CN1299725C - Giant knotweed containing capsule for treating hepatitis B and preparation technique thereof - Google Patents
Giant knotweed containing capsule for treating hepatitis B and preparation technique thereof Download PDFInfo
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- CN1299725C CN1299725C CNB2004100650203A CN200410065020A CN1299725C CN 1299725 C CN1299725 C CN 1299725C CN B2004100650203 A CNB2004100650203 A CN B2004100650203A CN 200410065020 A CN200410065020 A CN 200410065020A CN 1299725 C CN1299725 C CN 1299725C
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Abstract
The present invention discloses giant knotweed capsules for treating hepatitis B and a preparing method thereof. The Chinese medicine is composed of 11 raw material medicines, such as giant knotweed, ants, isatis roots, artemisiae scopariae, astragalus roots, wolfberry fruits, red sage roots, schisandra fruits, bupleurum roots, jujube, notoginseng, etc. The preparing method comprises: mixing the poached concentrated solution of the ants, the poached concentrated solution of the astragalus roots, the wolfberry fruits and the jujube and the concentrated solution extracted from the giant knotweed, the isatis roots, the red sage roots, the schisandra fruits, the bupleurum roots, the artemisiae scopariae by using ethanol; mixing the mixture with ant powder and notoginseng powder; carrying out drying. The Chinese medicine provided by the present invention has the advantages of proper preparation, exact effect, small toxic and side function, safe medication, good curative effect and good biologic utilization prospect, and can treat both manifestation causes and root causes of diseases. Additionally, the resource of the ants is effectively developed. In the preparation method, the ants are pre-treated and processed, and extraction and separation are respectively carried out according to the physicochemical property of the effective components in medicinal materials, such as liver protection, transaminase lowering, body immune function improvement, etc. Residue can be used as auxiliary materials, and the content of the major components can be increased to improve curative effect and save cost.
Description
Technical field
The present invention relates to the Chinese medicine of a kind of treatment and prevention hepatitis B, particularly relate to a kind of pharmaceutical composition (to call " giant knotweed containing capsule for treating hepatitis B " in the following text) that is used for the treatment of hepatitis B, the invention still further relates to the preparation technology of this medicine.
Background technology
Hepatitis, especially hepatitis B are China's commonly encountered diseases, frequently-occurring disease, the serious harm people health.It is damp and hot pathogenic that motherland's medical science thinks that hepatitis mostly is impression, and damp and hot pathogenic factor is invaded human body, is reluctant to leave with the passing of time, in the latent body, it is dirty then easily to injure liver, spleen etc., and liver is a viscus of storing blood, and damp and hot delay continues not understand, must cause prolonged illness and blood, the stasis of blood liver network that stagnates, or the wet stasis of blood knot or heat stagnation blood stasis mutually.Spleen preferring dryness to dampness, damp and hot evil poison accumulates to hold back to hand over and steams, and hepatopathy and spleen are stranded and hold back middle Jiao, and it is strongly fragrant that soil is stopped up wood, certainly will cause the catharsis mistake department of liver, and the dysfunction of the spleen in transportation and transformation of spleen forms stagnation of liver-QI with deficiency of the spleen and arrive, the card of humid-heat stagnation.The Therapeutic Principle is a strengthening vital QI to eliminate pathogenic factors, harmonizing the liver and spleen, and the eliminating evil clearing away heat-damp and promoting diuresis that focuses on, blood stasis dispelling detoxifcation is set upright and is focused on the spleen invigorating nourishing the liver, and the Shu Da irritability makes its heresy eutopic reduction of dispelling, to reach the purpose of rehabilitation.
Doctor trained in Western medicine is also thought, the pathogeny of chronic viral hepatitis B, and the one, because hepatitis B virus (exopathogen) long-term existence, the 2nd, the disorder of body's immunity, the Therapeutic Principle is that antiviral therapy (eliminating evil) and immune modulating treatment (setting upright) are taken into account.
At present hepatitis B is not still had the specific treatment medicine, on the market various medicines also curative effect differ, emphasize particularly on different fields.
Summary of the invention
The purpose of this invention is to provide a kind of few side effects, good effect, cost low, to the giant knotweed containing capsule for treating hepatitis B of hepatitis B treating both the principal and secondary aspects of a disease.
Another object of the present invention provides the preparation technology of this medicine.
Technical scheme of the present invention is to utilize the clear superiority of motherland's medical science, by organic compatibility of multiple medicine, reaches the effect of eliminating pathogenic factor for supporting vital QI, treating both the principal and secondary aspects of a disease.
The present invention by Rhizoma Polygoni Cuspidati, Formica fusca, Radix Isatidis, Herba Artemisiae Scopariae, the Radix Astragali, Fructus Lycii, Radix Salviae Miltiorrhizae, Radix Notoginseng, Fructus Jujubae, Fructus Schisandrae Chinensis, Radix Bupleuri etc. ten simply Chinese medicine form, Rhizoma Polygoni Cuspidati heat-clearing and toxic substances removing wherein, the dampness removing jaundice eliminating, be equipped with Herba Artemisiae Scopariae, Radix Bupleuri, Radix Isatidis, use its heat-clearing and toxic substances removing, promoting the function of the gallbladder to alleviate jaundice, suppress virus, soothing the liver, resolving depression pain relieving, hepatoprotective and promote hepatocellular repair; Add the Radix Astragali, Fructus Lycii, Fructus Schisandrae Chinensis, Fructus Jujubae, the benefiting action of tool supplementing QI and nourishing YIN, the phagocytosis of enhancing skein cell improves body's immunological function, reaches hepatoprotective and falls enzyme, prevents the effect that liver glycogen reduces; Radix Salviae Miltiorrhizae, Radix Notoginseng tool blood circulation promoting and blood stasis dispelling, pain relieving, microcirculation improvement improves the body oxygen-resistant ability, promotes tissue repair, dwindles the liver spleen of softening enlargement, reduces the effect of fibrosis; The effect of Formica fusca tool strengthening the body resistance liver-nourishing kidney-boosting, the antiinflammatory liver protection effect is also arranged, the intravital cursive script formaldehyde of Formica fusca can be regulated the human body function of immune system, Formica fusca also contains more protein, aminoacid and multivitamin, trace element and enzyme, triterpenoid compound, has hepatoprotective, falls enzyme, increases the effect of immune function.
In sum, our with the Rhizoma Polygoni Cuspidati heat-clearing and toxic substances removing, dampness removing jaundice eliminating, blood circulation promoting and blood stasis dispelling; The Formica fusca liver-nourishing kidney-boosting, kidney nourishing and strengthening, two medicines close and are monarch, help eliminating evil and complementary potentiation that set upright.Radix Isatidis, the detoxifcation of Herba Artemisiae Scopariae clearing away heat-damp and promoting diuresis; The Radix Astragali, Fructus Lycii QI invigorating spleen reinforcing nourishing the liver are ministerial drug altogether, and the former two helps Rhizoma Polygoni Cuspidati to clear away the dampness and heat, and the latter two help the Formica fusca tonify deficiency to keep fit.Assistant is with Radix Salviae Miltiorrhizae, Radix Notoginseng, blood circulation promoting and blood stasis dispelling, hepatoprotective collateral dredging, Fructus Jujubae, Fructus Schisandrae Chinensis spleen reinforcing nourishing the liver.Radix Bupleuri is gone into Liver Channel with dispersing the stagnated live-QI to relieve the stagnation of QI, and the accent blood of regulating the flow of vital energy makes for assistant is double.Full side is eliminating evil to mutually combine with setting upright, can clearing away heat-damp and promoting diuresis, and blood circulation promoting and blood stasis dispelling is evil to remove, again can be to asthenia of liver and spleen, the adulterated pathological characteristic Comprehensive Treatment of deficiency and excess.
Purpose of the present invention can realize by following measures:
Giant knotweed containing capsule for treating hepatitis B, it is mainly to be made by following bulk drugs:
Rhizoma Polygoni Cuspidati 1.77-5.32 part, Formica fusca 0.75-2.3 part, Radix Isatidis 0.89-2.67 part, Herba Artemisiae Scopariae 0.7-2 part, Radix Astragali 0.45-1.34 part, Fructus Lycii 0.35-1.06 part, Radix Salviae Miltiorrhizae 0.45-1.34 part, Radix Notoginseng 0.05-0.14 part, Fructus Jujubae 0.13-0.4 part, Fructus Schisandrae Chinensis 0.35-1.06 part, Radix Bupleuri 0.35-1.06 part.
Described giant knotweed containing capsule for treating hepatitis B, wherein each bulk drugs is preferred:
2.66 parts of Rhizoma Polygoni Cuspidati, 1.15 parts of Formica fuscas, 1.33 parts of Radix Isatidis, 1 part of Herba Artemisiae Scopariae, 0.67 part of the Radix Astragali, 0.53 part of Fructus Lycii, 0.67 part of Radix Salviae Miltiorrhizae, 0.07 part of Radix Notoginseng, 0.2 part in Fructus Jujubae, 0.53 part of Fructus Schisandrae Chinensis, 0.53 part of Radix Bupleuri.
Described giant knotweed containing capsule for treating hepatitis B, wherein used Formica fusca raw material is a Formica fusca.
The preparation technology of described giant knotweed containing capsule for treating hepatitis B comprises the following step:
A. get after Radix Notoginseng washes by prescription, oven dry is pulverized, and squirts with 60-90% ethanol, and airtight placements 12-36 hour taken out, 60-100 ℃ of oven dry, the 50-250 mesh sieve, get Radix Notoginseng powder, standby;
B. get the Formica fusca removal of impurity by prescription, clean, decoct with water 1-3 time, 1-3 hour at every turn, filter, merging filtrate, surveying relative density when being concentrated into 30-60 ℃ is the concentrated solution of 1.1-1.4, powder is beaten in the medicinal residues oven dry, crosses the 30-80 mesh sieve, gets Formica fusca powder, and is standby;
C. get the Radix Astragali, Fructus Lycii, Fructus Jujubae by prescription and decoct with water 1-3 time, each 1-3 hour, filter, it is standby to keep medicinal residues, gets to survey relative density when filtrate merging being concentrated into 30-60 ℃ and be the concentrated solution of 1.1-1.4, standby;
D. get Rhizoma Polygoni Cuspidati, Radix Isatidis, Herba Artemisiae Scopariae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Bupleuri and step c gained medicinal residues by prescription, add 60-90% alcohol reflux 1-3 time, each 1-4 doubly measures, extracted 1-3 hour, filter, merge extractive liquid, is surveyed relative density to being the concentrated solution of 1.1-1.4 relatively when being concentrated into 30-60 ℃, simultaneously, reclaim ethanol;
E. above-mentioned steps b, c, each concentrated solution of d gained are merged,, add appropriate amount of auxiliary materials, make capsule with step a, b gained Radix Notoginseng powder, Formica fusca powder mixing, drying.
The pulverizing of Radix Notoginseng can be that micropowder is pulverized among the described step of preparation process a, crosses the 100-250 mesh sieve; Or the room temperature fine powder is pulverized.
Among the described preparation technology gained concentrated solution among the step b is become powder in subzero 10 ℃～subzero 20 ℃ of lyophilizations, standby.
Respectively gained concentrated solution among step c, the d is spray dried to fine powder among the described preparation technology, standby.
Respectively with gained concentrated solution drying among step c, the d, room temperature is ground into fine powder, and is standby among the described preparation technology.
Fine powder in this description refers to meet all sieving (80 order) and contain by No. five and can be no less than 95% powder by No. six sieves (100 order) of pharmacopeia (calendar year 2001 version) regulation.
Beneficial effect of the present invention:
Chinese prescription provided by the invention is precise and appropriate, treating both the principal and secondary aspects of a disease, definite effect, toxic and side effects is little, drug safety, and to select the Formica fusca of one of principal agent in the medicine for use be the resources effective exploitation, has good curative effect and biological utilisation prospect, this medicine not only can be used for treatment and prevention hepatitis B, but also has the effect of improving fatty liver and liver cirrhosis; Formica fusca carries out pre-treatment processing in the preparation method, and carrying out extraction separation according to hepatoprotective in the medical material, the physicochemical property of falling the effective ingredient of effects such as enzyme, human body immunity improving function, its residue has improved the content of Main Ingredients and Appearance also as adjuvant, increase curative effect, saved cost.
Below animal experiment situation by medicine giant knotweed containing capsule for treating hepatitis B of the present invention further specify beneficial effect of the present invention.
Pharmacodynamics test of the present invention:
Laboratory animal: Kunming mouse, 18-25g; The SD rat, 130-150g; Sheldrake, at 12 monthly ages, average weight and sex ratio are close, raise under the same conditions.
The experiment medicine:
1, giant knotweed containing capsule for treating hepatitis B: press embodiment 1 preparation, be made into suspension, (be equivalent to 2.34g crude drug/kg) and 1g/kg and (be equivalent to 4.67g crude drug/kg) administration by 0.5g/kg respectively with 1%CMC (carboxymethyl cellulose).(annotate: according to the Chinese medicine naming rule, " tiger " in " giant knotweed containing capsule for treating hepatitis B " represents Rhizoma Polygoni Cuspidati, and " coltfoal " represents XUANJU, i.e. Formica fusca, more than two word tables show that the used monarch drug of this medicine is Rhizoma Polygoni Cuspidati and Formica fusca; " hepatitis B " expression can be used for treatment and prevention hepatitis B; " capsule " expression dosage form.)
2, Bifendate Tablet: Wujiang, Jiangsu pharmaceutical factory produces.
3, acyclovir slice: the Yellow River, Shanghai pharmaceutical factory produces.
Method and result:
One, giant knotweed containing capsule for treating hepatitis B is to carbon tetrachloride (CCL
4) cause the influence of mouse liver injury
Get 50 of mices, male and female half and half, body weight 23 ± 2g is equally divided into 5 groups, two groups of giant knotweed containing capsule for treating hepatitis B, irritate stomach respectively and give 0.5g/kg and 1g/kg, the bifendate group is irritated stomach and is given 100mg/kg, model group and normal control group, irritate stomach respectively and give distilled water, once a day, continuous 10 days, last administration pneumoretroperitoneum injection 0.1%CCL
4Olive oil 10ml/kg (the normal control group is not injected), water is can't help in fasting, sacrificed by decapitation animal after 20 hours, collect blood, separation of serum is measured aspartic acid aminotransferase (AST) and ALT (ALT), the results are shown in Table 1, and the same leaf liver of getting every animal does pathology section, carries out the tectology inspection.
Table 1 giant knotweed containing capsule for treating hepatitis B is to CCL
4Cause the influence (x ± SD IU/L) of mouse liver injury
| Group | Dosage (g/kg) | Number of animals (only) | ALT | AST |
| The normal control group | - | 10 | 39.75±6.51 | 54.93±13.61 |
| Model group | - | 10 | 130.25±55.23 | 192.26±57.68 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 80.63±31.65* | 128.68±46.94* |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 54.75±16.78* | 95.78±24.31** |
| The bifendate group | 100mg/kg | 10 | 46.18±12.34** | 72.55±18.29** |
Compare with model group:
*P＜0.05
*P＜0.01
The result shows that giant knotweed containing capsule for treating hepatitis B has tangible effect of reducing enzyme levels, and acts on enhancing with the dosage increasing.
The liver organization morphological examination shows that the normal group no abnormality seen changes; The visible lobules of liver structure disturbance of model group, the general swelling of hepatocyte, and agglomerating arrangement, and visible little focal necrosis, major part is a lytic necrosis, there is inflammatory cell infiltration at downright bad place, two groups of giant knotweed containing capsule for treating hepatitis B and bifendate treated animal lesion degree and scope obviously alleviate than model group, the lobules of liver structure is complete substantially, and hepatocyte is strand arranges, and only has part of hepatocytes slight degeneration and spotty necrosis to occur.
Two, giant knotweed containing capsule for treating hepatitis B is to CCL
4Cause the influence of rats'liver damage
Get 50 of rats, male and female half and half, body weight 140 ± 10g is equally divided into 5 groups, two groups of giant knotweed containing capsule for treating hepatitis B, irritate stomach respectively and give 0.5g/kg and 1g/kg, the bifendate group is irritated stomach and is given 100mg/kg, model group and normal control group, irritate stomach respectively and give distilled water, once a day, continuous 10 days, last administration pneumoretroperitoneum injection 0.1%CCL
4Olive oil 10ml/kg (the normal control group is not injected), water is can't help in fasting, and broken end is got blood after 20 hours, and separation of serum is measured AST and ALT (the results are shown in Table 2), and the same leaf liver of getting every animal does the pathology section, carries out the tectology inspection.
Table 2 giant knotweed containing capsule for treating hepatitis B is to CCL
4Cause the influence (x ± SD IU/L) of rats'liver damage
| Group | Dosage (g/kg) | Number of animals (only) | ALT | AST |
| The normal control group | - | 10 | 30.71±4.68 | 42.44±8.96 |
| Model group | - | 10 | 116.48±41.07 | 171.93±56.38 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 80.24±28.04* | 116.89±43.84* |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 51.87±14.69** | 83.49±35.84** |
| The bifendate group | 100mg/kg | 10 | 44.17±12.03** | 65.78±28.81** |
Compare with model group:
*P＜0.05
*P＜0.01
The result shows that giant knotweed containing capsule for treating hepatitis B has obvious effect of reducing enzyme levels, and acts on enhancing with the dosage increasing.The liver organization morphological examination shows, the normal group no abnormality seen changes, the visible swelling of liver cell of model group, cell outline is unclear, sinus hepaticus narrows down, and visible little focal necrosis, two groups of giant knotweed containing capsule for treating hepatitis B and bifendate treated animal lesion degree and scope obviously alleviate than model group, and hepatocyte only has part point-like degeneration necrosis and do not have focal necrosis.
Three, giant knotweed containing capsule for treating hepatitis B causes the influence of rats'liver damage to D-Gal
Get 50 of rats, male and female half and half, body weight 140 ± 10g, be equally divided into 5 groups, two groups of giant knotweed containing capsule for treating hepatitis B are irritated stomach respectively and are given 0.5g/kg and 1g/kg, the bifendate group is irritated stomach and is given 100mg/kg, model group and normal control group are irritated stomach respectively and are given distilled water, once a day, continuous 10 days, last administration pneumoretroperitoneum injection D-Gal 400ml/kg (the normal control group is not injected), water is can't help in fasting, and broken end is got blood after 20 hours, separation of serum, measure AST and ALT (the results are shown in Table 3), and the same leaf liver of getting every animal does the pathology section, carry out the tectology inspection.
Table 3 giant knotweed containing capsule for treating hepatitis B causes the influence (x ± SD IU/L) of rats'liver damage to D-Gal
| Group | Dosage (g/kg) | Number of animals (only) | ALT | AST |
| The normal control group | - | 10 | 42.94±7.86 | 56.78±15.23 |
| Model group | - | 10 | 176.34±41.28 | 187.28±51.36 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 135.17±33.65* | 141.46±35.73* |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 67.72±15.53** | 75.09±18.71** |
| The bifendate group | 100mg/kg | 10 | 71.42±18.12** | 81.36±20.24** |
Compare with model group:
*P＜0.05
*P＜0.01
The result shows that giant knotweed containing capsule for treating hepatitis B has obvious effect of reducing enzyme levels, and acts on enhancing with the dosage increasing.The liver organization morphological examination shows, the normal group no abnormality seen changes, the obvious swelling of the visible hepatocyte of model group, and it is extensively downright bad, two treated animal hepatic lesions of giant knotweed containing capsule for treating hepatitis B degree obviously is lighter than model group, and visible Kupffer cell hypertrophy, two treated animal hepatic injury degree, heavy dose of group obviously is lighter than small dose group, and bifendate treated animal lesion degree is similar to the heavy dose of group of giant knotweed containing capsule for treating hepatitis B.
Four, giant knotweed containing capsule for treating hepatitis B is to CCL
4Bring out the cirrhotic influence of rat
Get 90 of rats, male and female half and half, body weight 130 ± 10g is divided into 5 groups by close body weight, removes the normal control group and (does not inject CCL
4) be outside 10, all the other each groups are 20, respectively at subcutaneous injection 10%CCL
4Olive oil 5ml/kg, secondary weekly, continuous 3 months, in injection CCL
4Rose in 3 months, the beginning administration is irritated stomach respectively and is given giant knotweed containing capsule for treating hepatitis B 0.5g/kg, 1g/kg and bifendate 100mg/kg, model group and normal control group are irritated stomach respectively and are given distilled water 10ml/kg, once a day, and successive administration 2 months, after the last administration 24 hours, get respectively and respectively organize 10 animals, broken end is got blood, separation of serum, measure AST, ALT, total protein, albumin, A/G ratio, the results are shown in Table 4, and get the same leaf liver of each Mus and do the pathology section, carry out the tectology inspection.
Table 4 giant knotweed containing capsule for treating hepatitis B is to CCL
4Bring out rats'liver damage influence (n=10, x ± SD, IU/L)
| Group | Dosage (g/kg) | ALT (IU/L) | AST (IU/L) | Total protein | Albumin | A/G | Pathological change | ||
| Degeneration | Downright bad | Cirrhosis | |||||||
| The normal control group | - | 28.12 ±3.87 | 35.83 ±5.61 | 67.48 ±5.01 | 36.87 ±4.10 | 1.20/1 | 0 | 0 | 0 |
| Model group | - | 89.76 ± 25.39 | 114.37 ±46.81 | 48.21 ±7.16 | 21.96 ±4.93 | 0.84/1 | 10/ 10 | 6/10 | 7/10 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 78.58 ± 18.62 | 87.01 ±36.42 | 51.35 ±6.64 | 26.09 ±5.31 | 1.03/1 | 6/10 | 3/10 | 4/10 |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 59.86 ± 15.49 * | 62.71 ± 22.46 * | 59.77 ±8.32 * | 32.17 ±5.64 * | 1.17/1 | 4/10 | 1/10 | 2/10 |
| The bifendate group | 100 mg/kg | 42.51 ± 14.38 * | 58.64 ± 21.76 * | 61.18 ±5.14 * | 28.41 ±4.86 * | 1.15/1 | 1/10 | 1/10 | 1/10 |
Compare with model group:
*P＜0.05
The result shows that giant knotweed containing capsule for treating hepatitis B 1g/kg group and bifendate group have the liver function of improvement, fall effects such as enzyme and rising protein content, and liver parenchyma sexually transmitted disease (STD) reason is changed the effect of having clear improvement.
Five, giant knotweed containing capsule for treating hepatitis B is to the influence of rat bile secretory volume
Get 40 of rats, body weight 250 ± 10g, male and female half and half, earlier with urethane 1g/kg intraperitoneal injection of anesthesia animal, animal is fixed on the rat fixing head respectively, open the abdominal cavity, in ductus choledochus, insert drainage tube, collect 1 hour bile, animal is divided into 4 groups then, giant knotweed containing capsule for treating hepatitis B is irritated stomach respectively for two groups and is given 0.5g/kg, 1g/kg, the bifendate group is irritated stomach and is given 100mg/kg, the blank group is irritated stomach and is given distilled water, continue after the administration to collect bile 4 hours, per hour write down bile once, and irritate stomach and give 5% glucose saline 5ml/kg once, the results are shown in Table 5.
Table 5 giant knotweed containing capsule for treating hepatitis B is to the influence of rat bile secretory volume (x ± SD)
| Group | Dosage (g/kg) | Bile flow (ml/hkg, x ± SD) | |||||
| Number of animals (only) | Before the administration | After the administration (h) | |||||
| 1h | 1 | 2 | 3 | 4 | |||
| The blank group | - | 10 | 1.68± 0.20 | 1.63± 0.21 | 1.61± 0.19 | 1.46± 0.19 | 1.34± 0.16 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 1.63± 0.18 | 1.79± 0.12 | 1.88± 0.15** | 1.81± 0.11* | 1.61± 0.09 |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 1.66± 0.16 | 1.91± 0.18 | 2.08± 0.21** | 1.85± 0.20* | 1.72± 0.15 |
| The bifendate group | 100mg /kg | 10 | 1.61± 0.15 | 1,75± 0.18 | 1.78± 0.14 | 1.76± 0.17 | 1.74± 0.16 |
Compare before and after the administration:
*P＜0.05
*P＜0.01
Six, giant knotweed containing capsule for treating hepatitis B is to the influence of mice carbon clearance function
Get 40 of mices, body weight 19 ± 1g, male and female half and half are divided into 4 groups, and two groups of giant knotweed containing capsule for treating hepatitis B are irritated stomach respectively and given 0.5g/kg, 1g/kg, bifendate group and irritate that stomach gives 100mg/kg, the blank group is irritated stomach and given distilled water, once a day, continuous 7 days, the 8th day tail vein injection india ink (normal saline dilution in 1: 1.5) 10ml/kg injected back 1 minute and 5 minutes, get blood 20 μ l from eye socket respectively, add 0.1%Na
2CO
3Shake up among the solution 2ml, then with spectrophotometer in 680nm place colorimetric, measure optical density (OD), get simultaneously that each Hepar Mus is dirty weighs, and calculate and clean up index (K value) and phagocytic index (a value), the results are shown in Table 6.
Table 6 giant knotweed containing capsule for treating hepatitis B is to the influence of mice carbon clearance function (x ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | The K value | The a value |
| The blank group | - | 10 | 0.070±0.043 | 0.019±0.008 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 0.093±0.07 | 0.022±0.010 |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 0.107±0.09* | 0.031±0.011* |
| The bifendate group | 100mg/kg | 10 | 1.100±0.08* | 0.038±0.013* |
Compare with the blank group:
*P＜0.05
The result shows, what giant knotweed containing capsule for treating hepatitis B can obviously improve the mice carbon granules cleans up the exponential sum phagocytic index, shows that it has potentiation to the reticuloendothelial system phagocytic function.
Seven, giant knotweed containing capsule for treating hepatitis B is to the influence of mice serum hemolysin formation
Get 40 of mices, body weight 23 ± 1g, male and female half and half are divided into 4 groups, two groups of giant knotweed containing capsule for treating hepatitis B are irritated stomach respectively and are given 0.5g/kg, 1g/kg, bifendate group and irritate that stomach gives 100mg/kg, the blank group is irritated stomach and given distilled water, once a day, continuous 7 days, administration the 3rd day was in every Mus lumbar injection 20% sheep hemocyte (SRBC) 0.2ml, immunity back the 5th day, eye socket is got blood, and separation of serum is observed SRBC half hemolysis value (HC
50), the results are shown in Table 7.
The influence that table 7 giant knotweed containing capsule for treating hepatitis B forms the mice serum hemolysin (x ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | HC 50 |
| The blank group | - | 10 | 205±87 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 214±60 |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 289±71* |
| The bifendate group | 100mg/kg | 10 | 243±64 |
Compare with the blank group:
*P＜0.05
The result shows that giant knotweed containing capsule for treating hepatitis B has increases the effect that the mice serum hemolysin forms.
Eight, giant knotweed containing capsule for treating hepatitis B is to the active influence of mice serum total complement
Get 40 of mices, body weight 23 ± 1g, male and female half and half, be divided into 4 groups, two groups of giant knotweed containing capsule for treating hepatitis B are irritated stomach respectively and are given 0.5g/kg, 1g/kg, bifendate group and irritate that stomach gives 100mg/kg, the blank group is irritated stomach and given distilled water, once a day, and continuous 7 days, measure total complement activity in the serum with 50% hemolytic test method then, the results are shown in Table 8.
Table 8 giant knotweed containing capsule for treating hepatitis B is to the active influence of mice serum total complement (x ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | Total complement of serum content (unit/ml) |
| The blank group | - | 10 | 64.6±18.7 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 70.2±21.5 |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 86.3±20.9* |
| The bifendate group | 100mg/kg | 10 | 72.6±23.4 |
Compare with the blank group:
*P＜0.05
The result shows that the heavy dose of group of giant knotweed containing capsule for treating hepatitis B has the active effect of the mice serum total complement of increasing.
Nine, giant knotweed containing capsule for treating hepatitis B brings out the influence of mice delayed allergy to dinitrofluorobenzene (DNFB)
Get 40 of mices, body weight 22 ± 1g, male and female half and half are earlier with animal abdominal part depilation (3 * 3cm
2), be divided into 4 groups then, giant knotweed containing capsule for treating hepatitis B is irritated stomach respectively for two groups and is given 0.5g/kg, 1g/kg, the bifendate group is irritated stomach and is given 100mg/kg, the blank group is irritated stomach and is given distilled water, once a day, continuous 5 days, administration first day is evenly smeared 1%DNFB50 μ l in each Mus abdominal part depilation place, sensitized animal, after the sensitization the 5th day,, evenly be applied in mouse right ear and attack 1%DNFB10 μ l, put to death animal after 24 hours, with diameter is that the card punch of 9mm is got one of auricle (left and right sides ear same area) respectively, weighs, and gets each Mus spleen simultaneously and weighs, difference with left and right sides auricle weight is the swelling degree, and with the spleen of every 10g mice heavy (mg) as spleen index, calculate group difference at last, the results are shown in Table 9.
Table 9 giant knotweed containing capsule for treating hepatitis B brings out the influence (x ± SD) of mice delayed allergy to dinitrofluorobenzene
| Group | Dosage (g/kg) | Number of animals (only) | The ear method of double differences (mg) | Spleen index (mg) |
| The blank group | - | 10 | 3.375±1.93 | 40.01±9.68 |
| The giant knotweed containing capsule for treating hepatitis B group | 0.5 | 10 | 1.816±0.89* | 52.32±14.21* |
| The giant knotweed containing capsule for treating hepatitis B group | 1.0 | 10 | 1.065±0.678** | 63.48±21.53** |
| The bifendate group | 100mg/kg | 10 | 2.045±0913* | 49.47±16.58* |
Compare with the blank group:
*P＜0.05
*P＜0.01
The result shows, the mice delayed allergy that the obvious inhibition of giant knotweed containing capsule for treating hepatitis B is brought out by dinitrofluorobenzene.
Brief summary:
Above-mentioned experimental result shows, giant knotweed containing capsule for treating hepatitis B is to by CCL
4, the mice that causes of D-Gal, rats'liver damage, have tangible effect of reducing enzyme levels and improve the effect of liver organization pathological changes, its action intensity all strengthens with dosage, and in addition, giant knotweed containing capsule for treating hepatitis B also has the effect and the choleretic effect of certain adjusting immunologic function.
Ten, the present invention is to the medicine inhibition test of duck hepatitis-B animal model
Adopt vertical transmission infected duck hepatitis B virus (DHBV), DHBV-DNA to detect positive sheldrake, set up 6 groups separately, each group is 12 December sheldrakes of selecting at random in age, basic, normal, high three dosage of giant knotweed containing capsule for treating hepatitis B (being respectively 0.2g/kg, 0.6g/kg, 1.8g/kg) group and positive drug (acyclovir 100mg/kg) matched group, the administration of oral cavity route feed, 3 administrations next day of weekly, continuous 12 weeks; Each one in DHBV-DNA (+) matched group and the equal feed lactasinum of DHBV-DNA (-) matched group tablet, continuous 12 weeks.Below respectively organize sheldrake respectively before administration, second all venous blood collections after the administration around, after the 8th week, the 12 week and the drug withdrawal, method (Chen Yuanqing etc. according to foundation such as Chen Yuanqing, China's infectious disease magazine [1983] 1 (2) 163), do the DHBV-DNA dot blot hybridization test (the results are shown in Table 10) of serum.In second week of drug withdrawal, each is organized sheldrake blood-letting simultaneously and causes death and get liver, and puts formalin fixed liquid and 2.5% glutaraldehyde fixative is preserved, and makes duck liver routine pathology inspection (the results are shown in Table 11 and Fig. 1-6) and electron microscopic examination (the results are shown in Figure 7-12) respectively.
Table 10 giant knotweed containing capsule for treating hepatitis B is to the influence of sheldrake serum DHBV-DNA content
| Group | Dosage | Number of animals | Blood sampling time | Statistical test | ||||
| Before the administration | After the administration | After the drug withdrawal | ||||||
| The 4th week | The 8th week | The 12nd week | The 2nd week | |||||
| The giant knotweed containing capsule for treating hepatitis B low dose group | 0.2g/kg | A1 | ++ | + | - | - | +++ | P＜0.05 |
| A2 | + | - | + | - | - | |||
| A3 | ++ | +++ | +++ | + | + | |||
| A4 | + | + | + | + | - | |||
| A5 | + | - | - | - | - | |||
| A6 | + | ++ | +++ | - | + | |||
| A7 | + | + | + | - | - | |||
| A8 | + | + | +++ | - | + | |||
| A9 | + | + | - | - | - | |||
| A10 | + | - | - | - | - | |||
| A11 | + | +++ | + | ++ | +++ | |||
| A12 | +++ | ++ | + | - | - | |||
| Dosage group in the giant knotweed containing capsule for treating hepatitis B | 0.6g/kg | B1 | ++ | ++ | ++ | - | + | P＜0.05 |
| B2 | +++ | ++ | ++ | + | ++ | |||
| B3 | + | - | ++ | - | - | |||
| B4 | + | ++ | ++ | ++ | - | |||
| B5 | + | - | - | - | - | |||
| B6 | + | + | - | - | + | |||
| B7 | ++++ | ++++ | ++++ | ++++ | ++++ | |||
| B8 | + | + | + | +++ | ++ | |||
| B9 | +++ | ++ | +++ | + | ++ | |||
| B10 | + | +++ | ++ | ++ | + | |||
| B11 | ++ | + | - | - | - | |||
| B12 | ++ | + | ++ | - | ++ | |||
| The giant knotweed containing capsule for treating hepatitis B high dose group | 1.8g/kg | C1 | + | + | ++ | + | ++ | P＜0.05 |
| C2 | +++ | + | - | - | - | |||
| C3 | + | ++ | ++ | + | ++ | |||
| C4 | ++ | + | +++ | +++ | +++ | |||
| C5 | + | + | ++ | - | - | |||
| C6 | + | - | - | - | - | |||
| C7 | + | + | ++ | - | + | |||
| C8 | + | + | + | - | - | |||
| C9 | + | - | - | - | - | |||
| C10 | + | - | + | - | +++ | |||
| C11 | + | + | + | + | - | |||
| C12 | + | ++ | + | + | + | |||
| DHBV-DN | D1 | + | + | + | ++ | ++++ | P＞0.05 | |
| A (+) matched group | D2 | + | - | - | - | - | ||
| D3 | +++ | - | + | ++ | + | |||
| D4 | +++ | ++++ | ++++ | + | - | |||
| D5 | ++ | +++ | + | + | + | |||
| D6 | ++ | + | + | + | + | |||
| D7 | + | + | + | + | + | |||
| D8 | ++ | ++ | +++ | +++ | ++ | |||
| D9 | + | + | + | + | + | |||
| D10 | + | + | + | + | + | |||
| D11 | + | + | + | + | - | |||
| D12 | ++++ | ++ | +++ | +++ | ++++ | |||
| DHBV-DN A (+) matched group | E1 | - | - | - | - | - | P＞0.05 | |
| E2 | - | ++ | - | - | + | |||
| E3 | - | - | - | - | - | |||
| E4 | - | - | - | - | - | |||
| E5 | - | - | - | - | - | |||
| E6 | - | - | - | - | - | |||
| E7 | - | - | - | - | - | |||
| E8 | - | - | - | - | - | |||
| E9 | - | - | - | - | - | |||
| E10 | - | - | - | - | - | |||
| E11 | - | - | - | - | - | |||
| E12 | - | - | - | - | - | |||
| The acyclovir matched group | 100mg/ kg | F1 | ++++ | - | + | + | - | P＜0.01 |
| F2 | +++ | - | + | + | + | |||
| F3 | +++ | + | - | - | + | |||
| F4 | ++ | + | + | + | ++ | |||
| F5 | + | - | - | - | - | |||
| F6 | + | - | - | - | - | |||
| F7 | + | - | - | - | - | |||
| F8 | + | - | - | - | + | |||
| F9 | + | - | - | - | - | |||
| F10 | + | - | + | + | + | |||
| F11 | ++ | - | - | - | +++ | |||
| F12 | + | - | + | + | + |
In the table ++ ++ being equivalent to DHBV-DNA content is 100pg; +++be 50pg; ++ be 25pg; + be 10pg.
Tabular data as variance analysis, has significant difference before and after the medication after the natural logrithm conversion.
The result shows that various dose group sheldrake serum DHBV-DNA content of the present invention has apparent in view variation before and after medication, and the DHBV-DNA average content of medication period three group all has decline in various degree.In medication 12 during week, each group has 6-9 sheldrake serum DHBV-DNA to transfer feminine gender to respectively, negative conversion rate is respectively 75%, 50%, 58.33%, the prompting giant knotweed containing capsule for treating hepatitis B has significantly antivirus action, can suppress duplicating of DHBV-DNA, reduce the content of serum DHBV-DNA, even the level when finding the serum DHBV-DNA content of three medicine group sheldrakes in addition the 2nd week still can be maintained at drug withdrawal substantially after drug withdrawal, do not see some drugs (as foscarnet sodium and acyclovir) obviously " knock-on " or rise phenomenon after the common drug withdrawal, show that giant knotweed containing capsule for treating hepatitis B has the effect that continues the inhibition virus replication preferably.In this experiment, DHBV-DNA (+) is though matched group sheldrake serum DHBV-DNA content slightly changes, and statistical test does not have the significance meaning, has compared significant difference with the variation of medicine group.
Experimental group and matched group duck liver pathology inflammatory activity are relatively under table 11 light microscopic
| Group | The grade weight | Add up to | Weighted average | |||||
| ± | ±～+ | + | +～++ | ++ | ++～+++ | |||
| 0.25 | 0.5 | 1.0 | 1.5 | 2.0 | 2.5 | |||
| DHBV-DNA (-) group | 2 | 5 | 5 | 0 | 0 | 0 | 12 | 0.5625 |
| DHBV-DNA (+) group | 0 | 2 | 6 | 0 | 1 | 3 | 12 | 1.0833 |
| The acyclovir group | 2 | 4 | 3 | 3 | 0 | 0 | 12 | 0.6458 |
| The giant knotweed containing capsule for treating hepatitis B low dose group | 0 | 4 | 7 | 1 | 0 | 0 | 12 | 0.6475 |
| Dosage group in the giant knotweed containing capsule for treating hepatitis B | 0 | 6 | 5 | 1 | 0 | 0 | 12 | 0.6458 |
| The giant knotweed containing capsule for treating hepatitis B high dose group | 0 | 6 | 4 | 1 | 0 | 0 | 12 | 0.6363 |
The result shows, DHBV-DNA (+) group sheldrake hepatic tissue inflammatory changes between between " ±～+++" under the light microscopic, average weighted is 1.0833, significantly inflammation change occurs, the variation of similar chronic persistent hepatitis mainly shows as hepatic tissue portal area inflammation and lobule essence inflammation is obvious, swelling of liver cell is remarkable, the hole cell is active, the portal area bile duct proliferation, and have obvious fatty to become.The duck liver pathology of giant knotweed containing capsule for treating hepatitis B group all makes moderate progress, and inflammation alleviates, and changes to draw close to negative control group, and is wherein comparatively obvious with middle and high dosage group especially.Three dosage groups of acyclovir group situation and giant knotweed containing capsule for treating hepatitis B are similar substantially.
Toxicology test of the present invention:
One, acute toxicity test
Because giant knotweed containing capsule for treating hepatitis B toxicity is lower, can't measure oral LD
50Value, and the unsuitable lumbar injection of this medicine are so carry out the oral mtd test of mice with Cmax and maximum administration volume.
1, acute toxicity test in mice
Get 50 of mices, male and female half and half, divide 5 groups at random, every group is a dosage, and dosage is respectively 1.27g/kg, 1.69g/kg, 2.25g/kg, 3.00g/kg, 4.00g/kg, and water is can't help in fasting before the test, each group is pressed above-mentioned dosage respectively with gastric infusion of 0.4ml/10g after 16 hours, observed 7 days continuously after the administration, record animal ordinary circumstance and death condition are put to death animal and are performed an autopsy on sb after 7 days.
The result: by behind the above-mentioned dosed administration, each treated animal removes administration activity on same day minimizing place, surplus no abnormal reaction, and all appearance is dead for each group in 7 days, sees Table 12, can't measure LD
50Value.Each treated animal main organs of postmortem, the perusal no abnormality seen changes.
The mice LD of table 12 giant knotweed containing capsule for treating hepatitis B
50Measurement result
| Dosage (g/kg) | Log10 dose | Number of animals (only) | Death toll (only) | Mortality rate (%) | LD 50And put doubly and limit |
| 1.27 | 0.104 | 10 | 0 | 0 | Do not measure |
| 1.69 | 0.228 | 10 | 0 | 0 | |
| 2.25 | 0.352 | 10 | 0 | 0 | |
| 3.00 | 0.477 | 10 | 0 | 0 | |
| 4.00 | 0.602 | 10 | 0 | 0 |
2, mtd test
Get mice (body weight 19 ± 1g), rat (respectively 20 of body weight 220 ± 20g) respectively, male and female half and half, elder generation's fasting 16 hours, use the giant knotweed containing capsule for treating hepatitis B suspension of 100mg/ml (Cmax) concentration then, mice was pressed the 0.4ml/10g body weight, rat is pressed 2ml/100g body weight gastric infusion, was administered once successive administration 3 times every 4 hours, observe after the administration animal in 7 days the outward appearance behavior, ingest, feces and death condition and toxic reaction, dead animal was not put to death after 7 days and is performed an autopsy on sb.
Result: after mice, continuous 3 times (in 1 day) administrations of rat difference, observed 7 days continuously, none death of animal, the outward appearance behavior is no abnormal, and activity is freely, do not have excited and the inhibition phenomenon, food ration is respectively mice 6.5 ± 1.3g/ days, rat 32.6 ± 4.8g/ days, and feces is graininess, does not have the phenomenon of having loose bowels, hair color is submissive glossy, and all no abnormal change of main organs perusal is shown in postmortem.The result shows that the mice maximum tolerated dose is 12g/kg (folding crude drug amount 56.04g/kg), 240 times of the daily dose that is equivalent to be grown up, and the rat maximum tolerated dose is 6g/kg, 120 times (clinical adult oral dose on the one is 3g/60kg) of the daily dose that is equivalent to be grown up.
Two, long term toxicity test
160 of SD rats, body weight 109.37 ± 19.56g, Mus age was 6 weeks, was divided into four groups at random, 40 every group, male and female half and half, be blank group (giving equal-volume solvent 1%CMC) and the high, medium and low dosage group of the present invention (being respectively 1g/kg, 2g/kg, 4g/kg), respectively gavage once morning and afternoon every day, and irritating body of stomach long-pending is the 2ml/100g body weight, continuous 6 months, administration finished to observe for 3 weeks again.The result shows whole experimental session, all no abnormal variations of ordinary circumstance such as each treated animal growth, food drink, activity, weightening finish, feces; Administration three months, administration finish, the observation period finishes back three dosage treated animals and there is no the overt toxicity reaction, and blood parameters such as routine blood test, platelet, clotting time and liver, renal function and pathological examination are compared no significant difference (P＞0.05) with matched group.Test dose be equivalent to be grown up 20,40,80 times of clinical consumption, prompting the present invention is used for clinical relatively safety.
Description of drawings
Fig. 1 is DHBV-DNA (-) matched group duck liver pathological section light microscopic photo.
Fig. 2 is a giant knotweed containing capsule for treating hepatitis B low dose group duck liver pathological section light microscopic photo.
Fig. 3 is a dosage group duck liver pathological section light microscopic photo in the giant knotweed containing capsule for treating hepatitis B.
Fig. 4 is a giant knotweed containing capsule for treating hepatitis B high dose group duck liver pathological section light microscopic photo.
Fig. 5 is DHBV-DNA (+) matched group duck liver pathological section light microscopic photo.
Fig. 6 is an acyclovir matched group duck liver pathological section light microscopic photo.
Fig. 7 is DHBV-DNA (-) matched group duck liver pathological section electromicroscopic photograph.
Fig. 8 is a giant knotweed containing capsule for treating hepatitis B low dose group duck liver pathological section electromicroscopic photograph.
Fig. 9 is a dosage group duck liver pathological section electromicroscopic photograph in the giant knotweed containing capsule for treating hepatitis B.
Figure 10 is a giant knotweed containing capsule for treating hepatitis B high dose group duck liver pathological section electromicroscopic photograph.
Figure 11 is DHBV-DNA (+) matched group duck liver pathological section electromicroscopic photograph.
Figure 12 is an acyclovir matched group duck liver pathology slice electromicroscopic photograph.
The specific embodiment
Further the present invention is illustrated below by embodiment, every part amount is all in 100 grams among the listed embodiment.
Embodiment 1
Prescription: 2.66 parts of Rhizoma Polygoni Cuspidati, 1.15 parts of Formica fuscas, 1.33 parts of Radix Isatidis, 1 part of Herba Artemisiae Scopariae, 0.67 part of the Radix Astragali, 0.53 part of Fructus Lycii, 0.67 part of Radix Salviae Miltiorrhizae, 0.07 part of Radix Notoginseng, 0.2 part in Fructus Jujubae, 0.53 part of Fructus Schisandrae Chinensis, 0.53 part of Radix Bupleuri.
Preparation technology: get after Radix Notoginseng washes by prescription, oven dry is pulverized, and squirts with 80% ethanol, and airtight placement 24 hours is taken out, 90 ℃ of oven dry, and micropowder is pulverized, and crosses 200 mesh sieves, gets Radix Notoginseng powder, and is standby; Get the Formica fusca removal of impurity by prescription, clean, decoct with water 3 times, each 2 hours, filter, merging filtrate, it is standby to survey relative density when being concentrated into 50 ℃ and be 1.3 concentrated solution, and powder is beaten in medicinal residues A oven dry, crosses 50 mesh sieves, gets Formica fusca powder, and is standby; Get the Radix Astragali, Fructus Lycii, Fructus Jujubae by prescription and decoct with water 3 times, each 2 hours, filter, it is standby to keep medicinal residues B, and getting and surveying relative density when filtrate merging concentrating 50 ℃ is 1.25 concentrated solution, standby; Get Rhizoma Polygoni Cuspidati, Radix Isatidis, Herba Artemisiae Scopariae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Bupleuri and medicinal residues B by prescription, add 80% alcohol reflux 3 times, each 3 times of amounts, extracted 2 hours, and filtered merge extractive liquid,, reclaim ethanol, survey relative density when being concentrated into 50 ℃ to the concentrated solution that is 1.3 relatively; Above-mentioned each concentrated solution is merged, with gained Radix Notoginseng powder, Formica fusca powder mixing, drying, add appropriate amount of auxiliary materials, break into fine powder, common process is made capsule.
Embodiment 2
Prescription: 1.77 parts of Rhizoma Polygoni Cuspidati, 2.3 parts of Formica fuscas, 2.67 parts of Radix Isatidis, 2 parts of Herba Artemisiae Scopariaes, 0.45 part of the Radix Astragali, 0.35 part of Fructus Lycii, 1.34 parts of Radix Salviae Miltiorrhizaes, 0.05 part of Radix Notoginseng, 0.13 part in Fructus Jujubae, 1.06 parts of Fructus Schisandrae Chinensis, 1.06 parts of Radix Bupleuri.
Preparation technology: get after Radix Notoginseng washes by prescription, oven dry is pulverized, and squirts with 60% ethanol, and airtight placement 36 hours is taken out, 70 ℃ of oven dry, and micropowder is pulverized, and crosses 250 mesh sieves, gets Radix Notoginseng powder, and is standby; Get the Formica fusca removal of impurity by prescription, clean, decoct with water each 3 hours 2 times, filter, merging filtrate, the survey relative density is 1.1 concentrated solution when being concentrated into 30 ℃, concentrated solution sieves to such an extent that fine powder A is standby after subzero 20 ℃ of lyophilizations, powder is beaten in the oven dry of Formica fusca medicinal residues in addition, cross 80 mesh sieves, get Formica fusca powder, standby; Get the Radix Astragali, Fructus Lycii, Fructus Jujubae by prescription and decoct with water 2 times, each 3 hours, filter, it is standby to keep medicinal residues D, and getting and surveying relative density when filtrate merging being concentrated into 30 ℃ is 1.15 concentrated solution, and the concentrated solution spray drying is sieved to such an extent that fine powder B is standby; Get Rhizoma Polygoni Cuspidati, Radix Isatidis, Herba Artemisiae Scopariae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Bupleuri and medicinal residues D by prescription, add 70% alcohol reflux 3 times, each 3 times of amounts, extracted 2 hours, and filtered merge extractive liquid,, survey relative density when being concentrated into 40 ℃ to the concentrated solution that is 1.1 relatively, the concentrated solution spray drying is sieved to such an extent that fine powder C is standby, simultaneously, reclaims ethanol; Fine powder A, B, C are merged, with gained Radix Notoginseng powder, Formica fusca powder mixing, add appropriate amount of auxiliary materials, common process is made capsule.
Embodiment 3
Prescription: 5.32 parts of Rhizoma Polygoni Cuspidati, 0.75 part of Formica fusca, 0.89 part of Radix Isatidis, 0.7 part of Herba Artemisiae Scopariae, 1.34 parts of the Radixs Astragali, 1.06 parts of Fructus Lycii, 0.45 part of Radix Salviae Miltiorrhizae, 0.14 part of Radix Notoginseng, 0.4 part in Fructus Jujubae, 0.35 part of Fructus Schisandrae Chinensis, 0.8 part of Radix Bupleuri.
Preparation technology: get after Radix Notoginseng washes by prescription, oven dry is pulverized, and squirts with 90% ethanol, and airtight placement 12 hours is taken out, and 80 mesh sieves are crossed in 60 ℃ of oven dry, get Radix Notoginseng powder, and are standby; Get the Formica fusca removal of impurity by prescription, clean, decoct with water 2 times, each 3 hours, filter, merging filtrate, it is standby to survey relative density when being concentrated into 40 ℃ and be 1.2 concentrated solution, and powder is beaten in medicinal residues A oven dry, crosses 70 mesh sieves, gets Formica fusca powder, and is standby; Get the Radix Astragali, Fructus Lycii, Fructus Jujubae by prescription and decoct with water 3 times, each 2 hours, filter, it is standby to keep medicinal residues B, and getting and surveying relative density when filtrate merging being concentrated into 40 ℃ is 1.25 concentrated solution, standby; Get Rhizoma Polygoni Cuspidati, Radix Isatidis, Herba Artemisiae Scopariae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Bupleuri and medicinal residues B by prescription, add 60% alcohol reflux 3 times, each 3 times of amounts, extracted 3 hours, and filtered merge extractive liquid,, reclaim ethanol, survey relative density when being concentrated into 40 ℃ to the concentrated solution that is 1.2 relatively; Above-mentioned each concentrated solution is merged, with gained Radix Notoginseng powder, Formica fusca powder mixing, drying, add appropriate amount of auxiliary materials, break into fine powder, common process is made capsule.
Prescription: 3.8 parts of Rhizoma Polygoni Cuspidati, 2.0 parts of Formica fuscas, 1.5 parts of Radix Isatidis, 1.3 parts of Herba Artemisiae Scopariaes, 0.8 part of the Radix Astragali, 1.0 parts of Fructus Lycii, 0.8 part of Radix Salviae Miltiorrhizae, 0.1 part of Radix Notoginseng, 0.18 part in Fructus Jujubae, 0.5 part of Fructus Schisandrae Chinensis, 0.7 part of Radix Bupleuri.
Preparation technology: get after Radix Notoginseng washes by prescription, oven dry is pulverized, and squirts with 70% ethanol, and airtight placement 24 hours is taken out, and 50 mesh sieves are crossed in 70 ℃ of oven dry, get Radix Notoginseng powder, and are standby; Get the Formica fusca removal of impurity by prescription, cleaning decocts with water 3 times, and each 2 hours, filter, merging filtrate, the survey relative density is 1.1 concentrated solution when being concentrated into 60 ℃, powder is beaten in medicinal residues A oven dry, crosses 50 mesh sieves, gets Formica fusca powder, and is standby; Get the Radix Astragali, Fructus Lycii, Fructus Jujubae by prescription and decoct with water 3 times, each 2 hours, filter, it is standby to keep medicinal residues B, and getting and surveying relative density when filtrate merging being concentrated into 60 ℃ is 1.1 concentrated solution, standby; Get Rhizoma Polygoni Cuspidati, Radix Isatidis, Herba Artemisiae Scopariae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Bupleuri and medicinal residues B by prescription, add 80% alcohol reflux 3 times, each 3 times of amounts, extracted 2 hours, and filtered merge extractive liquid,, reclaim ethanol, survey relative density when being concentrated into 60 ℃ to the concentrated solution that is 1.1 relatively; Above-mentioned each concentrated solution is merged, with gained Radix Notoginseng powder, Formica fusca powder mixing, drying, add appropriate amount of auxiliary materials, break into fine powder, common process is made capsule.
Claims (8)
1, a kind of pharmaceutical composition that is used for the treatment of hepatitis B is characterized in that making the raw materials of effective components medicine and consists of by weight:
Rhizoma Polygoni Cuspidati 1.77-5.32 part, Formica fusca 0.75-2.3 part, Radix Isatidis 0.89-2.67 part, Herba Artemisiae Scopariae 0.7-2 part, Radix Astragali 0.45-1.34 part, Fructus Lycii 0.35-1.06 part, Radix Salviae Miltiorrhizae 0.45-1.34 part, Radix Notoginseng 0.05-0.14 part, Fructus Jujubae 0.13-0.4 part, Fructus Schisandrae Chinensis 0.35-1.06 part, Radix Bupleuri 0.35-1.06 part.
2, pharmaceutical composition according to claim 1 is characterized in that each bulk drugs is:
2.66 parts of Rhizoma Polygoni Cuspidati, 1.15 parts of Formica fuscas, 1.33 parts of Radix Isatidis, 1 part of Herba Artemisiae Scopariae, 0.67 part of the Radix Astragali, 0.53 part of Fructus Lycii, 0.67 part of Radix Salviae Miltiorrhizae, 0.07 part of Radix Notoginseng, 0.2 part in Fructus Jujubae, 0.53 part of Fructus Schisandrae Chinensis, 0.53 part of Radix Bupleuri.
3, pharmaceutical composition according to claim 1 and 2 is characterized in that used Formica fusca raw material is a Formica fusca.
4, claim 1 or 2 described preparation of drug combination technologies is characterized in that comprising the following step:
A. get after Radix Notoginseng washes by prescription, oven dry is pulverized, and squirts with 60-90% ethanol, and airtight placements 12-36 hour taken out, 60-100 ℃ of oven dry, the 50-250 mesh sieve, get Radix Notoginseng powder, standby;
B. get the Formica fusca removal of impurity by prescription, clean, decoct with water 1-3 time, 1-3 hour at every turn, filter, merging filtrate, surveying relative density when being concentrated into 30-60 ℃ is the concentrated solution of 1.1-1.4, powder is beaten in the medicinal residues oven dry, crosses the 30-80 mesh sieve, gets Formica fusca powder, and is standby;
C. get the Radix Astragali, Fructus Lycii, Fructus Jujubae by prescription and decoct with water 1-3 time, each 1-3 hour, filter, it is standby to keep medicinal residues, gets to survey relative density when filtrate merging being concentrated into 30-60 ℃ and be the concentrated solution of 1.1-1.4, standby;
D. get Rhizoma Polygoni Cuspidati, Radix Isatidis, Herba Artemisiae Scopariae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Bupleuri and step c gained medicinal residues by prescription, add 60-90% alcohol reflux 1-3 time, each 1-4 doubly measures, extracted 1-3 hour, filter, merge extractive liquid, is surveyed relative density to being the concentrated solution of 1.1-1.4 relatively when being concentrated into 30-60 ℃, simultaneously, reclaim ethanol;
E. above-mentioned steps b, c, each concentrated solution of d gained are merged,, add appropriate amount of auxiliary materials, make capsule with step a, b gained Radix Notoginseng powder, Formica fusca powder mixing, drying.
5, preparation technology according to claim 4, the pulverizing that it is characterized in that Radix Notoginseng among the step a is that micropowder is pulverized, and crosses the 100-250 mesh sieve; Or the room temperature fine powder is pulverized.
6, preparation technology according to claim 4 is characterized in that gained concentrated solution among the step b is become powder in subzero 10 ℃～subzero 20 ℃ of lyophilizations, and is standby.
7, preparation technology according to claim 4 is characterized in that respectively gained concentrated solution among step c, the d being spray dried to fine powder, and is standby.
8, preparation technology according to claim 4 is characterized in that respectively with gained concentrated solution drying among step c, the d, room temperature is ground into fine powder, and is standby.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100650203A CN1299725C (en) | 2004-10-19 | 2004-10-19 | Giant knotweed containing capsule for treating hepatitis B and preparation technique thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100650203A CN1299725C (en) | 2004-10-19 | 2004-10-19 | Giant knotweed containing capsule for treating hepatitis B and preparation technique thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1634329A CN1634329A (en) | 2005-07-06 |
| CN1299725C true CN1299725C (en) | 2007-02-14 |
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| CNB2004100650203A Expired - Fee Related CN1299725C (en) | 2004-10-19 | 2004-10-19 | Giant knotweed containing capsule for treating hepatitis B and preparation technique thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1113779A (en) * | 1994-06-17 | 1995-12-27 | 殷广全 | Anti- hepatitis B preparation |
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2004
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1113779A (en) * | 1994-06-17 | 1995-12-27 | 殷广全 | Anti- hepatitis B preparation |
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Owner name: JIANGSU TIANZHAO PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME OR ADDRESS: TIANZHAO PHARMACEUTICAL IND CO., LTD., HUAI'AN |
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Address after: 210007, Nanjing Garden Street, Jiangsu, 28 Garden Patentee after: JIANGSU TIANZHAO PHARMACEUTICAL Co.,Ltd. Address before: 210007, Nanjing Garden Street, Jiangsu, 28 Garden Patentee before: Huaian Tianzhao Pharmaceutical Co.,Ltd. |
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Owner name: JIANGSU RENSHOU PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: JIANGSU TIANZHAO PHARMACEUTICAL CO., LTD. |
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Address after: 223200 Industrial Zone, Chuzhou District, Jiangsu, Huaian Patentee after: JIANGSU RENSHOU PHARMACEUTICAL Co.,Ltd. Address before: 210007, Nanjing Garden Street, Jiangsu, 28 Garden Patentee before: JIANGSU TIANZHAO PHARMACEUTICAL Co.,Ltd. |
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Address after: 223200 Industrial Zone, Huaian District, Jiangsu, Huaian Patentee after: JIANGSU RONGYU PHARMACEUTICAL Co.,Ltd. Address before: 223200 Industrial Zone, Chuzhou District, Jiangsu, Huaian Patentee before: Jiangsu Renshou Pharmaceutical Co.,Ltd. |
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Granted publication date: 20070214 |