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Title:  Pharmaceutical composition against type I allergy and the preparation thereof

United States Patent:  6,641,846

Issued:  November 4, 2003

Inventors:  Zhang; Zuoguang (Beijing, CN); Fu; Yanling (Beijing, CN)

Assignee:  Tianjin Yanling Health Food Co. (Beijing, CN)

Appl. No.:  761055

Filed:  January 16, 2001

Abstract

The invention is related to a pharmaceutical composition with its main effects against Type I Allergy and the process thereof. The composition mainly comprises the following raw materials by weight ratio: 30.about.60 parts of Fructus Jujubae, 12.about.55 parts of Radix Astragali, 8.about.15 parts of Radix glycyrrhizae, 6.about.12 parts of Ramulus cinnamomi, 6.about.12 parts of Ginger and 4.about.8 parts of Green tea.

SUMMARY OF THE INVENTION

According to the present invention, the said medicament is prepared with purely natural herbs as its raw materials that can be taken as medicaments or as food. Such medicament has no side effects and can regulate immune functions of human body, harmonize allergic constitution of patients, inhibit and prevent human Allergy.

The embodiment of this invented medicament is based on the knowledge and pathogenesis of incidence of allergic diseases in traditional Chinese medicine in combination of the research achievements in the modern medicine and pharmacology. By use of pharmacologically acceptable active herb with function of immune regulation, the anti-allergic effects of the traditional Chinese herb medicines are strengthened and optimized, especially, this immune regulator not only can be taken for a long time to prevent incidence of allergic diseases through correcting allergic constitution of patient, but also can cure symptoms of allergic diseases effectively by their incidence.

In order to achieve the object of this invention, the following technical embodiments are taken for the present invention:

As mentioned above, this invention refers especially to a pharmaceutical composition with its main effects against Type I Allergy. In the invention, common jujube fruit (Fructus Jujubae) is used in fresh or dried one. It is a fruit of Ziziphus jujuba Mill. Membranous milk vetch root (Radix Astragali), a root of herb called Astragalus membranaceus (Fisch.) Bge. or Astragalus membranaceus (Fisch.) Bge. Var. mongholicus Bge. Hsiao and ural Licorice root (Radix glycyrrhizae), a root of herb called Glycyrrhiza uralensis Fisch., Cassiabarktree branchlet (Ramulus cinnamomi), Ginger and Green tea are also used as raw material for the herb medicament.

A herb medicament or pharmaceutical composition is prepared as the raw materials in accordance with the following weight ratio:

              Fructus Jujubae            30 .about.  60 parts
              Radix Astragali            12 .about. 55 parts
              Radix glycyrrhizae          8 .about. 15 parts
              Ramulus cinnamomi           6 .about. 12 parts
              Ginger                      6 .about. 12 parts
              Green tea                   4 .about. 8 parts

The preferred prescription of this pharmaceutical composition is prepared with the raw materials in accordance with the following weight ratio:

              Fructus Jujubae             35 .about. 55 parts
              Radix Astragali            15 .about. 50 parts
              Radix glycyrrhizae          8 .about. 12 parts
              Ramulus cinnamomi           6 .about. 10 parts
              Ginger                      6 .about. 10 parts
              Green tea                   5 .about. 7 parts

The most preferred prescription of this pharmaceutical composition is prepared as raw materials in accordance with the following weight ratio:

                Fructus Jujubae             50 parts
                Radix Astragali            30 parts
                Radix glycyrrhizae         10 parts
                Ramulus cinnamomi           8 parts
                Ginger                      8 parts
                Green tea                   6 parts

In the above-mentioned pharmaceutical composition with its main effects against Type I Allergy, optionally, common peony root, the root of herbaceous peony (Radix Paeoniae Alba)(10 20 parts) and/or Baikal skullcap root (Radix scutellariae) (10-20 parts) can also be added to strengthen its anti-allergic effects further.

The pharmaceutical composition mentioned in this invention contains pharmaceutically acceptable additives. And the mentioned medicament can be made to form any type of drug described in pharmacy, preferably drug in form of powder or tablet.

This invention is also related to an extract of the pharmaceutical composition with its main effects against Type I Allergy. The said extract is obtained with the following steps:

1. 30.about.60 weight parts of Fructus Jujubae are putted into a warm alcohol solution and keeping its pH value between 3.6.about.3.8. After it is extracted and filtered, the extract solution is obtained. Then, the said extract solution is absorbed several times with macro porous resin for eliminating sugar. After concentrating and drying in vacuum, the dried extract of Fructus Jujubae is obtained.

2. 6.about.12 weight parts of ginger are squeezed and filtered with a plate frame filter. The extracted liquid of ginger is obtained.

3. 4.about.8 weight parts of green tea are infiltrated into boiled water and filter them with a plate frame filter. The extracted liquid of green tea is obtained.

4. 15.about.55 weight parts of Ramulus cinnamomi, 8.about.15 weight parts of Radix glycyrrhizae, 6-12 parts of Ramulus cinnamomi are mixed together and decocted. The volatile oil of mixture is collected. After mixture is filtered, the mixed extracted liquid is obtained.

5. The said mixed extracted liquid obtained in step 4 is mixed and concentrated with the extracted liquid of green tea. Then, above extracted liquid of ginger is added and concentrated continuously until it reaches the relative density of 1.1.about.1.4/80.about.85oC. Then, one thick paste is obtained and followed by vacuuming it into a dry extract.

6. The dry extract obtained in step 5 is grinded and mixed with the dry extract of Fructus Jujubae obtained in step 1. The extract of this invention is obtained.

In the above-mentioned extraction method, preferably the extract is prepared with the materials in accordance with the following weight ratio:

              Fructus Jujubae             35 .about. 55 parts
              Radix Astragali            15 .about. 50 parts
              Radix glycyrrhizae          8 .about. 12 parts
              Ramulus cinnamomi           6 .about. 10 parts
              Ginger                      6 .about. 10 parts
              Green tea                   5 .about. 7 parts

In addition, in the above-mentioned extraction method, it is most preferable that the extractive is prepared with the materials in accordance with the following weight ratio:

                Fructus Jujubae             50 parts
                Radix Astragali            30 parts
                Radix glycyrrhizae         10 parts
                Ramulus cinnamomi           8 parts
                Ginger                      8 parts
                Green tea                   6 parts

In the above-mentioned extraction method, optionally, common peony root, the root of herbaceous peony (Radix Paeoniae Alba) (10.about.20 parts) and/or Baikal skullcap root (Radix scutellariae) (10.about.20 parts) can also be added to strengthen its anti-allergic effects further.

The above-mentioned extract can be processed into any form of a drug described in the pharmacy. In the above-mentioned extract, it can contain the pharmaceutically acceptable additives.

In addition, this invention refers also to one method for a pharmaceutical composition with its main effects against Type I Allergy. This method comprises the following steps:

1. 30.about.60 weight parts of Fructus Jujubae are putted into a warm alcohol solution and keeping its pH value between 3.6.about.3.8. After it is extracted and filtered, the extract solution is obtained. Then, the said extract solution is absorbed several times with macro porous resin for eliminating sugar. After concentrating and drying in vacuum, the dried extract of Fructus Jujubae is obtained.

2. 6.about.12 weight parts of ginger are squeezed and filtered with a plate frame filter. The extracted liquid of ginger is obtained.

3. 4.about.8 weight parts of green tea are infiltrated into boiled water and filter them with a plate frame filter. The extracted liquid of green tea is obtained.

4. 15.about.55 weight parts of Ramulus cinnamomi, 8.about.15 weight parts of Radix glycyrrhizae, 6.about.12 parts of Ramulus cinnamomi are mixed together and decocted. The volatile oil of mixture is collected. After mixture is filtered, the mixed extracted liquid is obtained.

5. The said mixed extracted liquid obtained in step 4 is mixed and concentrated with the extracted liquid of green tea. Then, above extracted liquid of ginger is added and concentrated continuously until it reaches the relative density of 1.1.about.1.4/80.about.85oC. Then, one thick paste is obtained and followed by vacuuming it into a dry extract.

6. The dry extract obtained in step 5 is grinded and mixed with the dry extract of Fructus Jujubae obtained in step 1. The extract of this invention is obtained.

In the above-mentioned method, Furthermore, optionally, common peony root, the root of herbaceous peony (Radix Paeoniae Alba)(10.about.20 parts) and/or Baikal skullcap root (Radix scutellariae) (10.about.20 parts) can also be added in step 4 to strengthen its anti-allergic effects further.

According to the invention, the said pharmaceutical composition and the extract can also be used to produce health food or food additives.

The composition or extract of this invention have the following features and advantages:

As an anti-allergic immune regulator, this pharmaceutical composition or extract have the preventive and curing dual functions against Type I Allergy without toxic side effects. When it is taken over a long period of time, it can correct allergic constitution and strengthen human immunity.

1. All the raw materials selected for the preparation of this pharmaceutical composition or extract of this invention are the natural edible plants that can be taken not only as food, but also as medicines. All the parts of the components comply with the "Regulations of Health Food Management" and the "Law of Drug" of the People's Republic of China. And it does not have toxic side effects. Man can take it over a long period of time.

2. With this pharmaceutical composition or extract of this invention, the present common method that a medicament is taken for treatment only after allergic diseases occur is changed. It can regulate human camp/cGMP and IgE, improve human immunity and correct allergic physique to inhibit and prevent effectively from the incidence of allergic diseases.

3. This pharmaceutical composition or extract of this invention have dual effects, that is, anti-histamine and inhibitors of allergic reaction mediums.

4. Besides the preventive and resistant functions of Type I Allergy, This pharmaceutical composition or extract of this invention can also increase immunity of physiques and strengthen human resistance to diseases.

5. For this pharmaceutical composition or extract of this invention, it is not only examined with human and animal tests, but also proven that it has prophylactic and anti-allergic effects. And the structure, contents and mechanism of its main function factors (cAMP of Fructus Jujubae, glycoside of Radix scutellariae, licorice acid) are also clarified.

6. This pharmaceutical composition or extract of this invention need not to be decocted. It is easy to transport and take it. They comply with the "Regulations of Health Law of the People's Republic of China".

7. This pharmaceutical composition or extract of this invention has potential values to develop series of products (health food and medicaments).

The present pharmaceutical composition or extract of this invention can be applied in the following area.

1. This product can be used as health food to regulate immune functions, correcting human allergic physique, inhibiting and preventing allergic reactions.

2. This product can be used as a medicament to cure Type I Allergy.

3. On the basis of this product, the series of anti-allergic medicaments can be explored and developed to cure allergic rhinitis, allergic asthma and allergic dermatitis and the like.

Claim 1 of 19 Claims

We claim:

1. A pharmaceutical composition for treating Type I Allergy, mainly comprising the following raw materials by weight ratio:

              Fructus Jujubae           30 .about. 60 parts,
              Radix Astragali          12 .about. 55 parts,
              Radix glycyrrhizae        8 .about. 15 parts,
              Ramulus cinnamomi         6 .about. 12 parts,
              Ginger                    6 .about. 12 parts, and
              Green tea                 4 .about. 8 parts.




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