CN104013742A - Traditional Chinese medicine oral preparation for treating systemic lupus erythematosus - Google Patents

Traditional Chinese medicine oral preparation for treating systemic lupus erythematosus Download PDF

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Publication number
CN104013742A
CN104013742A CN201410308419.3A CN201410308419A CN104013742A CN 104013742 A CN104013742 A CN 104013742A CN 201410308419 A CN201410308419 A CN 201410308419A CN 104013742 A CN104013742 A CN 104013742A
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weight portion
lupus erythematosus
systemic lupus
oral preparation
semen
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CN201410308419.3A
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刘学键
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Abstract

The invention discloses a traditional Chinese medicine oral preparation for treating systemic lupus erythematosus. The composition is prepared from the following Chinese medicinal materials in parts by weight: 23-30 parts of kelp, 26-35 parts of verbena, 50-80 parts of lotus leaves, 8-13 parts of zaocys dhumnade, 40-53 parts of semen lepidii and 26-35 parts of semen plantaginis. The traditional Chinese medicine preparation disclosed by the invention has a certain immune inhibition effect, and can partially replace an immunosuppressive agent, thereby achieving the targets of improving the symptoms of the systemic lupus erythematosus and controlling the disease.

Description

A kind of oral preparation of Chinese traditional medicinal of systemic lupus erythematosus
Technical field
The invention belongs to technical field of Chinese medicines, relate in particular to a kind of oral preparation of Chinese traditional medicinal of systemic lupus erythematosus.
Background technology
Systemic lupus erythematosus (sle) (systemic lupus erythematosus; SLE) be a kind of diffusivity, general autoimmune disease, mainly involve mucocutaneous, skeletal muscle, kidney and central nervous system, also may involve multiple organs and the systems such as lung, heart, blood simultaneously, show various clinical symptoms, its cause of disease and pathogeny are still not clear.Because of its immunity damage widely, the many internal organs in the each position of whole body all can be got involved, and clinical manifestation is varied.
At present, there is no the way of radical cure for this disease, and the state of an illness can steadily worsen suddenly in the several months treatment in the situation that.The Main Means of this disease of western medical treatment is hormone and immunosuppressant, but hormone has sizable side effect, and long-term a large amount of use hormone is unfavorable for patient's physical and mental health, and moreover, subtracting of hormone stops very likely causing aggravation.Because systemic lupus erythematosus (sle) main causes of death are Lupus activity and infection, therefore how more effectively to control Lupus activity and protect from infection, explore and reasonably patient is injured to minimum therapeutic scheme, significant to further raising survival and the quality of making the life better.Chinese medicine is in the untoward reaction that improves and alleviate hormone, immunosuppressant, and the immeasurable curative effect that alternative hormone, immunosuppressant treatment are brought into play on is also more and more paid attention to by medical circle.Therefore,, by researching and developing a kind of evident in efficacy, safe Chinese patent medicine, this seems particularly important.
Summary of the invention
In order to make up the deficiencies in the prior art, the misery of mitigation system patients with SLE, the invention provides a kind of oral preparation of Chinese traditional medicinal of systemic lupus erythematosus, and it is evident in efficacy, safe and reliable, has wide potential applicability in clinical practice.
The present invention does further further investigation to obtain on the basis of folk remedy, and concrete technical scheme is as follows:
An oral preparation of Chinese traditional medicinal for systemic lupus erythematosus, is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Thallus Laminariae (Thallus Eckloniae) 23-30 weight portion, Herba Verbenae 26-35 weight portion, Folium Nelumbinis 50-80 weight portion, Zaocys 8-13 weight portion, Semen Lepidii (Semen Descurainiae) 40-53 weight portion, Semen Plantaginis 26-35 weight portion.
Preferably, the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus as above, it is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Thallus Laminariae (Thallus Eckloniae) 25-28 weight portion, Herba Verbenae 29-32 weight portion, Folium Nelumbinis 58-63 weight portion, Zaocys 9-11 weight portion, Semen Lepidii (Semen Descurainiae) 45-47 weight portion, Semen Plantaginis 29-32 weight portion.
In most preferred embodiment of the present invention, oral preparation of Chinese traditional medicinal as above is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Thallus Laminariae (Thallus Eckloniae) 26 weight portions, Herba Verbenae 30 weight portions, Folium Nelumbinis 60 weight portions, Zaocys 10 weight portions, Semen Lepidii (Semen Descurainiae) 46 weight portions, Semen Plantaginis 30 weight portions.
It should be noted that, the traditional Chinese medicinal material raw materials adopting in the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus of the present invention has following source: Thallus Laminariae (Thallus Eckloniae) is selected the dry thallus of Alariaceae plant Thallus Laminariae (Thallus Eckloniae) (goose palm dish) Ecklonia kurome Okam..Herba Verbenae is selected the dry aerial parts of Verbenaceae Herba Verbenae Verbena officinalis L..Folium Nelumbinis is selected the dried leaves of nymphaeaceae plant lotus Nelumbo nucifera Gaertn..Zaocys is selected the dry body of Colubridae animal Zaocys Zaocys dhumnades (Cantor).Semen Lepidii (Semen Descurainiae) is selected the dry mature seed of crucifer Lepidium sativum L. Lepidium apetalum Willd..Semen Plantaginis is selected the dry mature seed of Plantaginaceae plant Herba Plantaginis Plantago asiatica L..
Further preferably, the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus as above is oral formulations.
Again further preferably, the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus as above is oral liquid, granule, Tablet and Capsula agent.In the above-mentioned oral formulations process of preparation, can adopt conventional pharmaceutic adjuvant and the technique in pharmaceutics field, pharmaceutic adjuvant wherein comprises filler, disintegrating agent, binding agent, lubricant.
Chinese medicine preparation of the present invention has the effect of certain Immunosuppression, can partly substitute immunosuppressant, reaches the object of improving symptom, controlling the state of an illness.During by this Chinese medicine preparation commissural arch phosphamide systemic lupus erythematosus, the effect can reinforced immunological suppressing, effectively controls the state of an illness, and toxic and side effects that can antagonism cyclophosphamide, reduces complication, i.e. efficacy enhancing and toxicity reducing.Meanwhile, the dependence that Chinese medicine preparation associating treated with cyclophosphamide pulse of the present invention can also alleviate patient's exogenous hormone, the consumption of minimizing hormone, removes smoothly and subtracts hormone, improves the quality of living.
Detailed description of the invention
Be Preparation Example and the clinical practice example of oral preparation of Chinese traditional medicinal of the present invention below, the present invention is described further and explanation.
The preparation of embodiment 1 Chinese medicine granules
Take Thallus Laminariae (Thallus Eckloniae) 3.0kg, Herba Verbenae 3.5kg, Folium Nelumbinis 7.0kg, Zaocys 1.3kg, Semen Lepidii (Semen Descurainiae) 5.0kg and Semen Plantaginis 3.5kg merge, decoct with water twice, add water for the first time as 10 times of amounts of medical material weight, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, 0.08MPa, while being evaporated to 70 DEG C at 70 DEG C, relative density is 1.15, adding 95% (v/v) ethanol makes to reach 85% (v/v) containing alcohol amount, stir, hold over night, filter, filtrate is at 0.08MPa, the extractum that when concentrating under reduced pressure becomes to 65 DEG C under 65 DEG C of conditions, relative density is 1.15g/mL, extractum is put in stainless steel disc, vacuum drying (60 DEG C following) becomes dried cream powder broken, add cane sugar powder, make 40 order granule powder packaging, every bag 20g.
The preparation of embodiment 2 Chinese medicine oral liquid
Take Thallus Laminariae (Thallus Eckloniae) 0.26kg, Herba Verbenae 0.30kg, Folium Nelumbinis 0.60kg, Zaocys 0.10kg, Semen Lepidii (Semen Descurainiae) 0.46kg and Semen Plantaginis 0.30kg merge, decoct with water twice, add water for the first time as 10 times of amounts of medical material weight, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, 0.08MPa, while being evaporated to 70 DEG C at 70 DEG C, relative density is 1.15, adding 95% (v/v) ethanol makes to reach 75% (v/v) containing alcohol amount, stir, hold over night, filter, filtrate is at 0.08MPa, when under 65 DEG C of conditions, concentrating under reduced pressure becomes to 65 DEG C, relative density is 1.15g/mL, add suitable quantity of water and sucrose is mixed with oral liquid.
The preparation of embodiment 3 Chinese medicine capsules
Take Thallus Laminariae (Thallus Eckloniae) 2.3kg, Herba Verbenae 3.2kg, Folium Nelumbinis 8.0kg, Zaocys 0.8kg, Semen Lepidii (Semen Descurainiae) 5.3kg and Semen Plantaginis 3.2kg merge, decoct with water twice, add water for the first time as 10 times of amounts of medical material weight, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, 0.08MPa, while being evaporated to 70 DEG C at 70 DEG C, relative density is 1.15, adding 95% (v/v) ethanol makes to reach 85% (v/v) containing alcohol amount, stir, hold over night, filter, filtrate is at 0.08MPa, the extractum that when concentrating under reduced pressure becomes to 65 DEG C under 65 DEG C of conditions, relative density is 1.15g/mL, extractum is put in stainless steel disc, vacuum drying (60 DEG C following) becomes dried cream powder broken, add cane sugar powder and dextrin, dry method is made 40 order granules, add appropriate Pulvis Talci, mix, filled capsules shell, packaging.
The preparation of embodiment 4 Chinese medicinal tablets
Take Thallus Laminariae (Thallus Eckloniae) 2.8kg, Herba Verbenae 2.6kg, Folium Nelumbinis 5.0kg, Zaocys 1.1kg, Semen Lepidii (Semen Descurainiae) 4.0kg and Semen Plantaginis 2.6kg merge, decoct with water twice, add water for the first time as 10 times of amounts of medical material weight, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, 0.08MPa, while being evaporated to 70 DEG C at 70 DEG C, relative density is 1.15, adding 95% (v/v) ethanol makes to reach 85% (v/v) containing alcohol amount, stir, hold over night, filter, filtrate is at 0.08MPa, the extractum that when concentrating under reduced pressure becomes to 65 DEG C under 65 DEG C of conditions, relative density is 1.15g/mL, extractum is put in stainless steel disc, vacuum drying (60 DEG C following) becomes dried cream powder broken, add starch, carboxymethyl starch sodium, dry method is made 40 order granules, add appropriate Pulvis Talci, direct compression, packaging.
The Clinical Treatment Test of embodiment 5 Chinese medicinal formulaes to Patients with SLE
Patients with SLE 53 examples, male 4 examples, female's 49 examples, minimum 26 years old of age, maximum 63 years old, average (38.7 ± 12.5) year.The primary symptom of clinical manifestation: erythema, aphtha, arthralgia, red tongue, Tai Bai or Huang, or deep red tongue, few tongue; Double disease: xerostomia, alopecia, brothers' ecchymosis, heating, the long-pending drink of stagnant heat, constipation with dry stool, edema.All cases are divided into test group (27 example) and matched group (26 example) at random, and two groups of ages, sex ratio, compared with no significant difference, have comparability.
Matched group patient selects cyclophosphamide (Hengrui Medicine Co., Ltd., Jiangsu Prov.'s production) treatment, and application quantity is 0.8~1.0g monthly, monthly divides 1~2 intravenous drip, continuous application half a year.Test group adds and uses Chinese medicinal formulae of the present invention on the medication basis of matched group, consists of: Thallus Laminariae (Thallus Eckloniae) 26g, Herba Verbenae 30g, Folium Nelumbinis 60g, Zaocys 10g, Semen Lepidii (Semen Descurainiae) 46g, Semen Plantaginis 30g.1 dose of every day, conventional water decocts into 400mL decoction, each 200mL, and every day is sooner or later respectively once oral, takes half a year continuously.
Treatment fore-and-aft observing also records clinical primary symptom and double disease, and treatment finishes rear detection urine protein, and determines clinical efficacy by following criterion:
Alleviate: treatment primary symptom in 3~April disappears the disease disappearance of holding concurrently completely; Take medicine continuously and can keep alleviating, it is completely normal that test rating is tending towards, and lupus nephritis person albuminuria disappears.
Effective: treatment primary symptom in 3~April takes a turn for the better, the disease of holding concurrently is most of to be disappeared; The stable disease of taking medicine continuously, lupus nephritis person albuminuria is reduced to "+" or turns out cloudy.
Effective: treatment primary symptom in 3~April, the disease of holding concurrently are taken a turn for the better to some extent; Lupus nephritis person albuminuria reduces.
Invalid: though treatment June above primary symptom, hold concurrently disease make moderate progress unstable, accidental activity indication, and primary symptom, hold concurrently disease all without improver, albuminuria without change even increase the weight of.
Table 1 liang group patient clinical symptom variation situation (example)
Table 2 liang group patient's Clinical efficacy comparison [example]
24h albuminuria Quantitative Comparison (g/24h) before and after table 3 liang group patient treatment
With this group before treatment, p< 0.05; ★ ★ p< 0.01; With matched group comparison, p< 0.05, ▼ ▼ p< 0.01.
Result of the test by table 2 can find out, test group obvious effective rate is higher than western medicine group, Chinese medicinal formulae associating treated with cyclophosphamide pulse better efficacy of the present invention is described and can reduces the untoward reaction of medicine.Result of the test by table 3 can be found out, compares western medicine group, test group 24h albuminuria quantitatively lower ( p< 0.01), illustrate that Chinese medicinal formulae of the present invention has the effect of certain Immunosuppression.

Claims (6)

1. the oral preparation of Chinese traditional medicinal of a systemic lupus erythematosus, it is characterized in that, described oral preparation of Chinese traditional medicinal is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Thallus Laminariae (Thallus Eckloniae) 23-30 weight portion, Herba Verbenae 26-35 weight portion, Folium Nelumbinis 50-80 weight portion, Zaocys 8-13 weight portion, Semen Lepidii (Semen Descurainiae) 40-53 weight portion, Semen Plantaginis 26-35 weight portion.
2. the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus according to claim 1, it is characterized in that, described oral preparation of Chinese traditional medicinal is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Thallus Laminariae (Thallus Eckloniae) 25-28 weight portion, Herba Verbenae 29-32 weight portion, Folium Nelumbinis 58-63 weight portion, Zaocys 9-11 weight portion, Semen Lepidii (Semen Descurainiae) 45-47 weight portion, Semen Plantaginis 29-32 weight portion.
3. the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus according to claim 2, it is characterized in that, described oral preparation of Chinese traditional medicinal is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Thallus Laminariae (Thallus Eckloniae) 26 weight portions, Herba Verbenae 30 weight portions, Folium Nelumbinis 60 weight portions, Zaocys 10 weight portions, Semen Lepidii (Semen Descurainiae) 46 weight portions, Semen Plantaginis 30 weight portions.
4. according to the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus described in claim 1-3 any one, it is characterized in that, described oral preparation of Chinese traditional medicinal is oral formulations.
5. the oral preparation of Chinese traditional medicinal of systemic lupus erythematosus according to claim 4, is characterized in that, described oral formulations is oral liquid, granule, tablet or capsule.
6. the application of traditional Chinese medicinal material raw materials compositions in the medicine of preparing systemic lupus erythematosus described in claim 1-3 any one.
CN201410308419.3A 2014-07-01 2014-07-01 Traditional Chinese medicine oral preparation for treating systemic lupus erythematosus Pending CN104013742A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102225153A (en) * 2011-06-10 2011-10-26 南京中医药大学 Traditional Chinese medicine composition for treating systemic lupus erythematosus and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102225153A (en) * 2011-06-10 2011-10-26 南京中医药大学 Traditional Chinese medicine composition for treating systemic lupus erythematosus and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
刘真: ""经方治疗系统性红斑狼疮的临床研究"", 《中国优秀硕士学位论文全文数据库医药卫生科技辑》 *
周德生等: "《中医验方全书珍藏超值版》", 31 August 2013 *

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Inventor after: Chen Xiaoli

Inventor before: Liu Xuejian

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Application publication date: 20140903