘉应学院 | Cinnamomum camphora extract microemulsion gel and preparation method thereof |
| CN114452318A (en) * | 2022-02-22 | 2022-05-10 | 威高(北京)医疗科技有限公司 | Anti-inflammatory traditional Chinese medicine composition for sanitary products and preparation method and application thereof |
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