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(11) Patent Number: K.E 511

(45) Date of grant: 08/05/2012
 
(12) PATENT
 
(51) Int.CI.: A61K36/315 (2006.01), A61K36/484(2006.01), A61K36/258 (2006.01), A61K36/804 (2006.01)

(21)    Application Number: FCE/P/2012/001480

(22)    Filing Date: 22/11/2010

(73) Owner:JIN MA BROTHERS TRADE CO. LTD P.O. BOX 29634-00100,NAIROBI.

(72) Inventor:JIN XIAN JUN,P. 0. BOX 29634-00100, NAIROBI.
 
(54)    Title: COMPOSITION FOR TREATING VIRAL INFECTIONS

(57) Abstract:The present invention discloses a composition for treating viral infection. The composition comprises dextrin organic solvent and herbal extracts of Chinese medicinal plant: Radix rehmanniae, Isatis indgotica fort, Glycyhiza uralensis, Radix ginseng and Radix et Rhizoma rhein. The disclosed composition comprises the said extracts in the amounts ranging from 5wt % to 35wt %. The said herbal composition can be formulated in form of a solution, tablet, capsule, powder, candy, gel or emulsion. The herbal composition has a cytotoxic effect on HIV infected cells and in particular, it can be used in treating HIV I AIDS related diseases.
 
DESCRIPTION

TITLE: COMPOSITION FOR TREATING VIRAL INFECTIONS

FIELD OF THE INVENTION

The present invention relates to a therapeutic composition comprising Chinese herbs potentially

beneficial for immune enhancement and treatment of viral infections.


10    BACKGROUND OF THE INVENTION


Acquired immune deficiency syndrome, commonly known as AIDS, is a disease caused by a

retrovirus  called  human  immunodeficiency  virus  (HIV).  First  recognized  in  1981,  this

devastating disease has  spread on an international scale with millions  of people world-wide

15    considered to be HIV - infected. The virus preferentially targets the helper T cells, which play a central role in the fimctioning of the immune system.


In  most  cases  the  virus,  once  incorporated  into  the  helper  T -cell,  remams  dormant  for  an

unspecified period of time. Once activated, however, the virus rapidly destroys the helper T cells,

20    thereby crippling the immune system. It is at this stage that the symptoms of AIDS become evident. These include: enlarged lymphoid glands; unexplained rapid weight loss and diarrhea; fever and night sweats; dermatitis and skin eruptions and lesions; diminished sensitivity to skin

tests;  dermatitis  and skin eruptions  and lesions;  diminished sensitivity to  skin tests;  memory

disorder and behavioral changes; increased incidence of certain cancers. A common tumor of

25    AIDS patients is Kaposi's sarcoma, resulting in purplish marks on the skin; and increased susceptibility to opportunistic infections that rarely infect normal individuals. It is these infections that generally cause the patient's death within a few years of the onset of symptoms.
 

Most patients infected with the HN virus will develop AIDS, reflecting a breakdown in their immune system's capability to ward off foreign and "self-generated antigens. Viral infections are

30    unfmiunately an almost unavoidable challenge to the health of most human and other mammals,
 

and while many viral infections are successfully cleared by the immune system of the infected individual before substantial damage arises, some viral infections lead to severe damage or even death. There are many known antiviral dmgs. However, all or almost all of them suffer :fi:om one or more disadvantages, most notably adverse side-effects, built-up of viral resistance,

5    complicated administration schedules, and often high cost. Therefore, there is a need for simple and effective antiviral compositions that are well tolerated, simple to administer, and relatively inexpensive

Unless expressly stated otherwise, the term "AIDS" should be interpreted herein to include ARC

(AIDS  related  complex).  Additionally, patients who  develop  AIDS  often experience various

10    uncomfortable, and often painful, symptoms. Although some compositions are available that are marketed toward relieving some of the symptoms experienced by AIDS patients, there is still a need for improved and lower cost compositions for the relief of AIDS symptoms.

Numerous treatments for HIV are known in the art, and among other pharmaceutically active

compounds, reverse transcriptase inhibitors have provided significant therapeutic effect to many

15    HIV infected patients. For example, Lamivudine (3TC) or Zidovudine (AZT) have been prescribed for numerous year. However, numerous viral strains have recently emerged with marked resistance against these compounds. To overcome resistance to at least some degree, new nucleoside-type inhibitors may be administered (alone or in combination with other nucleoside-type inhibitors), and exemplary alternative dmgs include Stavudine (d4T), Didanosine (ddl),

20    Combivir (a combination of Lamivudine and Zidovudine), and Trizivir (a combination of 3TC, AZT and Abacavir.


Unfmiunately, development of resistance against one nucleoside-type inhibitor may also be accompanied by resistance (to at least some degree) against another nucleoside-type inhibitor,

25    frequently necessitating a switch to a different class of pharmaceutically active molecules. For example, non-nucleoside-type inhibitors (e.g., Nevirapine, Delavirdine, Efavirenz) are a structurally relatively inhomogeneous group of compounds and are thought to bind in a non-nucleoside pocket of the reverse transcriptases, thereby significantly increasing antiviral efficacy where nucleoside-type inhibitors is employed.
 

30
 

Unfmiunately, antiviral treatment in many HIV- infected patients often only postpones onset of AIDS and/or ARC, in part owing to the potent medication that ultimately weakens the patients' condition. Moreover, patients tend to develop secondary diseases, including Karposi's sarcoma and opportunistic infections. Once AIDS develops, the immune system's capability to ward off

5    foreign antigens diminishes and bacterial, fungal, and viral infections are unfortunately almost always unavoidable. Besides the obvious lack of sufficient immunity (e.g., development of oral

candidiasis, secondary bacterial infection, secondary viral infection, elevated liver enzyme value), AIDS associated symptoms often aggravate a patients subjective condition. Most typically, AIDS associated symptoms include development of and pain associated with

10    peripheral neuropathy and/or Kaposi's sarcoma, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, depression, and insomnia.


Cunently, there is no cure for AIDS and attempts to produce a vaccine have been hindered by the fact that the virus is capable of changing its outer membrane configuration. Although the use

15    of various herbs has been described in related areas, the synergistic combination of the subject invention has never previously been described.


In view of the above, there exists a great need for therapeutic compositions useful in enhancing the immune system.

20

Prior Art Patent Applications

There are several patents on Chinese herbal medicine teaching similar methods of preparations to the present invention but none of them specifically uses an organic solvent to extract therapeutic composition from Radix family. For instance, national Chinese patent Nos. CN1422629 A

25    20030611 filed in China on 6th December, 2001 discloses "Feigan-Luqi powder for treating AIDS"; CN1223125 A 19990721 filed in China on 26th February, 1998 discloses an "Injection for prevention and cure of AIDS and process thereof' using Chinese medicinal material of R. isatis leaf and roots among other plants. Some international patents an AIDS cure have been

filed under the Patent Cooperation Treaty (PCT)  but do not teach the same subject matter being

30    propagated  in  the  present  invention.  For  example,  PCTIUS03/17131  dated  29th  May,  2003
 

teaches about the "Relief of AIDS Symptoms, using a combination of herbal composition drawn from Radix ginseng" and other herbs but in combination with bile and a chelator.


Objects of the Invention

5

It is the objects of the present invention to provide a herbal composition that can treat HIV/AIDS based on synergistic effect.

Yet  another  object  of the  present  invention  is  to  disclose  a  method  of preparing  herbal

10    composition that can treat HIVI AIDS involving systematic steps and using an organic solvent extract.

Another object of the present invention is to formulate herbal composition extracts in specified amounts ranging from 5wt% to 35wt% dissolved in water.

15

Yet another object of the present invention is to provide different forms of therapeutic fonnulation including liquid, capsules, emulsion, candy and powder.


SUMMARY OF INVENTION

20

The present invention is directed to a Chinese herbal composition and method thereof capable of improving, treating and preventing HIV/AIDS in a human subject. Particularly contemplated in this invention is a composition including herbal extracts prepared from plants selected from the group consisting of: Radix rehmanniae, Isatis indgotica fort, Glycyhiza uralensis, Radix ginseng

25    and Radix et Rhizoma rhein. Additionally disclosed is a subject matter of an organic solvent extract which is dextrin. The extracts being contemplated in the present invention are fonnulated in various amounts range from 5 - 35 wt %. Further contemplated in the present invention are various types of fonnulation of the herbal composition in form of tablets, powder, solution, gel candy, emulsion and capsules.
 

Various objects, features, aspects and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention along with the following tables.

s    DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS


The term "patient" of "subject" is used throughout the specification to describe a human to whom treatment with the compositions and methods according to the present invention is provided. The tenn "effective concentration" or "effective amount" is used to describe an

10    amount or concentration of an active agent or composition according to the present invention which is used in the present invention to produce an intended result.

The subject matter of the invention will now be described in terms of its preferred embodiments.


15    The inventor discovered that a combination of any of sever~l herbal compositions (or their constituents) is effective in improving quality of life for HIV/AIDS patients when administered in right quantities. The term "herbal composition" as used herein means the whole or any part of a plant including a root, leaf, stem and the flower that is processed from; Radix rehmanniae, Isatis indgotica fort, Glycyhiza uralensis, Radix ginseng and Radix et Rhizoma rhein including

20    extracts thereof.


The disclosed herbal composition may be obtained through any of the following procedures

a)    Extraction,

b)    Emulsion, or

25    c)  Grinding.


The herb itself may be administered in any kind of form including whole plant. In most cases, herb is administered for instance, acetylsalycillic acid in pill form is called aspirin, but if extracted, is a herb.
 
The inventor discovered that symptoms of a viral infection, especially HN, can be significantly improved by a combination of all the said herbs and administered as an antiviral agent. This reduces the viral serum titer of the virus by at least 20%. It is contemplated that the term "HN related conditions" as used herein refers to intrinsic and extrinsic challenges to an immune

5    system that may develop in an apparent disease while the patient has a detectable HIV serum virus titer. Such challenges include:
i.    Bacterial infections: e.g. Pneumocystic carni, tuberculosis, salmonellosis, mycobacterium avium complex.
11.    Viral infections:    e.g.  Cytomegalovirus,  Herpes  simplex,  Hepatitis,   Varicella
10    zoster, Epstein -barr.   
111.    Fungal infections:    -e.g. Candidiasis, Cryptococcal meningities, histoplasmosis
lV.    Parasite infections:    - e.g.  Toxoplasmosis, Cryptosporidiosis, and

v.    Kaposi Sarcoma.


15    Photochemical Analysis of Herbal Compositions


Several groups of herbal composition are contemplated. Especially preferred are antiviral compotmds found in herbal compositions are extracted from; Radix rehmanniae, Isatis indgotica

fort, Glycyhiza uralensis, Radix ginseng and Radix et Rhizoma rhein.

20

1. Glycyhiza uralensis


The root of this plant has a unique sweet taste that is attributed to potassium I calcium salts of glycynhizic acid. It is traditionally used as a tonic, spasmolytic, expectorant and as a

25    pharmaceutical modulator. The main constituent is a pentacyclic triterpinoid saponin lmown as glycYIThizic acid. Its genin is glycynhetinic acid and the sugar component is made of two

glucoronic acid molecules. A polysaccharide, Glycynhizan UA isolated from the plant is found to have immunological activity. The polysaccharide has a mass of 85.000 and is composed of: L-arabinose. D-galactose. L-rhamnose and D-galacturonic acid. Other constituents include;

30    Licoarylcournarin and flavonoids. The flavonoids, which have a unique yellow colour, include liquiritin and isoliquiritin (which is an aldosse reductase inhibitor that may be effective in
 

preventing Diabetic complications). G. uralensis differs from G. glabra in that it contains as much glycynhizin as other Glycynhiza species. In addition it contains a number of new Olean-type triterpene oligosaccharides called liquiorices saponins.


5    2. Rehmannia glutionisa


Also called Radix rehmannia, the plant is commonly lmown as the Chinese foxglove. Its main pharmacological actions include: antifungal, hypertension, tonic, diuretic, hypoglycemic,

laxative and hypercholesterolemia. The plant is commonly used in clinics in the orient where it's

10    known as a yellow earth. It is used to revitalize the body and helps with Diabetes, constipation, urinary tract infections and hypertension. It is also protective to the liver and helps prevents the depletion of stored glycogen, which makes it beneficial for hyperglycemia. It also has an

antifungal effect and has been used for Candidiasis. It can lower blood glucose and help lower

blood sugar while increasing to the brain. It is a blood tonic and diuretic. Chinese doctors have

15    used it with liquorices for the treatment of hepatitis. Clinical research done on 62 patients with hypertension and who took Rehmania for two weeks showed that their blood pressure and cholesterol had decreased. There was also an improvement in their cerebral blood flow and the ECG.

20    The main side effects associated with Radix rehmannia are mild and include dianhea. Abdominal pain, dizziness, lack of energy and palpitations. These symptoms usually disappear on continued administration of the herb. Its main chemical constituents are amino acids, sugars and minerals (alanine, argentine, Beta- sitosterol, calcium, zinc, rehmanniosides, rehmaglutins, methinine, mmmitol, glucose, and D- galactose).

25

3. Jsatis indigotica Fort (Radix isatidis)


Radix isatidis is obtained from the roots oflsatis tinctoriaL. fmnily cruciferae or Baphicacanthus

cusia. The root is slender and linear  10-20cm long.  0.5-  1.0 em in diameter.  Its epidemis is

30    yellow in colour and has a bitter taste. The root is indicated for seasonal febrile disease, bubonic plague, pumps, sore throat and skin inflammatory diseases.
 



Phannacology actions include the following: it is clinically effective on influenza and experimentally vimstatic on influenza vims PR8. It also contains indicant, an active component that has bacteriostatic activity. It has been shown to be clinically effective on hepatitis A and B.

s    encephalitis and herpes. An important observation is that it has no obvious toxicity. The administration decoction is 15- 30g.


The constituents include: mustard oil glycosides, cardiac glycosides, mucilage and fixed oils.

Mustard oil glycosides include glucosinate compounds like sinigrin and sinalloin. Many of these

10    compounds have an anti-thyroid and goiter- inducing effect in man. Sinigrin is also found in horseradish leaves and in black mustard seeds. Mustard oil glycosides have been shown to significantly increase the non specific resistance of the plants to microorganisms, which dismpt plant cell. In large doses, the root has emetic properties.


15    Herbal Formulations

The herbal compositions described above are used in quantities sufficient to reduce a semm concentration in an amount of at past 20% as demonstration table below:

                           
    S.NO.    CONSTITUENT    QUANTITY    ACTIVITY
                        INWT%   
                           
                           
    1            !sa tis indgotica fort ( Ban lan gen)    15-25    Active
                           
                           
    2            Glycyrrhiza uralensis Fish (Ganchao)    15-25    Active
                           
    3            Radix rehmanniae (Shengdi)    10-35    Active
                           
    4            Radix ginseng (Ren Shen)    10-35    Active
                           
                           
    5            Radix et Rhizomarhei ( Dahuang)    5-15    Active
                           
    6            Dextrin (Additive/ organic solvent    15    Active
                           

20    Table 1: pharmaceutical fonnula of the products  based on Chinese Pharmacopoeia (51/z  edition)


Examples of Most Preferred Method of Preparing Herbal Composition
 

Contemplated compositions may be produced using a variety of methods. However, it IS prefened that the following method be used:

First, the extract is prepared using dextrin as organic solvent. Isatis indgotica fort, Glycyhiza uralensis and Radix et Rhizoma rhein are cleaned and dried. Then they are placed into an

5    extracting tank. Four parts water is added to 1 part herbal composition. The mixture is then boiled for approximately two hours. The liquid is extracted, producing a first extractant and a

first supernatant. The supernatant is poured off. Next, water is again added, now at a ratio of 3 parts water to 1 part supernatant. The mixture is then boiled for approximately 1 hour. The liquid is then extracted for the second time, producing a second extractant and a second supernatant.

10    Then, the first and second extractants are mi:r:ed together, filtered, and concentrated.


Second, the powder is prepared. Radix Ginseng and Radix Rehmanniae are cleaned. They are then dried using a vacuum cold drying process wherein the temperature is approximately 50 degrees Celsius. Next, the dried plant material is ground into a powder.

Third, the extract and the powder are mixed together well. This mixture is fmiher dried using the

15    vacuum cold drying process. After drying, the mixture is ground to a powder and sifted. Finally, dextrin is added to the mixture, and mixed well.

Lastly, the powder is put into capsules, with each capsule containing approximately 0.25 grams of powder.

It should be appreciated that the approximate raw material to end material ratio for the following

20    ingredients: !sa tis indgotica fort, Glycyhiza uralensis and Radix et Rhizoma rhein are 6: 1 while the other ingredients (Radix Ginseng and Radix Rehmanniae) are in a ratio of 1 : 1.

These embodiments are set fmih to aid in the understanding of the subject composition and method of use. However, these preferred embodiments are not to be construed as limiting. A unique natural composition derived from plant extracts has been demonstrated to overcome

25    many of the debilitating symptoms of AIDS. This composition, which is typically orally ingested, represents a breakthrough in the pharmaceutical management of AIDS patients.
 

In summary, infection by the AIDS virus leads ultimately to the destruction of the T. Sub. H cell population. Because of the key regulatory role of this particular cell population, which is essential for the adequate :functioning of the B cells (antibody response) and the cytoxic T cells (cell - mediated response), the entire immune system is rendered quite inactive. The infected

5    individual is then prone to a greater incidence of certain cancers and to infection by other opportunistic microorganisms. It is this latter effect that frequently leads to the death of the infected person. The subject composition, by being able to elevate the T. sub. H cell population, has the potential to prolong the life of AIDS suffers by restoring the T cell profile to normal

levels.

10

Testing results of capsules containing the subject composition show that the product complies with the British Pharmacopoeia specifications during its two year shelf life. The herbal powder is packed into moisture permeable gelatin capsules of preferred size.


15    The subject powder maintains a brown colour and does not lose its character under the cycling effect of night and day. Smell and taste are unchanged during storage.


Pilot studies have demonstrated that the subject composition causes: reversal of gland swelling;

restoration of feeling of well being and associated weight gain; improvement in response to skin

20    hypersensitivity tests; and increase in the circulating concentration of helper T cells (CD 4-Positive cells). Associated with this is an improvement in the CD4/CD8 ratio, with many patients retuming to a normal ratio. It is expected that the optimal time for therapy with the subject

composition should commence in relation to the first appearance of symptoms, or may be used as a prophylactic prior to any indications.

25

Pilot studies on the effectiveness of the subject composition in protecting AIDS patients against depletion of the helper T cells have been conducted in several countries in Africa including Kenya and have been found to be very effective.


30    CLINICAL STUDIES
 

Experiments 1
 

52 patients with HN were tested with ELISA for vims and treated with the said formulation. The observations were as shown in Table 2 below. Patients were chosen according to the following criteria:

Patients tested positive to  HN using ELISA and/or Western Blot,  T-lymphocyte  count was

5    abnmmal (e.g., T4 to T8 ratio was below 1, the number of T4 cells was below 400/mm\ pregnancy was excluded, and all patients agreed to, use treatment with herbal medicine. Total

munber of patients was 52 with 25 men and 27 women. Average age was about 31 years, with the oldest being 35, and the youngest being 25. According to the CDC classification, the 52 cases all had HN associated symptoms (20 diagnosed as HIV or AIDS-related syndromes (ARC) and

10    37 diagnosed as AIDS). Two capsules of the composition as described above were given three

times    a    day    over    a    course    of    3    months.




Treatment was evaluated using ELISA test to indicate the presence of the HIV vims, flow cytometry (FACSCAN) every three months before or after treatment to calculate the rate ofT4

15    to T8, and the quantity ofT4 (in cubic centimeters) as the index to measure the immune function of treated patients. Diagnostic records were prepared, including physical sign or appearance, appearance of the tongue, and pulse condition. The following symbols were used: evident: (+++);general, (++);slight(+); fluctuant±); and negative(-). A numeric score was based on the conversion table 2 shown below:

S.NO.    Numeric Score    Symbol    Description   
               
                                   
                                   
1                    6        +++    Evident   
                                   
2                    4        ++    General   
                                   
3                    2        +    Slight   
                            -       
4                    1        +    Fluctuant   
                                   
5                    0        -    -ve   
                                   
                                   


Table 2: Numerical Scores for Results/Efficacy ofthe Herbal Composition
 


Results Using the Composition
 

The weight of patients in the treatment class remained relatively stable, with a fluctuation of approximately 2 kg. Clinical symptoms generally improved and especially included tiredness, fever, cough, shortness of breath, chest aches, diarrhea, anorexia, night sweat, and lymphadenectasis. All the patients appeared to be in good condition and reported an average

5    score in improvement of symptoms of 4.6.


The ratio of T4 to T8 of the 52 patients before and after the treatment shows 17 patients who have increased ratios, while the other 35 show no evident change. The numbers ofT4 cells of the 17 patients increased. According to the study, the immune function is divided into three conditions after treatment such improvement, no change and worse, In this study, 17 cases

10    improved, 17 cases showed no change and 18 cases became worse. Thus, while contemplated compositions have at least some effect on the physiology and/or immune system, symptomatic relief was significantly improved.

Table 3 below demonstrates the effectiveness of the therapeutic composition on a sample of 52 adult patients' indication a reasonable degree of effectiveness:

S.NO.    INEFFECTIVE        EFFECTIVE    PARTIALLY    NO    TOTAL   
                           
                                    EFFECTIVE    EFFECT       
                                                   
No.    3                        6    18    24        51.92   
                                               
%age    5.76%                11.53%    34.62%    48.08%        100%   
                                                                                           
15

Table 3: Effectiveness of the Herbal Composition


The contemplated composition may be administered in numerous forms and dosages, and most typically as oral composition. For example, where the composition is in powdered fonn, a capsule, dragee, or tablet may be used. On the other hand, where the composition is in liquid

20    form, the composition may be administered as a syrup, elixir, etc. Furthermore, all parenteral forms of administration are also deemed suitable.

Upon reading the subject application, various alternative embodiments will become obvious to those skilled in the art. These embodiments are to be considered within the scope and spirit of the subject invention, which is only to be limited by the claims which follow and their equivalents.
 
Industrial Application


The disclosed herbal composition can be applied and produced in an industry. Exemplary extract

5    can be done in an aqueous environment prepared from a combination of cleared and dried Radix rehmanniae, Isatis indgotica fort, Glycyhiza uralensis, Radix ginseng and Radix et Rhizoma rhein as in table 1 above.

Therefore, fmiher contemplated methods include methods of marketing in which in one step

contemplated  composition  is  advertised,  offered  for  sale,  or  otherwise  provided  (e.g.,  sold,

10    mailed, etc). In another step, information is provided that the composition provides symptomatic relief to a patient diagnosed with a disease (and especially AIDS/ARC). In such infonnation, reduction of peripheral neuropathy, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, oral candidiasis, secondary bacterial infection, secondary viral infection, elevated liver enzyme values depression, and/or insomnia is particularly contemplated.

15
 

TITLE: COMPOSITION FOR TREATING VIRAL INFECTIONS


ABSTRACT


The  present  invention  discloses  a  composition  for  treating  viral  infection.  The

composition comprises dextrin organic solvent and herbal extracts of Chinese medicinal

plant: Radix rehnwnniae, Isatis indgotica fort,  Glycyhiza uralensis, Radix ginseng and

Radix et Rhizoma rhein. The disclosed composition comprises the said extracts in the amounts ranging from 5wt % to 35wt %. The said herbal composition can be formulated in form of a solution, tablet, capsule, powder, candy, gel or emulsion. The herbal composition has a cytotoxic effect on HIV infected cells and in particular, it can be used in treating HIV/AIDS related diseases.
 
CLAIMS

We claim:

1.    A herbal composition having a cytotoxic effect on HIV infected cells, comprising:  a)  an

5    organic solvent extract of Isatis indgotica fort; b) an organic solvent extract of Glyrryhiza uralensis; c) an organic solvent extract of Radix ginseng. ; d) an organic solvent extract of Radix Rehmanniae; d) an organic solvent extract of Radix et Rhizoma Rhei.

2. The herbal composition of claim 1, wherein the organic solvent is Dextrin.

10

3.    The herbal composition of claim 1, wherein the amounts of the extracts of a), b), c), d) and e) range from 15-25 wt %, 15-25wt %, 10-35 wt%, 10-35wt% and 5-15wt%, respectively.


4.    The herbal composition of claim 1, which can be further formulated into preparations in the

15    form of a solution, tablet, capsule, powder, candy, gel or emulsion.

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